Collaborations in Human Subject Research: Considerations of Investigator and IRB Responsibilities OH

1
Collaborations in Human Subject
Research Considerations of Investigator and
IRB Responsibilities OHRP VCU
ConferenceSeptember 16, 2008Richmond, Virginia

• Rosemary H. Kelso, MSWDirectorOffice of
  Research Subjects ProtectionVirginia
  Commonwealth University

Betsy C. Conner, CIPManagerOffice of Research
Subjects ProtectionsEastern Virginia Medical
School
2
Topics

• Terms of Federalwide Assurance
• Define the terms collaborating institution and
  independent investigator
• Engagement of the collaborating institution in
  the research
• Effect of various types of funding
• IRB Review
• Designation of IRB on the Assurance
• IRB Authorization Agreement
• Independent Investigators
• Other Issues

3
Terms of the Federalwide Assurance

• Requirement for Assurances for Collaborating
  Institutions
• Written Agreements with Independent Investigators
  Who are not Otherwise Affiliated with the
  Institution

4
Definitions

• Define a collaborating institution
• Legal entity of your institution
• By agreement, etc.
• Define an independent investigator
• Employment
• Faculty status, etc.

5
Is a site engaged in research?

• (OHRP Guidance, Engagement of Institutions in
  Research, January 26, 1999)
• An institution becomes "engaged" when its
  employees or agents1 (i) intervene or interact
  with living individuals for research purposes or
  (ii) obtain individually identifiable private
  information for research purposes 45 CFR
  46.102(d),(f).
• An institution is automatically considered to be
  "engagedwhenever it receives a direct HHS award
  to support such research. In such cases, the
  awardee institution bears ultimate responsibility
  for protecting human subjects under the award.

6
Effect of funding

• Direct federal funds
• Subcontracts
• Non-federal (industry) funds

7
IRB Review

• Given the Terms of Assurance and the desire to
  facilitate research at the institution, an
  institution may want to consider
• Allowing another institution to rely on its IRB
  review of the protocol
• Deferring to another institutions IRB
• Review by both institutions
• Covering independent investigators who are not
  otherwise affiliated with an institution under
  your institutions Federalwide Assurance

8
Designation of IRB

• List IRB on the FWA of applicable institution
• Complete an IRB Authorization Agreement
• All human subjects research
• Specific protocol(s)
• Other
• Signatory officials

9
Independent Investigators

• Working with collaborating investigators
• Commitment Statement of an Individual
  Investigator to Institutional Human Subject
  Protection Policies and IRB/IEC Oversight (OHRP
  sample Individual Investigator Agreement 1/6/2005)

10
Other issues to consider

• Is there value to research subjects?
• Level of risk.
• Where are potential subjects to be enrolled?
• Who will conduct consent and enroll?
• Level of investigator oversight, especially
  across sites.
• Does the collaborating institution require human
  research protection training? If so, what type?

11
Other issues to consider

• Any previous compliance issues for the
  collaborating institution? Previous experience
  with site?
• Location of the collaborating institution to the
  IRB.
• Compliance program available at either
  institution?

12
Other issues to consider

• Does an IRB with oversight already exist?
• What is the involvement of the independent
  investigator(s)?
• Liability issues for IRB / Institution?
• Other institutional policies that may be
  applicable (even if/when federal requirements are
  not).

13
(No Transcript)