Consent Process Models
What is the process for obtaining consent?
The process for obtaining consent includes the steps that will be followed and the resources/information that will be used to inform the participant. The process for obtaining consent should be customized to fit the needs of the participants, while considering a study's risks and procedures, as well as the study location and the study team's access to the participants.
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Prior to enrolling a participant in a study, investigators must:
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What information will be provided to the participants during the consent process?
Investigators must provide important information about the study to participants during the consent process, such that participants can make a decision about being in the study. This information is generally provided in a written consent form, but may also be given in another written format (a letter, an email), or may be provided verbally.
The IRB provides a Consent Process Checklist that includes all of the required elements of consent. Study teams may design their own consent process procedure based on the consent elements in the regulations; these will be accepted by the IRB, so long as the required elements are included.
If you have justification for leaving out one or more of the consent elements that are applicable to your study, you must request an Alteration of Informed Consent in the IRB application. You will be asked to provide justification as part of the Alteration request.
Consent Process Example Scenarios
Consider the example scenarios below when designing your consent process. These examples may not be appropriate for all studies and should be customized to specific research when proposed to the IRB.
| Consent Process Example | Description |
| Remote consent process when a signed consent form is required | Though a signed consent form may be necessary before beginning study procedures, it may be acceptable to obtain consent remotely (via telephone or video conferencing) before the first study visit. |
| Mailed or online questionnaire using a consent cover letter | When questionnaire or survey research is minimal risk, a waiver of documentation of consent may be utilized. When a consent cover letter accompanies the questionnaire, consent to participate is given by completing and returning the questionnaire. |
| Opt-out parental notification for children's participation in research conducted at school | Based on the nature of a research project and according to the preferences of an individual school or school district, it may be acceptable to inform parents of research conducted at an elementary or secondary school and use an opt-out model if a parent wishes to have their child excluded from the study. The requirements for a waiver of parental permsision must be met. |
| Consent process with non-English speaking participants documented by a short form | When a full translation of the consent form cannot be obtained for a non-English speaking participant, the IRB may approve a short form consent process. The translated short form must be used in combination with the full English version of the consent form, facilitated by an interpreter. |
| Consent process using FDA-compliant electronic consent (eConsent) in REDCap | A consent process using REDCap eConsent that requires FDA 21 CFR Part 11 complaince requires preparation in REDCap and a thorough explanation in the IRB application. This example provides an outline of how a study team can prepare and utilize FDA-compliant eConsent in REDCap. |
| Coming soon: Focus groups or interviews using a consent cover letter |
When a focus group or interview is minimal risk, a waiver of documentation of consent is often justified. When a consent cover letter is provided to potential participants, their consent can be documented using written communication or a note-to-file drafted by the study team. |
| Coming soon: Consent process with a legally authorized representative |
Coming soon! |
| Coming soon: Consent process for children who are wards of the state |
Coming soon! |
| Coming soon: Consent process with a participant and a caregiver who is not acting as a legally authorized representative |
Coming soon! |
| Coming soon: Consent process involving a witness for participants who cannot read or are physically unable to sign the consent form |
Coming soon! |
External References
- DHHS Common Rule, Elements of Informed Consent: 46 CFR 46.116
- FDA, Elements of Informed Consent: 21 CFR 50.25
- VHA Handbook, 1200.05: Requirements for the Protection of Human Subjects in Research
- HIPAA Elements of Authorization: 45 CFR 164.508(c)