ELEMENT II.2.A.

ELEMENT II.2.A.: The IRB or EC has and follows written policies and procedures for determining when activities are exempt from applicable laws and regulations, when permitted by law or regulation and exercised by the IRB or EC. Such policies and procedures indicate that exemption determinations are not to be made by researchers or others who might have a conflict of interest regarding the studies.

If the laws, regulations, codes, and guidance under which an organization conducts research involving human participants permit the use of exemptions, the organization should have policies to differentiate between research involving human participants that is exempt and research involving human participants that is not exempt. A determination of exemption should consider the criteria for exemption of all applicable laws, regulations, codes, and guidance, because activities that are exempt from one set of rules might not be exempt from another set of rules. For example, laws and regulations in some countries do not allow exemptions, and in that case even though the research may be covered by DHHS regulations, exemptions would not be allowed.

When research is not covered by DHHS regulations, or other laws or regulations that limit exemptions to specific exemption categories, organizations may define additional exemption categories beyond those specified in regulation. Written materials should define equivalent protections when creating additional exemptions.

The organization should provide written decisions and maintain records of exemption determinations. The person making a decision about whether an activity is exempt should have the authority to represent the organization,

and have no direct involvement in the activity he or she is examining. The person making a decision should be familiar with laws, regulations, codes, and guidance governing the research, organizational policies, and the nature of the research to make sound judgments. Policies and procedures should describe the communication of exemption determinations to researchers.

An organization may elect to restrict or not use the categories of exemption, and to require such research to meet all regulatory criteria for approval. If so, this should be stated in policies and procedures.

Generally, the authority to make exemptions determinations rests with the IRB or EC. However, this is not a requirement to meet this Element. For example, exemption determinations may be made by qualified staff who are not members of the IRB or EC. Organizations may choose to delegate to an entity other than the IRB or EC or an individual the authority to make exemption determinations, except where prohibited in law, regulation, or guidance. For example, for organizations that follow DHHS regulations, some exemption determinations may not be made by staff, but require a limited IRB review by an IRB or EC member. (See Element II.2.C.)

Regulatory and guidance references

DHHS: 45 CFR 46.101(b), 45 CFR 46.301(a), 45 CFR 46.401(b), 45 CFR 46.101(b)(1), 45 CFR 46.101(b)(2), 45 CFR 46.101(b)(3), 45 CFR 46.101(b)(4), 45 CFR 46.101(b)(5), 45 CFR 46.101(b)(6). OHRP Guidance at 45 CFR 46.101(b)(5): Exemption for Research and Demonstration Projects on Public Benefit and Service Programs, OHRP Guidance on the Involvement of Prisoners in Research, May 23, 2003, Federal Register, Vol. 48, pp. 9266-9270, March 4,1983
DoD: DoDI 3216.02, Definitions
FDA: 21 CFR 56.104(c)-(d)
VA: VHA Directive 1200.05(3), 10
AAHRPP Tip Sheet: Review of Research involving Prisoners and the Role of the Prisoner Representative

Required written materials

Essential requirements:
1. Policies and procedures describe the process for making exemption determinations, including:
  1. A description of the entity or individuals who are authorized to make exemption determinations.
  2. Which research studies involving human participants are exempt.
  3. Information for researchers:
    1. Whom to ask for an authoritative decision about whether research involving human participants is exempt from regulation.
    2. What information to submit.
  4. The process to provide determinations about whether research involving human participants is exempt from regulation that includes:
    1. Specific titles of persons or offices authorized to make determinations.
    2. Criteria used to make determinations.
    3. The process used to communicate determinations.
  5. The requirement that exemption determinations may not be made solely by the researcher, or someone with a conflict of interest in the research.
When following DHHS regulations:
1. The criteria for exemptions are consistent with:
  1. Subpart A of the DHHS regulations.
  2. Subpart B of the DHHS regulations.
  3. Subpart D of the DHHS regulations.
2. Written materials define benign behavioral intervention, consistent with the organization’s research portfolio.
3. When permitted, IRB or EC members may conduct a limited review of certain exempt research. (See Element II.2.C.)
When following FDA regulations:
1. The criteria for exemptions are consistent with FDA regulations.
When following VA requirements:
1. Exempt determinations may be made by the IRB Chair, an experienced IRB member, or qualified administrative staff with expertise in applying human research exempt regulations.
2. The determination of exempt status for research and demonstration projects meeting the criteria for exempt category 5 must be made by the Under Secretary for Health on behalf of the Secretary of VA, after consultation with Office of Research and Development (ORD), Office of Research Oversight (ORO), Office of General Counsel (OGC), and other experts, as appropriate. (See Table II.2.A.1. for Category 5)
3. The researcher may not self-certify that a study is exempt.
4. For VA Facilities:
  1. Research 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
Template letters to researchers

Outcomes

The IRB or EC recognizes the difference between exemption criteria that are requirements of laws, regulations, codes, and guidance and additional criteria based on local policy.
Decisions about whether research involving human participants is exempt are made promptly.
Decisions about whether research involving human participants is exempt are made accurately.

Proceed To: ELEMENT II.2.B.

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT II.2.A.