Consent & Waiver of Consent

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. 

The IRB may waive the requirement for the investigator to obtain a signed consent form for some or all participants if either of the conditions below are true:

1. The research is not FDA regulated.  The FDA has not adopted this category so it cannot be used if the research is subject to the FDA regulations 21 CFR 50.  The written script of the information to be provided orally and all written information to be provided include all required and appropriate elements of consent disclosure in the HRP-314 WORKSHEET Criteria for Approval.  The only record linking the participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each participant will be asked whether or not he or she wants documentation linking him or her to the research.  The participant’s wishes will govern.
2. The written script of the information to be provided orally (if consent is obtained in person) and all written information to be provided or electronically displayed include all required and appropriate elements of consent disclosure in the HRP-314 WORKSHEET Criteria for Approval.  The research presents no more than minimal risk of harm to participants (i.e., the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests) and involves no procedures for which written consent is normally required outside of the research context.  The research does not involve newborn dried blood spots.

Verbal Consent

• 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.

Online Consent

• 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.

• If PHI is being obtained in conjunction with a verbal/online consent, an alteration of HIPAA authorization must be obtained.

The IRB often grants a waiver of consent for retrospective chart review studies.

On rare occasions, prospective collection of data through intervention or interaction with participants may be granted a waiver of consent.  With compelling reason, a waiver of consent may be granted for studies where secondary participants may be involved and it would be either prohibitive or potentially dangerous to obtain a consent.  For example, parental permission for a child to participate may be waived if consenting the parent could be detrimental to the child.

As another example, some research designs require that participants be left unaware of the particular purpose of the research, because the participants’ responses might be biased if they know in advance what the investigators are seeking. Such research designs do not preclude offering potential participants some information about the research and giving them the opportunity to decide whether or not to participate.

Additional Provisions For Participants Who Are Children

The IRB may waive the requirements for obtaining parental or guardian permission under the following provision:

1. The IRB determines that a research protocol is designed to study conditions in children or a participant population for which parental or guardian permission is not a reasonable requirement to protect the participants (for example, neglected or abused children), and the following 2 additional criteria are also met:
   1. an appropriate mechanism is in place to protect the children, and
   2. the waiver is not inconsistent with federal, state, or local law (45 CFR 46.408(c)). The choice of an appropriate substitute mechanism (for example, appointing a child advocate or an assent monitor) for protecting children participating in research would depend on the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and the child’s age, maturity, status, and condition (45 CFR 46.408(c)). Note that an IRB may waive the requirement for obtaining parental or guardian permission under 45 CFR 46.408(c) even if the research involves more than minimal risk to the child subjects.

HHS Scenarios For Possible Waivers

For adults and children, a waiver or alteration of the requirements for obtaining informed consent can occur under any of the following three provisions set forth by HHS:

1. Research in general: an IRB may waive or alter the requirement of informed consent under 45 CFR 46.116(d), provided that the IRB finds and documents that all of the following four conditions are met:
   1. the research involves no more than minimal risk to the participants;
   2. the waiver or alteration will not adversely affect the rights and welfare of the participants;
   3. the research could not practicably be carried out without the waiver or alteration; and
   4. whenever appropriate, the participants will be provided with additional pertinent information after participation.
2. Public benefit or service programs: an IRB may approve a consent procedure that alters some or all of the elements of informed consent, or waive the requirement to obtain informed consent under HHS regulations at 45 CFR 46.116(c), provided that the IRB finds and documents that both of the following conditions are met:
   1. the research could not practicably be carried out without the waiver or alteration; and
   2. the research or demonstration project is to be conducted by or participant to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:
      1. public benefit or service programs;
      2. procedures for obtaining benefits or services under those programs;
      3. possible changes in or alternatives to those programs or procedures; or
      4. possible changes in methods or levels of payment for benefits or services under those programs.
3. Research in emergency settings: an IRB may also waive the requirement for obtaining informed consent if it finds and documents that the research meets the requirements of the HHS Secretarial waiver under 45 CFR 46.101(i) that permits a waiver of the general requirements for obtaining informed consent in a limited class of research in emergency settings.

FDA Scenarios For Possible Waivers

The FDA only permits an IRB to approve a clinical investigation without participants’ informed consent in the following circumstances:

1. Emergency Use
2. Exception from Informed Consent for Planned Emergency Research
3. Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable
4. Circumstances when the U.S. President may waive informed consent for military personnel for administration of an investigational product to members of the armed forces

If PHI is being obtained in conjunction with a verbal/online consent, an alteration of HIPAA authorization must be obtained.