Information regarding noncompliance in human participant studies may come to the attention of the IRB through several pathways. These include information contained in new applications, continuing reviews, adverse experience reports, reports from collaborators, employees, participants, or others.
The IRB Chair reviews allegations of noncompliance.The IRB Chair makes a determination as to whether the alleged practices appear to (1) cause injury or any other unanticipated problems involving risks to participants or others, or (2) constitute serious or continuing noncompliance with IRB determinations or federal regulations. In such cases, the IRB Chair shall notify the Vice Provost for Graduate Studies and Research (or designated Institutional Official) and suspend the study procedures pending a timely investigation and review.
Investigations of allegations of noncompliance brought to the IRB focus on the protection of study participants. In cases that involve allegations of research misconduct, the IRB Chair contacts the Vice Provost for Graduate Studies and Research (or designated Institutional Official) for further action. This does not preclude the IRB Chair or any member of the IRB from independently contacting the Research Compliance Office about any allegation of research misconduct.Inquiries or investigations into research misconduct do not preclude IRB review and actions. Depending on the nature of the incident, an ad-hoc committee may be established by the Vice Provost for Graduate Studies and Research.
Listed below are the recommended procedures for resolving alleged noncompliance:
- When made aware of a potential problem, the Research Compliance Office staff compiles information and presents concerns to the IRB Chair.
- The IRB Chair determines whether to pursue the matter with the PI via telephone call, e-mail, memorandum, or in person.
- The purpose of such contact is fact-finding, i.e., to determine whether the problem is intentional, unintentional and/or the result of mistake or oversight.
- Care is taken to maintain confidentiality when leaving messages for the PI via voice mail or with secretarial and support staff.
- The IRB Chair documents the outcome of any and all communications and discussions in writing, by either e-mail or memorandum with a copy to the IRB files. Such documentation should be factual and objective, and include timelines for resolution (e.g. meeting dates, response deadlines).
- When the initial inquiry does not result in resolution of the matter, a meeting with the PI is scheduled as soon as possible
- Any discussions and effort to achieve resolution are documented in the IRB files, and presented to the IRB by the IRB Chair.
- When a review of relevant documents and meetings as described above do not lead to resolution, the IRB Chair schedules a review by the full IRB at the next available meeting.
- If a quorum of IRB members are present, and after discussion, the IRB shall determine appropriate actions.
- The IRB has the authority to suspend or terminate IRB approval of protocols that are found to be non-compliant with institutional policies and procedures, state laws, and/or federal laws or regulations.
- Other sanctions recommended to the Vice Provost for Graduate Studies and Research by the IRB may include, but are not limited to the recommendation of routine compliance audits, letters of reprimand, and restrictions on serving as an investigator on human participants protocols.
- The IRB sends written notification of actions taken to the PI with copies to the Vice Provost for Graduate Studies and Research (or designated Institutional Official).