Selecting an Institutional Review Board

1
Selecting an Institutional Review Board other
related topicsRegion/ORD Training Workshop on
Protection of Human Subjects in EPA's Research
and Non-Research StudiesSeptember 2005

• Rebecca L. Calderon, Ph.D, M.P.H.
• Director
• Human Studies Division

2
What is a Federal Wide Assurance (FWA)?

• The Federal Wide Assurance (FWA) is the only type
  of new assurance of compliance accepted and
  approved by OHRP for institutions engaged in
  non-exempt human subjects research conducted or
  supported by HHS. Under an FWA, an institution
  commits to HHS that it will comply with the
  requirements set forth in 45 CFR part 46, as well
  as the Terms of Assurance.
• FWAs also are approved by OHRP for federal wide
  use, which means that other federal departments
  and agencies that have adopted the Federal Policy
  for the Protection of Human Subjects (also known
  as the Common Rule) may rely on the FWA for the
  research that they conduct or support.
  Institutions engaging in research conducted or
  supported by non-HHS federal departments or
  agencies should consult with the sponsoring
  department or agency for guidance regarding
  whether the FWA is appropriate for the research
  in question. There are two versions of the FWA
  and the Terms of Assurance, one of each
  for domestic (U.S.) institutions and
  for international (non-U.S.) institutions.

3
Terms of Federal wide Assurance

• Human Subjects Research must be guided by Ethical
  Principles All of the Institutions HSR
  regardless of funding is subject to ethical
  principles
• Applicability all HSR conducted or supported by
  any federal department or Agency that has adopted
  the Common Rule
• Compliance with Federal Policy for the Protection
  of Human Subjects and Other Applicable Federal
  State, Local or Institutional Laws, Regulations
  and policies EPA 40 CFR part 26
• Written Procedures
• Scope of IRBs Responsibilities
• Informed Consent Requirements
• Requirements for assurances for collaborating
  Institutions
• Written Agreements with Independent Investigators
  Who are not Otherwise Affiliated with the
  Institution
• Institutions Support for the IRB
• Educational training
• Renewal of Assurance (every 3 years)

4
Where to look?

• http//www.hhs.gov/ohrp/assurances/

5
Voluntary accreditation

• The Association for the Accreditation of Human
  Research Protection Programs, Inc. (AAHRPP), is a
  nonprofit organization that works with
  organizations that conduct human research to
  raise the level of protection for research
  participants.  AAHRPP accredits organizations
  that can demonstrate they provide participant
  safeguards that surpass the threshold of state
  and federal requirements. The accreditation
  program utilizes a voluntary, peer-driven,
  educational model. For organizations interested
  in learning more about AAHRPP accreditation,
  visit www.aahrpp.org. 

6
Commercial IRBs

• Specified service contractual service
• Western Institutional Review Board (WIRB)
• Schulman Associates Institutional Review, Inc
• Sterling Institutional Review Board
• Independent Review Consulting, Inc

7
Considerations

• FWA IRB listed (HSD UNC)
• Collaborators
• State/local requirements
• Special populations (Indian Health Service)
• International Studies
• Multiple IRB Primary then concurring
• Fed gtgt State gtgt Local

8
EPA IRB

• Recommendation to HSD to establish IRB - HSPPO
• ORD moving to harmonize
• ORD IRB?
• EPA IRB?
• Uniform and flexible
• HSSRO
• the protection of participants in research
  should be our primary priority

8
9
Miscellaneous

• Messing up?
• Administrative
• Adverse Events
• IRB but no EPA approval
• No approval at all (surveys)
• Reporting requirements IRB and/or HSSRO

10
Miscellaneous

• EPA employee on IPA
• Paper Reduction Act
• Communication
• Individual Consent Form
• Community (Report or Presentation)
• Officials
• Ownership of data
• Protection of confidentiality