reviewed by a convened meeting, depending on the nature of the problem.
OHRP guidance indicates that when reviewing a report of an unanticipated problem, the IRB should consider whether the affected research protocol still satisfies the requirements for IRB approval. In particular, the IRB should consider whether risks to subjects are still minimized and reasonable in relation to the anticipated benefits, if any, to the subjects and the importance of the knowledge that may reasonably be expected to result. At the conclusion of its review, the IRB may require that corrective actions be taken or that substantive changes be made to a protocol.
Examples of corrective actions or substantive changes that the IRB may consider in response to an unanticipated problem include: changes to the research protocol initiated by the investigator prior to obtaining IRB approval to eliminate apparent immediate hazards to subjects; modification of inclusion or exclusion criteria; implementation of additional procedures for monitoring subjects; suspension of enrollment of new subjects; suspension of research procedures in currently enrolled subjects; modification of informed consent documents to include a description of newly recognized risks; and provision of additional information about newly recognized risks to previously enrolled subjects.
When reviewing a report of an unanticipated problem, the IRB may also determine that the incident, experience, or outcome does not meet all three criteria for an unanticipated problem. In such cases, further reporting to appropriate institutional officials, funding agencies, and/or OHRP would not be required.
Once the IRB has reached a decision in response to an unanticipated problem, OSP staff will provide the investigator with a summary of the IRB's evaluation and decision in writing. OSP staff will be responsible for providing a report about any adverse event that qualifies as unanticipated problem to KSU's Provost (or an another official designated as KSU's Institutional Official for the purposes of the FWA) in cases in which the event is related to research participation, presents greater risk to human subjects, and exceeds the frequency of occurrence initially anticipated in the research. If applicable, the OSP staff will also provide a report about the event to the funding agency and OHRP.
The ethical conduct of research is a shared responsibility, requiring cooperation, collaboration, and trust among investigators, the participants who enroll in research, IRB members, and OSP staff. As the body responsible for ensuring the protection of the rights and welfare of research subjects at KSU, the IRB addresses allegations of noncompliance with IRB requirements and/or federal regulations.
Anyone, including research participants, may submit concerns or allegations having to do with noncompliance involving human subjects research to the OSP verbally or in writing. OSP staff and the IRB may also identify concerns regarding noncompliance during the continuing review process. The OSP and IRB will maintain confidentiality regarding the