Distribution of Meeting Materials
- The committee meeting agenda and review materials for both paper and electronic submissions 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 and approval;
- previously approved exempt/expedited research proposals, full board studies and full board; modifications for review;
- adverse event information to be reviewed;
- new proposals, modifications, renewals, and other unanticipated problems.
- Electronic Submissions (New Projects, Reconsidered Projects, Renewals, Renewals with Modifications and Modifications for studies initially submitted through the OSIRIS system)
All members will have access via laptop to the complete submission for IRB review which includes the following, when applicable:
- OSIRIS protocol application;
- Renewal Report Form;
- Modification Cover Sheet;
- investigator written or sponsor-provided protocol;
- 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.;
- scientific evaluation ;
- DHHS approved grant; DHHS approved-sample consent; DHHS-approved protocol;
- information relevant to humanitarian use devices;
- other materials specific to the proposed study (e.g. investigator’s brochure or investigator correspondence with applicable regulatory agencies. etc.).
- Paper Submissions (Renewals, Renewals with Modifications, and Modifications for studies in existence prior to inception of OSIRIS)
Paper submissions will be scanned into the OSIRIS system so that all members will have access to a copy of the complete submission which includes the information listed in #3 above.
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 21 CFR 56.111 (if applicable). 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, 21 CFR 50.20 (if applicable) and any other relevant ethical or compliance considerations.
- For electronic submissions, reviewers are expected to document concerns through the use of the Reviewer Note tab. For paper submissions, reviews are expected to be documented by submitting the IRB Reviewer Report Form to IRB staff prior to the convened meeting.
- In addition to reviewing the above material, the primary reviewer will also be responsible for ensuring general consistency between (where applicable) the federal grant 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.