IRB Protocol Records
IRB Protocol Records
Version |
Date Updated |
Printable Version |
| 1.5 | June 21, 2018 | 0882.pdf |
Description
Approved by: Human Protections Administrator and Director of OPRS
AAHRPP REF#: 119
AAHRPP Elements: II. 5.A
POLICY
POLICY
- 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 protocol record is maintained within OPRS Live.
PROCEDURES
- The record for each protocol contains, when relevant, the following:
- Protocols (all IRB submitted versions) for biomedical research;
- 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;
- 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 medical device, drug or biologic, Investigator Brochure, Device manual or FDA-approved product labeling, as relevant;
- 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.
- Amendments 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 guidance, 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 or FDA specific findings.
- 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;
- IRB Authorization Agreements;
- Certificates of confidentiality;
- Significant Financial Interest – Disclosure and Management Plan (SFI-DMP);
- Correspondence between federal agencies or external sponsors concerning protocol matters;
- 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.
- Transition Plan for OPRS Live:
- As OPRS transitions from a paper-based records system to an electronic-based system via OPRS Live, there will be two methods of record retention: paper and electronic.
- Paper-based submissions
- Submissions that are accepted by OPRS in paper format will continue to be processed and stored as paper records until a protocol submission is received and accepted via OPRS Live.
- Paper submissions will include the full submission, expedited review guide/meeting minutes, approval notices, approved documents, and other protocol related correspondence as indicated above.
- Submissions submitted via OPRS Live
- Once a submission for a protocol is accepted by OPRS via OPRS Live, the submission records will be maintained as electronic records.
- Submissions, approved documents, and other protocol related correspondence and documentation will no longer be filed with the paper-based protocol record.
- Protocol records will be a combination of paper and electronic records once a protocol submission is accepted via OPRS Live. The exception to this statement would be Initial Reviews, Exemptions, and Determinations of Not Human Subjects that are originally submitted and received via OPRS Live.
- Please note that despite the submission method, the policy and procedures stated above will continue to be followed and all required documents will continue to be maintained with the protocol record.
- Research Reviewed by CHAIRb
- The policy and processes described above are consistent with research reviewed by CHAIRb; however, the research protocol file is contained within the CHAIRb Portal.
REFERENCES
21 CFR 56.115(a)-(b)
45 CFR 46.115(a)-(b)
OHRP Guidance on Written Institutional Review Board (IRB) Procedures
FDA Information Sheets: Frequently Asked Questions: IRB Records
OHRP Guidance: IRB Review of HHS Applications for Support, dated May 31, 2000
REVISION LOG
| Version (#, date) | Replaces (#, date) | Summary of changes |
| 1.1, 3/13/09 | 1.0, 12/09/08 | 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) |
| 1.2, 4/20/09 | 1.1, 3/13/09 | Addition of Section I.N (University Counsel correspondence) and Section I.O (Correspondence regarding administrative changes or matters) |
| 1.3, 5/10/12 | 1.2, 4/20/09 | Updated approver title, AAHRPP element, document list |
| 1.4, 02/08/16 | 1.3, 5/10/12 | Remove references to VA; addition of CHAIRb; addition of explanation regarding transition of records during beta testing of OPRS Live. |
| 1.5, 06/21/18 | 1.4, 02/08/16 | Clarification that protocols are only required for biomedical research. |