The Federal-Wide Assurance with OHRP/DHHS details the relationship of Kenyon College and the Office for Human Research Protections within DHHS. This agreement and other DHHS policies empower the IRB with the authority to review, approve, require modification in, or disapprove research activities conducted by Kenyon College investigators, including jurisdiction over proposed changes in previously approved human subjects research.
For approved research, the IRB also determines which activities require continuing review more frequently than the maximum interval of twelve months.
IRB decisions and requirements for revisions, if any, are conveyed to investigators in writing, with the provision of an opportunity for appeal to the IRB by the investigator in the case of disapproval. Although research may receive IRB approval, the department chair or other administrative officials may conclude that the research project does not meet the policies and goals of the college and may disapprove, suspend, or terminate a project. However, IRB decisions to require modifications in, disapprove as submitted, suspend or terminate a project are final. Further, no committee or official can approve an investigator to conduct any human subjects research that the IRB has not approved. [See 45 CFR 46.112 .]
The IRB must insure that voluntary informed consent will be obtained by research investigators and their staff in a manner that meets the requirements of Title 45 Code of Federal Regulations Part 46, sections 116 and 117. (See section 5.0 of this manual, Informed Consent: Process and Documentation.)
The IRB holds the authority to observe or have a third party observe the consent process when deemed necessary. IRB approval means that the research has been reviewed and may be conducted within the constraints set forth by the IRB and by other institutional and federal requirements.