ELEMENT II.2.B.

ELEMENT II.2.B.: The IRB or EC has and follows written policies and procedures for addressing protection of participants in research that is exempt from applicable laws and regulations. These functions may be delegated to an entity other than the IRB or EC.

Generally, when a research study is determined to be exempt, it is exempt from the laws, regulations, codes, or guidance that govern the research, and there are no required provisions to protect the participants enrolled in the research study. For example, there may be no requirement for IRB review, or only a requirement for a limited IRB or EC review. There may be no requirement for consent, and no prohibition against the use of coercion, undue influence, or deception to recruit participants. Although most exempt research requires no further oversight to be conducted ethically, some exempt research raises ethical concerns or requires measures to protect participants.

This Element looks for a process to address the ethical concerns of research that is exempt. The person who makes determinations of exemption may also conduct the ethical evaluation of exempt research.

Regulatory and guidance references

DOE: 10 CFR 745, DOE Order 443.1C (November 2019)
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 evaluation of exempt research as to whether it fulfills the organization’s ethical standards. Such an evaluation might include:
  1. The research holds out no more than minimal risk to participants.
  2. Selection of participants is equitable.
  3. If there is recording of identifiable information, there are adequate provisions to maintain the confidentiality of the data.
  4. If there are interactions with participants, the IRB or EC should determine whether there should be a consent process that will disclose such information as:
    1. That the activity involves research.
    2. A description of the procedures.
    3. That participation is voluntary.
    4. Name and contact information for the researcher.
    5. There are adequate provisions to maintain the privacy interests of participants.
When following DHHS requirements:
1. When permitted, the IRB or EC may conduct a limited review of the research. (See Element II.2.C.)
When following DOE requirements:
1. When conducting or reviewing classified research, exemptions (as per 10 CFR Part 745.104) will not be used. The fact that research meets a particular exemption category may be noted, but review by a convened IRB is required.
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.

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

Reviewer checklist

Outcomes

When appropriate, participants involved in exempt research are provided additional protections.

Proceed To: ELEMENT II.2.C.

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT II.2.B.