IRBNet Guidance

All SAVAHCS Institutional Review Board (IRB) applications, IRB forms, and guidance documents for study submissions are available on the IRBNet website. Prior to submitting IRB applications, investigators and study staff conducting VA research at SAVAHCS must obtain an IRBNet account. 

Committee Meeting Schedules

All research study application packages must be complete and submitted in IRBNet. To be considered for the next committee meeting agenda, allow time to submit applications prior to the committee meeting for review:

• SRS Committee | Monthly – 1st Thursday
• VA Central IRB Panel 3 Committee | Bimonthly – 2nd  Tuesday
• R&D Committee | Monthly – 3rd  Wednesday

Policy 

The "Common Rule" is a federal policy in the United States that protects human research subjects. Its core principles are rooted in the ethical guidelines of the Belmont Report, which are respect for persons, beneficence, and justice. The rule requires Institutional Review Boards (IRBs) to oversee research involving humans to ensure informed consent, a fair risk/benefit ratio, and equitable selection of participants. 

Core principles

• Respect for Persons: This principle requires protecting individual autonomy, which includes obtaining voluntary and informed consent from participants.
• Beneficence: Researchers must protect participants from harm and maximize potential benefits while minimizing risks. This involves a thorough risk/benefit assessment.
• Justice: This principle calls for the fair distribution of the benefits and burdens of research. It requires that the selection of research subjects be equitable. 

Key components and requirements

• Institutional Review Board (IRB) review: Researchers must get their studies approved by an IRB, which is a committee that reviews research involving human subjects to ensure it is ethical and compliant.
• Informed consent: Potential participants must be given information about the study in an understandable format so they can make a voluntary decision about whether to participate.
• Informed consent elements: The rule outlines specific elements that must be included in consent forms, such as details on risks, withdrawal procedures, and any costs to the participant. The Revised Common Rule also includes new elements for applicable situations, such as information on commercial profit, clinically relevant results, and whole genome sequencing.
• Data and privacy protection: The rule defines "private information" and specifies when obtaining it is considered research involving human subjects, with a focus on protecting this information from being made public.
• Consent posting: For clinical trials, the rule requires that one version of the consent form be posted on a public federal website after recruitment closes.
• Cooperative research: As of January 2020, the revised rule requires all multi-site studies that are subject to the rule to use a single IRB for review.