Full Board Review
- Initial review – IRB members will have access to all the relevant research materials necessary for IRB review. The documents include the full protocol, a proposed informed consent document (ICD), approved contract or funded grant (as applicable), the investigator's brochure (IB) if one exists, product inserts, any recruitment materials, and data gathering instruments (e.g., questionnaires, data collection sheets, case report forms, etc.), CVs, researcher responsibility forms, conflict of interest forms, Defense Medical research Network (DRMN) coversheet, human subjects protections training certifications, FDA Form 1572 (for investigational new drug studies), and current provider licenses (for FDA regulated and National Institutes of Health funded studies). These materials should be available to IRB members at least 2 weeks in advance of the meeting date to allow sufficient time for review of the material.
- Continuing review – In conducting continuing review of research not eligible for expedited review, IRB members will be provided a progress report (3204A/B), relevant IRB minutes and the most recent versions of the protocol, ICD, IB and any modifications previously approved by the IRB. Any new changes to the protocol or ICD will require a separate amendment application. The progress report must include the following information:
- the number and classification of subjects accrued
- a summary of adverse events and any unanticipated problems involving risks to subjects or others and any withdrawal of subjects from the research or complaints about the research since the last IRB review
- a summary of any relevant recent literature, interim findings, and amendments or modifications to the research since the last review;
- any other relevant information pertaining to risks associated with the research.
- Review of protocol changes – The modification request must include an explanation of the changes, a copy of the revised protocol and revised ICD reflecting the changes, if applicable, and other relevant documents. The HRPPO staff will ensure that each revision to a research protocol has been incorporated into the existing protocol and submitted as a revised protocol with the appropriate revision date noted on each page of the protocol. This procedure is the same with revised ICDs and other related materials. The most recently revised and approved versions supersede all other previously approved versions. Minor changes to the research that are minimal risk to subjects may be reviewed by the IRB chairperson or by another experienced reviewer designated by the chairperson from among the members of the IRB under an expedited review procedure in accordance with 45 CFR 46.110(b)(2). Changes to the research that are more than minor would require further review by the IRB at a convened meeting.
- Review of reports of unanticipated problems involving risks to subjects or others or of serious or continuing noncompliance – The unanticipated problem report will include a determination by the PI of the causality or interrelatedness to the research. A corrective and preventive action plan must also be included in the report, as applicable.
- Consent Document approval and expiration dates – To help ensure that only the current, IRB-approved consent documents are presented to subjects and serve as a reminder to the investigators of the need for continuing review, the HRPPO staff will affix the IRB approval and expiration dates to all approved ICDs and instruct that only copies of these dated documents must be used in obtaining consent from subjects. The same applies to all accompanying approved advertisements.
- Review of Minor Changes - The following changes to an approved research protocol can be delegated to the Chair or Vice Chair for approval:
- Typographical corrections
- Change in members of the research team excluding the PI.
- Low risk activities, procedures or venue that do not affect the outcome of the study or increase the risk to subjects.
Expedited (Administrative) Review of Minimal Risk Research
Only the IRB Chairperson, or one or more experienced reviewers designated by the Chairperson from among members of the IRB, may carry out the expedited review. The person(s) conducting the expedited review may either approve, require modifications (to secure approval) or refer the research to the convened IRB.