2.8 Limited IRB Review

Note: This policy is NOT valid until after the effective date for the Revised Rule. Prior to that effective date the Organization does not perform limited IRB review.


1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements and procedure for limited IRB review.


2.0 Policy

It is the policy of the Organization that research which satisfy the criteria for exemption under 45 CFR 46.104(d)(2 or 3) undergo limited IRB review if information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects.


3.0 Limited IRB Review

  • 3.1. Limited IRB review will be conducted for research which satisfy the criteria for exemption as follows:
    • 3.1.1. Exempt Category 2 section (iii) [45 CFR 46.104(d)(2)(iii)]; that is research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) … if the information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects.
    • 3.1.2. Exempt Category 3 section (i)(C) [45 CFR 46.104(d)(3)(i)(C)]; that is, research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and … the information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects.
    • 3.1.3. The Organization does not currently utilize exempt categories 7 and 8 (secondary research for which broad consent is required); therefore, limited IRB review is not used in that context.

4.0 Criteria for Approval

  • 4.1. For research to be approved under exempt category 2 section (iii) or category 3 section (i)(C) limited IRB review must find that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data [45 CFR 46.111(a)(7)].
  • 4.2. Since the adequacy of provisions to maintain confidentiality depend, in part, on the nature of the research, the methods involved, the characteristics of the subject population (including the vulnerability of subjects) and the risks related to the research, limited IRB review will take into account all this additional factors.

5.0 Procedure

  • 5.1. Research which appears to be eligible for approval under exempt categories 2 section (iii) or 3 section (i)(C) must be submitted on an Exempt Educational, Behavioral, and Social Science Research Application, and must contain enough information for limited IRB as described in section 4.0 above. The submission must include:
    • 5.1.1. The full protocol or application containing the relevant information to determine whether the proposed research fulfills the criteria for approval.
    • 5.1.2. Surveys, interview scripts
    • 5.1.3. Proposed consent form(s).
    • 5.1.4. Recruitment material.
  • 5.2. Limited IRB review may be performed by expedited review, as described in HRPP policy 2.3 (Expedited Review).
    • 5.2.1. If the expedited reviewer cannot determine that the criteria for approval defined in section 4.0 are satisfied, then the research will be referred to the convened IRB. The reviewer must document the rationale for this determination and the rationale for review by the convened IRB.
    • 5.2.2. The expedited reviewer may not disapprove the research.
    • 5.2.3. Limited IRB review determinations will be documented on the Limited IRB Review Checklist.
  • 5.3. Limited IRB review determinations:
    • 5.3.1. The research is no more than minimal risk.

    • 5.3.2. For exemption Categories 2 section (iii) and 3 section (i)(C), there are adequate protections for privacy interests of participants and the confidentiality of the data.

      Note: For exemption Category 7 and 8, UNMC does not currently allow investigators within the Organization to use broad consent for storage, maintenance or secondary use of identifiable private information or identifiable biospecimens.

    • 5.3.3. The research fulfills the ethical standards of the Organization as per HRPP policy 1.1 (Human Research Protection Program).

    • 5.3.4. The research does not involve minors.

    • 5.3.5. Selection of subjects must be equitable.

    • 5.3.6. The research does not involve prisoners, except for research aimed at involving a broader participant population that only incidentally includes prisoners.

    • 5.3.7. The research is not regulated by the FDA.

  • 5.4. The investigator will be informed of the findings of the limited IRB review as per HRPP policy 2.3 (Expedited Review).
  • 5.5. Research approved by limited IRB review under exempt categories 2 section (iii) or 3 section (i)(C) does not require continuing review unless the expedited reviewer determines that such review would meaningfully protect the rights and welfare of human subjects of research.
  • 5.6. The IRB retains the authority to suspend or terminate IRB approval of research approved with a limited review as per HRPP policy 8.6 (Study Hold, Suspension, and Termination).

ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 INITIAL JANUARY 24, 2018