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

DHHS: 45 CFR 46.116, 45 CFR 46.116(a)(7), 45 CFR 46.117(a)
FDA: 21 CFR 50.20, 21 CFR 50.25(a)(7), 21 CFR 50.27(a), 21 CFR 50.27(b)(2), FDA Information Sheets: Frequently Asked Questions: Informed Consent Process, A Guide to Informed Consent.
VA: 38 CFR 16.116, 38 CFR 16.116(a)(7), 38 CFR 16.117(a), 38 CFR 16.117(c), VHA Directive1200.05(3), 5
ICH-GCP(E6)(R2): 4.6.6, 4.8
ICH-GCP(E6)(R3): III.2.8., III.2.8.10., III.2.8.13.
AAHRPP Tip Sheet: Following the Guideline of the International Conference on Harmonisation – Good Clinical Practice (E6)

Required written materials

Essential requirements:
1. Policies and procedures pertaining to Elements II.3.F., II.3.G., and II.4.B.
When following DHHS regulations:
1. Policies and procedures pertaining to Elements II.3.F., II.3.G., and II.4.B.
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.
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.
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.
When following ICH-GCP(E6)(R2) guideline:
1. Policies and procedures describe that prior to the beginning of the trial, the investigator should have the IRB/EC’s written approval/favorable opinion of the written informed consent form and any other written information to be provided to participants.
When following ICH-GCP(E6)(R3) guideline:
1. Policies and procedures describe that:
  1. researchers and research staff provide all the disclosures and follow the requirements pertaining to consent covered by ICH-GCP.
  2. When a clinical trial includes participants who may only be enrolled in the trial with the consent of the participant’s legally acceptable representative, the participants should be informed about the trial in a manner that facilitates their understanding and, if capable, the participant should sign and date the informed consent form or assent form as appropriate.
When following ICH-GCP(E6)(R2) or ICH(E6)(R3) guidelines:
1. Policies and procedures describe that:
  1. In obtaining and documenting informed consent, the investigator should comply with the applicable regulatory requirement(s), and should adhere to GCP and to the ethical principles that have their origin in the Declaration of Helsinki.
  2. The investigator, or a person designated by the investigator/institution, should explain the correct use of the investigational product(s) to each subject and should check, at intervals appropriate for the trial, that each subject is following the instructions properly.
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.
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.

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT III.1.F.