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Investigation of Problems/Noncompliance

Investigation of Problems and Noncompliance:

If any member of the IRB receives information about injuries to participants, unanticipated problems involving risk to participants or others, or serious noncompliance, through a source other than the PI or co-PI, he or she will immediately inform the IRB Chairperson and OSRP. The IRB Chairperson may temporarily suspend IRB approval for a study, pending investigation by the OSRP and further IRB review, after learning of the problem, adverse effect, or noncompliance. 

A subcommittee of the IRB consisting of the IRB Chairperson, an IRB member or alternate who is the community representative, and another IRB member, who holds tenure and is outside the PI’s department, will investigate the allegation of a problem involving risk to participants or others, an adverse effect, or noncompliance.  The IRB Chairperson will request an interview with the individual(s) alleging the problem, adverse effect, or noncompliance. The IRB Chairperson will share the results of this interview or written correspondence with the other members of the ad hoc committee, and they will decide how to proceed.  The IRB Chairperson will notify the PI in writing within 5 working days that an allegation of problem, adverse effect, or noncompliance was received.  Following the interview or upon receipt of a written allegation, the IRB Chairperson will request an interview with the PI and any other researchers involved, in order to assess the situation, require changes in the protocol, if necessary, and resolve the issues without further official action. The committee members will decide if both need to be present at the interview with the PI and other researchers involved. If the ad hoc committee members are not satisfied with the results of the initial interview with the PI, they may expand the investigation. The ad hoc committee members may interview the research staff and any other persons who have relevant information, including research participants. The committee will produce written summaries to the interviewed parties for comments, and written comments received will be included in the record of the investigation.

The committee will prepare a report which includes a description of the investigative activities, how and from whom information was obtained about the problem(s), a list of those interviewed, a summary of records obtained, findings, basis of findings, and actions taken.  Before the report is shared with the IRB, identifying information which may put the individual making the allegation at risk may be removed.  The final report, which contains all identifying information, will be filled with confidential project records.

The PI’s Department Head, other appropriate University Administrative officials, OHRP, and funding agency (if applicable) officials will be notified if problems are confirmed by the ad hoc committee.