ELEMENT II.3.F.

ELEMENT II.3.F.: The IRB or EC has and follows written policies and procedures to evaluate the consent process and to require that the researcher appropriately document the consent process.

To approve research, the IRB or EC has to determine that the consent process meets these criteria for approval of research:

The researcher obtains the legally effective consent of the participant or the participant’s legally authorized representative.
The consent process provides sufficient opportunity for the participant or the participant’s legally authorized representative to consider whether to participate.
The consent process minimizes the possibility of coercion or undue influence.
The consent discussion is in language understandable to the participant or the representative.
The consent discussion is free of exculpatory language through which the participant or the legally authorized representative is made to waive or appear to waive any of the participant’s legal rights.
Documentation of consent contains all applicable basic and additional elements of disclosure (See Table II.3.F.), and meets requirements in law and regulation, either with a long-form consent document, or a short-form consent document, or a broad consent document.

The IRB or EC should evaluate whether a research study satisfies these criteria. This cannot be accomplished solely by evaluating a written consent document, since the consent process is an ongoing discussion that should be culturally and linguistically appropriate to the study population, and not simply a consent document. Instead, the IRB or EC should know the nature and circumstances of the consent process, such as who will conduct the consent interview, the timing of obtaining consent, and any waiting period between informing the participant and obtaining consent, and based on this information determine whether the criteria for approval of research are met.

Another criterion for approval of research is that researchers inform prospective participants of required disclosures. The IRB or EC should evaluate whether research submitted for review satisfies this criterion. This cannot be accomplished solely by evaluation of a written consent document, because the consent document does not reflect all the information communicated to the participant during the consent process. Therefore, the IRB or EC should evaluate the information that will be communicated to the participant during the consent process, and determine which information will be disclosed.

When reviewing research, the IRB or EC should evaluate whether the consent process will be documented using a consent document.

Regulatory and guidance references

DHHS: 45 CFR 46.109(b), 45 CFR 46.109(e), 45 CFR 46.111(a)(4), 45 CFR 46.116, 45 CFR 46.117, OHRP Guidance on Exculpatory Language in Informed Consent, OHRP Guidance on Obtaining and Documenting Informed Consent of Subjects Who Do Not Speak English
DOD: Instruction 3216.2, para. 5.3.4; SECNAVINST 3900.39D, para. 6a(5)
DOE: 10 CFR 745, DOE Order 443.1B, Chg. 1 (April 21, 2016), DOE Notice 443.1 (January 21, 2016), and their accompanying Contractor Requirements Documents (CRDs)
DOJ: 28 CFR 512.16
FDA: 21 CFR 50.20, 21 CFR 56.109(b), 21 CFR 56.109(f), 21 CFR 56.111(a)(4), 21 CFR 50.25(a), 21 CFR 50.25(b), 21 CFR 50.27(a), 21 CFR 50.27(b), 21 CFR 56.111(a)(5), FDA Information Sheets: A Guide to Informed Consent, Frequently Asked Questions: Informed Consent Document Content, Recruiting Study Subjects, IRB Procedures, FDA Information Sheets: Frequently Asked Questions: Informed Consent Process, Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials
ICH-GCP: 2.9, 3.1.5, 3.1.9, 4.3.4, 4.8.1-4.8.9, 4.8.11
NIH: Final NIH Policy for Data Management and Sharing
VA: VHA Directive 1200.05(3), 12
AAHRPP Tip Sheet: Following the Guideline of the International Conference on Harmonisation – Good Clinical Practice (E6)
AAHRPP Tip Sheet: State and Local Law
AAHRPP Tip Sheet: Sufficient Information to Determine Whether the Criteria for Approval are Met

Required written materials

Essential requirements:
1. Policies and procedures describe the evaluation of the consent process:
  1. Applications include a description of the consent process including:
    1. The person who will conduct the consent interview.
    2. The person who will provide consent or permission.
    3. Any waiting period between informing the prospective participant and obtaining consent.
    4. Steps taken to minimize the possibility of coercion or undue influence.
    5. The language used by those obtaining consent.
    6. The language understood by the prospective participant or the legally authorized representative.
    7. The information to be communicated to the prospective participant or the legally authorized representative.
  2. In order to approve research, policies and procedures have the IRB or EC determine:
    1. The researcher will obtain the legally effective consent of the participant or the participant’s legally authorized representative.
    2. The circumstances of the consent process provide the prospective participant or the legally authorized representative sufficient opportunity to consider whether to participate.
    3. The circumstances of the consent process minimize the possibility of coercion or undue influence.
    4. The individuals communicating information to the participant or the legally authorized representative during the consent process will provide that information in language understandable to the participant or the representative.
    5. The information being communicated to the participant or the representative during the consent process will not include exculpatory language through which the participant or the legally authorized representative is made to waive or appear to waive any of the participant’s legal rights.
  3. In order to approve research, policies and procedures have the IRB or EC determine that in seeking consent, the required disclosures (See Table II.3.F.) will be provided to each participant or a legally authorized representative in accordance with legal and regulatory requirements. (See Tip Sheet: Criteria for Approval)
  4. Policies and procedures have the IRB or EC consider whether additional disclosures (See Table II.3.F.) are required for inclusion in the consent process.
  5. Policies and procedures have the IRB or EC determine that the consent process will be documented according to legal and regulatory requirements, or equivalent protections.
When following DHHS regulations:
1. Written materials have the IRB or EC determine:
  1. The required and appropriate additional elements of disclosure are included in the consent process.
  2. The consent document begins with a concise and focused presentation of key information that is most likely to assist a prospective participant or legally authorized representative in understanding the reasons why one might or might not want to participate in the research.
    1. Written materials define for researchers what the organization considers “key information”.
    2. Written materials specify what the organization considers a “concise” presentation of key information.
2. Long form of consent documentation
  1. To allow the use of the long form of consent documentation, policies and procedures have the IRB or EC determine that:
    1. The consent process and documentation as a whole presents information in sufficient detail, and facilitates the prospective participant’s or legally authorized representative’s understanding.
    2. The consent document embodies the basic and required additional elements of disclosure, including required disclosures when the research involves private identifiable information or identifiable biospecimens. (See Tip Sheet 1: Criteria for Approval)
    3. The participant or the participant’s legally authorized representative will sign the consent document.
    4. A copy of the consent document will be given to the person signing the consent document.
    5. The researcher will give either the participant or the representative adequate opportunity to read the consent document before it is signed.
3. Short form of consent documentation
  1. To allow the use of the short form of consent documentation, policies and procedures have the IRB or EC determine that:
    1. The consent document states that the basic and appropriate additional elements of disclosure (See Table II.3.F.1.) have been presented orally to the participant or the participant’s legally authorized representative, including required disclosures when the research involves private identifiable information or identifiable biospecimens. (See Tip Sheet 1: Criteria for Approval)
    2. A written summary embodies the basic and required additional elements of disclosure.
    3. There will be a witness to the oral presentation.
    4. For participants who do not speak English, the witness is conversant in both English and the language of the participant.
    5. The participant or the participant’s legally authorized representative will sign the consent document.
    6. The witness will sign both the short form and a copy of the summary
    7. The person actually obtaining consent will sign a copy of the summary
    8. A copy of the signed short form will be given to the participant or the legally authorized representative
    9. A copy of the signed summary will be given to the participant or the legally authorized representative.
4. Broad consent
  1. To allow the use of broad consent, policies and procedures have the IRB or EC determine that:
    1. The study is limited to the storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens (collected for either research studies other than the proposed research, or non-research purposes).
    2. The study has undergone limited IRB review and meets requirements for exempt Category 7 or Category 8. (See Elements II.2.A. and II.2.C.)
    3. Researchers must provide all required disclosures for broad consent to each participant or participant’s legally authorized representative. (See Table II.3.F.1.)
    4. If there is a change made for research purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data.
  2. Posting of clinical trial consent form
    1. Written materials must describe the process for posting one IRB-approved consent form for each clinical trial conducted or supported by a Federal department or agency on a website specified by the US Federal government.
    2. Written materials specify the person or role responsible for posting the consent form.
    3. The consent form must be posted on the website after the clinical trial is closed to recruitment, but no later than 60 days after the last study visit by any participant, as required by the protocol.
    4. Written materials must describe the process to request from the Federal funding agency an exception to the requirement to post the consent document, and the process to redact confidential commercial information from the consent form.
When following FDA regulations:
1. Policies and procedures have the IRB or EC determine that the required and appropriate additional elements of disclosure are included in the consent process.
2. Policies and procedures have the IRB or EC determine that:
  1. The consent document embodies the basic and required additional elements of disclosure.
  2. There is a statement noting the possibility that the FDA may inspect the records that will be provided to each participant.
  3. There is a statement that a description of the clinical trial will be available on http://www.clinicaltrials.gov as required by U.S. law. The website will not include information that can identify the participant. At most the website will include a summary of the results. The participant can reach the website at any time.
  4. The participant or the participant’s legally authorized representative will sign and date the consent document.
  5. The researcher will give either the participant or the legally authorized representative adequate opportunity to read the consent document before it is signed.
3. Short-form Consent When Following FDA Regulations
  1. To allow the use of the short form of consent documentation when following FDA regulations, policies and procedures have the IRB or EC determine that:
    1. The consent document states that the elements of disclosure (See Table II.3.F.1.) required by regulations have been presented orally to the participant or the participant’s legally authorized representative.
      1. A written summary embodies the basic and appropriate additional elements of disclosure.
      2. There will be a witness to the oral presentation.
      3. For participants who do not speak English, the witness is conversant in both English and the language of the participant.
      4. The participant or the participant’s legally authorized representative will sign the consent document.
      5. The witness will sign both the short form and a copy of the summary.
      6. The person actually obtaining consent will sign a copy of the summary.
      7. A copy of the signed short form will be given to the participant or the legally authorized representative.
      8. A copy of the signed summary will be given to the participant or the legally authorized representative.
4. With regard to data retention when participants withdraw from a clinical trial, policies and procedures have the IRB or EC:
  1. When a participant withdraws from a study, the data collected on the participant to the point of withdrawal remains part of the study database and may not be removed. The consent document cannot give the participant the option of having data removed.
  2. A researcher may ask a participant who is withdrawing whether the participant wishes to provide continued follow-up and further data collection subsequent to their withdrawal from the interventional portion of the study. Under this circumstance, the discussion with the participant distinguishes between study-related interventions and continued follow-up of associated clinical outcome information, such as medical course or laboratory results obtained through non-invasive chart review, and address the maintenance of privacy and confidentiality of the participant's information.
  3. The researcher must obtain the participant’s consent for this limited participation in the study (assuming such a situation was not described in the original consent document). The IRB or EC must approve the consent document.
  4. If a participant withdraws from the interventional portion of a study and does not consent to continued follow-up of associated clinical outcome information, the researcher must not access for purposes related to the study the participant's medical record or other confidential records requiring the participant's consent. However, a researcher may review study data related to the participant collected prior to the participant's withdrawal from the study, and may consult public records, such as those establishing survival status.
When following DoD requirements:
1. Consent documents must include additional DoD elements of disclosure. (See Table II.3.F.)
2. Policies and procedures have the IRB or EC determine that the disclosure for research-related injury follow the requirements of the DoD component.
3. For greater than minimal risk research involving DoD-personnel, when recruitment and consent occur in a group setting, the IRB must appoint an ombudsperson. The ombudsperson:
4. If the research involves a human being as an experimental subject and is supported by DoD-appropriated funds, informed consent must be obtained from the participant in advance, in accordance with 10 USC 980.
When following DOE requirements:
1. When research is classified, consent documents must disclose:
  1. The identity of the sponsoring agency, unless the sponsor requests it not be done. The only acceptable reason for non-disclosure is that disclosure could compromise intelligence sources or methods. Additionally, the research must be no more than minimal risk to participants; and the IRB must determine that by not disclosing the identity the researchers will not adversely affect the participants.
  2. That the project is classified, what it means for the purposes of the research project, and what part of the research that applies to.
2. The IRB must determine if participants need access to classified information to make a valid consent decision.
3. Consent documents must include additional DOE elements of disclosure. (See Table II.3.F.1.)
When following DOJ requirements:
1. Policies and procedures indicate that for National Institute of Justice-funded research:
  1. Under a privacy certificate, researchers and research staff do not have to report child abuse unless the participant signs another consent document to allow child abuse reporting.
2. Consent documents must include additional DOJ elements of disclosure. (See Table II.3.F.)
When following the ICH-GCP (E6) guideline:
1. Consent documents must include additional ICH-GCP (E6) elements of disclosure. (See Table II.3.F.)
2. Policies and procedures on documentation of the consent process include:
  1. Prior to a participant’s participation in the trial, the written consent document should be signed and personally dated by the participant or by the participant's legally acceptable representative.
  2. Prior to a participant’s participation in the trial, the written consent document should be signed and personally dated by the person who conducted the informed consent discussion.
  3. If a participant is unable to read or if a legally acceptable representative is unable to read, an impartial witness should be present during the entire informed consent discussion.
    1. After the written consent document and any other written information to be provided to participants is read and explained to the participant or the participant’s legally acceptable representative, and after the participant or the participant’s legally acceptable representative has orally consented to the participant’s participation in the trial and, if capable of doing so, has signed and personally dated the consent document, the witness should sign and personally date the consent document.
    2. By signing the consent document, the witness attests that the information in the consent document and any other written information was accurately explained to, and apparently understood by, the participant or the participant's legally acceptable representative, and that consent was freely given by the participant or the participant’s legally acceptable representative.
    3. Prior to participation in the trial, the participant or the participant's legally acceptable representative should receive a copy of the signed and dated written consent document and any other written information provided to the participants.
When following VA requirements:
1. The consent document must be signed and dated by the participant or legally authorized representative. The IRB may waive the requirement for the signature of the person obtaining consent when there is no physical contact with the participant (e.g., where the only contact with the participant is through telephone or mail). A physical or electronic copy must be given or made available to the person signing the form.
2. The informed consent for research must include information describing any photographs, video, and/or audio recordings to be taken or obtained for research purposes; how the photographs, video, and/or audio recordings will be used for the research; and whether the photographs, video, and/or audio recordings will be disclosed outside VA.
  1. An informed consent to take a photograph, video and/or audio recording cannot be waived by the IRB.
  2. The consent for research does not give legal authority to disclose the photographs, video, and/or audio recordings outside VA.
3. Consent documents must include additional VA elements of disclosure. (See Table II.3.F.)

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

Application form
Reviewer checklist
Consent template

Outcomes

Unless waived, IRB or EC members determine that the consent process will seek the legally effective consent of participants or their legally authorized representatives.
IRB or EC members determine that the required and additional elements of disclosure, when appropriate, are included in the consent process.
IRB or EC members determine that the consent process will be documented as required.

Proceed To: ELEMENT II.3.G.

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT II.3.F.