Other than those studies specifically listed and qualify for Exempt and Expedited levels of review, these research studies are subject to a full committee review. Applications for full board review are reviewed at a convened meeting of the IRB. Studies assigned to full board review are reviewed by members ahead of time, and then discussed at the meeting. The Committee then votes on whether or not to approve the study. Investigators are requested to attend the scheduled Board meeting to make a brief presentation about the protocol and answer any questions the Board may have.
Important information for student serving as investigator – please review this page.
The following are instructions for preparing an application for Full Board Review:
2) List all members of the research team (if applicable) who will be involved in the study. If not known at the time of the application, these names may be forwarded to the ORPC when hired. All members must have completed the CITI training before engaging participants in the study.
3) Complete the below appropriate forms that are applicable to your project; at the minimum complete the Application for Approval of Use of Human Participants and Informed Consent documents (note: follow these basic instructions for creating consent documents). When completing the application forms, please keep the use of jargon or technical terms at a minimum. Otherwise, provide an explanation of these terms within the body of the proposal. Review of protocols are performed by someone who may not be familiar with the investigator’s field or discipline. Be sure to follow all instructions on the forms.
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When completing an Application for Approval of Use of Human Participants for full board review:
a) provide an evaluative summary of relevant literature on the topic of the protocol. If adverse effects have been documented, indicate how the research addresses or attempts to prevent such effects. Complete citations of prior research and, If possible, copies of relevant articles must be included with the protocol application.
b) provide an evaluative summary if the proposed research includes invasive procedure and indicate which databases have been consulted (e.g., Medline). Investigators are required to summarize these findings, including findings of adverse effects and steps to be undertaken prevent such events from occurring in the protocol.
c) provide a list of three experts in the investigator’s field who can independently evaluate the proposal and assist the IRB in the review process.
4) Electronically submit the protocol and any accompanying documents to firstname.lastname@example.org. Full board protocols must be received no later than 30 days prior to a regularly scheduled IRB meeting.
Please be sure to include the applicable pages with the signature of the investigators. A scanned version as a PDF document is acceptable. If that’s not possible, fax that page (and that page only) to the ORPC at (410) 455-3868. Protocol applications will not be processed until this face page is received. Copies of approval documentation from collaborating institutions, which must accompany the protocol submission, may be faxed if electronic versions are not available.
Investigators will be notified of the IRB’s decision of approval by the ORPC following the scheduled meeting.
IRB Application and Pre-review Consultation
The ORPC staff is available to answer any questions regarding the IRB submission process and IRB review of research studies. We also provide pre-review consultation to discuss all aspects of IRB review, from preparing the submission to completion of the study. We’re also available to make presentations about the IRB for groups of any size, including graduate or undergraduate classes, faculty meetings or other meetings. If you have any questions, please contact the office staff. We also offer in person review sessions on twice a month on Wednesdays between 12:00 pm and 1:00 pm during the academic year. Please visit our registration page to arrange a time.
Grant Congruency Review
Grant to protocol review is required when investigators seek or obtain funding to conduct research with animals, human subjects or biohazardous/recombinant DNA use. All research procedures outlined in a grant/contract submission must be covered in an approved protocol and all compliance committee approvals must be secured prior to the release of research funds.
Examples of information required for congruency review include:
- Specific aims of the research
- Animal/human/biohazardous material/recombinant DNA use research work scope
- Procedures proposed in a grant application
- Collaborations or subrecipients proposed in a grant
- Revisions to grant due to grant reviewer comments
- Modifications to protocol applications, performed at different times in a protocol time cycle
- Co-investigators and/or research personnel
Congruency reviews are conducted by the ORPC. If questions arise during the congruency review, the ORPC will contact the PI for additional information, clarification of discrepancies or request that a protocol submission or modification be made to the appropriate compliance committee (e.g., IRB, IACUC, IBC). The Office of Sponsored Programs will be notified of the review. The PI is responsible for notifying OSP of new funding or amendments made to protocols.