ELEMENT II.2.C.

Organizations that follow DHHS regulations may conduct a “limited IRB review” by IRB or EC members of certain exempt research. Limited IRB review is a new requirement created under the revised Common Rule, including the revised DHHS regulations. Under the revised DHHS regulations, some “exempt” research is no longer exempt from requirements for IRB or EC review, but requires limited IRB review. Limited IRB review may not be conducted by staff – it must be conducted by a member of the IRB or EC, and has different requirements from other exempt research. (see Elements II.2.A. and II.2.B.)

For research requiring limited IRB review, there are two

different review standards. (See Table II.2.C.1.) Some exempt categories require the IRB or EC reviewer to determine that there are adequate protections for privacy interests of participants and the confidentiality of identifiable data, but other exempt categories require review of broad consent.

Written materials should describe a procedure for conducting limited IRB or EC review. Written materials should specify what research is eligible for limited review, the process for limited IRB review, and the required determinations by the reviewer conducting limited IRB review.

Regulatory and guidance references

DHHS: 45 CFR 46.111(a)(8)
VA: 1200.05 section 10

Required written materials

When following DHHS regulations:
1. Policies and procedures describe what research is eligible for limited IRB or EC review. (See Table II.2.C.1.)
  1. Eligible research is deemed to be no more than minimal risk.
  2. Eligible research meets one or more exempt categories 2, 3, 7, or 8.
2. Written materials specify the information that researchers must submit for limited IRB or EC review, including:
  1. The full protocol, application, or a protocol summary containing the relevant information to determine whether the proposed research fulfills the relevant criteria for approval required under limited IRB view.
  2. Proposed consent document, if applicable.
3. Written materials specify that IRB or EC members conducting limited IRB review may not disapprove research.
4. Written materials specify the required determinations when conducting limited IRB or EC review.
  1. For exemption Categories 2 and 3, there are adequate protections for privacy interests of participants and the confidentiality of identifiable data. (See Table II.2.C.1.)
  2. For exemption Category 7, broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained. (See Element II.3.F. and Table II.3.F.1.)
  3. For exemption Category 8, broad consent was appropriately documented or a waiver of documentation of consent was appropriate. (See Element II.3.F. and Element II.3.G., and Table II.3.F.2.)
5. Written materials describe the evaluation of exempt research under limited IRB review to whether it fulfills the organization’s ethical standards. (See Element II.2.B.)
6. Written materials specify that continuing review is not required for studies that qualify for a limited review.
7. Written materials specify that the organization retains the authority to suspend or terminate IRB or EC approval of research approved with a limited review.
When following VA requirements:
1. For exempt research activities involving the researcher interacting with human participants or obtaining information by educational tests, survey or interview procedures, or behavioral interventions, the following information must be given to the prospective human participant as applicable in writing or orally:
  1. The activity is research.
  2. Participation is voluntary.
  3. Permission to participate can be withdrawn.
  4. Permission for use of data can be withdrawn for exempt research activities involving the collection and use of identifiable data.
  5. Contact information for the VA researcher.
2. If an exempt activity requires a limited IRB review, the limited IRB review must be completed prior to approval by the R&D Committee.
3. Research that has undergone limited IRB review and determined to be exempt requires approval by the R&D Committee and requires continuing review by the R&D Committee unless it is under the oversight of another subcommittee (e.g., Safety Review Subcommittee).

Common types of materials that may be used to meet the element

Application form
Reviewer checklist

Outcomes

Reviewers conducting limited IRB or EC review are experienced IRB or EC members.
Research protocols or plans reviewed by the limited IRB or EC review were eligible for such review and did not require review by a convened IRB or EC or the expedited procedure.
Research approved through the limited IRB or EC review procedure meets the required criteria for approval.

Proceed To: Element II.2.D.

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT II.2.C.