or a study such that important conclusions can no longer be reached, and it may suggest a likelihood that noncompliance will continue without intervention. Continuing noncompliance may also include failure to respond to a request from the IRB to resolve an episode of noncompliance or a pattern of minor noncompliance.
After receiving an allegation, OSP staff will share it immediately with the IRB Chair. The IRB Chair in consultation with OSP staff will conduct an initial assessment of the allegation. If the IRB Chair and OSP staff determine that an allegation or concern is substantiated but it has to do with minor or administrative issues, the IRB Chair or the OSP staff member serving as the HRPP specialist may manage the concern through communications with the principal investigator and/or the complainant.
After an initial assessment, the IRB Chair and HRP Specialist may determine that the noncompliance is not serious or continuing and no additional action is needed, or determine further inquiry and a convening of the full IRB are necessary. If the IRB Chair and HRP Specialist determines that the allegation may be substantiated and may involve serious or continuing noncompliance, the full IRB will convene and decide if further investigation is needed before corrective action is considered. If the allegation is sufficiently substantiated after the initial assessment and further investigation is not needed, the Board will allow the principal investigator to respond to the allegation either by meeting with the IRB or in writing before deciding on and directing corrective action, which may include suspension or termination of IRB approval.
If the IRB decides to pursue an investigation, the IRB Chair in conjunction with OSP staff will appoint an ad hoc subcommittee to conduct the investigation. The ad hoc subcommittee will consist of a minimum of three voting IRB members. OSP staff will also provide a letter to the individual against whom the allegation was raised (if the individual is not the principal investigator, staff will also notify the principal investigator of the project in question) notifying them of the investigation.
The ad hoc committee will gather information pertaining to the nature of the allegation, the approved IRB protocol, and the procedures followed in conducting the study. An IRB representative will interview the complainant or, in cases where the complainant requests anonymity, the individual who received the original allegation will interview the complainant. The ad hoc committee will also interview the principal investigator and, if applicable, anyone else against whom the allegation has been raised. Depending on the nature of the allegation/concern and the information collected during the interviews, the ad hoc committee may interview other individuals. In addition, the committee may examine research data, both published and unpublished; informed consent/assent forms; medical records; inclusion/exclusion criteria; and any other pertinent information. The ad hoc committee, in cases of a credible allegation of serious or continuing noncompliance, will have authority to request an interview with anyone related to the project or request.