In addition to the requirements described elsewhere in the Investigator Manual and in the Toolkit library, you are responsible for the following after you receive IRB approval:
- Do not start human research activities until you have the final IRB approval letter.
- 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.
- 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.
- Delegate responsibility to the research staff in accordance with the staff’s training and qualifications.
- Assure that all procedures associated with the research are performed, with the appropriate level of supervision, only by individuals who are licensed or otherwise qualified to perform them.
- Monitor the research study and perform quality management activities to ensure the protection of subjects and the quality of the research data.
- 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.
- Ensure that only IRB-approved investigators obtain informed consent from potential subjects.
- 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
- 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.
- 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
- Update study personnel
- Personally conduct or supervise the human research. Recognize that the investigator is accountable for the failures of any study team member.
- 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.
- When required by the IRB ensure that consent or permission is obtained in accordance with the relevant current protocol as approved by the IRB.
- Do not modify the study or project without prior IRB review and approval unless necessary to eliminate apparent immediate hazards to subject.
- Protect the rights, safety, and welfare of subjects involved in the research.
- Submit to the IRB:
- Proposed modifications to the approved research
- If required, a continuing review application as requested in the approval letter.
- Report any information items as listed within the Investigator Manual.
- 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.
- 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 timingof enrollment (“bonus payments.”)
- See additional requirements of various federal agencies as listed with Appendix A of the Investigator Manual. These represent additional requirements and do no override the baseline requirements of this section.
- If the IRB directs or your study is selected for post-approval review, cooperate with post-approval monitoring staff to complete the review.
- 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.
Amendments
You must report planned changes in a study and receive approval from the IRB prior to implementing these changes, except where necessary to eliminate apparent immediate hazards to the subjects.
Since some changes to research previously determined to be exempt may alter either the category(ies) under which the exemption was granted or require that the project be reviewed under a different review process, certain amendments to these applications need to be submitted as changes.
Protocol amendment requests are submitted within the eProtocol system.
Continuing Review
If your study requires continuing review, you must submit your continuing review no later than 30 days prior to the last day of approval to allow sufficient time for IRB review. If the approval of human research expires because you have failed to submit the continuing review application or you submitted the continuing review application without enough time for IRB review prior to expiration, all human research procedures related to the protocol or study under review must cease, including recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collection or analysis of private identifiable information.
Continuing review applications are submitted within the eProtocol system.
Reporting Requirements
What is Reportable New Information?
Reportable New Information (RNI) is a catch-all category that includes any event (i.e., an accident, experience, new information or outcome) that occurs during the course of a study that may:
- Place human subjects or others at a greater risk of harm,
- Adversely affect the safety, rights or welfare of human subjects,
- Compromise the quality or integrity of the research data,
- Significantly adversely affect the Human Research Protection Program (HRPP), or
- Represent a pattern of on-going non-compliance.
Reportable New Information must be promptly reported to the IRB. Report of information items are submitted via use of the Report form in eProtocol.