HRPP policies & procedures manual

702: Documentation of informed consent

1. Purpose

This policy describes the requirements for documentation of informed consent and circumstances when the IRB may waive the requirement to document informed consent.

2. Policy

Unless specifically waived by the IRB, all subjects, or their legally authorized representatives, must document that they are consenting to participate in any research project that is conducted at WSU.

3. Specific policies

Each subject or his/her legally authorized representative must sign and date a copy of the current IRB-approved consent form prior to enrollment or any participation in any phase of the study, and be given a copy of the signed document, unless the requirement is waived by the IRB.

The IRB may approve procedures for documentation of informed consent that involve:

  1. a written consent form signed by the subject, or
  2. in limited circumstances, a waiver of the requirement for a signed written consent form.

Each of these two options is described in detail below. It is the responsibility of the IRB to determine which of the procedures described below is appropriate for documenting informed consent in protocols that it reviews. Usually, only option (a) will be appropriate.

3.1 Written consent form signed by the subject

Mentally disabled or cognitively impaired subjects: Studies involving subjects who may have impaired decision-making capabilities may take place over extended periods. The IRB should consider whether periodic re-consenting of individuals should be required to ensure that a subject’s continued involvement is voluntary. The IRB may require investigators to re-consent subjects after taking into account the study’s anticipated length and the condition of the individuals to be included. Additionally, the IRB should consider whether and when to require a reassessment of decision-making capacity.

Subjects who do not understand English should be presented with an informed consent document written in a language understandable to them.

3.2 Waiver of documentation

The IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if the IRB finds either:

  • That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from breach of confidentiality and the research is not FDA-regulated.Each subject will be asked whether the subject wants documentation linking the subject with the research and the subject’s wishes will govern, or
  • That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with:

  • A cover letter explaining the research
  • Consent statement with all the elements that states consent is implied by returning the survey

The investigator must provide the IRB with a completed written consent document containing all the elements of consent and study information that will be provided to the subject.

3.3 Consents for mail, telephone and Internet surveys

When research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context, the following may be considered:

Fax or mail

The IRB may approve informed consent sent by mail in one of two ways.

  1. The investigator mails or faxes the consent document along with a letter requesting participation. The subject signs the consent and returns it with his/her survey.  If the study is to be anonymous, the consent form is separated immediately upon opening the package.
  2. The investigator sends a consent statement to the subject which includes a statement that by returning the completed survey, the subject is providing and documenting his/her consent.

The IRB may approve telephone consent for survey research. The investigator must use a script when obtaining consent by telephone. (The investigator must include the script in his/her IRB submission.) The script must contain a comprehensive, succinct description of the study and include the relevant elements of informed consent in narrative form. (All possible efforts should be made to mail the informed consent document in advance to the subject.) The interviewer solicits any questions the potential subject may have and answers them.  The investigator needs to document that the script was read, the individual was offered the opportunity to ask questions, and whether the subject agreed to or declined participation in the study. If an investigator is taping his/her phone conversations with the subject, the interviewer must immediately inform the subject that he/she is being taped.

Anonymous Internet-based surveys

It is sometimes appropriate to use a consent statement. Subjects would still need to be presented with the consent information, but would be informed that their consent is implied by submitting the completed survey and/or clicking on an “I agree” or “I do not agree” button on the website. The website needs to be designed to allow the subjects to print a copy of the consent statement for their records.

4. Applicable regulations and guidelines

21 CFR 50.23, 50.24

21 CFR 56.109(c), 56.109(d)

45 CFR 46.116

5. Forms

Addendum 5: Waiver of documentation of informed consent

6. Procedures employed to implement this policy & assignment of responsibility

Chairperson, IRB
Reviews submission to determine if circumstances warrant that the IRB may waive the requirement to document informed consents.
Reviews the consent documents using the appropriate checklists to capture all determinations.