Approved by: Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#: 119
AAHRPP Elements: II. 5.A
- IRB records for each protocol are organized to allow a complete historical reconstruction of the IRB actions related to review and approval of the research.
- The OPRS staff is responsible for organizing and maintaining the protocol record.
- The Assistant Directors for each IRB maintain the IRB roster files that contain each member’s curriculum vitae and appointment letters.
- The record for each protocol contains, when relevant, the following:
- Protocols (all IRB submitted versions);
- If study involves medical device, drug or biologic, Investigator Brochure, Device manual or FDA-approved product labeling, as relevant;
- UIC Application Form and associated appendices (original and any subsequent revisions);
- All IRB approved versions of informed consent document(s), HIPAA Authorizations, recruitment materials, and subject correspondence /information documents (when forms require a date stamp, the IRB retains one original stamped copy);
- If the research is awarded a grant, contract, or cooperative agreement from an HHS agency and UIC is the awardee (primary institution), the entire HHS application or proposal (exclusive of appendices) must be kept among the IRB records ;
- Scientific Evaluations, including CC-PRC and CRC approval, when available;
- DHHS-or sponsor approved template consent document(s) and protocol, when they exist, if applicable;
- If study involves a medical device, IDE approval letter, FDA PMA or 510(k) approval letter or approved labeling, as appropriate;
- If study involves a drug or biologic, IND approval letter from FDA, IND printed in sponsor’s protocol, letter from sponsor confirming IND number, FDA exemption determination letter, or approved labeling;
- Progress reports submitted by investigators to sponsor;
- continuing review activities and submission materials;
- portion of the meeting minutes relevant to actions for the specific protocol when IRB review occurs at the convened level and relevant review guides when IRB review occurs at the expedited level;
- Data and Safety Monitoring reports;
- Events requiring prompt reporting submissions, including but not limited to:
- Reports of injuries to subjects;
- unanticipated problems;
- internal (unanticipated) serious adverse events;
- protocol deviations;
- significant new findings; and
- potential non-compliance.
- Amendment (modification) to previously approved research submissions;
- All correspondence between the IRBs and investigators;
- Statements of significant new findings provided to participants;
- For exemption determinations: the record documents the justification and specific exemption category determinations;
- Records document determinations and protocol specific findings by IRB as required by laws, regulations , codes and guidances, including but not limited to 111 or 116 criteria, waiver or alteration of the consent process , waiver of documentation, vulnerable populations, significant risk device, or DoD, ED FDA or VA specific findings.
- Correspondence between the IRBs, IRB Coordinators and/or IRB Assistant Directors and University Counsel concerning subject injury language.
- Relevant correspondence between the IRB Coordinators/IRB Assistant Directors with investigators or their research coordinators concerning administrative changes or other protocol specific matters;
- Correspondence from other review committees, including but not limited to IBC, ESCRO, RDRC, and Radiation Safety;
- Correspondence between IRB and JBVAMC R&D office
- IRB Authorization Agreements;
- Certificates of confidentiality;
- Conflict of interest management documentation and correspondence (SEAM);
- Correspondence between federal agencies or external sponsors concerning protocol matters;
- Correspondence between the IRBs and the JBVAMC R&D Committee:
- Final Research Report;
- For initial and continuing review of research by the expedited procedure, the protocol record indicates:
- justification for using expedited procedure, e.g., specific permissible category and minimal risk determination;
- actions taken by the reviewer;
- Any findings required under the regulations or institutional polices to be documented.
- IRB Rosters and IRB Member Curriculum Vitae
- OPRS ADs maintain IRB roster files that contain each IRB member’s resume.
- Following each updating of the roster on the OHRO website, the Assistant to the Director, files a copy of the roster in the central office files.
- Filing of IRB minutes and agendas are described in UIC HSPP Policy IRB Meeting Records - Filing of Minutes and Agenda Documents.
|Version (#, date)
||Replaces (#, date)
||Summary of changes
||Clarification regarding HHS grant, contract, or cooperative agreement materials. Addition of FDA IND and IDE approval letters (Section I.F). Addition of required documentation if subject is unable to make decisions (Section I.G)
||Addition of Section I.N (University Counsel correspondence) & Section I.O (Correspondence regarding administrative changes or matters)
||Updated approver title, AAHRPP element, document list