IRB Member Conflicts of Interest

1
IRB Member Conflicts of Interest

• (Your CoI not Investigator CoI)

2
What do these legal cases have in common?

• 1974 Prisoners at MD State Penitentiary v State
  of MD
• 1983 Head v Volloton
• 2001 Robertson v McGee

3
IRB members were named as defendants
4

• Code of Federal Regulations
• TITLE 45--PUBLIC WELFARE SUBTITLE A--DEPARTMENT
  OF HEALTH AND HUMAN SERVICES
• PART 46_PROTECTION OF HUMAN SUBJECTS
• Sec. 46.107 IRB membership.
• Each IRB shall have at least five members
• (b) Every nondiscriminatory effort will be made
  to ensure that no IRB consists entirely of men or
  entirely of women
• (c) Each IRB shall include at least one member
  whose primary concerns are in scientific areas
  and at least one member whose primary concerns
  are in nonscientific areas.
• (d) Each IRB shall include at least one member
  who is not otherwise affiliated with the
  institution
• (e) No IRB may have a member participate in the
  IRB's initial or continuing review of any project
  in which the member has a conflicting interest,
  except to provide information requested by the
  IRB.
• (f) An IRB may, in its discretion, invite
  individuals with competence in special areas to
  assist in the review of issues which require
  expertise beyond or in addition to that available
  on the IRB. These individuals may not vote with
  the IRB.

5
Its all about relationships
IRB Member
The Researchers
The Research Sponsor
Subjective
The Research

• Financial
• Employment
• Personal
• Collegial
• Appearances

Sources of IRB Member CoI
6
IRB Management of CoI(Principals)

• Disclosure and Documentation
• Recusal
• Affirming absence of CoI

7
IRB Management of CoI(Procedures)

• Member identifies potential CoI from
  agenda/protocols
• Member either recuses her/himself or discloses
  specifics of potential conflict
• IRB Chair renders final decision on whether or
  not significant conflict exists (assumes recusal)
  and whether or not to ask the conflicted member
  to provide info

8
IRB Management of CoI(Procedures, contd)

• IRB minutes and records reflect all disclosed
  conflicts (no details) and details of
  disclosures where the conflicted IRB member
  provides info at the IRBs request
• Where appropriate, Consent Forms adequately
  disclose CoI to participants and inform
  participants of associated risks