From owner-sci-resources@net.bio.net Wed Mar 02 22:00:00 1994 Path: biosci!biosci!not-for-mail From: Marvin.Stodolsky@mailgw.er.doe.gov Newsgroups: bionet.announce,bionet.sci-resources Subject: DOE Human Genome Program Announcement - Tech. Advances Date: 3 Mar 1994 10:44:00 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 151 Sender: kristoff@net.bio.net Approved: bionews-moderator@net.bio.net Distribution: bionet Message-ID: NNTP-Posting-Host: net.bio.net Xref: biosci bionet.announce:989 bionet.sci-resources:928 The US Department of Energy's 1994 competition for Research Financial Assistance within the Human Genome Program was announced in the Federal Register, 02/18/94 Vol. 59, No. 034, pages 30-32, Program Notices 94-12: Human Genome Program-Technological Advances. The full texts can also be accessed electronically through: anonymous ftp TO oerhp01.er.doe.gov for /genome/9412.txt anonymous ftp TO fedix.fie.com for files /DOE/DOENOTE.TXT or /DOE/DOENOTE.EXE. gopher TO fedix.fie.com telnet TO fedix.fie.com DOENOTE.EXE is the compressed version of DOENOTE.TXT which expands itself on DOS based systems. DOENOTE also contains several other DOE non-genome program notices. Some background information relevant to the Genome program is available by gopher at GOPHER.GDB.ORG ================================================================= Preapplications are due by April 15, 1994 and formal applications by July 14, 1994. Please note that the following addresses are ONLY for the short preapplications: US Mail Express Delivery Services ----------------- ------------------------- David A. Smith David A. Smith attn. Notice 94-12 attn. Notice 94-12 US Dept. of Energy US Dept. of Energy OHER, ER-72 GTN 19901 Germantown Rd. Washington, DC 20585 Germantown, MD 20874 The facsimile number is: (301) 903-8521. with secretary Joann Corcoran at telephone: (301) 903-6488. Internet address: genome@oerhp01.er.doe.gov Email submissions should use ASCII text format (please do NOT send LaTeX, TeX or Postscript files!). Materials for the formal applications will be returned with DOE responses to appropriate preapplications. ================================================================== Department of Energy Human Genome Program Announcement Program Notice 94-12: Human Genome Program-Technological Advances SUMMARY: The Office of Health and Environmental Research (OHER) of the Office of Energy Research (ER), U.S. Department of Energy (DOE), hereby announces its interest in receiving applications in support of the Human Genome Program. This Program is a coordinated, multidisciplinary, goal oriented, research effort aimed at improving technologies that will lead to a detailed understanding of the human genome at the molecular level. Several research goals are encompassed in this notice, with collaborative, multidisciplinary efforts specifically encouraged. Research will be supported for the development of: 1) integrated approaches to large-scale human genome sequencing that may include supportive mapping and automation; 2) cost-effective DNA sequencing systems that promise more than a 10-fold improvement in throughput; 3) software and resources for real-time analysis and annotation of data from high-speed DNA sequencing systems; (4) resources for facile entry and retrieval of data in community genome maps and DNA sequence databases, including coordinated entry or retrieval across multiple, complementary databases. PREAPPLICATIONS: Potential applicants are strongly encouraged to submit a brief preapplication that consists of two to three pages of narrative describing the research project objectives and methods of accomplishment. These will be reviewed relative to the scope and research needs of the DOE's Human Genome Program. Preapplications referencing Program Notice 94-12 should be received by April 15, 1994, and sent to Dr. David A. Smith, Office of Health and Environmental Research, ER-72 (GTN), Wash- ington, D.C. 20585. Telephone and FAX numbers are required parts of the preapplication and electronic mail addresses are desirable. A response to the preapplications discussing the potential program relevance of a formal application generally will be communicated within 30 days of receipt. FORMAL APPLICATION DATES: Formal applications submitted in response to this notice must be received by 4:30 p.m., E.D.T., July 14, 1994, to be accepted for merit review in September 1994, and to permit timely consideration for award in Fiscal Year 1995. ADDRESS: Formal applications referencing Program Notice 94-12 should be forwarded to: U.S. Department of Energy, Office of Energy Research, Acquisition and Assistance Management Division, ER-64 (GTN), Washington, D.C. 20585, ATTN: Program Notice 94-12. The following address must be used when submitting applications by U.S. Postal Service Express Mail or any commercial mail delivery service, or when handcarried by the applicant: U.S. Department of Energy, Office of Energy Research, Acquisition and Assistance Management Division, ER-64, 19901 Germantown Road, Germantown, MD 20874. SUPPLEMENTARY INFORMATION: It is anticipated that approximately $5,000,000 will be available for grant awards during FY 1995, contingent upon availability of appropriated funds. Multiple year funding of grant awards is expected, and is also contingent upon availability of funds. Previous awards have ranged from $79,000 per year up to $1,000,000 per year with terms from one to three years. Most awards are in the $200,000 to $400,000 per year range for three years. Similar award sizes are anticipated for new grants. Information on the development and submission of applications, eligibility, limitations, evaluation, selection process, and other policies and procedures may be found in the Application Guide for the Office of Energy Research Financial Assistance Program and 10 CFR Part 605. The Application Guide is available from the U.S. Department of Energy, Office of Health and Environmental Research, Health Effects and Life Sciences Research Division, ER-72 (GTN), Washington, D.C. 20585. Telephone requests may be made by calling (301) 903-6488. The Office of Energy Research, as part of its grant regulations, requires at 10 CFR 605.11(b) that a grantee funded by ER and performing research involving recombinant DNA molecules and/or organisms and viruses containing recombinant DNA molecules shall comply with the National Institutes of Health "Guidelines for Research Involving Recombinant DNA Molecules" (51 FR 16958, May 7, 1986), or such later revision of those guidelines as may be published in the Federal Register. The dissemination of materials and research data in a timely manner is essential for progress towards the goals of the DOE Human Genome Program. The OHER requires the timely sharing of resources and data. Applicants should, in their applications, discuss their plans for disseminating research data and materials that may include, where appropriate, putting cell lines, probes, sequence data, software, etc., into public repositories. Once OHER and the applicant have agreed upon a distribution plan, it will become part of the award conditions. Funds to defray the costs of disseminating materials or submitting data to repositories are allowable; however, such requests must be adequately justified. Applicants should also provide timelines projecting progress toward achieving proposed goals. FOR FURTHER INFORMATION CONTACT: Dr. David A. Smith, Office of Health and Environmental Research, ER-72 (GTN), Office of Energy Research, U.S. Department of Energy, Washington, D.C. 20585, (301) 903-6488. FROM: The Federal Register, Friday, February 18, 1994, Vol. 59, No. 034, pages 30-32, 59 FR 8183 "Energy Research Financial Assistance Program Notice 94-12: Human Genome Program-Technological Advances" From owner-sci-resources@net.bio.net Wed Mar 02 22:00:00 1994 Path: biosci!biosci!not-for-mail From: Marvin.Stodolsky@mailgw.er.doe.gov Newsgroups: bionet.announce,bionet.sci-resources Subject: DOE Human Genome Program Announcement - ELSI Date: 3 Mar 1994 10:44:05 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 174 Sender: kristoff@net.bio.net Approved: bionews-moderator@net.bio.net Distribution: bionet Message-ID: NNTP-Posting-Host: net.bio.net Xref: biosci bionet.announce:990 bionet.sci-resources:929 The US Department of Energy's 1994 competition for Research Financial Assistance within the Human Genome Program was announced in the Federal Register, 02/18/94 Vol. 59, No. 034, pages 32-34, Program Notices 94-13: Human Genome - Ethical, Legal, and Social Implications. The full texts can also be accessed electronically through: anonymous ftp TO oerhp01.er.doe.gov for /genome/9413.txt anonymous ftp TO fedix.fie.com for files /DOE/DOENOTE.TXT or /DOE/DOENOTE.EXE. gopher TO fedix.fie.com telnet TO fedix.fie.com DOENOTE.EXE is the compressed version of DOENOTE.TXT which expands itself on DOS based systems. DOENOTE also contains several other DOE non-genome program notices. Some background information relevant to the Genome program is available by gopher at GOPHER.GDB.ORG ================================================================= Preapplications are due by April 15, 1994 and formal applications by July 14, 1994. Related telephone queries should be made to Daniel W. Drell at 301/903-4742. Please note that the following addresses are ONLY for the short preapplications: US Mail Express Delivery Services ----------------- ------------------------- Daniel W. Drell Daniel W. Drell attn. Notice 94-12 attn. Notice 94-12 US Dept. of Energy US Dept. of Energy OHER, ER-72 GTN 19901 Germantown Rd. Washington, DC 20585 Germantown, MD 20874 The facsimile number is: (301) 903-8521. with secretary Joann Corcoran at telephone: (301) 903-6488. Internet address: Daniel.Drell@mailgw.er.doe.gov Email submissions should use ASCII text format (please do NOT send LaTeX, TeX or Postscript files!). Materials for the formal applications will be returned with responses to relevant preapplications. ============================================================= DOE HUMAN GENOME PROGRAM ANNOUNCEMENT Notice 94-13: Human Genome Program- Ethical, Legal, and Social Implications SUMMARY: The Office of Health and Environmental Research (OHER) of the Office of Energy Research (ER), U.S. Department of Energy (DOE), hereby announces its interest in receiving applications in support of the Ethical, Legal, and Social Implications (ELSI) subprogram of the Human Genome Program (HGP). The HGP is a coordinated, multidisciplinary, goal-oriented, research effort aimed at improving technologies that will lead to a detailed understanding of the human genome at the molecular level. This particular research notice encompasses research grants that address ethical, legal, and social issues that may arise from the use of information and knowledge resulting from the HGP. The DOE especially encourages the submission of applications to conduct multidisciplinary, empirical research on privacy issues from the creation, use, maintenance, and disclosure of genetic information. This may include (but is not limited to) issues of ownership and control of genetic information and the protection of the privacy of genetic information in various settings including the workplace. Applications should demonstrate knowledge of the relevant literature, and should include detailed plans for the gathering and analysis of factual information and the exploration of issues associated with the ethical, legal, and social implications of the knowledge gained from the HGP. All applications should include, where appropriate, detailed discussion of human subjects protection issues; e.g., storage of, manipulation of, and access to data. Where survey techniques are proposed, provisions to ensure the inclusion of women, minorities, and potentially disabled individuals must be described, unless specific exclusions are scientifically necessary and justified in detail. All proposed research applications should address the issue of efficient dissemination of results to the widest appropriate audience. The DOE is also soliciting applications for the preparation and dissemination of educational materials in any appropriate medium that will enhance public understanding of both the scientific aspects and the ethical, legal, and social aspects of the HGP. In addition, the DOE is encouraging applications for the support of conferences focusing on specific issues or areas of concern related to the ethical, legal, and social implications of the HGP. Educational and conference applications should also demonstrate awareness of the relevant literature, and include detailed plans for the accomplishment of project goals, including, where appropriate, video productions. In the case of educational {pg 8185} activities, the DOE strongly recommends inclusion of assessments of effectiveness of the proposed activities. In the case of all conferences, a fairly detailed and complete roster of committed speakers is necessary. At the completion of the conference, a summary or report is required. Educational and conference applications must also demonstrate awareness of the need to reach the widest appropriate audience. PREAPPLICATIONS: Potential applicants are strongly encouraged to submit a brief preapplication that consists of two to three pages of narrative describing the research project objectives and methods of accomplishment. These will be reviewed relative to the scope and research needs of the DOE's Human Genome Program. Preapplications referencing Program Notice 94-13 should be received by April 15, 1994, and sent to Dr. Daniel W. Drell, Office of Health and Environmental Research, ER-72 (GTN), Washington, DC 20585. Telephone and FAX numbers are required parts of the preapplication, and electronic mail addresses are desirable. A response to the preapplications discussing the potential program relevance of a formal application generally will be communicated within 30 days of receipt. SUPPLEMENTAL INFORMATION It is anticipated that approximately $1,000,000 will be available for grant awards in this area during FY 1995, contingent upon availability of appropriated funds. Multiple year funding of grant awards is expected, and is also contingent upon availability of funds. Previous awards have ranged from $60,000 per year up to $500,000 per year with terms from one to three years. Similar award sizes are anticipated for new grants. Information about development and submission of applications, eligibility, limitations, evaluation, selection process, and other policies and procedures may be found in the Application Guide for the Office of Energy Research Financial Assistance Program and 10 CFR part 605. The Application Guide is available from the U.S. Department of Energy, Office of Health and Environmental Research, Health Effects and Life Sciences Research Division, ER-72 (GTN), Washington, DC 20585. Telephone requests may be made by calling (301) 903-6488. The dissemination of materials and research data in a timely manner is essential for progress towards the goals of the DOE Human Genome Program. The OHER requires the timely sharing of resources and data. Applicants should, in their applications, discuss their plans for disseminating research results and materials that may include, where appropriate, publication in the open literature, wide-scale mailings, etc. Once OHER and the applicant have agreed upon a distribution plan, it will become part of the award conditions. Funds to defray the costs of disseminating results and materials are allowable; however, such requests must be sufficiently detailed and adequately justified. Applicants should also provide timelines projecting progress toward achieving proposed goals. DATES: Formal applications submitted in response to this notice must be received by 4:30 p.m., e.d.t., July 14, 1994, to be accepted for merit review in September 1994, and to permit timely consideration for award in Fiscal Year 1995. ADDRESSES: Formal applications referencing Program Notice 94-13 should be forwarded to: U.S. Department of Energy, Office of Energy Research, Acquisition and Assistance Management Division, ER-64 (GTN), Washington, DC 20585, ATTN: Program Notice 94-13. The following address must be used when submitting applications by U.S. Postal Service Express Mail or any commercial mail delivery service, or when handcarried by the applicant: U.S. Department of Energy, Office of Energy Research, Acquisition and Assistance Management Division, ER-64, 19901 Germantown Road, Germantown, MD 20874. FOR FURTHER INFORMATION CONTACT: Dr. Daniel W. Drell, Office of Health and Environmental Research, ER-72 (GTN), Office of Energy Research, U.S. Department of Energy, Washington, DC 20585, (301) 903-6488. From: Federal Register, Friday, February 18, 1994, Vol. 59, No. 034, 59 FR 8184. "Energy Research Financial Assistance Program Notice 94-13: Human Genome Program-Ethical, Legal, and Social Implications" From owner-sci-resources@net.bio.net Thu Mar 10 22:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 6 March 1994 Date: 10 Mar 1994 18:31:46 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 160 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2lol6i$jju@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Bulletin Title: NSF Bulletin March Vol 21; No. 7 File size (bytes): 38610 STIS Filename: bul9403 Document Type: Form Title: NSF Form 98A1 - Final Project Report File size (bytes): 994 STIS Filename: fm98a1 Also available: fm98a1.ps Title: NSF Form 98A2 - Final Project Report File size (bytes): 994 STIS Filename: fm98a2 Also available: fm98a2.ps Title: NSF Form 98A3 - Final Project Report File size (bytes): 994 STIS Filename: fm98a3 Also available: fm98a3.ps Title: NSF 94-3 - Grant Proposal Guide Forms Kit File size (bytes): 1277 STIS Filename: nsf943 Also available: nsf943.zip Document Type: Letter Title: Federal SBIR Conference - Houston, File size (bytes): 2091 STIS Filename: lsbi9401 Document Type: Press Release Title: PRELIMINARY CLUES ABOUT ELECTRICAL FIELDS' IMPACT ON CELLS File size (bytes): 2695 STIS Filename: pr943 Title: NSF-SUPPORTED RESEARCH RESULTS PRESENTED AT SAN DIEGO OCEAN SCIENCES MEETING File size (bytes): 7412 STIS Filename: pr945 Title: VERMONT TO RECEIVE THREE-YEAR EPSCoR AWARD TO STRENGTHEN RESEARCH EFFORTS File size (bytes): 3792 STIS Filename: pr946 Title: NSB GIVES GREEN LIGHT TO NSFNET'S NEXT STEPS- NEW ARCHITECTURE AND A CUTTING-EDGE NETWORK File size (bytes): 6425 STIS Filename: pr948 Document Type: Program Guideline Title: NSF 94-23 Combined Research-Curriculum Development Program File size (bytes): 17084 STIS Filename: nsf9423 Title: NSF 94-27--Management of Technological Innovation File size (bytes): 23351 STIS Filename: nsf9427 Title: NSF 94-30 Transformations to Quality Organizations File size (bytes): 23112 STIS Filename: nsf9430 Document Type: Recruit Title: Physical Science Administrator (Program Director) File size (bytes): 4834 STIS Filename: vex9415 Title: Cooperative Education Program (CO-OP) File size (bytes): 4044 STIS Filename: vgs9446 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Committees Title: NSF Advisory Committee Meetings File size (bytes): 1084 STIS Filename: cmpublic Document Type: Letter Title: Current List of REU Sites File size (bytes): 54535 STIS Filename: reulist Title: Current List of REU Sites File size (bytes): 54535 STIS Filename: reulist Document Type: Phone Book Title: NSF Alpha Telephone Directory File size (bytes): 112839 STIS Filename: phnalpha Title: NSF Organizational Directory File size (bytes): 94725 STIS Filename: phnorg Document Type: Program Guideline Title: NSF 94-29 - Interagency Program Announcement File size (bytes): 14831 STIS Filename: nsf9429 ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve nsf9429, the text of your message should be as follows: get nsf9429 Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf9429, you would enter: ftp> get nsf9429 WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Sun Mar 13 22:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 13 March 1994 Date: 14 Mar 1994 12:42:16 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 194 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2m2i78$rtf@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Form Title: FM 1207A - GPG Cover Sheet for Proposal to NSF Form 1 of 2 File size (bytes): 773 STIS Filename: fm1207a Also available: fm1207a.ps Title: FM 1207B - GPG Cover Sheet for Proposal to NSF Form 2 of 2 File size (bytes): 773 STIS Filename: fm1207b Also available: fm1207b.ps Title: FM 1207C - GPG Instructions on Certification (1) File size (bytes): 7444 STIS Filename: fm1207c Title: FM 1207D - GPG Instructions for Certification (2) File size (bytes): 4546 STIS Filename: fm1207d Title: FM 1358 - GPG Project Summary File size (bytes): 743 STIS Filename: fm1358 Also available: fm1358.ps Title: FM 1359 - GPG Table of Contents File size (bytes): 745 STIS Filename: fm1359 Also available: fm1359.ps Title: FM 1360 - GPG Project Description File size (bytes): 747 STIS Filename: fm1360 Also available: fm1360.ps Title: FM 1361 - GPG Bibliography File size (bytes): 740 STIS Filename: fm1361 Also available: fm1361.ps Title: FM 1362 - GPG Biographical Sketch File size (bytes): 747 STIS Filename: fm1362 Also available: fm1362.ps Title: FM 1363 - GPG Facilities, Equipment & Other Resources Form File size (bytes): 772 STIS Filename: fm1363 Also available: fm1363.ps Title: PKUnZip Program (ShareWare owned by PKWare, INC) File size (bytes): 492 STIS Filename: pkunzip Also available: pkunzip.exe Title: PKUnZip Program (ShareWare owned by PKWare, INC) File size (bytes): 492 STIS Filename: pkunzip Also available: pkunzip.exe Document Type: General Publication Title: Graduate Research Fellowships - A Directory of Coordinating Officials File size (bytes): 69890 STIS Filename: nsf9424 Also available: nsf9424.wp5 Title: NSF 94-25 Directory of NSF-Supported UFE Projects File size (bytes): 125843 STIS Filename: nsf9425 Document Type: News Title: Tips 40114 Tip Sheet File size (bytes): 4608 STIS Filename: tip40114 Title: Tip40128 Tip Sheet File size (bytes): 10243 STIS Filename: tip40128 Title: TIP40214 Tip Sheet File size (bytes): 7303 STIS Filename: tip40214 Title: tip40225 Tip Sheets File size (bytes): 6302 STIS Filename: tip40225 Document Type: Press Release Title: NSF-SUPPORTED RESEARCHERS REPORT FINDINGS ON EVOLUTION OF CELLS File size (bytes): 4475 STIS Filename: pr9410 Title: RISING SEA LEVEL AND SUBSIDING COASTLINES- A NEW REPORT PROBES "THAT SINKING FEELING!" File size (bytes): 4890 STIS Filename: pr941 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Form Title: FM 1030 - GPG Summary Proposal Budget Form File size (bytes): 756 STIS Filename: fm1030 Also available: fm1030.ps Title: FM 1225 - GPG Information about PI's / PD's File size (bytes): 757 STIS Filename: fm1225 Also available: fm1225.ps Title: FM 1239 - GPG Current and Pending Support File size (bytes): 755 STIS Filename: fm1239 Also available: fm1239.ps Title: FM 1263 - NSF Grant Transfer Request Form File size (bytes): 755 STIS Filename: fm1263 Also available: fm1263.ps Title: FM 1328 - Annual NSF Grant Progress Report Form File size (bytes): 761 STIS Filename: fm1328 Also available: fm1328.ps Document Type: Phone Book Title: NSF Alphabetic Phone Directory File size (bytes): 113272 STIS Filename: phnalpha Title: NSF Organizational Phone Directory File size (bytes): 96684 STIS Filename: phnorg Document Type: Recruit Title: Senior Executive Service Nationwide Vacancy Listing File size (bytes): 31753 STIS Filename: sesvac ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve sesvac, the text of your message should be as follows: get sesvac Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve sesvac, you would enter: ftp> get sesvac WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Mon Mar 21 22:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 20 March 1993 Date: 21 Mar 1994 16:42:40 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 131 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2mleu0$c0p@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Dir of Awards Title: NSF MINORITY GRADUATE FELLOWSHIP PROGRAM FOR FISCAL YEAR 1994 FELLOWSHIP AWARDS File size (bytes): 25930 STIS Filename: gf94mawd Also available: gf94mawd.dlm Title: NSF MINORITY GRADUATE FELLOWSHIP PROGRAM FOR FISCAL YEAR 1994 HONORABLE MENTIONS File size (bytes): 43633 STIS Filename: gf94mhm Also available: gf94mhm.dlm Title: NSF GRADUATE FELLOWSHIP PROGRAM FOR FISCAL YEAR 1994 FELLOWSHIP AWARDS File size (bytes): 159741 STIS Filename: gf94rawd Also available: gf94rawd.dlm Title: NSF GRADUATE FELLOWSHIP PROGRAM FOR FISCAL YEAR 1994 HONORABLE MENTIONS File size (bytes): 252266 STIS Filename: gf94rhm Also available: gf94rhm.dlm Document Type: Press Release Title: FEATURE- SECOND NATIONAL CONFERENCE ON SCIENCE EDUCATION REFORM SEEKS TO BUILD ON SUCCESSES File size (bytes): 9931 STIS Filename: pr9411 Title: NEW REPORT RELEASED-TEN-YEAR REVIEW OF THE NATIONAL SCIENCE FOUNDATION'S LONG-TERM ECOLOGICAL RESEARCH PROGRAM File size (bytes): 5080 STIS Filename: pr9412 Title: EARTHQUAKE HAZARDS IN SOUTHERN CALIFORNIA- IS A LARGER QUAKE ON THE WAY? File size (bytes): 5924 STIS Filename: pr9413 Title: FEATURE-LINGUISTS STRIVE TO DOCUMENT RAPIDLY DISAPPEARING LANGUAGES File size (bytes): 7337 STIS Filename: pr9414 Title: NSF-FUNDED SEARCH GATHERS COMPUTER TECHNOLOGY TO HELP TEACH LEARNING-DISABLED STUDENTS File size (bytes): 4148 STIS Filename: pr9415 Document Type: Recruit Title: Senior Advisor for Planning, Analysis and Policy File size (bytes): 8706 STIS Filename: vep9410 Title: Biologist (Science Assistant) File size (bytes): 3681 STIS Filename: vex9416 Document Type: STIS Title: NSF Organization Codes File size (bytes): 3522 STIS Filename: stisorgs ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Committees Title: NSF Advisory Committee Meetings File size (bytes): 2522 STIS Filename: cmpublic Document Type: Dir of Awards Title: NSF 93-65 Engineering Directorate Directory of Awards File size (bytes): 876852 STIS Filename: nsf9365 Also available: nsf9365.ps nsf9365.wp5 ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve nsf9365, the text of your message should be as follows: get nsf9365 Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf9365, you would enter: ftp> get nsf9365 WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Mon Mar 21 22:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 11, pt. 1, 18 March 1994 Date: 22 Mar 1994 10:52:15 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1499 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2mneov$2r6@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19940318 V23N11 P1O2 ************************************ X-comment: RFAs described: AI-94-010, RR/OD-94-004 NIH GUIDE - Vol. 23, No. 11 - March 18, 1994 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NIH GUIDELINES ON THE INCLUSION OF WOMEN AND MINORITIES AS SUBJECTS IN CLINICAL RESEARCH National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N2 ********************************************************** ELECTRONIC GRANT APPLICATIONS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N3 ********************************************************** FINANCIAL MANAGEMENT WORKSHOP National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N4 ********************************************************** RESEARCH RESOURCES AT THE CARIBBEAN PRIMATE RESEARCH CENTER National Center for Research Resources INDEX: RESEARCH RESOURCES $$INDEX N5 ********************************************************** GRANT WRITING WORKSHOP FOR NUTRITION FOR PA-94-033 National Cancer Institute INDEX: CANCER $$INDEX N6 ********************************************************** EXTENSION OF COOPERATIVE AGREEMENTS FOR THE MULTICENTER AIDS COHORT STUDY National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** EVALUATION OF ISCHEMIC HEART DISEASE IN WOMEN - CLINICAL CENTERS (RFP NHLBI-HC-94-13) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R2 06/15/94 ************************************************* MULTICENTER AIDS COHORT STUDY PATHOGENESIS RESEARCH LABORATORY (RFA AI-94-010) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R3 06/16/94 ************************************************* SCIENCE EDUCATION PARTNERSHIP AWARD (RFA RR/OD-94-004) National Center for Research Resources INDEX: RESEARCH RESOURCES ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** STUDIES ON ENVIRONMENTAL TOXICANTS AND THE IMMUNE SYSTEM (PA-94-049) National Institute of Environmental Health Sciences National Institute of Allergy and Infectious Diseases INDEX: ENVIRONMENTAL HEALTH SCIENCES; ALLERGY, INFECTIOUS DISEASES $$INDEX P2 ********************************************************** EXPLORATORY GRANTS TO STIMULATE CORRELATIVE LABORATORY STUDIES AND INNOVATIVE CLINICAL TRIALS (PA-94-050) National Cancer Institute INDEX: CANCER ERRATUM $$INDEX E1 ********************************************************** MORE FACULTY DEVELOPMENT AWARD (PAR-94-034) National Institute of General Medical Sciences INDEX: GENERAL MEDICAL SCIENCES This publication is available electronically to institutions via BITNET or INTERNET and is also on the NIH GOPHER. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** NIH GUIDELINES ON THE INCLUSION OF WOMEN AND MINORITIES AS SUBJECTS IN CLINICAL RESEARCH NIH GUIDE, Volume 23, Number 10, March 11, 1994 P.T. 34; K.W. 1014006 National Institutes of Health The following is a reprint of the Notice of the NIH Guidelines that was published as a separate Part IV in the Federal Register of March 9, 1994 (59 FR 11146-11151). SUMMARY: The National Institutes of Health (NIH) is establishing guidelines on the inclusion of women and minorities and their subpopulations in research involving human subjects, including clinical trials, supported by the NIH, as required in the NIH Revitalization Act of 1993. EFFECTIVE DATE: March 9, 1994 ADDRESSES: Although these guidelines are effective on the date of publication, written comments can be sent to either the Office of Research on Women's Health, National Institutes of Health, Building 1, Room 203, Bethesda, MD 20892, or to the Office of Research on Minority Health, National Institutes of Health, Building 1, Room 255, Bethesda, MD 20892. During the first year of implementation, NIH will review the comments and experience with the guidelines in order to determine whether modifications to the guidelines are warranted. SUPPLEMENTAL INFORMATION: NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research I. INTRODUCTION This document sets forth guidelines on the inclusion of women and members of minority groups and their subpopulations in clinical research, including clinical trials, supported by the National Institutes of Health (NIH). For the purposes of this document, clinical research is defined as NIH-supported biomedical and behavioral research involving human subjects. These guidelines, implemented in accordance with section 492B of the Public Health Service Act, added by the NIH Revitalization Act of 1993, Public Law (PL) 103-43, supersede and strengthen the previous policies, NIH/ADAMHA Policy Concerning the Inclusion of Women in Study Populations, and ADAMHA/NIH Policy Concerning the Inclusion of Minorities in Study Populations, published in the NIH Guide for Grants and Contracts, Vol. 19, No. 31, August 24, 1990 and Vol. 19, No. 35, September 28, 1990. The 1993 guidelines continue the 1990 guidelines with three major additions. The new policy requires that, in addition to the continuing inclusion of women and members of minority groups in all NIH-supported biomedical and behavioral research involving human subjects, the NIH must: o ensure that women and members of minorities and their subpopulations are included in all human subject research; o for Phase III clinical trials, ensure that women and minorities and their subpopulations must be included such that valid analyses of differences in intervention effect can be accomplished; o not allow cost as an acceptable reason for excluding these groups; and, o initiate programs and support for outreach efforts to recruit these groups into clinical studies. Since a primary aim of research is to provide scientific evidence leading to a change in health policy or a standard of care, it is imperative to determine whether the intervention or therapy being studied affects women or men or members of minority groups and their subpopulations differently. To this end, the guidelines published here are intended to ensure that all future NIH-supported biomedical and behavioral research involving human subjects will be carried out in a manner sufficient to elicit information about individuals of both genders and the diverse racial and ethnic groups and, in the case of clinical trials, to examine differential effects on such groups. Increased attention, therefore, must be given to gender, race, and ethnicity in earlier stages of research to allow for informed decisions at the Phase III clinical trial stage. These guidelines reaffirm NIH's commitment to the fundamental principles of inclusion of women and racial and ethnic minority groups and their subpopulations in research. This policy should result in a variety of new research opportunities to address significant gaps in knowledge about health problems that affect women and racial/ethnic minorities and their subpopulations. The NIH recognizes that issues will arise with the implementation of these guidelines and thus welcomes comments. During the first year of implementation, NIH will review the comments, and consider modifications, within the scope of the statute, to the guidelines. II. BACKGROUND The NIH Revitalization Act of 1993, PL 103-43, signed by President Clinton on June 10, 1993, directs the NIH to establish guidelines for inclusion of women and minorities in clinical research. This guidance shall include guidelines regarding: (a) the circumstances under which the inclusion of women and minorities as subjects in projects of clinical research is inappropriate...; (b) the manner in which clinical trials are required to be designed and carried out ....; and (c) the operation of outreach programs... 492B(d)(1) The statute states that: In conducting or supporting clinical research for the purposes of this title, the Director of NIH shall ... ensure that - A. women are included as subjects in each project of such research; and B. members of minority groups are included in such research. 492B(a)(1) The statute further defines "clinical research" to include "clinical trials" and states that In the case of any clinical trial in which women or members of minority groups will be included as subjects, the Director of NIH shall ensure that the trial is designed and carried out in a manner sufficient to provide for valid analysis of whether the variables being studied in the trial affect women or members of minority groups, as the case may be, differently than other subjects in the trial. 492B(c) Specifically addressing the issue of minority groups, the statute states that The term "minority group" includes subpopulations of minority groups. The Director of NIH shall, through the guidelines established... define the terms "minority group" and "subpopulation" for the purposes of the preceding sentence. 492B(g)(2) The statute speaks specifically to outreach and states that The Director of NIH, in consultation with the Director of the Office of Research on Women's Health and the Director of the Office of Research on Minority Health, shall conduct or support outreach programs for the recruitment of women and members of minority groups as subjects in the projects of clinical research. 492B(a)(2) The statute includes a specific provision pertaining to the cost of clinical research and, in particular clinical trials. (A)(i) In the case of a clinical trial, the guidelines shall provide that the costs of such inclusion in the trial is (sic) not a permissible consideration in determining whether such inclusion is inappropriate. 492B(d)(2) (ii) In the case of other projects of clinical research, the guidelines shall provide that the costs of such inclusion in the project is (sic) not a permissible consideration in determining whether such inclusion is inappropriate unless the data regarding women or members of minority groups, respectively, that would be obtained in such project (in the event that such inclusion were required) have been or are being obtained through other means that provide data of comparable quality. 492B(d)(2) Exclusions to the requirement for inclusion of women and minorities are stated in the statute, as follows: The requirements established regarding women and members of minority groups shall not apply to the project of clinical research if the inclusion, as subjects in the project, of women and members of minority groups, respectively- (1) is inappropriate with respect to the health of the subjects; (2) is inappropriate with respect to the purpose of the research; or (3) is inappropriate under such other circumstances as the Director of NIH may designate. 492B(b) ...(B) In the case of a clinical trial, the guidelines may provide that such inclusion in the trial is not required if there is substantial scientific data demonstrating that there is no significant difference between- (i) the effects that the variables to be studied in the trial have on women or members of minority groups, respectively; and (ii) the effects that the variables have on the individuals who would serve as subjects in the trial in the event that such inclusion were not required. 492B(d)(2) III. POLICY A. Research Involving Human Subjects It is the policy of NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification establishes to the satisfaction of the relevant Institute/Center Director that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. Exclusion under other circumstances may be made by the Director, NIH, upon the recommendation of an Institute/Center Director based on a compelling rationale and justification. Cost is not an acceptable reason for exclusion except when the study would duplicate data from other sources. Women of childbearing potential should not be routinely excluded from participation in clinical research. All NIH-supported biomedical and behavioral research involving human subjects is defined as clinical research. This policy applies to research subjects of all ages. The inclusion of women and members of minority groups and their subpopulations must be addressed in developing a research design appropriate to the scientific objectives of the study. The research plan should describe the composition of the proposed study population in terms of gender and racial/ethnic group, and provide a rationale for selection of such subjects. Such a plan should contain a description of the proposed outreach programs for recruiting women and minorities as participants. B. Clinical Trials Under the statute, when a Phase III clinical trial (see Definitions, Section V-A) is proposed, evidence must be reviewed to show whether or not clinically important gender or race/ ethnicity differences in the intervention effect are to be expected. This evidence may include, but is not limited to, data derived from prior animal studies, clinical observations, metabolic studies, genetic studies, pharmacology studies, and observational, natural history, epidemiology and other relevant studies. As such, investigators must consider the following when planning a Phase III clinical trial for NIH support. o If the data from prior studies strongly indicate the existence of significant differences of clinical or public health importance in intervention effect among subgroups (gender and/or racial/ethnic subgroups), the primary question(s) to be addressed by the proposed Phase III trial and the design of that trial must specifically accommodate this. For example, if men and women are thought to respond differently to an intervention, then the Phase III trial must be designed to answer two separate primary questions, one for men and the other for women, with adequate sample size for each. o If the data from prior studies strongly support no significant differences of clinical or public health importance in intervention effect between subgroups, then gender or race/ethnicity will not be required as subject selection criteria. However, the inclusion of gender or racial/ethnic subgroups is still strongly encouraged. o If the data from prior studies neither support strongly nor negate strongly the existence of significant differences of clinical or public health importance in intervention effect between subgroups, then the Phase III trial will be required to include sufficient and appropriate entry of gender and racial/ethnic subgroups, so that valid analysis of the intervention effect in subgroups can be performed. However, the trial will not be required to provide high statistical power for each subgroup. Cost is not an acceptable reason for exclusion of women and minorities from clinical trials. C. Funding NIH funding components will not award any grant, cooperative agreement or contract or support any intramural project to be conducted or funded in Fiscal Year 1995 and thereafter which does not comply with this policy. For research awards that are covered by this policy, awardees will report annually on enrollment of women and men, and on the race and ethnicity of research participants. IV. IMPLEMENTATION A. Date of Implementation This policy applies to all applications/proposals and intramural projects to be submitted on and after June 1, 1994 (the date of full implementation) seeking Fiscal Year 1995 support. Projects funded prior to June 10, 1993, must still comply with the 1990 policy and report annually on enrollment of subjects using gender and racial/ethnic categories as required in the Application for Continuation of a Public Health Service Grant (PHS Form 2590), in contracts and in intramural projects. B. Transition Policy NIH-supported biomedical and behavioral research projects involving human subjects, with the exception of Phase III clinical trial projects as discussed below, that are awarded between June 10, 1993, the date of enactment, and September 30, 1994, the end of Fiscal Year 1994, shall be subject to the requirements of the 1990 policy and the annual reporting requirements on enrollment using gender and racial/ethnic categories. For all Phase III clinical trial projects proposed between June 10, 1993 and June 1, 1994, and those awarded between June 10, 1993 and September 30, 1994, Institute/Center staff will examine the applications/proposals, pending awards, awards and intramural projects to determine if the study was developed in a manner consistent with the new guidelines. If it is deemed inconsistent, NIH staff will contact investigators to discuss approaches to accommodate the new policy. Administrative actions may be needed to accommodate or revise the pending trials. Institutes/Centers may need to consider initiating a complementary activity to address any gender or minority representation concerns. The NIH Director will determine whether the Phase III clinical trial being considered during this transition is in compliance with this policy, whether acceptable modifications have been made, or whether the Institute/Center will initiate a complementary activity that addresses the gender or minority representation concerns. Pending awards will not be funded without this determination. Solicitations issued by the NIH and planned for release after the date of publication of the guidelines in the Federal Register will include the new requirements. C. Roles and Responsibilities While this policy applies to all applicants for NIH-supported biomedical and behavioral research involving human subjects, certain individuals and groups have special roles and responsibilities with regard to the adoption and implementation of these guidelines. The NIH staff will provide educational opportunities for the extramural and intramural community concerning this policy; monitor its implementation during the development, review, award and conduct of research; and manage the NIH research portfolio to address the policy. 1. Principal Investigators Principal investigators should assess the theoretical and/or scientific linkages between gender, race/ethnicity, and their topic of study. Following this assessment, the principal investigator and the applicant institution will address the policy in each application and proposal, providing the required information on inclusion of women and minorities and their subpopulations in research projects, and any required justifications for exceptions to the policy. Depending on the purpose of the study, NIH recognizes that a single study may not include all minority groups. 2. Institutional Review Boards (IRBs) As the IRBs implement the guidelines, described herein, for the inclusion of women and minorities and their subpopulations, they must also implement the regulations for the protection of human subjects as described in Title 45 CFR Part 46, "Protection of Human Subjects." They should take into account the Food and Drug Administration's "Guidelines for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs," Vol. 58 Federal Register 39406. 3. Peer Review Groups In conducting peer review for scientific and technical merit, appropriately constituted initial review groups (including study sections), technical evaluation groups, and intramural review panels will be instructed, as follows: o to evaluate the proposed plan for the inclusion of minorities and both genders for appropriate representation or to evaluate the proposed justification when representation is limited or absent, o to evaluate the proposed exclusion of minorities and women on the basis that a requirement for inclusion is inappropriate with respect to the health of the subjects, o to evaluate the proposed exclusion of minorities and women on the basis that a requirement for inclusion is inappropriate with respect to the purpose of the research, o to determine whether the design of clinical trials is adequate to measure differences when warranted, o to evaluate the plans for recruitment/outreach for study participants, and o to include these criteria as part of the scientific assessment and assigned score. 4. NIH Advisory Councils In addition to its current responsibilities for review of projects where the peer review groups have raised questions about the appropriate inclusion of women and minorities, the Advisory Council/Board of each Institute/Center shall prepare biennial reports, for inclusion in the overall NIH Director's biennial report, describing the manner in which the Institute/Center has complied with the provisions of the statute. 5. Institute/Center Directors Institute/Center Directors and their staff shall determine whether: a) the research involving human subjects, b) the Phase III clinical trials, and c) the exclusions meet the requirements of the statute and these guidelines. 6. NIH Director The NIH Director may approve, on a case-by-case basis, the exclusion of projects, as recommended by the Institute/Center Director, that may be inappropriate to include within the requirements of these guidelines on the basis of circumstances other than the health of the subjects, the purpose of the research, or costs. 7. Recruitment Outreach by Extramural and Intramural Investigators Investigators and their staff(s) are urged to develop appropriate and culturally sensitive outreach programs and activities commensurate with the goals of the study. The objective should be to actively recruit the most diverse study population consistent with the purposes of the research project. Indeed, the purpose should be to establish a relationship between the investigator(s) and staff(s) and populations and community(ies) of interest such that mutual benefit is derived for participants in the study. Investigator(s) and staff(s) should take precautionary measures to ensure that ethical concerns are clearly noted, such that there is minimal possibility of coercion or undue influence in the incentives or rewards offered in recruiting into or retaining participants in studies. It is also the responsibility of the IRBs to address these ethical concerns. Furthermore, while the statute focuses on recruitment outreach, NIH staff underscore the need to appropriately retain participants in clinical studies, and thus, the outreach programs and activities should address both recruitment and retention. To assist investigators and potential study participants, NIH staff have prepared a notebook, "NIH Outreach Notebook On the Inclusion of Women and Minorities in Biomedical and Behavioral Research." The notebook addresses both recruitment and retention of women and minorities in clinical studies, provides relevant references and case studies, and discusses ethical issues. It is not intended as a definitive text on this subject, but should assist investigators in their consideration of an appropriate plan for recruiting and retaining participants in clinical studies. The notebook is expected to be available early in 1994. 8. Educational Outreach by NIH to Inform the Professional Community NIH staff will present the new guidelines to investigators, IRB members, peer review groups, and Advisory Councils in a variety of public educational forums. 9. Applicability to Foreign Research Involving Human Subjects For foreign awards, the NIH policy on inclusion of women in research conducted outside the U.S. is the same as that for research conducted in the U.S. However, with regard to the population of the foreign country, the definition of the minority groups may be different than in the U.S. If there is scientific rationale for examining subpopulation group differences within the foreign population, investigators should consider designing their studies to accommodate these differences. V. DEFINITIONS Throughout the section of the statute pertaining to the inclusion of women and minorities, terms are used which require definition for the purpose of implementing these guidelines. These terms, drawn directly from the statute, are defined below. A. Clinical Trial For the purpose of these guidelines, a "clinical trial" is a broadly based prospective Phase III clinical investigation, usually involving several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a standard or control intervention or comparing two or more existing treatments. Often the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care. The definition includes pharmacologic, non- pharmacologic, and behavioral interventions given for disease prevention, prophylaxis, diagnosis, or therapy. Community trials and other population-based intervention trials are also included. B. Research Involving Human Subjects All NIH-supported biomedical and behavioral research involving human subjects is defined as clinical research under this policy. Under this policy, the definition of human subjects in Title 45 CFR Part 46, the Department of Health and Human Services regulations for the protection of human subjects applies: "Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information." These regulations specifically address the protection of human subjects from research risks. It should be noted that there are research areas (Exemptions 1-6) that are exempt from these regulations. However, under these guidelines, NIH-supported biomedical and behavioral research projects involving human subjects which are exempt from the human subjects regulations should still address the inclusion of women and minorities in their study design. Therefore, all biomedical and behavioral research projects involving human subjects will be evaluated for compliance with this policy. Research involving the collection or study of existing data, documents, records, pathological specimens, diagnostic specimens, or tissues which are individually identifiable also is included within the term "research involving human subjects." C. Valid Analysis The term "valid analysis" means an unbiased assessment. Such an assessment will, on average, yield the correct estimate of the difference in outcomes between two groups of subjects. Valid analysis can and should be conducted for both small and large studies. A valid analysis does not need to have a high statistical power for detecting a stated effect. The principal requirements for ensuring a valid analysis of the question of interest are: o allocation of study participants of both genders and from different racial/ethnic groups to the intervention and control groups by an unbiased process such as randomization, o unbiased evaluation of the outcome(s) of study participants, and o use of unbiased statistical analyses and proper methods of inference to estimate and compare the intervention effects among the gender and racial/ethnic groups. D. Significant Difference For purposes of this policy, a "significant difference" is a difference that is of clinical or public health importance, based on substantial scientific data. This definition differs from the commonly used "statistically significant difference," which refers to the event that, for a given set of data, the statistical test for a difference between the effects in two groups achieves statistical significance. Statistical significance depends upon the amount of information in the data set. With a very large amount of information, one could find a statistically significant, but clinically small difference that is of very little clinical importance. Conversely, with less information one could find a large difference of potential importance that is not statistically significant. E. Racial and Ethnic Categories 1. Minority Groups A minority group is a readily identifiable subset of the U.S. population which is distinguished by either racial, ethnic, and/or cultural heritage. The Office of Management and Budget (OMB) Directive No. 15 defines the minimum standard of basic racial and ethnic categories, which are used below. NIH has chosen to continue the use of these definitions because they allow comparisons to many national data bases, especially national health data bases. Therefore, the racial and ethnic categories described below should be used as basic guidance, cognizant of the distinction based on cultural heritage. American Indian or Alaskan Native: A person having origins in any of the original peoples of North America, and who maintains cultural identification through tribal affiliation or community recognition. Asian or Pacific Islander: A person having origins in any of the original peoples of the Far East, Southeast Asia, the Indian subcontinent, or the Pacific Islands. This area includes, for example, China, India, Japan, Korea, the Philippine Islands and Samoa. Black, not of Hispanic Origin: A person having origins in any of the black racial groups of Africa. Hispanic: A person of Mexican, Puerto Rican, Cuban, Central or South American or other Spanish culture or origin, regardless of race. 2. Majority Group White, not of Hispanic Origin: A person having origins in any of the original peoples of Europe, North Africa, or the Middle East. NIH recognizes the diversity of the U.S. population and that changing demographics are reflected in the changing racial and ethnic composition of the population. The terms "minority groups" and "minority subpopulations" are meant to be inclusive, rather than exclusive, of differing racial and ethnic categories. 3. Subpopulations Each minority group contains subpopulations which are delimited by geographic origins, national origins and/or cultural differences. It is recognized that there are different ways of defining and reporting racial and ethnic subpopulation data. The subpopulation to which an individual is assigned depends on self-reporting of specific racial and ethnic origin. Attention to subpopulations also applies to individuals of mixed racial and/or ethnic parentage. Researchers should be cognizant of the possibility that these racial/ethnic combinations may have biomedical and/or cultural implications related to the scientific question under study. F. Outreach Strategies These are outreach efforts by investigators and their staff(s) to appropriately recruit and retain populations of interest into research studies. Such efforts should represent a thoughtful and culturally sensitive plan of outreach and generally include involvement of other individuals and organizations relevant to the populations and communities of interest, e.g., family, religious organizations, community leaders and informal gatekeepers, and public and private institutions and organizations. The objective is to establish appropriate lines of communication and cooperation to build mutual trust and cooperation such that both the study and the participants benefit from such collaboration. G. Research Portfolio Each Institute and Center at the NIH has its own research portfolio, i.e., its "holdings" in research grants, cooperative agreements, contracts and intramural studies. The Institute or Center evaluates the research awards in its portfolio to identify those areas where there are knowledge gaps or which need special attention to advance the science involved. NIH may consider funding projects to achieve a research portfolio reflecting diverse study populations. With the implementation of this new policy, there will be a need to ensure that sufficient resources are provided within a program to allow for data to be developed for a smooth transition from basic research to Phase III clinical trials that meet the policy requirements. VI. DISCUSSION -- Issues in Scientific Plans and Study Designs A. Issues in Research Involving Human Subjects The biomedical and behavioral research process can be viewed as a stepwise process progressing from discovery of new knowledge through research in the laboratory, research involving animals, research involving human subjects, validation of interventions through clinical trials, and broad application to improve the health of the public. All NIH-supported biomedical and behavioral research involving human subjects is defined broadly in this guidance as clinical research. This is broader than the definition provided in the 1990 NIH Guidance and in many program announcements, requests for applications, and requests for proposals since 1990. The definition was broadened because of the need to obtain data about minorities and both genders early in the research process when hypotheses are being formulated, baseline data are being collected, and various measurement instruments and intervention strategies are being developed. Broad inclusion at these early stages of research provides valuable information for designing broadly based clinical trials, which are a subset of studies under the broad category of research studies. The policy on inclusion of minorities and both genders applies to all NIH-supported biomedical and behavioral research involving human subjects so that the maximum information may be obtained to understand the implications of the research findings on the gender or minority group. Investigators should consider the types of information concerning gender and minority groups which will be required when designing future Phase III clinical trials, and try to obtain it in their earlier stages of research involving human subjects. NIH recognizes that the understanding of health problems and conditions of different U.S. populations may require attention to socioeconomic differences involving occupation, education, and income gradients. B. Issues in Clinical Trials The statute requires appropriate representation of subjects of different gender and race/ethnicity in clinical trials so as to provide the opportunity for detecting major qualitative differences (if they exist) among gender and racial/ethnic subgroups and to identify more subtle differences that might, if warranted, be explored in further specifically targeted studies. Other interpretations may not serve as well the health needs of women, minorities, and all other constituencies. Preparatory to any Phase III clinical trial, certain data are typically obtained. Such data are necessary for the design of an appropriate Phase III trial and include observational clinical study data, basic laboratory (i.e., in vitro and animal) data, and clinical, physiologic, pharmacokinetic, or biochemical data from Phase I and Phase II studies. Genetic studies, behavioral studies, and observational, natural history, and epidemiological studies may also contribute data. It is essential that data be reviewed from prior studies on a diverse population, that is, in subjects of both genders and from different racial/ethnic groups. These data must be examined to determine if there are significant differences of clinical or public health importance observed between the subgroups. While data from prior studies relating to possible differences among intervention effects in different subgroups must be reviewed, evidence of this nature is likely to be less convincing than that deriving from the subgroup analyses that can be performed in usual- sized Phase III trials. This is because the evidence from preliminary studies is likely to be of a more indirect nature (e.g. based on surrogate endpoints), deriving from uncontrolled studies (e.g., non-randomized Phase II trials), and based on smaller numbers of subjects than in Phase III secondary analyses. For this reason, it is likely that data from preliminary studies will, in the majority of cases, neither clearly reveal significant differences of clinical or public health importance between subgroups of patients, nor strongly negate them. In these cases, Phase III trials should still have appropriate gender and racial/ethnic representation, but they would not need to have the large sample sizes necessary to provide a high statistical power for detecting differences in intervention effects among subgroups. Nevertheless, analyses of subgroup effects must be conducted and comparisons between the subgroups must be made. Depending on the results of these analyses, the results of other relevant research, and the results of meta-analyses of clinical trials, one might initiate subsequent trials to examine more fully these subgroup differences. C. Issues Concerning Appropriate Gender Representation The "population at risk" may refer to only one gender where the disease, disorders, or conditions are gender specific. In all other cases, there should be approximately equal numbers of both sexes in studies of populations or subpopulations at risk, unless different proportions are appropriate because of the known prevalence, incidence, morbidity, mortality rates, or expected intervention effect. D. Issues Concerning Appropriate Representation of Minority Groups and Subpopulations in All Research Involving Human Subjects Including Phase III Clinical Trials While the inclusion of minority subpopulations in research is a complex and challenging issue, it nonetheless provides the opportunity for researchers to collect data on subpopulations where knowledge gaps exist. Researchers must consider the inclusion of subpopulations in all stages of research design. In meeting this objective, they should be aware of concurrent research that addresses specific subpopulations, and consider potential collaborations which may result in complementary subpopulation data. At the present time, there are gaps in baseline and other types of data necessary for research involving certain minority groups and/or subpopulations of minority groups. In these areas, it would be appropriate for researchers to obtain such data, including baseline data, by studying a single minority group. It would also be appropriate for researchers to test survey instruments, recruitment procedures, and other methodologies used in the majority or other population(s) with the objective of assessing their feasibility, applicability, and cultural competence/relevance to a particular minority group or subpopulation. This testing may provide data on the validity of the methodologies across groups. Likewise, if an intervention has been tried in the majority population and not in certain minority groups, it would be appropriate to assess the intervention effect on a single minority group and compare the effect to that obtained in the majority population. These types of studies will advance scientific research and assist in closing knowledge gaps. A complex issue arises over how broad or narrow the division into different subgroups should be, given the purpose of the research. Division into many racial/ethnic subgroups is tempting in view of the cultural and biological differences that exist among these groups and the possibility that some of these differences may in fact impact in some way upon the scientific question. Alternatively, from a practical perspective, a limit has to be placed on the number of such subgroups that can realistically be studied in detail for each intervention that is researched. The investigator should clearly address the rationale for inclusion or exclusion of subgroups in terms of the purpose of the research. Emphasis should be placed upon inclusion of subpopulations in which the disease manifests itself or the intervention operates in an appreciably different way. Investigators should report the subpopulations included in the study. An important issue is the appropriate representation of minority groups in research, especially in geographical locations which may have limited numbers of racial/ethnic population groups available for study. The investigator must address this issue in terms of the purpose of the research, and other factors, such as the size of the study, relevant characteristics of the disease, disorder or condition, and the feasibility of making a collaboration or consortium or other arrangements to include minority groups. A justification is required if there is limited representation. Peer reviewers and NIH staff will consider the justification in their evaluations of the project. NIH interprets the statute in a manner that leads to feasible and real improvements in the representativeness of different racial/ethnic groups in research and places emphasis on research in those subpopulations that are disproportionately affected by certain diseases or disorders. VII. NIH CONTACTS FOR MORE INFORMATION The following senior extramural staff from the NIH Institutes and Centers may be contacted for further information about the policy and relevant Institute/Center programs: Dr. Marvin Kalt National Cancer Institute Executive Plaza North, Room 600A 6130 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-5147 Dr. Richard Mowery National Eye Institute Executive Plaza South, Room 350 6120 Executive Boulevard Rockville, MD 20892 Telephone: (301) 496-5301 Dr. Lawrence Friedman National Heart, Lung and Blood Institute Federal Building, Room 212 7550 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-2533 Dr. Miriam Kelty National Institute on Aging Gateway Building, Room 2C218 7201 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-9322 Dr. Cherry Lowman National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard Rockville, MD 20892 Tel: (301) 443-0796 Dr. George Counts National Institute of Allergy and Infectious Diseases Solar Building, Room 207P 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-8214 Dr. Michael Lockshin National Institute of Arthritis and Musculoskeletal and Skin Diseases Building 31, Room 4C32 Bethesda, MD 20892 Telephone: (301) 496-0802 Ms. Hildegard Topper National Institute of Child Health and Human Development Building 31, Room 2A03 Bethesda, MD 20892 Telephone: (301) 496-0104 Dr. Earleen Elkins National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400 6120 Executive Boulevard Rockville, MD 20892 Telephone: (301) 496-8683 Dr. Norman S. Braveman National Institute on Dental Research Westwood Building, Room 509 Bethesda, MD 20892 Telephone: (301) 594-7648 Dr. Walter Stolz National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 657 Bethesda, MD 20892 Telephone: (301) 594-7527 Ms. Eleanor Friedenberg National Institute on Drug Abuse Parklawn Building, Room 10-42 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-2755 Dr. Gwen Collman National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-4980 Dr. Lee Van Lenten National Institute of General Medical Sciences Westwood Building, Room 905 Bethesda, MD 20892 Telephone: (301) 594-7744 Dr. Dolores Parron National Institute of Mental Health Parklawn Building, Room 17C-14 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-2847 Dr. Constance Atwell National Institute of Neurological Disorders and Stroke Federal Building, Room 1016 7550 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-9248 Dr. Mark Guyer National Center for Human Genome Research Building 38A, Room 605 Bethesda, MD 20892 Telephone: (301) 496-0844 Dr. Teresa Radebaugh National Center for Nursing Research Westwood Building, Room 754 Bethesda, MD 20892 Telephone: (301) 594-7590 Dr. Harriet Gordon National Center for Research Resources Westwood Building, Room 10A03 Bethesda, MD 20892 Telephone: (301) 594-7945 Dr. David Wolff Fogarty International Center Building 31, Room B2C39 Bethesda, MD 20892 Telephone: (301) 496-1653 $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** ELECTRONIC GRANT APPLICATIONS NIH GUIDE, Volume 23, Number 11, March 18, 1994 P.T. 34; K.W. 1004017, 1014006 National Institutes of Health The National Institutes of Health plans to develop an automated means to acquire, process, and distribute electronic grant applications. As part of the process, technical specifications for the format and content of acceptable electronic applications will be published. The intention is to provide the opportunity for commercial developers, institutions, or others outside the NIH to develop software to prepare and submit electronic PHS grant applications. This notice is to invite those interested in this effort to identify themselves, so the NIH can keep them informed and solicit their input as the project proceeds. If interested, send name, E-mail address, postal address, and telephone number to: J.T. Lowrie Division of Research Grants Information Systems Branch Westwood Building, Room 120 Bethesda, MD 20892 $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** FINANCIAL MANAGEMENT WORKSHOP NIH GUIDE, Volume 23, Number 11, March 18, 1994 P.T. 34; K.W. 1014006 National Institutes of Health The Louisiana State University Medical Center, New Orleans, in conjunction with the National Institutes of Health (Division of Financial Management) is sponsoring a workshop to be held in New Orleans on May 2-3, 1994. The agenda for the workshop will include the following topics: o The System for the Electronic Transmittal of Financial Status reports (FSRs) o The Payment Management System/Federal Cash Transactions Report (PMS-272) o The NIH initiative on late FSRs o Shannon Awards o Indirect Costs INQUIRIES For further information and a registration form, contact: Ms. Darleen Galatas Louisiana State University Medical Center 433 Bolivar Street, Room 612 New Orleans, La 70112-2223 Telephone: (504) 568-3675 $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** RESEARCH RESOURCES AT THE CARIBBEAN PRIMATE RESEARCH CENTER NIH GUIDE, Volume 23, Number 11, March 18, 1994 P.T. 34; K.W. 1002002 National Center for Research Resources The Caribbean Primate Research Center (CPRC) operates three research facilities for behavioral, biomedical, and anthropological studies and dissertation research. Cayo Santiago: An island colony of approximately 1000 provisioned, free-ranging rhesus macaques ideal for both short- and long-term observational research. An annual capture also facilitates non- invasive biomedical investigations and surveys on a limited basis. Computerized demographic data are available on over 12 macaque generations. These include individual identifications, matriline, group affiliation, reproductive history, birth and death dates. Sabana Seca: A field station housing approximately 900 macaques, many derived from Cayo Santiago, in outdoor corrals, pens, and individual cages primarily for biomedical studies, breeding, and behavioral research that require frequent handling of animals. CPRC Skeletal Collection: A curated collection of over 2500 complete or nearly-complete skeletons of six species of nonhuman primates, mostly rhesus macaques and patas monkeys. The collection is ideal for studies of spontaneous and acquired joint and bone diseases, physical anthropology, growth and development, and bone remodeling. Available supporting data include basic demographic information, medical records and thoracic radiographs, a selection of cephalometric radiographs and reproductive history. Use is generally limited to non-destructive studies, but limited destructive sampling is permissible given sufficient justification. The Caribbean Primate Research Center is partially funded by NIH program project grant RR03640. INQUIRIES Investigators and students wishing to avail themselves of the CPRC's unique research resources should send a letter of intent and/or contact staff members. For an information packet, contact: Dr. Matt J. Kessler, Director Caribbean Primate Research Center University of Puerto Rico Medical Sciences Campus P.O. Box 1053 Sabana Seca, PR 00952-1053 (USA) FAX: (809) 795-6700 $$N4 END ************************************************************ $$N5 BEGIN ********************************************************** GRANT WRITING WORKSHOP FOR NUTRITION FOR PA-94-033 NIH GUIDE, Volume 23, Number 11, March 18, 1994 P.T. 34; K.W. 0710095, 1014006 National Cancer Institute A national workshop to discuss Program Announcement PA-94-033, "Culturally Sensitive Intervention Strategies for Promoting or Implementing Compliance with NCI Dietary Guidelines among African Americans," has been scheduled for Thursday, April 14 from 8:30am to 5:00pm on the NIH campus in Bethesda, MD, Building 31C, Conference Room 6. Topics related to grant writing will be discussed as they specifically relate to this program announcement. This one-day workshop will be of interest to both new and senior Principal Investigators. Discussion of issues related to community nutrition interventions in African Americans will be included. Topics for discussion include dietary change in African Americans; specific aims, background, and significance of the program announcement; research design and methods; budget preparation; grants review; and assurances and certifications. No registration fee will be charged. Time will be available for conference participants to meet informally with NIH representatives to discuss their individual ideas. This workshop is open to the public. Persons interested in attending the workshop will be expected to pay their own expenses. For persons who are unable to attend, a transcript of the meeting will be made available, and may be obtained by contacting Dr. Jacqueline Whitted at the address listed under INQUIRIES. Speakers will include several NCI and NIH staff involved in the management, review, and administration of this program announcement. INQUIRIES For further information, contact: Dr. Jacqueline Whitted Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 232 Bethesda, MD 20892 Telephone: (301) 496-8584 FAX: (301) 496-8675 DATE: April 14, 1994 LOCATION National Institutes of Health Building 31C, Conference Room 6 9000 Rockville Pike Bethesda, Maryland $$N5 END ************************************************************ $$N6 BEGIN ********************************************************** EXTENSION OF COOPERATIVE AGREEMENTS FOR THE MULTICENTER AIDS COHORT STUDY NIH GUIDE, Volume 23, Number 11, March 18, 1994 P.T. 34; K.W. 0715008, 0765033 National Institute of Allergy and Infectious Diseases The National Institute of Allergy and Infectious Diseases (NIAID) has an active interest in the support of research projects addressing epidemiologic, etiologic, and pathogenetic patterns and trends in HIV infection and AIDS in various population groups. Studies are currently supported that focus on minorities, children, mothers and infants, women, and men. One group of these studies is the Multicenter AIDS Cohort Study (MACS), which was initiated in 1983 and is currently supported through cooperative agreements. Because the current awardees have unique access to the study cohorts, study data, and study specimens and have unique expertise with respect the integration of these elements, the NIAID intends to invite applications for competitive renewal of these studies through a competition limited to the current awardess only. One component of the current cooperative agreements (basic research using specimens from study cohorts) will not be included in any resultant awards; such studies will only be supported through open competitions. Although competition for this cooperative agreement study extension is limited, NIAID wishes to call attention to its ongoing interest in applications for prospective studies related to the etiology, pathogenesis, prevention, diagnosis, and treatment of HIV infection and its sequellae. INQUIRIES For further information contact: Lewis K. Schrager, M.D. Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2B10 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-6177 $$N6 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN NHLBI-HC-94-13 ******************************************* EVALUATION OF ISCHEMIC HEART DISEASE IN WOMEN - CLINICAL CENTERS NIH GUIDE, Volume 23, Number 11, March 18, 1994 RFP AVAILABLE: NHLBI-HC-94-13 P.T. 34, II; K.W. 0715040, 0745020 National Heart, Lung, and Blood Institute The National Heart, Lung, and Blood Institute (NHLBI) requires three to five clinical centers to evaluate innovative diagnostic methods that will improve the diagnostic reliability of cardiovascular testing in evaluation of ischemic heart disease in women. Innovative approaches proposed in evaluation of myocardial ischemia should include physiologic or functional measurements such as impaired metabolism, perfusion, or endothelial function as well as assessment of epicardial coronary arteries by angiography. Each clinical center will be fully independent and expected to fulfill all the requirements outlined in the Request for Proposals (RFP). The clinical centers will evaluate diagnostic methods and perform common study protocols, including angiography, on 100 participants annually for three years. The anticipated period of performance is from December 30, 1994 through December 29, 1998. INQUIRIES This is an announcement for an RFP. RFP No. NHLBI-HC-94-13 will be available on or about March 14, 1994 with proposals due May 31, 1994. Three to five awards are anticipated to be made in December 1994. Written requests must cite RFP No. NHLBI-HC-94-13 and include two, self-addressed mailing labels. Requests for copies of the RFP are to be sent to: Donna J. Neal Contracts Operations Branch National Heart, Lung, and Blood Institute Federal Building, Room 3C16 7550 Wisconsin Avenue Bethesda, MD 20892 $$R1 END ************************************************************ $$R2 BEGIN AI-94-010 FULL-TEXT ************************************** MULTICENTER AIDS COHORT STUDY PATHOGENESIS RESEARCH LABORATORY NIH GUIDE, Volume 23, Number 11, March 18, 1994 RFA AVAILABILE: AI-94-010 P.T. 34; K.W. 0715008, 0765033, 1002008, 0710070, 1002019, 1002045 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: April 1, 1994 Application Receipt Date: June 15, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES" BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The Vaccine Trials and Epidemiology Branch (VTEB) of the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID) administers major, prospective studies of HIV infection and disease in large, multicenter cohort studies, including the Multicenter AIDS Cohort Study (MACS). The purpose of this RFA is to fund a laboratory or a consortium of laboratories to study the immunologic, virologic, and other biologic determinants of disease progression, and factors which mitigate HIV-mediated immune system destruction among participants in the MACS. The work to be accomplished requires diverse expertise in HIV virology, immunology, genetics, and molecular biology that must be applied in a highly coordinated manner to adequately address the issues of interest. Proposed studies should utilize an interdisciplinary approach, with well-integrated research plans. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, MACS Pathogenesis Research Laboratory(s), is related to the priority area of HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-10473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit and for-profit research institutions, public and private organizations such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Foreign organizations are not eligible to apply. Domestic applications may not include international components. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Awards will be made as Cooperative Agreements (U01s). Cooperative Agreements are grants awarded to institutions when it is desired to encourage investigator-initiated research in areas of special importance to the NIH. It is an "assistance" mechanism rather than an "acquisition" mechanism, in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. The nature of NIAID staff participation is described in the RFA. Under the RFA, the Principal Investigator(s) assumes prime responsibility for the direction and completion of the research. This RFA solicitation represents a single competition with a specified deadline for receipt of applications. Reissuance of this RFA will be dependent on the state of science and findings at the completion of this cooperative agreement. Awards will be made for a twelve month budget period within a total project period not to exceed four years. The anticipated award date is April 1, 1995. Funding beyond the first and subsequent years of the award will be contingent upon satisfactory performance during the preceding years and upon the availability of funds for this purpose. FUNDS AVAILABLE Approximately $800,000 will be available for funding the total costs, both direct and indirect, for the initial year of awards made pursuant to this RFA. The NIAID anticipates making one or two awards as a result of this RFA. The issuance of the final award or awards will be dependent upon receipt of applications of high scientific merit that cover the range of scientific objectives in a comprehensive manner, and upon the availability of funds. RESEARCH OBJECTIVES The ongoing Multicenter AIDS Cohort Study (MACS), which includes four clinical centers and a data center, is supported by VTEB, CRP, DAIDS, NIAID. Studies of HIV-related malignancy in the MACS are co-funded by the NCI. The MACS was created in 1983 as a study of HIV infection in homosexual and bisexual men; over 5,500 men have been enrolled in the MACS since 1984. MACS study sites are located at Johns Hopkins University, Baltimore, MD; the University of Pittsburgh, Pittsburgh, PA; the Howard Brown Memorial Clinic/Northwestern University, Chicago, IL; and the University of California at Los Angeles in Los Angeles, CA. The Center for the Analysis of MACS Data (CAMACS) is located at Johns Hopkins University in Baltimore, MD. The NIAID intends to renew support for the MACS clinical sites and data center to follow and study selected MACS participants for clinical and laboratory outcomes and to collect specimens for pathogenesis research. The selected participants to be followed will include: (1) HIV-seropositive MACS participants, (2) HIV-seronegative MACS participants at high risk of HIV acquisition based on behavioral assessments, and (3) a limited number of seronegative men who are at lower risk of HIV infection. Blood specimens from MACS participants are obtained every six months, are processed and stored as frozen serum, plasma, and cells in the NIAID HIV Vaccine Trials and Epidemiology Specimen Repository, and will be made available to the MACS Pathogenesis Research Laboratory(s). Prospectively obtained samples of blood and other body fluids and tissues, such as semen and lymph nodes, for specific MACS pathogenesis protocols also may be made available, contingent on study feasibility, obtaining local IRB approval and necessary informed consent, and the agreement of the participants who comprise the MACS cohort. Applications are invited to conduct laboratory investigations on the pathogenesis of HIV infection using clinical specimens from the MACS and emphasizing close integration of the immunologic, virologic, and other biological investigations being planned. Preference will be given for studies of high scientific merit for which the cohort research approach, the use of the unique epidemiologic and clinical laboratory database of the MACS, and the stored MACS specimens from the NIAID HIV Vaccine Trials and Epidemiology Specimen Repository is essential. Each application must address the first of the following two areas of pathogenesis research. Applicants have the option of addressing the second area of pathogenesis research listed below: 1. The identification and characterization of the host immunologic factors and the virologic factors that correlate with the progression and/or non-progression of HIV disease in individuals who maintain high (e.g., above 500 CD4+ cells per microliter), stable CD4+ cell counts despite long periods of HIV infection; 2. The identification and characterization of the host immunologic factors and the virologic factors that correlate with the progression and/or non-progression of HIV disease in individuals who whose CD4+ cell counts decline to low levels (e.g., below 200 CD4+ cells per microliter) but who remain clinically stable for prolonged periods. SPECIAL REQUIREMENTS The MACS Pathogenesis Research Laboratory(s) will propose and conduct the relevant studies in collaboration with the MACS research infrastructure. The Principal Investigator(s) of the MACS Pathogenesis Research Laboratory(s) will be members of the MACS Pathogenesis Steering Committee, responsible for designing and implementing pathogenesis research in the MACS under this RFA. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines On the Inclusion of Women and Minorities as Subjects in Clinical Research." See the RFA for details. LETTER OF INTENT Prospective applicants are asked to submit, by April 1, 1994, a letter of intent that includes a descriptive title of the proposed research; the name, address, and telephone number of the Principal Investigator; the identities of other key personnel and participating institutions (if applicable); and the number and title of this RFA. The letter of intent does not commit the sender to submit an application, is not a requirement for submission of an application, and will not enter into the review of subsequent applications. Letters of intent are to be sent to Dr. Dianne Tingley at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these Cooperative Agreements. These forms are available at most institutional offices of sponsored research; the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248; and from the NIH Program Administrator listed under INQUIRIES. Additional instructions for preparation of applications are provided in the RFA. Applications not received by June 15, 1994 will be returned to the applicant without review. REVIEW CONSIDERATIONS From owner-sci-resources@net.bio.net Mon Mar 21 22:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AI-94-010 - V23(11) 03/18/94 Date: 22 Mar 1994 10:52:39 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 747 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2mnepn$2s5@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AI94010 AI-94-010 P1O1 *************************************** MULTICENTER AIDS COHORT STUDY PATHOGENESIS RESEARCH LABORATORY NIH GUIDE, Volume 23, Number 11, March 18, 1994 RFA: AI-94-010 P.T. 34; K.W. 0715008, 0765033, 1002008, 0710070, 1002019, 1002045 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: April 1, 1994 Application Receipt Date: June 15, 1994 PURPOSE The Vaccine Trials and Epidemiology Branch (VTEB) of the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), administers major, prospective studies of HIV infection and disease in large, multicenter cohort studies. The largest and longest-running of these studies is the Multicenter AIDS Cohort Study (MACS). The MACS was created in 1983 as a study of HIV infection in homosexual and bisexual men; over 5,500 men have participated in the MACS since the initial 1984 enrollment. The National Cancer Institute co-funds MACS studies of malignancy in HIV infection. The purpose of this Request for Applications (RFA) is to fund a laboratory or a consortium of laboratories to study the immunologic, virologic, and other biologic determinants of disease progression and factors that mitigate HIV-mediated immune system destruction among participants in the MACS. The work to be accomplished requires diverse expertise in HIV virology, immunology, genetics, and molecular biology that must be applied in a highly coordinated manner to adequately address the issues of interest. Therefore, proposed studies should utilize an interdisciplinary approach in which the research plans are well integrated and are based on appropriate collaborations. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, MACS Pathogenesis Research Laboratory, is related to the priority area of HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-10473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit and for-profit research institutions, public and private organizations such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Foreign organizations are not eligible to apply. Domestic applications may not include international components. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Successful applicants funded under this RFA will be supported through a National Institutes of Health (NIH) Cooperative Agreement (U01). Cooperative agreements are grants awarded to institutions when it is desired to encourage investigator-initiated research in areas of special importance to the NIH. It is an "assistance" mechanism, rather than an "acquisition" mechanism, in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH will support and/or stimulate the recipient's activity by working jointly with the awardee in a partner role; the NIH will not assume direction, prime responsibility, or a dominant role in the activity. The advantage of the cooperative agreement funding mechanism for this RFA is to ensure coordination of use of valuable research specimens and data derived from the MACS. This coordination is critical due to the finite and irreplaceable nature of the resource of MACS specimens, and the need to do diverse studies on the same samples. Details of the responsibilities, relationships, and governance of the study to be funded under this cooperative agreement are discussed later in this document under the section "Terms and Conditions of Award." The NIAID intends to award one or two Cooperative Agreements for laboratory studies on the pathogenesis of HIV/AIDS in MACS participants. A collaborative and innovative interdisciplinary approach to address the full spectrum of research objectives is essential. Therefore, applicants are encouraged to coordinate, through the use of consortium arrangements or subcontracts, integrated approaches with individuals or institutions having relevant and demonstrated ability in immunologic, virologic, genetic, and other molecular biologic techniques necessary to address the stated objectives. This RFA solicitation represents a single competition with a specified deadline for receipt of applications. The anticipated award date is April 1, 1995. Awards will be made for a twelve month budget period within a total project period not to exceed four years. Funding beyond the first and subsequent years of the award will be contingent upon satisfactory performance during the preceding years and upon the availability of funds for this purpose. Reissuance of this RFA will be dependent on the state of science and findings at the completion of the grant period. FUNDS AVAILABLE Approximately $800,000 will be available for funding the total costs, both direct and indirect, for the initial year of awards made pursuant to this RFA. The NIAID anticipates making one or two awards as a result of this RFA. The issuance of the final award or awards will be dependent upon receipt of applications of high scientific merit that cover the range of scientific objectives in a comprehensive fashion, and upon the availability of funds. RESEARCH OBJECTIVES Background The ongoing Multicenter AIDS Cohort Study (MACS), which includes four clinical centers and a data center, is supported by VTEB, CRP, DAIDS, NIAID. Studies of HIV-related malignancy in the MACS are co-funded by the NCI. MACS clinical centers are located at Johns Hopkins University, Baltimore, MD; the University of Pittsburgh, Pittsburgh, PA; the Howard Brown Memorial Clinic/Northwestern University, Chicago, IL; and the University of California at Los Angeles in Los Angeles, CA. The Center for the Analysis and Management of MACS Data (CAMACS) is located at Johns Hopkins University in Baltimore, MD. The MACS was created in 1983 as a study of HIV infection in homosexual and bisexual men; over 5,500 men have been enrolled in the MACS since 1984. The remarkable dedication of MACS participants and MACS site study staff has resulted in a high retention rate with a loss to follow-up of approximately 20 percent among HIV-infected men after ten years. Because of the continuing unique scientific contributions of this large prospective, multi-site cohort study, the NIAID intends to renew support for the MACS clinical centers and data center to follow and study selected MACS participants for clinical and laboratory outcomes and to collect specimens for pathogenesis research. The selected participants to be followed will include: (1) all HIV-seropositive men who were enrolled in the study as seroprevalent cases or who have seroconverted while in the study, (2) HIV-seronegative men at high risk of HIV acquisition based on behavioral assessments, and (3) a matched subset of HIV-seronegative men who are at lower risk of HIV infection. The NIAID currently plans to follow these MACS participants from the present time through at least 1999. The MACS research infrastructure offers a unique focus for study of HIV pathogenesis including: 1. A ten year prospective cohort study with well documented longitudinal clinical and laboratory outcomes data of HIV infection and disease. 2. A repository of clinical specimens of serum, plasma, and PBMCs that cover the natural history of HIV infection and disease. 3. Extensive clinical, epidemiologic, and statistical expertise within the MACS infrastructure that will be available to assist in the design and analysis of the laboratory studies. Approximately 1,800 men were found to be HIV-seropositive upon initial enrollment in 1984-1985; an additional 350 HIV- seropositive men were enrolled from 1987-1991. Over 450 of the seronegative men have seroconverted while being followed in the MACS. Approximately seventy men have displayed no CD4+ cell loss despite at least nine years of HIV infection (and without receipt of antiretroviral therapy). On the other end of the spectrum, at least twenty men have rapidly developed immunodeficiency disease, developing AIDS within three years of documented seroconversion. Other potentially important variants from the classical pattern of HIV-mediated CD4+ cell decline have been documented among HIV-infected MACS participants, including persons remaining clinically stable for long periods despite very low CD4+ cell counts. Additionally, the MACS follows at least 250 men who did not become infected with HIV despite a history of high-risk sexual behavior. MACS participants are followed at the clinical centers every six months, where they respond to a detailed health questionnaire, receive a physical examination, and have blood specimens taken. Blood specimens are processed and stored as frozen serum, plasma, and cells in the NIAID HIV Vaccine Trials and Epidemiology Specimen Repository. These stored specimens will be made available to the MACS Pathogenesis Research Laboratory. In addition, arrangements may be made with the MACS sites via the NIAID Program Officer to prospectively collect samples of blood and other body fluids and tissues, such as semen and lymph nodes, for specific MACS pathogenesis protocols, and to increase the frequency of follow-up for a small number of participants where necessary. Availability of these additional specimens and ability to increase follow-up frequency will be contingent on study feasibility, obtaining local IRB approval and necessary informed consent, and the agreement of the participants who comprise the MACS cohort. Further information regarding the MACS research infrastructure, cohort organization, sample sizes, MACS publications bibliography, specific characteristics of MACS participants (e.g., men who are rapid progressors, seroconverters, and slow progressors) and specific features of the stored specimens (e.g., numbers, types, prior experience with quality of stored cells) will be provided upon contacting the MACS Program Officer listed under INQUIRIES. Research Scope Additional study of host immunologic, virologic, genetic, and other determinants of HIV infection and disease progression is needed to gain a better understanding of the pathogenesis of HIV/AIDS. This information is crucial for the development of effective therapies for HIV/AIDS and design of vaccines against HIV infection. Accordingly, the NIAID is encouraging intensive broad-based laboratory studies including state-of-the-art and innovative approaches to the study of host and viral factors that contribute to the pathogenesis of HIV infection and disease. Applications are invited from investigators to conduct laboratory investigations on the pathogenesis of HIV infection using clinical specimens available from the MACS. The proposed studies should emphasize close integration of the immunologic, virologic, and other biological investigations being planned. Preference will be given for studies of high scientific merit for which the cohort research approach is essential, including effective utilization of the unique MACS database and the MACS-derived specimens stored at the NIAID HIV Vaccine Trials and Epidemiology Branch Specimen Repository. Each application must address the first of the following two areas of pathogenesis research. Applicants have the option of addressing the second area of pathogenesis research listed below: 1. The identification and characterization of the host immunologic factors and the virologic factors that correlate with the progression and/or non-progression of HIV disease in individuals who maintain high (e.g., above 500 CD4+ cells per microliter), stable CD4+ cell counts despite long periods of HIV infection; 2. The identification and characterization of the host immunologic factors and the virologic factors that correlate with the progression and/or non-progression of HIV disease in individuals whose CD4+ cell counts decline to low levels (e.g., below 200 CD4+ cells per microliter) but who remain clinically stable for prolonged periods. Highly innovative and creative approaches to studying the general areas covered in item (1) above (required) and item (2) above (optional), as well as related issues concerning the study of HIV pathogenesis in MACS participants, are encouraged. Examples of investigations sought through this RFA include, but are not limited to, those listed below: o Studies of humoral antibody responses (e.g., binding, neutralizing, enhancing, ADCC), cell-mediated responses (e.g., cytotoxic T cell activity), and nonspecific immune responses or immunoregulatory events (e.g., lymphokine secretion, natural killer cell activity, apoptosis) that may mediate or protect against immune system destruction or other HIV-related pathology, including characterization of the pattern of responses in the various stages of HIV infection and identification of the specific epitopes of HIV involved; o Studies of viral variables correlated with HIV pathogenesis (e.g., HIV phenotype, viral load, pattern of sequence variation during infection); o Studies of host and viral factors that may explain long-term clinical stability sometimes noted in subjects with low CD4+ cell counts; o Studies of other host factors that enhance viral replication, HIV pathogenesis, (e.g., studies of histopathology, immune dysregulation, genetic susceptibility, etc.) during the course of HIV infection from initial infection through development of disease. SPECIAL REQUIREMENTS A. Cooperation, Collaboration and Meetings The MACS Pathogenesis Research Laboratory(s) will propose and conduct the relevant pathogenesis studies in the areas of research listed above. As work progresses, the Principal Investigator(s) may seek input from the MACS clinical and data centers and the NIAID Program Officer regarding design and implementation of studies. Therefore, to be considered responsive to this RFA, an applicant must include a statement of willingness to work in close cooperation and collaboration with the MACS research infrastructure, whenever this is indicated. The Principal Investigator(s) of the MACS Pathogenesis Research Laboratory(s) will be members of the MACS Pathogenesis Steering Committee established under this RFA. The MACS Pathogenesis Steering Committee will be composed of the Principal Investigator(s) from the MACS Pathogenesis Research Laboratory(s), the Principal Investigators of the MACS clinical sites, the Principal Investigator from the MACS data center, and the NIAID Program Officer. Each member of the Steering Committee will have one vote. The chairperson, who will be someone other than the NIAID Program Officer, will be selected by the Steering Committee. Subcommittees will be established by the Steering Committee as it deems appropriate; the Program Officer will serve on subcommittees as he/she deems appropriate. Awardees will be required to accept and implement the protocols and procedures approved by the Steering Committee. The MACS Pathogenesis Steering Committee will be the primary organization responsible for the coordination of the activities of the MACS Pathogenesis Research Laboratory(s) with the MACS clinical centers and the MACS data center. The NIAID Program Officer will help facilitate coordination of pathogenesis research activities between the MACS Pathogenesis Research Laboratory(s), the MACS clinical centers, and the MACS data center. The MACS Pathogenesis Steering Committee will have monthly conference calls and will meet approximately three times yearly, either in the Washington, DC metropolitan area or in conjunction with national HIV/AIDS scientific meetings. Senior investigators of the MACS Pathogenesis Research Laboratory(s) are also expected to participate as members of the MACS Laboratory Research Working Group, created under this RFA. This group will include senior investigators in the MACS "core" laboratories performing routine laboratory and virology assays at the MACS clinical sites (described in greater detail under "Specimens", below), as well as a representative from the MACS data center. The LRWG will have regular conference calls and two annual meetings per year that usually will be held at one of the MACS clinical sites, or at the site(s) of the MACS Pathogenesis Research Laboratory(s). In addition, senior investigators from the MACS Pathogenesis Research Laboratory(s) will be expected to attend and present data at the Annual Research Meeting of the MACS, which is held in the Rockville, MD area. Applicants should include in their application a statement of their willingness to participate in the required meetings described above and should include funds for these meetings in their budget requests. Note that one of the Pathogenesis Steering Committee meetings and one of the LRWG meetings will be held in conjunction with the annual research meeting of the MACS. B. Specimens MACS specimens for the conduct of studies undertaken by the MACS Pathogenesis Research Laboratory(s) will be provided from the NIAID HIV Vaccine Trials and Epidemiology Specimen Repository. Fresh blood and body fluid specimens, and biopsy and necropsy tissue specimens, will be made available to the MACS Pathogenesis Research Laboratory(s) according to the needs of specific protocols. In special cases when specimens are no longer available from the NIAID HIV Vaccine Trials and Epidemiology Specimen Repository, (e.g., due to their prior usage), the NIAID Program Officer will facilitate the efforts of the MACS Pathogenesis Research Laboratory(s) in obtaining appropriate specimens from the MACS clinical centers. Applicants to this RFA should be aware that the MACS Pathogenesis Research Laboratory(s) will not have sole access to MACS specimens in the NIAID HIV Vaccine Trials and Epidemiology Specimen Repository. MACS specimens also will be made available by the NIAID to independent investigators upon review and approval of requests for specific research purposes. However, the release of MACS specimens for studies to be undertaken by the MACS Pathogenesis Research Laboratories will be based upon an expedited approval process, requiring NIAID Program Officer approval of specimen utilization. Use of MACS samples from the NIAID VTEB Repository will require review and approval by the DAIDS repository review process. The NIAID Program Officer will be responsible for ensuring that the efforts of the MACS Pathogenesis Research Laboratory(s) are compatible with those sponsored by other NIAID groups, particularly the contract anticipated to be awarded in 1994 for "Correlates of Immune Protection in AIDS." Applicants for this RFA also should note that core laboratory studies are conducted by the MACS clinical site laboratories, including quantitation of CD4+ and CD8+ T cell subsets on all MACS participants and HIV serology on all seronegative MACS participants. These data are included in the general MACS epidemiologic and clinical laboratory database and are available for research sponsored under this RFA, through collaboration with the MACS clinical sites and data center as facilitated by the NIAID Program Officer. A list of the specific assays and studies to be performed by the MACS core laboratories is available from the Program Officer listed under INQUIRIES. C. Reporting, Access to Data, and Publication of Research Findings The reporting requirements currently required of all awardees of traditional NIH research project grants will apply to the recipient(s) of this RFA. Program staff will have access to all study protocols and data generated under this cooperative agreement. Awardee(s) will retain rights to the data (see below). All data from the MACS Pathogenesis Research Laboratory(s) that require analysis with other MACS data will be submitted to the MACS data center as facilitated by the NIAID Program Officer. These laboratory data will remain the intellectual property of the awardee from which they originated, even following submission to the MACS data center and will not be used without the permission of the Principal Investigator of the specific MACS Pathogenesis Research Laboratory which generated these data. Data forms and software for transferring laboratory data to the MACS data center will be developed by the data center with the technical assistance of the grantee. Publications of results from MACS Pathogenesis Research Laboratory investigations must make appropriate acknowledgement of contributions made by MACS clinical and data centers. D. Terms and Conditions of Award Consistent with the concept of a cooperative agreement, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardee(s) and the NIAID Program Officer. 1. Awardee Rights and Responsibilities The Principal Investigator(s) of the MACS Pathogenesis Research Laboratory(s) under this RFA will be responsible for the overall conduct of the studies performed at the Principal Investigator's institution or at the subcontracting laboratories within a proposed consortium. This responsibility includes the production of high quality data and the analysis and publication of the research results. 2. NIAID Rights and Responsibilities The NIAID will have substantial scientific-programmatic involvement during conduct of this activity, through technical assistance, advice, and coordination above and beyond normal program stewardship for grants, as described below: The NIAID will assist the Principal Investigator(s) of the MACS Pathogenesis Research Laboratory(s) selected under this RFA through a Program Officer who will be designated by the Chief, VTEB, CRP, DAIDS. The role of NIAID Program Officer will be to facilitate and not to direct the activities of the laboratory investigators funded through this cooperative agreement. The NIAID Program Officer will support and facilitate the performance of research efforts of the laboratory or laboratories selected under this RFA in the following ways: a. by providing ongoing assistance and coordination in overall research planning, data gathering methodologies, analysis, and reporting; b. by providing the assistance of the MACS data center to support the awardee or awardees in areas including statistical and data collection, analysis, and publication; c. by ensuring that coordination of communication and facilitation of information exchange occurs between the laboratory or laboratories selected under this RFA and the MACS clinical sites, the MACS "core" laboratories, the MACS clinical centers, and the MACS data center; d. by releasing relevant MACS specimens from the NIAID HIV Vaccine Trials and Epidemiology Specimen Repository. 3. Collaborative Responsibilities The Principal Investigator(s) of the MACS Pathogenesis Research Laboratory(s) will be responsible for the scientific conduct of these studies. The NIAID Program Officer will be responsible for facilitating these collaborations. The Principal Investigator(s) of the MACS Pathogenesis Research Laboratory(s) will be members of the MACS Pathogenesis Steering Committee established under this RFA. The MACS Pathogenesis Steering Committee will be composed of the Principal Investigator(s) from the MACS Pathogenesis Research Laboratory(s), the Principal Investigators from the MACS clinical sites, the Principal Investigator from the MACS data center, and the NIAID Program Officer. Awardees will be required to accept and implement the protocols and procedures approved by the Steering Committee. Senior investigators of the MACS Pathogenesis Research Laboratory(s) are also expected to participate as members of the MACS Laboratory Research Working Group, created under this RFA. This group will include senior investigators in the MACS "core" laboratories performing routine laboratory and virology assays at the MACS clinical sites, as well as a representative from the MACS data center. 4. Arbitration Any disagreement that may arise on scientific/programmatic matters within the scope of the award, between award recipients and NIAID, may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the MACS Pathogenesis Steering Committee (or by the individual awardee in the event of an individual disagreement), a second member selected by the NIAID, and a third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS Ordinarily, for projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. However, the MACS is a study of homosexual and bisexual men, including men of minority racial and ethnic background. Hence, a specific justification for the absence of women in this study need not be provided. Seven hundred and fifty men of minority background were enrolled in the MACS from 1984-1985. An additional 432 minority men were enrolled in the MACS from 1987-1991 in a targeted effort to enroll men from minority backgrounds in the study. Five hundred and seventy one men of minority background continue to be followed in the MACS; 299 of these men are HIV-seropositive. Applicants are encouraged to include proposals for research projects that best utilize the relatively limited specimens available from minority MACS participants. Biohazard and Biosafety Procedures Applicants should ensure and document that adequate procedures are in place for avoidance of biohazards and enhancing of biosafety. The following reference is available from the Occupational Safety and Health Branch, NIH Division of Safety, telephone 301-496-2960: Richmond JY, McKinney RW, eds. Biosafety in Microbiological and Biomedical Laboratories, 1993. Washington, DC: US Department of Health and Human Services, Public Health Service. HHS Publication no. (CDC) 93-8395. LETTER OF INTENT Prospective applicants are asked to submit, by April 1, 1994, a letter of intent that includes a descriptive title of the proposed research; the name, address, and telephone number of the Principal Investigator; the identities of other key personnel and participating institutions (if applicable), and the number and title of this RFA. The letter of intent does not commit the sender to submit an application, is not a requirement for submission of an application, and will not enter into the review of subsequent applications. The information contained in the letter will be used to allow NIAID staff to estimate the number and scope of applications to be reviewed, and help avoid conflict of interest in the review process. Letters of intent are to be sent to Dr. Dianne Tingley at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these cooperative agreements. These forms are available at most institutional offices of sponsored research; the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594- 7250; and from the NIH Program Administrator listed under INQUIRIES. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face pag