PIs and research staff are required to:
- Protect the rights and welfare of human subjects who participate in research.
- Understand the ethical standards and regulatory requirements governing research activities with human subjects.
- Independently conduct or supervise the research.
- Ensure that all staff, collaborators, and colleagues assisting in the conduct of the study are informed about the study, regulations governing research, and organizational policies.
- Ensure that all research activities have IRB approval and other approvals required by the organization before human subjects are involved.
- Implement the research activity as it was approved by the IRB.
- Obtain the informed consent of subjects before they are involved in the research and document consent as approved by the IRB.
- Maintain written records of IRB reviews and decisions.
- Obtain and keep documented evidence of informed consent of the subjects (or their legally authorized representatives [LARs]).
- Obtain IRB approval for any proposed change to the research plan prior to its implementation.
- Comply with the IRB requirements for timely reporting of unanticipated problems involving risks to subjects or others including adverse events, safety reports received from the sponsor, or data safety and monitoring summary reports.
- Obtain continuation approval from the IRB on the schedule prescribed by the IRB.
- Make provisions for the secured retention of complete research records and all research materials.
- Ensure the confidentiality and security of all information obtained from and about human subjects.
- Verify that IRB approval has been obtained from all participating organizations in collaborative activities with other organizations.
- Notify the IRB regarding the emergency use of an investigational drug or device within five working days (or sooner if required by the IRB’s policies) of the test article’s administration.
- Notify the IRB of any relevant new information that may impact the safety/security of subjects’ health or privacy.
