Summary of OHRP Determination Letters for 2011

The number of determination letters issued by the Office of Human Research Protections (OHRP) dropped over the past ten years, and 2011 marked the fewest letters since 2000 (earliest year currently listed on the OHRP website).

In 2011, 17 determination letters were published on the OHRP website. Six letters were follow-up correspondence to previous letters, mostly related to alleged non-compliance of researchers. Seven letters responded to reports of alleged non-compliance, and two letters communicated the findings from on-site evaluations. One letter was related to issues with IRB policies and procedures, and one corrected a previous letter. Eighteen different organizations received the letters (four organizations received two letters in 2011, and four letters were written to multiple institutions). Eleven letters concluded with “no further action required,” while six called for a corrective action plan.

Significant findings requiring corrective actions included:

• Policies and procedures lacked sufficient detail.
• “Minor” amendments were not defined.
• Documentation was missing for both criteria for waivers of the consent process and for consent.
• Substantive modifications following conditional approval were not reviewed by the convened IRB.
• The IRB failed to adequately review recruitment materials and process.
• The IRB failed to consider additional protection for vulnerable participants as part of criteria for approval.
• Exempt determinations were incorrect.
• Cases of non-compliance, unanticipated problems involving risks to participants or others, and suspensions and terminations of IRB approval were not reported to OHRP.
• Consent forms did not describe all risks.
• Researchers initiated research without first obtaining consent.
• Researchers failed to report new or increased risks to the IRB or participants.
• Researchers made changes to protocol without approval from the IRB.

Four of the letters went to AAHRPP accredited organizations. One letter followed an on-site evaluation and listed only a “minor procedural problem.” Two letters, initial and follow-up, were to the same organization, concerning allegations of investigator non-compliance. This was determined to be generally unproven, but it led to two minor required actions, which were resolved quickly as acknowledged by the follow-up letter. The fourth letter was written to three organizations; two are currently accredited but were not accredited at the time the research with alleged non-compliance was reviewed. That incident is still an open case.

Reading and analyzing OHRP determination letters can provide useful information on issues that the OHRP is monitoring and on common findings among organizations.