Distribution of Meeting Materials
- The committee meeting agenda and review materials will be distributed to the IRB committee members at a minimum of five days prior to the scheduled IRB committee meeting. Due to the nature of the information reviewed by Committee F, which may require immediate attention, the five day minimum will not apply to this committee.
- The agenda indicates:
- The meeting date, time and location;
- Educational topics for discussion;
- Conflict of interest disclosure;
- Previous meeting minutes for review;
- A listing of previously approved expedited research proposals, full board studies and full board modifications;
- Reportable New Information;
- New proposals, modifications, and continuing reviews, as applicable
- All members will have access via laptop to the complete submission for IRB review which includes the following, when applicable:
- PittPRO application;
- Continuing Review Report Form;
- Amendment Cover Sheet;
- Investigator written or sponsor-provided protocol;
- Investigator Brochure
- Informed consent documents;
- Recruitment materials to include advertisements, flyers, phone screening procedures, scripts, and/or screening questions;
- Measures that will be utilized in the study, e.g. survey instruments, questionnaires, interview scripts, recruitment material, etc.;
- Documentation of scientific review;
- Applicable ancillary review approvals;
- Grant application
- Other materials specific to the proposed study
Review of Materials Prior to the Meeting
- Vice Chairs and assigned reviewers are expected to conduct an in-depth review of all materials in advance of the meeting. Reviewers are provided with access to the IRB Reviewer Checklists as a guide to ensure inclusion of the regulatory criteria and informed consent requirements that must be met as per 45 CFR 46.111 and/or 21 CFR 56.111 . In addition, assigned reviewers are expected to evaluate informed consent documents from the perspective of addressing the required and additional elements of informed consent addressed under 45 CFR 46.116 and/or 21 CFR 50.20 and any other relevant ethical or compliance considerations.
- Reviewers are encouraged to document concerns through the use of the Reviewer Sheet. However, review information can also be documented in PittPRO through a note. All reviewer comments will be taken into consideration at the meeting and included in the minutes, if applicable.
- In addition to reviewing the above material, the primary reviewer will also be responsible for ensuring general consistency between (where applicable) the PittPRO application, sponsored protocol and/or investigator brochure.
- Committee members who are not assigned as reviewers are expected to review the provided materials in advance of the meeting in enough depth to be familiar with the materials and prepared to discuss them at the meeting.