ccas annual conference: new orleans, la november 11, 2010 the role of deans: regulatory &...
TRANSCRIPT
CCAS Annual Conference:New Orleans, LA
November 11, 2010
The Role of Deans:
Regulatory & Administrative
Responsibilities Michelle Feige, MSWPublic Health Analyst
Division of Education and Development (DED)Office for Human Research Protections (OHRP)
Department of Health & Human Services (DHHS)
Office for Human Research Protections
Presentation Overview
• What is OHRP?
• Regulatory Provisions
• What is Non-Exempt Human Subjects Research?
• Terms of the FWA & Role of Institutional Official
• Compliance
• Contact Information
What is OHRP?
4 4
OHRP’s Organizational Structure
OHRP, Office of the DirectorJerry Menikoff, Director
Melody Lin, Deputy DirectorMichael Carome, Associate Director for Regulatory Affairs
Division of Compliance
OversightKristina Borror
Director
Division of Policy and Assurances
Irene Stith-ColemanDirector
Division of Education and Development
Elyse I. SummersDirector
HHS Kathleen Sebelius, Secretary Other HHS Agencies (FDA, NIH, CDC, etc)
International ActivitiesMelody Lin, Deputy Director
Office of the Assistant Secretary for Health Howard Koh, Assistant Secretary for Health
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Title 45 Code of Federal
RegulationsPart 46
Regulations for Protection of Human Subjects
HHS regulations: Title 45 CFR part 46• Subpart A – basic HHS Policy - “The Common
Rule” or Federal Policy - Basic IRB & informed consent requirements - Other federal departments & agencies have
adopted – FDA has its own
Departments of Agriculture, Energy, Commerce, HUD, Justice, Defense, Education, Veterans Affairs, Transportation, HHS, & Homeland Security. NSF, NASA, EPA, AID, Social Security Administration*, CIA, and the Consumer Product Safety Commission
*only in part
HHS Regulations: Title 45 CFR part 46, cont’d
• Subpart B - Pregnant Women, Human
Fetuses, and Neonates
• Subpart C - Prisoners
• Subpart D - Children
• Subpart E – IRB Registration (effective
7/2009)
Other Regulatory Entities…
FDA Regulations
Other Dept/Agencies
State and Local Laws
Institutional Policies
The Regulations Apply When:
Research involving human subjects conducted or supported by HHS that is not otherwise exempt
-OR-
Non-exempt human subject research
covered by Assurance of Compliance
Do the Regulations Apply?
1. Does activity involve Research?
2. Does research involve Human Subjects?
3. Is human subjects research Exempt?
ASK QUESTIONS IN THIS ORDER!
What is Research?
Research - a systematic
investigation designed to
develop or contribute to
generalizable knowledge
includes research
development, testing,
evaluation, e.g., pilot studies
§46.102(c)
Where Can You Find Help?
• Human Subject Regulations Decision Chartshhs.gov/ohrp/humansubjects/guidance/
decisioncharts.htm
• FAQs on Quality Improvement Activitieshhs.gov/ohrp/qualityfaq.html
• Guidance on Engagement in Human Subjects Researchhhs.gov/ohrp/humansubjects/guidance/engage08.html
CALL US!!!
Basic Protections
AB
C
Assurance of Compliance
Institutional Review Board
Legally EffectiveInformed Consent
Terms of the Federalwide Assurance (FWA) and the Institutional Official’s Role
Are you an Institutional Official?
If so, do you know the Terms of the Assurance (FWA)?
Responsibilities of Institutional
(FWA Signatory) Officials• Providing sufficient resources, space, and staff to
support the IRB's review and record keeping duties
• Setting the "tone" for an institutional culture of respect for human subjects
• Ensuring that investigators fulfill their responsibilities
• Implementing appropriate oversight mechanisms to ensure compliance with HHS regulations and effective administration of the HRPP
Common Determinations of
Non-Compliance
What should you worry about?
Percentage of Citations of Noncompliance and Deficiencies
34
20
15
5 5 InformedConsent
IRB InitialReview
Written SOP
IRB Reviewof ProtocolChanges
ContinuingReview
Solutions to Correct/Prevent Noncompliance
EducationAdequate IRB staff and resourcesAdequate IRB documentation (in
particular, adequate minutes of IRB meetings)
Periodic self-assessment of institutional system for protecting human subjects & self reporting
Adequate written procedures
What Can Happen?
Restriction SuspensionTermination
of FWA
Institution/IO Held Responsible, Not IRB
Common Areas of Noncompliance-Reference
Recent Compliance Oversight Determinations:
http://www.hhs.gov/ohrp/compliance/findings.pdf
Determination letters: http://www.hhs.gov/ohrp/compliance/letters/index.html
Key Points
Know what the regulations are and when they apply
Understand your responsibilities under the regulations and your Federalwide Assurance
Be compliant
Keep in touch!
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Contact Information
OHRP website: http://www.hhs.gov/ohrp/
OHRP telephone: 1-866-447-4777
OHRP e-mail: [email protected]
JOIN THE OHRP LISTSERV!
Michelle Feige: Telephone: 240-453-8207
E-mail: [email protected]