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Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

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Latest Update: May 15, 2022

Table of Contents

INTRODUCTION DOMAIN I: ORGANIZATION DOMAIN II: INSTITUTIONAL REVIEW BOARD OR ETHICS COMMITTEE DOMAIN III: RESEARCHER AND RESEARCH STAFF TABLES

ELEMENT III.1.F.

ELEMENT III.1.F.: Researchers employ consent processes and methods of documentation appropriate to the type of research and the study population, emphasizing the importance of comprehension and voluntary participation to foster informed decision-making by participants.

Researchers and research staff should understand the concept of respect for persons and the obligation to obtain the consent of participants or their legally authorized representatives. Researchers and research staff should understand that consent is a continual process, and conduct the consent process in a way that meets the criteria for legally effective consent. Researchers and research staff should understand the difference between the consent process, itself, and documentation of the consent process. Researchers and research staff should know how to document the consent of a participant or a legally authorized representative.


Regulatory and guidance references


Required written materials

  1. Essential requirements:
    1. Policies and procedures pertaining to Elements II.3.F., II.3.G., and II.4.B.
  2. When following DHHS regulations:
    1. Policies and procedures pertaining to Elements II.3.F., II.3.G., and II.4.B.
  3. When following DoD requirements:
    1. Policies and procedures pertaining to Elements II.3.F., II.3.G., and II.4.B. that address specific DoD requirements.
  4. When following DHHS or FDA regulations:
    1. When the long form of consent documentation is used, researchers or research staff follow regulatory and IRB or EC requirements.
    2. When the short form of consent documentation is used, researchers or research staff follow regulatory and IRB or EC requirements.
  5. When following FDA regulations:
    1. Policies and procedures pertaining to Elements II.3.F., II.3.G., and II.4.B. that address essential requirements.
  6. When following the ICH-GCP (E6) guideline: 
    1. Policies and procedures describe that researchers and research staff provide all the disclosures and follow the requirements pertaining to consent covered by ICH-GCP.
  7. When following VA requirements:
    1. Policies and procedures pertaining to Elements II.3.F., II.3.G., and II.4.B. that address specific VA requirements.
  8. In the cases above, the policies and procedures pertaining to Elements II.3.F., II.3.G., and II.4.B. also address the written material requirements for this Element. If the same policies and procedures are provided to researchers and research staff, simply reference those documents in the application for this Element. If there are additional materials, such as an Investigator Handbook or Web pages for researchers, that are not included in the materials used to support Elements II.3.F., II.3.G., and II.4.B., but are in support of Element III.1.F., include them here.

Outcomes

  • Researchers and research staff understand the difference between the consent process and the documentation of the consent process.
  • Researchers and research staff understand consent to be an ongoing process throughout the participant’s involvement in the research.
  • Researchers and research staff:
    • Obtain the legally effective consent of the participant or the participant’s legally authorized representative.
    • Provide the prospective participant or the legally authorized representative sufficient opportunity to consider whether to participate.
    • Minimize the possibility of coercion or undue influence.
    • Communicate with the participant or the legally authorized representative in language understandable to the participant or the legally authorized representative. Do not use exculpatory language when communicating with a prospective participant or the legally authorized representative.
    • Document the consent process as required.


Proceed To: ELEMENT III.1.G.