SOP #03 IRB Records

IRB Records

Standard Operating Policy Institutional Review Board
Policy Number: 03
Effective Date: 10/8/2022
Owner: Vice President of Academic Affairs
Author: CSS IRB

1. Policy

The College of St. Scholastica IRB prepares and maintains documentation of its activities as required by federal regulation and in accordance with the IRB’s record retention policy. Required documents must be submitted to the appropriate funding entity as required. This policy applies to all controlled documents used in research reviewed by the IRB.

2. Purpose

Federal regulations require the IRB to maintain documentation of its research activities. This SOP outlines the criteria for maintaining these documented records and the length of time IRB records shall be retained.

3. Definitions

IRBNet – The CSS IRB electronic IRB management system.

Serious Adverse Events – Any adverse event that meets any of the following conditions:

  • Results in death;

  • Is life-threatening;

  • Requires hospitalization;

  • Results in persistent or significant disability/incapacity;

  • Results in congenital anomaly or a birth defect;

  • May jeopardize the subject’s health and may require medical or surgical intervention.

Unanticipated Problems Involving Risks to Subjects or Others (UPIRSO) – any incident, experience, or outcome that meets all of the following criteria:

  • Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB approved research protocol, Investigator's Brochure, and informed consent document; and (b) the characteristics of the subject population being studied;

  • Related or possibly related to a subject’s participation in the research; and

  • Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) related to the research than was previously known or recognized.

Controlled Documents - A controlled document is any digital or hard-copy entity which is required by a company, a standards organization, or a regulatory agency to be managed within a tightly controlled process that maintains the integrity of the document’s content through revisions. Examples of controlled documents include operating procedures, contracts, and plans.

4. Procedure

45 CFR §46.115 establishes the rules for maintaining IRB records. The College of St. Scholastica IRB prepares and maintain adequate documentation of IRB activities, including the following:

  1. CSS IRB written and approved Standard Operating Procedures (SOP’s).

  2. Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent forms, progress reports submitted by investigators, and reports of injuries to subjects such as Unanticipated Problems Involving Risks to Subjects or Others (UPIRSO) and Serious Adverse Events.

  3. Records of continuing review activities, including the rationale for conducting continuing review of research that otherwise would not require continuing review.

  4. For initial or continuing reviews conducted by expedited procedures, IRB records will include the following:

    • Copies of all documentation submitted;

    • Descriptions of the actions taken by the reviewer (See, CSS IRB SOP #12 Criteria for Approval of IRB Research);

    • Specific permissible category(s) permitting review by expedited procedures (See CSS IRB SOP #11 CSS IRB Expedited Review Procedure and Checklist);

    • Determinations required by the regulations and protocol-specific findings justifying those determinations for the following:

    • Waiver or alteration of the consent process (See, CSS IRB SOP #15 Waiver or Alteration of Consent (Waiver Request Form Reviewer Checklist);

    • Research involving pregnant women, human fetuses, or neonates (See, CSS IRB SOP#35 Research Involving Pregnant Women and Reviewer Checklist);

    • Research involving children (See, CSS IRB SOP#33 Research Involving Children and Investigator/Reviewer Checklist);

    • Research involving participants with diminished capacity to consent (See, CSS IRB SOP #23 Vulnerable Subjects/Populations);

    • Waiver or alteration of HIPAA research authorization determinations required by the Privacy Rule and Minnesota law.

  5. For exempt research (See, CSS IRB SOP #10 Exempt Review Determination Process and Checklist), records will include the following:

    • Copies of all documentation submitted;

    • Any associated correspondence between investigators and the CSS IRB;

    • Exempt determinations, including citations of the specific category(ies) justifying the exemption.

  6. For activities determined by the CSS IRB Chair not to be research involving human subjects (See, CSS IRB SOP #07 Determination of Human Subject Research), records will

include copies of all documentation submitted and/or correspondence between investigators and the CSS IRB, as well as information documenting the determinations.

  1. Minutes of IRB meetings (See, CSS IRB SOP #17 IRB Meeting Minutes (Expedited/Exempt Approval Form), which shall be in sufficient detail to show:

    • Members and alternates in attendance for each action, including their representative capacities, scientific/non-scientific status, affiliation status, etc.;

    • Documentation regarding whether a quorum exists;

    • Names of any IRB members who leave the meeting due to a conflicting interest, along with the fact that a conflicting interest is the reason for the absence (as applicable);

    • Controverted Issues) (if any) and their resolution;

    • For initial and continuing review determination of the risk level (minimal risk/greater than minimal risk) (See, CSS IRB SOP #13 IRB Determination of Minimal Risk);

    • For initial and continuing review, the approval period (not to exceed one year);

    • Rationale for significant/non-significant risk device determinations;

    • A written summary of the discussion of controverted issues and their resolutions;

    • Determinations required by the regulations and protocol-specific findings justifying those determinations for the following:

      • Waiver or alteration of the consent process;

      • Research involving pregnant women, human fetuses, or neonates;

      • Research involving prisoners (See, CSS IRB SOP #34 Research Involving Prisoners);

      • Research involving children;

      • Research involving participants with diminished capacity to consent;

      • Waiver or alteration of HIPAA research authorization determinations required by the Privacy Rule and Minnesota law.

    • IRB minutes are approved by the convened IRB at a subsequent IRB meeting. Once approved, they may not be altered by anyone, including a higher authority, unless such alteration is reviewed and approved by the convened IRB. IRB minutes and decisions may be made available, upon request, to relevant individuals or institutional officials at CSS and/or its affiliates.

    • Actions taken by the IRB, including the number of votes for, against, or abstaining;

    • Separate deliberations for each action;

    • Basis for requiring changes in or disapproving research;

    • Summary of the discussion of controverted issues (See, CSS IRB SOP # 28

  2. Copies of all correspondence between the IRB and the investigators, including reports to regulatory agencies.

  3. A detailed list of IRB members that include:

    • Name;

    • CV;

    • Earned degrees;

    • Representative capacity;

    • Indications of experience such as board certifications or licenses sufficient to describe each member’s chief anticipated contributions to IRB deliberations; and,

    • Any employment or other relationship between each member and The College of St. Scholastica (e.g., full-time employee, part-time employee, member of governing panel or board, stockholder, paid or unpaid consultant).Written procedures for the IRB including but not limited to:

    • Conducting initial and continuing review of research and for reporting the findings and actions to the investigator and the institution;

    • Determining which projects require review more often than annually and which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review;

    • Ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that investigators will conduct the research activity in accordance with the terms of the IRB approval until any proposed changes have been reviewed and approved by the IRB, except when necessary to eliminate apparent immediate hazards to the subject.

  1. Statements of significant new findings provided to subjects, as required for informed consent.

  2. Documentation of exemptions including exemptions related to emergency uses.

  3. The rationale for an expedited reviewer's determination that research appearing on the expedited review list described is more than minimal risk.

  4. Federal Wide Assurances.

  5. Federal IRB Registration.

  6. Documentation of complaints and any related findings and/or resolution.

  7. Documentation of review by another institution’s IRB, when appropriate, specifying the responsibilities that an institution and an organization operating an IRB each will undertake to ensure compliance with the requirements of this policy. (See, CSS IRB SOP #19 Cooperative Research Authorization Agreements and Sample Agreement).

5. Maintenance and Retention of Records

  1. The CSS IRB will ensure that all records are stored confidentially in a secure location.

  1. IRB Members are required to return, destroy, and/or delete all IRB-related research protocol review material that is considered confidential and in excess of the required original documentation and appropriate controlled forms.

  2. The records required by this policy shall be retained for at least 3 years, and records relating to research that is conducted shall be retained for at least 3 years after completion of the research.

  3. Access to CSS IRB records is restricted to authorized CSS employees. IRB records are accessible for inspection and copying by representatives of the sponsor of the research, authorized representatives of federal agencies or departments, and by other authorized agents of regulatory or accrediting organizations, at reasonable times and in a reasonable manner. Records (in whole or in part) will also be made available as required under Minn. Statute §144.295 (Disclosure of Health Records for External Research).

  4. When electronic records and/or data (IRBNet) are used to meet regulatory requirements for IRB recordkeeping and retention, such records and/or data will be maintained in compliance with 21 CFR 11 and applicable FDA Guidance.

FDA 21 CFR Part 11, Electronic Records: Electronic Signatures – Scope and Application

Sec. 11.30 Controls for open systems.

Persons who use open systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, as appropriate, the confidentiality of electronic records from the point of their creation to the point of their receipt. Such procedures and controls shall include those identified in 11.10, as appropriate, and additional measures such as document encryption and use of appropriate digital signature standards to ensure, as necessary under the circumstances, record authenticity, integrity, and confidentiality.

References:

45 CFR 46.115

21 CFR 56.115

21 CFR 11

Purdue University - https://www.irb.purdue.edu/docs/new/sops-web.pdf Children’s Hospital of Philadelphia (CHOP) - https://irb.research.chop.edu/policies The Ohio State University - https://orrp.osu.edu/irb/osuirbpolicies/

This is a new policy per the 2018 Common Rule Requirements.

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