Belinda Seto, Ph.D.

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3rd Annual Medical Research Summit
Human Subjects Research Enhancements Awards
Belinda Seto, Ph.D. Acting Deputy Director for
Extramural Research National Institutes of Health
Renaissance Marriott Hotel Washington D.C. March
5-7, 2003
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TOPICS

• Background
• Opportunity
• Status
• Next steps
• More information

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BACKGROUND
Institutions Conducting Clinical Research
Involving Human Subjects

• Under increasing scrutiny in recent years
• Institutions now facing increasing demands
• for those conducting research
• Oversight
• Enhanced protections
• Increased education

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BACKGROUND
Institutions Conducting Clinical Research
Involving Human Subjects

• Institutional Responsibilities

• Ensure greater patient protection
• Promote patients rights and understanding
• of research
• Train investigators in ethical and scientific
• aspects of human subjects research

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BACKGROUND
Institutions Conducting Clinical Research
Involving Human Subjects

• Consequence of additional procedures
• and safeguards
• Creates burden for institutions in providing
• adequate resources

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OPPORTUNITY
NIH resources available to strengthen grantee
institutions efforts to protect their human
research subjects.
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OPPORTUNITY
Human Subjects Research Enhancement Award (S07)

• Short-term support to address
• institutional resource needs
• New human advocacy programs
• Improve/expand existing programs
• Strengthen oversight of human subjects
• research

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PURPOSE
Human Subjects Research Enhancement Award

• Infrastructure support for managing all
• aspects of clinical studies
• Activities to strengthen oversight of human
• subjects research and enhance protection of
• research subjects

KEY Sustainability of projects once
award period ends
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PROGRAM DESCRIPTION
Human Subjects Research Enhancement Award
Scope of Activities (examples)

• Educational initiatives for investigators,
• administrators and IRB members --
  safe/ethical
• conduct of clinical research
• Development of tracking systems for monitoring
• -- adverse event reporting
• -- human subjects protocols and clinical
  sites
• Systems for coordinating activities of multiple
  IRBs

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STATUS
Human Subjects Research Enhancements Award

• RFA Issued (Receipt Date May 7, 2002)
• http//grants.nih.gov/grants/guide/rfa-files/RFA-O
  D-02-003.html
• Sponsored by NIH I/Cs that support clinical
  research
• Pilot to support 174 institutions
• --receive significant NIH support for clinical
  research
• Applications reviewed for adherence to
  guidelines
• and cost allowability
• Funds transferred from sponsoring ICs to NCRR
• (administering awards )

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STATUSScope of Activities Funded
Sites
Total Sites
HUMAN SUBJECTS AND ETHICS-RELATED EDUCATIONAL
INITIATIVES, PROGRAMS, OR WEB SITES FOR PIs,
IRBs INFRASTRUCTURE, PROGRAMS, TECHNICAL
DEVELOPMENT FOR TRACKING SYSTEMS FOR MONITORING
ADVERSE EVENTS WEB SITES, INFRASTRUCTURE OR
EQUIPMENT TO FACILITATE IRB OR MULTIPLE
IRBs. TOOLS TO LINK IRBs, COMPLIANCE, CONFLICT OF
INTEREST, DATA SAFETY MONITORING BOARDS SYSTEMS
FOR SECURITY OF HUMAN SUBJECTS DATA MANUAL TO
AUTOMATED DATA MANAGEMENT ENHANCE OR IMPROVE
EXISTING HUMAN SUBJECTS MONITORING PROCESS
82 50 63 19 12 56
58 35 44 13 9 39
S07 SITES MAY HAVE MULTIPLE SCOPE OF ACTIVITY
PROJECTS
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STATUSScope of Activities Funded (cont.)
Sites
Total Sites
PROVIDE NETWORKING OR LINKS BETWEEN MULTIPLE IRBs
OR STUDY SITES WEB-BASED SUBMISSION, REVIEW,
TRACKING OF PROTOCOLS AND IRB MONITORING
PROGRAMS FOR ASSESSMENT, EVALUATION AND/OR
INDEPENDENT OVERSIGHT EDUCATION OF
PARTICIPANTS COMMUNITY OUTREACH, EDUCATION AND
SPEAKERS VIDEO AND/OR TELECONFERENCING
INFRASTRUCTURE
38 64 31 9 15 13
27 45 22 6 11 9
S07 SITES MAY HAVE MULTIPLE SCOPE OF ACTIVITY
PROJECTS
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STATUSScope of Activities Funded (cont.)
OTHER S07 RR18123-01 Develop policies and
administrative support to accomplish "local
concept review" of protocols to be conducted in
developing countries, using informants such as
Peace Corps volunteers, graduate students or
missionaries from the relevant countries. S07
RR18213-01 Train groups in Africa and Asian
regional offices using new human subjects
research ethics curriculum and then to offer
Train the Trainer sessions. Additional
components of application is to translate the
human subjects curriculum into Chinese
S07 SITES MAY HAVE MULTIPLE SCOPE OF ACTIVITY
PROJECTS
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NEXT STEPS
Human Subjects Research Enhancement Award

• Grantees to meet in D.C. to share information
• Types of initiatives
• Challenges encountered
• Successful strategies

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FOR MORE INFORMATION
Human Subjects Research Enhancement Award Website

• Provides access to community of
• awardee activities
• Chat room (grantees only) to promote
• exchange of ideas and progress

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http//grants1.nih.gov/grants/policy/hsrea/hsrea.h
tm
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CONCLUSION
Grantee institutions can benefit from NIH Human
Subjects Research Enhancement Awards to enhance
their efforts to protect their human research
subjects.