1.5 Responsibilities of the Investigator and Departments

Federal DHHS regulations, policies, and guidance documents describe the role of investigators, illustrating further the principles of mutual trust, collective responsibilities and the nature of decentralized accountability in human subjects research. Researchers must acknowledge and accept their own responsibilities for protecting the rights, privacy and welfare of the human subjects.

The application submitted to the IRB for review must demonstrate full compliance with federal, state, and college regulations and with all components of the Kenyon College Federal-Wide Assurance for the protection of human subjects in research .

Once IRB approval has been obtained, investigators (PI's) must maintain updated records to include the initial application, approval letter(s) from the IRB, modifications requested and approved, continuation or re-approval progress reports, instruments completed, consent forms administered and signed, correspondence related to the study, adverse event reports, if any, etc. These records must be maintained for review or audit by the IRB for a minimum period of three years after official closure of the study. In the case of student PI's, the sponsoring department or program should maintain the records.

Prior to submitting applications to the IRB for review, researchers must present the complete application to their department chair or administrative head to verify that the proposed study has undergone rigorous scientific merit review. The department chair, administrative division head, or other appointed college official must read the IRB application and certify with signature that:

• the study's purposes, rationale, design and methods are clearly stated and are scientifically sound;
• the protocol conforms to the norms, ethical standards and methods of procedure of the scholarly discipline;
• the proposed study involves no known risks to human subjects other than those specified;
• the principal investigator and other researchers are qualified to conduct the proposed study;
• the study facilities and resources are adequate for the safe conduct of the research;
• and the subject population, sampling procedures, and data to be collected are justified and adequate to meet study objectives.

Applications must affirmatively answer each of the departmental review criteria before submission to the IRB. In the case of student PI's, the responsible faculty member supervising the research must also review and sign the statement. The certification statement is part of the main application to the IRB and can be viewed at the "Forms" page of the IRB website.

If the research is approved by the IRB, investigators must obtain documented and legal informed consent from all research participants involved in each protocol, unless the IRB has granted a waiver, exception or alteration as provided for in the federal regulations and described in section 5.3 of this manual. Research investigators must also promptly report any injuries, unanticipated problems or adverse events to the IRB.

All amendments and modifications to a study need IRB approval before they are implemented. If the investigator wants to change anything in the research that would impact the subjects, such as recruitment procedures, key personnel, inclusion/exclusion criteria, research procedures, the informed consent document / process, or data elements collected, the investigator must obtain IRB review and approval prior to implementation of the changes. The only exception are changes necessary to immediately protect subjects' safety, as noted in 21 CFR 56.108(a)(4) and 56.115(a)(1). If an investigator is unsure about reporting changes to the IRB, they should call the IRB office and ask for guidance. The IRB office can also provide investigators with instructions for submitting a request to modify an IRB-approved research.

Progress reports as well as any proposed modifications to previously approved activities must be submitted in writing in the manner prescribed by the IRB.