650. IRB Records

Updated June 10, 2024

The �鶹ӳ�� IRB documents discussions, decisions, and findings from IRB meetings through its minutes; and for administrative, exempt, and expedited reviews, through documentation in IRBNet project files.

IRB discussions and decisions are documented in accordance with legal, regulatory and sponsor requirements, and organizational policies and procedures.

Through its online submission program (IRBNet), Research Integrity & Security maintains a complete set of materials relevant to the review of all projects/packages submitted for Administrative, Full Committee, Expedited, and Exempt Review. IRBNet automatically assigns a submission date to each project/package submitted for assessment, acknowledgement, or review.

Records for research that was conducted are retained for at least three years from the date of project closure or expiration of IRB approval. Records for not human research are kept for at least three years from the date of the determination. If a funding agency or sponsor, or other regulatory body requires IRB records for a given study to be stored longer than three years, Research Integrity & Security will document and comply with the mandated retention period.

IRBNet maintains a current record and complete historical archive of materials submitted for review, Board Documents (e.g., notification letters, date-stamped consent forms), and reviewer comments and worksheets. The archive includes all previous versions of revised documents.

IRBNet is designed to allow those with IRBNet Administrator status (i.e., Research Integrity & Security Director and staff), IRB members, and researchers to reconstruct the complete history of all project/package submissions and actions related to review and approval while maintaining appropriately secure and confidential* retention of documents.

Appropriately secure and confidential refers to situational access to project/package documents and IRBNet components. For example:

Individuals shared on projects are given full, write, or read access as warranted by their roles on the project and as specified by the Principal Investigator (PI) or another researcher with full access.
Individuals with full or write access can read but not alter documents in a specific package after the package has been submitted (unless the package is unlocked by an IRBNet Administrator).
Researchers can neither read nor alter Reviewer comments and documents, or meeting agendas or minutes.
IRB members when shared on a project/package by an IRBNet Administrator can read but not alter project documents.
IRB members when shared on a project/package by an IRBNet Administrator can note their own comments and add review documents and can read but not alter Reviewer comments/materials submitted by another IRB member.
Researchers and IRB members with shared access can read but not alter published Board Documents.
IRB members can read but not alter meeting agendas and minutes.
IRBNet Administrators can read but cannot add or alter project/package documents submitted by researchers.
IRBNet Administrators can note their own comments and add review documents and can read but not alter Reviewer comments/materials submitted by another IRB member.
IRBNet Administrators can prepare and publish Board Documents.
IRBNet Administrators can prepare agendas/minutes.
IRBNet Administrators may share read access with other entities as warranted (e.g., Sponsored Projects).

The materials required for review and consequently, available in the archives, vary for each project. For submission requirements by review type, refer to the relevant policy in the online Human Research Protection Program (HRPP) Policy Manual. As applicable, the following materials are available for projects/packages in IRBNet:

project cover sheet;
researcher request for human research determination or to use an external IRB;
exempt or IRB application;
relevant supplemental researcher forms for additional requirements for federal agencies, vulnerable populations, consent and/or HIPAA waivers/alterations, waivers of signed consent;
Investigator Brochure or device manual, package inserts/labels;
researcher request to amend previously approved research;
clinical trial or sponsor protocol;
scientific evaluations or safety committee approvals (when provided by an entity other than the IRB);
recruitment materials;
consent documents (including the versions submitted by researchers and the stamped, IRB-approved versions);
research instruments;
data and safety monitoring reports;
progress reports submitted by researchers (i.e., continuing review researcher forms);
problem reports (e.g., researcher reports of unauthorized changes to study procedures, deviations, local serious adverse events (SAEs), serious problems, new risks, changes to expected harms or benefits, breaches of privacy or confidentiality, complaints, or other reportable situations);
documentation of IRB assessment, review, determination, and notification for problem reports including unanticipated problems involving participants or others, noncompliance, or significant new findings;
reviewer comments and review worksheets;
notifications of initial, continuing, and amendment review determinations (for details about letters/notifications, see the policy for notifying investigators and others in the online HRPP Policy Manual); and
other relevant correspondence between the IRB and researchers.

NOTE: Determination and approval letters for exemptions and expedited reviews document the applicable review category as justification for the type of review.

IRB records are made available, as appropriate, for inspection and copying by authorized representatives of the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Veterans Affairs (VA), federal agencies funding the research, external IRBs, Affiliate Institution administrators, and sponsors at reasonable times and in a reasonable manner. All other requests for IRB records are subject to approval by the Director of Research Integrity & Security, who will notify the IRB Chair about such disclosures.