In addition to the requirements described elsewhere in this manual and in the Toolkit library, you are responsible for the following after you receive IRB approval:

1. Do not start human research activities until you have the final IRB approval letter.
2. 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 their resources.
3. 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.
   1. Delegate responsibility to the research staff in accordance with the staff’s training and qualifications.
   2. Assure that all procedures associated with the research are performed, with the appropriate levelof supervision, only by individuals who are licensed or otherwise qualified to perform them.
   3. Monitor the research study and perform quality management activities to ensure the protection of subjects and the quality of the research data.
4. Obtain the legally effective informed consent from human subjects or their representatives, using only the currently approved informed consent documents, and provide a copy to the subject, if applicable.
   1. Ensure that only IRB-approved investigators obtain informed consent from potential subjects.
5. If unavailable to conduct this research personally, as when on sabbatical leave or vacation, arrange for another IRB-approved investigator on this study to assume direct responsibility, or notify the IRB of alternate arrangements
6. Maintain accurate and complete research records, including but not limited to, entire copies of signed informed consent and authorization documents (original, wet-ink version is required when study is FDA regulated), and retain these records according to IRB policy and the applicable regulatory retention terms.
7. Fully inform the IRB of all locations in which human subjects will be recruited for this project and obtain and maintain current IRB approvals/letters of agreement when applicable
8. Update study personnel; see “Update Personnel.”
9. Personally conduct or supervise the human research. Recognize that the investigator is accountable for the failures of any study team member.
   1. Conduct the human research in accordance with the relevant current protocol as approved
      by the IRB, and in accordance with applicable federal regulations and local laws.
   2. When required by the IRB ensure that consent or permission is obtained in accordance withthe relevant current protocol as approved by the IRB.
   3. Do not modify the study or project without prior IRB review and approval unless necessary to eliminate apparent immediate hazards to subject.
   4. Protect the rights, safety, and welfare of subjects involved in the research.
10. Submit to the IRB:
    1. Proposed modifications to the approved research, as described in this manual. (See “How to Submit a Change” and “Change Requirements”)
    2. If required, a continuing review application asrequested in the approval letter. (See “Continuing Review Requirements”)
11. Report any of the information items listed in “Reportable Event Requirements.”
12. Submit an updated disclosure of financial interests within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new financial interest.
13. Do not accept or provide payments to professionals in exchange for referrals of potential subjects (“finder’s fees.”)
14. Do not accept payments designed to accelerate recruitment that were tied to the rate or timingof enrollment (“bonus payments.”)
15. See additional requirements of various federal agencies in this manual’s appendices. These represent additional requirements and do no override the baseline requirements of this section.
16. If the IRB directs or your study is selected for an onsite post-approval review, cooperate with post-approval monitoring staff to complete the onsite review.
17. If the study is a clinical trial and supported by a Common Rule agency, one IRB-approved version of a consent form that has been used to enroll participants must be posted on a public federal website designated for posting such consent forms. The form must be posted after recruitment closes, and no later than 60 days after the last study visit. Please contact the study sponsor with any questions.