The protection of the rights and welfare of human subjects in research does not end with the IRB review. Researchers are ultimately responsible for the conduct of their research. Though research responsibility may be delegated to research staff, researchers must maintain oversight and retain ultimate responsibility for the conduct of those to whom they delegate responsibility.
Responsibilities of the investigator include, but are not limited to:
- Obtain IRB approval or an exemption determination before conducting research involving human subjects.
- Do not start Human Research activities until you have obtained all other required institutional approvals, including approvals of departments or divisions that require approval prior to commencing research that involves additional resources. For instance when an investigational drug or biologic is involved, you are required to defer responsibility for accounting, storage and dispensing, etc. to Investigational Drug Services (IDS) Pharmacy.
- Ensure that there are adequate resources to carry out the research safely. This includes, but is not limited to, sufficient investigator time, appropriately qualified research team members, equipment, and space.
- Ensure that Research Staff are qualified (e.g., including but not limited to appropriate training, education, expertise, credentials, protocol requirements and, when relevant, privileges) to perform procedures and duties assigned to them during the study.
- Personally conduct or supervise the Human Research.
- Protect the rights, safety, and welfare of subjects involved in the research.
- Comply with the current protocol as approved by the IRB.
- When required by the IRB, ensure that consent or permission is obtained as required by the protocol and as indicated in your submission.
- Do not modify the Human Research without or implement a planned deviation from the approved protocol without prior IRB review and approval unless necessary to eliminate apparent immediate hazards to subject(s).
- Report to the IRB all required reports within the required reporting timeframe.
- Submit an updated disclosure of financial interests for you and your key research staff within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new financial interest.
- Do not accept or provide payments to professionals in exchange for referrals of potential subjects (“finder’s fees.”)
- Do not accept payments designed to accelerate recruitment that were tied to the rate or timing of enrollment (“bonus payments.”)
- Follow applicable federal department or agency requirements when conducting human subject research funded or supported by that department or agency.