SOP #21 Limited IRB Review

Owner: Vice President of Academic Affairs
Author: CSS IRB
Contact: irb@css.edu
Policy Number: 21
Effective Date:10/8/2021

1. Policy

The new provision for limited IRB review (45 CFR §46.104 d(2)(3), §46.111 (a)(7)). review allows certain research to be categorized as exempt, even when the identifiable information might be sensitive or potentially harmful if disclosed. In order to qualify for exemption, the study must meet the standards of the limited IRB review.   If the information is both identifiable and sensitive or potentially harmful, the safeguards offered by the limited IRB review may allow an exemption determination to be made. See also, CSS IRB SOP #10 Exempt Determination Review Process and Checklist; CSS IRB SOP #26 Survey Research and Internet Research; and CSS IRB SOP #25 Focus Groups / Video /Audio and Digital Recordings with Review Application Template /Sample Consent Forms.

2. Purpose

When reviewing the exempt categories 2 and 3 (CSS IRB SOP #10 Exempt Determination Review Process and Checklist), the limited IRB review assures adequate protections for the privacy of subjects and adequate plans to maintain the confidentiality of the data. In limited IRB review, the IRB must determine that certain conditions, which are specified in the regulations, are met.  This document describes the procedure for conducting a Limited IRB Review.

3. Context

There are four exemptions that may require limited IRB review: Exemptions 2, 3, 7, and 8.  The CSS IRB does not recognize Exemption 7 and Exemption 8.  Limited IRB Review is required for exemption 2(iii), and 3(i)(C) for privacy and confidentiality protection under §46.111 (a)(7). Limited IRB review is required in the following circumstances:

  1. Exempt category 2 (educational tests, surveys, interview or observations of public behavior).
    When the information is recorded by the investigator in an identifiable manner and disclosure of the subject’s responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement or reputation.
  2. Exempt category 3 (benign behavioral interventions).
    When the information is recorded by the investigator in an identifiable manner and disclosure of the subject’s responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement or reputation. (45 CFR 46.104(d)(2)(iii), 46.104(d)(3)(i)(C))

4. Similarities with expedited IRB review

LIRB is conducted by an IRB member who is authorized to conduct expedited IRB review. The research must be considered minimal risk.  LIRB is focused on one (and only one) of the standard criteria for IRB approval: that there are appropriate protections for subject confidentiality and privacy.  There is no expiration date associated with approval granted through LIRB.

5. Differences compared with expedited IRB review

Because LIRB focuses on only one of the standard IRB criteria for approval, many of the waivers and determinations associated with expedited IRB review are not required.

LIRB is not allowed for research that must comply with the regulations of the Food and Drug Administration (FDA) or the federal Department of Justice (DOJ).

Granting LIRB approval to a study simultaneously grants exempt status to the study. After LIRB approval has been granted, the study is exempt and there are no longer any formally-designated IRB responsibilities.

6. Reviews Related to Privacy and Confidentiality

In order to assure appropriate protections, the limited IRB review may consider the following topics:

  • The nature of the identifiers associated with the data
  • The justification for needing identifiers in order to conduct the research
  • Characteristics of the study population
  • The proposed use of the information
  • The overall sensitivity of the data being collected
  • Persons or groups who will have access to study data
  • The process used to share the data
  • The likely retention period for identifiable data
  • The security controls in place
    • Physical safeguards for paper records
    • Technical safeguards for electronic records
    • Secure sharing or transfer of data outside the institution, if applicable
  • The potential risk for harm that would occur if the security of the data was compromised.

7. Researcher responsibilities

The application process and materials are the same as for any proposed human subjects research activity.

The study is simultaneously granted exempt status with approval. This means:

  • Continuing review is not required.
  • Modification applications are not required unless changes being considered by the researcher might affect the exempt status or are included in the list of changes below that always require a modification. Researchers are responsible for consulting the CSS Exemption Checklist before making changes, to assess whether a Modification application should be submitted. Or, they may simply submit a Modification application and let the CSS IRB make the assessment (and if necessary, to simultaneously conduct a review). Changes that always require a Modification application are:
    • New types of subjects, data, or specimens
    • New types of procedures, when it means that the research methods no longer fit into the exempt category to which the study was assigned
    • Increased risk or assessment that risk is greater than previously realized
    • Obtaining funding from the federal Department of Justice
    • New intent to submit the research data to the FDA

▪      Reports of New Information are not required unless the researcher believes that the new information could affect the exempt status of the research or wants to request the assistance of the IRB in assessing and managing a situation.

8. Procedure

Limited IRB review may be done via the expedited review mechanism, that is, by the Chair or an experienced IRB member designated by the Chair, or by the convened IRB. Continuing review is not required.

  1. Identify the necessity for LIRB. This is accomplished through the standard CSS IRB application process (See, SOP #12 Criteria for IRB Approval of Research.). At the conclusion of the application review an expedited reviewer is assigned (See, SOP #11 CSS IRB Expedited Review Procedure and Checklist)) to conduct the LIRB.
  2. Conduct the review.
  3. Criterion for approval. The application materials are reviewed against the applicable criterion for approval (45 CFR 46.111(a)(7)): When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
  4. Consent process and/or form. Exempt research is not required to have a formal consent process or form. The LIRB reviewer will not review any consent process or form that is provided with the application. However, it is CSS policy that studies that will interact with participants are expected to provide the participants with the following information:
  • A statement that the activity is research and that participation is voluntary;
  • An opportunity for participants to choose whether to participate in the research;
  • A brief description of the primary study procedure(s);
  • The lead researcher’s name, affiliation, and contact information;
  • Contact information for CSS IRB, in case of questions or concerns;
  • Informing parents in advance that their children will be participating in research.
  1. Possible outcomes. The Common Rule allows only the following outcomes. The application cannot be disapproved.
  • Conditional approval - Modifications Required to Secure Approval. This is an intermediate step that must eventually result in approval or referral for standard IRB review.
  • Approval (i.e., exempt status).
  • Referral for review by the expedited or convened IRB process.  If the limited IRB review does not result in approval under the exempt categories, then the IRB can evaluate whether approval is appropriate under the expedited categories. Expedited research must meet all the approval criteria under 45 CFR 46.111, including either informed consent or waiver of consent.  (See,​​​​​​​ CSS IRB SOP #12 Criteria For IRB Approval Of Research and Checklist.)
  • Determination that LIRB is not required because the activity qualifies for exempt status without LIRB, or it is Not Research, Not Human Subjects, or Not Engaged.
  1. Documentation. The outcome is documented by following the appropriate procedure for documentation.
  2. Communication of outcome to the researcher. The Exempt letter template is used.
  3. Report to the IRB. The Common Rule requires that all IRB members be advised of research proposals that have been approved under LIRB or expedited procedures. This is accomplished by providing all IRB members with a quarterly report of all LIRB approvals completed during the calendar quarter, as part of IRB meeting materials.

References:

University of Washington SOP Limited Review

https://www.washington.edu/research/policies/sop-limited-irb-review-2/ KUMC Guidance on Limited IRB Review -

http://www.kumc.edu/Documents/hrpp/Topical%20Guidance/KUMC%20Guidance%20on%20Limited%2 0IRB%20Review.pdf

OHRP Companion Q&As about the Revised Common Rule – Limited Review https://www.hhs.gov/ohrp/sites/default/files/Revised-Common-Rule-Q%26As-08-20-2018.pdf

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

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