Institutional Review Boards as Guardians of Social Justice in Human Research Patricia M. Alt, Ph.D. Dept. of Health Science Towson University Towson, MD

No Relationships to Disclose Presenter Disclosure Patricia M. Alt, Ph.D. The following personal financial relationships with commercial interests relevant to this presentation existed during the past 12 months: No Relationships to Disclose

Pressures on IRBs What are the pressures on IRB members which might lead to approval of inadequate protocols? An anonymous online survey of IRB members in 2010 asked their perceptions of key areas for concern. Links to the survey were distributed through two listservs, one for Research Administrators and one under the IRBForum.

Responses A total of 114 responses were received. 60% of respondents indicated that their IRB had not experienced “more than usual” pressures to approve protocols, but in response to open-ended questions provided much more nuanced insights.

Has your IRB experienced more than usual pressures to approve some protocols? No=60.5% Sometimes=24.6% Yes=14.9%

Circumstances creating “more than usual” pressures on IRBs 43% of respondents answered this question, with an average of 1.5 answers each Top responses were: Projects which are already funded (19%) Projects done by close colleagues or IRB members (19%)

Additional sources of pressure Protocols from other institutions (14.6%) Keeping a relationship with a particular researcher for the institution (14.6%) Protocols funded by for-profit entities (13%) Principal Investigator prestige and/or clout (6%)

Additional sources of pressure (2) Time constraints (5%) Principal Investigator non-compliance with IRB procedures (3%) Perceptions of the IRB as “too conservative” (3%) Pressure to accept other IRBs’ findings (2%)

Are other IRBs which review the same protocols more or less careful than yours? Yes=75.5% No=10.9% Not Sure=13.6%

Why might differences in IRB review exist? Received 46 open-ended responses. Key findings: Other IRBs are less careful (26%) Don’t know about other IRBs (11%) Variations in institutional & member expertise (11%)

Why might differences in IRB review exist? (2) Flexibility of regulations leads to variation in reviews (9%) Staff knowledge and rigor (7%) Other IRBs are equally careful (4%) Also discussion of variation in perspectives in different types of institution and in international settings

When is it appropriate to defer to another IRB? And when not? This question received 65 open-ended responses Appropriate: When the research is being conducted primarily at another site (41%) Never (18) or Not sure/NA (3) = (33%) When the research fits tightly defined limits & is low risk (9%)

When is it appropriate to defer to another IRB? And when not? Not appropriate: If the other IRB is less stringent (6%) When study is not low risk (5%) If research is being conducted at your site (5%) When there is a real or potential conflict of interest (3%)

Under what circumstances has your IRB found it difficult to ensure truly informed consent? 57 respondents (50%) Leading categories named were: MD-patient or therapist-patient relationships (27%) Teacher-student relationships (19%) $ rewards for participation (17%) Family member involvement (14%) Not an issue (9.5%)

Additional Informed Consent Concerns Identified Other issues raised were: Participant inability to understand consent forms and process (6%) Cultural differences from and/or identification with the researcher (3%) Time pressures (2.5%) Research done in work settings (2.5%)

When research is conducted in treatment settings, does it affect how carefully your IRB scrutinizes it? Yes=45% No=37% Sometimes=18%

In what ways might the setting of research affect IRB scrutiny? 60 participants responded Most common answers: Treatment confusion & potential for coercion in clinical settings (27%) When studying vulnerable populations (25%) No effect due to setting (18%) Ability to provide truly informed consent (10%) Student-teacher situations (5%) Confidentiality concerns (5%) Researcher safety (5%)

Are there differences in oversight depending on the type of IRB? 69 participants responded 41% were unsure 22% thought there were no differences 16% saw case-by-case variations, dependent on institutions, IRB members, or research projects 9% saw large academic institutions as too relaxed on details 7% saw commercial IRBs as more lenient Other responses varied widely

What are the benefits and risks of centralized IRB review of multi-site projects? 66 participants responded 18% were not sure or saw no benefits or risks Benefits: Better coordination/efficiency of review (39%) More rapid approval (20%) More understanding of the underlying scientific concerns (8%) Less time, costs, consent documents (3% each)

What are the benefits and risks of centralized IRB review of multi-site projects? Loss of local control/lack of understanding of population being studied (38%) Central IRBs seen as more lenient (15%) Local IRBs still have to monitor projects for compliance (7.5%) Concerns about time, lack of trust, CIRB independence from sponsors (3% each)

With what type(s) of IRB are you affiliated? 112 respondents (~23% connected with >one IRB) 29.5% Hospital 25% Research-intensive University 24% Regional medical center 19.6% Non-research-intensive College or University 14% Non-profit organization 8% Public agency 5% Free-standing IRB 1% Basic sciences research institute

Key findings so far Respondents were affiliated primarily with universities and/or medical institutions Main pressures identified were connected with maintaining funding, institutional relationships with particular researchers, protocols coming from other institutions, and the influence of for-profit funders. Informed consent concerns particularly focused on researcher-subject relationships and on financial rewards for participation

Key findings so far (2) Research being conducted in clinical settings was identified as possibly subject to treatment confusion and coercion Research on vulnerable populations particularly needed careful IRB scrutiny Concern about loss of local IRB oversight, yet awareness of possible improved efficiency and coordination with central IRB review or with deferral to another IRB

Next steps Revise and expand survey to reflect feedback from this self-selected sample Distribute survey more directly to a representative sample of the 2875 IRB Organizations now registered with the Office of Human Research Protection Clarify the pressures on IRBs and develop methods to reduce their impact