Obtaining informed consent is a basic ethical obligation and a legal requirement for researchers. Informed consent is the process by which sufficient information is provided to a potential participant, in a language which is easily understood by the participant, so that the individual can make a voluntary decision as to whether or not to participate in the research study.
The requirement for informed consent is defined by the:
- Department of Health & Human Services (HHS) regulations at 45 CFR part 46
- Food and Drug Administration (FDA) regulations at 21 CFR part 50
You must describe your process for obtaining informed consent for participation in the protocol. The process you employ for obtaining informed consent will depend on the research setting and your participant population. An in-depth description of the Process to Obtain Informed Consent has been provided for reference as you write the study protocol, which is based off HRP-090 – SOP Informed Consent.
If you will be recruiting from a non-English speaking population, the informed consent documents should be translated into the language of that population. However, a study may unexpectedly have a potential participant that is non-English speaking, and there is not enough time to translate the consent form. In those cases, the Short Form Written Consent Process may be used. Please see HRP-317 WORKSHEET Short Form Consent Documentation for additional details and requirements.
If you will be accessing student education records for the purpose of your research study, the Family Educational Rights and Privacy Act (FERPA) may apply. Please see the HRP-331 WORKSHEET FERPA Compliance for additional details and requirements.
Types of Consent
There are different methods of informed consent depending on the research study. Consent (and authorization) are commonly documented by obtaining a signature from the participants. However, if certain criteria are met, the study team has the option to request for alterations of the consent process. Below you will find the different types of informed consent. Please note that regardless of the method of consent, all approval criteria for the consent process must be met (See HRP-314 WORKSHEET Criteria for Approval, Item 7).
Northwestern IRB consent form templates should be used, and may be downloaded from our Biomedical and Social Behavioral Consent Templates webpage.
Written Documentation of Informed Consent (Worksheet HRP-314, Item 7 and SOP HRP-091)
In Person Written Consent (Standard)
- The typical Written Consent process takes place in person. A potential participant or Legally Authorized Representative (LAR) is provided a physical copy of the consent form during the consent process. The research team will discuss the study in depth with the potential participant/LAR and answer any questions they may have. Sufficient time will be provided to the individual/LAR to consider participation, including the opportunity to discuss the research study with anyone outside of the study team. If the participant/LAR chooses to take part in the research study, a written signature and date is obtained from the participant/LAR, as well as the person obtaining consent, and a signed/dated copy is provided to the participant.
Electronic Written Consent (eConsent)
- Electronic Written Consent that captures an electronic signature and date from the study participant as well as the person obtaining consent, often referred to as “eConsent”, can take place either in person or remotely. Study teams may opt to consent individuals in person using an electronic device such as a tablet or computer. Alternatively, they may remotely consent participants in their home or other sites, using email or electronic platform, in conjunction with a telephone call or teleconference. The Investigator and/or their delegate is responsible for carrying-out an effective informed consent process, whether it is in person or remote. The protocol should describe this process, including steps to verify the identity of the participant, ensuring an in-depth discussion of the study and answering all questions. The OHRP & FDA Use of Electronic Informed Consent Guidance may be useful in developing your electronic/online informed consent process, including verifying the identity of participants that are consented electronically. HRP-331 WORKSHEET FERPA Compliance Item 8 includes information on Electronic Written Consent requirements.
- Different platforms can be used to obtain valid electronic signature such as: REDCap, DocuSign, AdobeSign and others. If your study is FDA-regulated or is obtaining HIPAA authorization, the platform must be secure and compliant with 21 CFR Part 11. Part 11 compliance for electronic written consent may be requested through REDCap. Additionally, REDCap can sync with StudyTracker. Visit the REDCap website for more information.
It is considered a best practice to document in the participant file that the informed consent process has occurred. The study team should document the consent process in the study record, such as with a documentation of consent process form or note-to-file.
Waiver of Documentation of Informed Consent (Checklist HRP-411)
This process is often used in minimal risk research involving the administration of online or mailed surveys, telephone interviews, or when anonymous sensitive information is collected and there is a desire to not have written documentation that links the participant to the research study.
- Some minimal risk studies may qualify for verbal consent. Verbal consent can take place over the phone, a teleconference platform such as Zoom, or even in person. This can include use of a verbal informed consent script and/or providing the potential participant with a document describing the study (with required elements of informed consent) in combination with a discussion between the participant and study team. The study must meet the waiver of documentation of consent criteria for the study team to be able to obtain verbal consent listed in HRP-411 – CHECKLIST Waiver of Written Documentation of Consent. Verbal consent does not require a signature from the participant; it is sufficient for the participant to verbally agree to take part in the research study as witnessed by a consenting study team member. It is considered a best practice to document in the participant file that the verbal consent process has occurred. The study team should document the consent process in the study record, such as with a documentation of consent process form or note-to-file.
- Some minimal risk studies may qualify for online consent or emailing of a document that does not capture the participant’s electronic signature. For example, a simple online survey study may meet the criteria for a waiver of written documentation of consent (HRP-411 – CHECKLIST Waiver of Written Documentation of Consent. If so, the participant can simply select ‘I agree’ or ‘I disagree’ or ‘continue’ to consent to participate rather than providing an electronic signature. Different platforms can be used to obtain online consent without documentation of signature, such as REDCap, Qualtrics, etc. The platform must be able to determine who provides consent.
Waiver of Alteration of Informed Consent (Checklist HRP-410)
Some minimal risk studies, where it is not possible to obtain informed consent, may qualify for a waiver or alteration to the requirements of informed consent. This means that all or some of the elements of informed consent may be waived. The protocol should include the justification for how the study meets the required waiver/alteration criteria (HRP-410 – CHECKLIST Waiver or Alteration to Informed Consent). For example, a data review protocol where many participants may no longer be coming to the institution and the study would not be feasible without the waiver of informed consent.
For Studies Using PHI: Research that is using or disclosing Protected Health Information (PHI) must be conducted in accordance with the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA) and requires completion of the HIPAA authorization.
- Please see guidance about PHI and HIPAA policy here.
- Please see guidance about HIPAA-compliance of Zoom during the consent process here.
Waiver of Alteration to HIPAA Authorization (Checklist HRP-441)
Some studies may meet the criteria to either waive HIPAA authorization or alter the requirements of the authorization. The protocol should include the justification for how the study meets the required waiver/alteration criteria (HRP-441 – CHECKLIST HIPAA – Waiver Authorization).
A complete waiver of HIPAA may be granted when it is not possible to obtain the participants signature, and it is not possible to provide the participant with the authorization information. A waiver of HIPAA authorization may also be granted when a study does not intend to obtain HIPAA authorization on behalf of the covered entity, but needs access to PHI for recruitment purposes (i.e., contact information from EDW).
There are also circumstances when an alteration to HIPAA may be appropriate. For example, with studies looking to enroll participants who may not have access or skills to using technology that allows for an electronic signature, such as the elderly or people with limited resources, and it is not possible to obtain the written signature. In such cases, the IRB also approves a waiver of documentation of consent, and the investigators must obtain verbal authorization instead of a written authorization. The verbal consent/authorization must contain all the required elements of consent plus HIPAA Authorization.