The convened IRB may suspend approval of a protocol when it is believed to be in the best interest of participants to stop some or all protocol related activities temporarily. Studies may be suspended, put on hold during an investigation of noncompliance, or following a protocol deviation, adverse event, or unanticipated problem involving risks to participants or others. These protocols are still considered to be active studies and hence require continuing review by the IRB. OSP staff will provide the principal investigator a letter notifying them of the suspension and explaining the reasons for it.
The convened IRB may terminate approval of a protocol when it is believed to be in the best interest of participants to stop protocol related activities permanently. Studies may be terminated following an investigation of noncompliance, protocol deviation, or unanticipated problem involving risks to participants or others. OSP staff will provide the principal investigator a letter notifying them of the termination and the reasons for it.
If approval of study is suspended or terminated, new participants may not be enrolled and no study procedures may take place, except when the IRB determines that continuation of study procedures is in the best interest of currently enrolled participants.
In addition to notifying the principal investigator of the suspension or termination of IRB approval, the OSP will report the suspension or termination to the principal investigator's immediate supervisor, chair, and/or dean, and KSU's designated Institutional Official. In cases of termination, if applicable, the OSP will also notify the funding agency, the OHRP, and the research integrity offices and/or IRBs of any institution that may be collaborating with KSU on the study.
The OSP will be responsible for IRB records in accordance with 45 CFR § 46.115, which states that the University is required to prepare and maintain documentation of IRB activities including the following: