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Consent & Waiver of Consent

Table of Contents

Consent is typically 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 obtaining informed consent. Please note that regardless of the method of consent, all approval criteria for the consent process must be met. Consent is usually obtained concurrently with HIPAA authorization in order to view the medical record for participants. At Northwestern University, HIPAA authorization is obtained on the same document as the consent. More information on obtaining HIPAA authorization can be found here.

You must describe your process for obtaining informed consent for participation in the protocol.   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 Short Form Written Consent Process may be used.

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.

Written Documentation of Informed Consent (Standard Written Consent or Electronic Written Consent)

Description

Most research studies utilize “standard written consent” as this is most preferable for ensuring understanding. Prospective participants, their legally authorized representative, or the parents of children who are potential participants are presented with a consent document on which they sign their name to document that they agree to participate in the study. This can also be done electronically. A copy is given to the participant. Participants and their legally authorized representatives must be given ample time to review the consent with the study team.

In addition to obtaining written informed consent for participation in the research study, you must obtain written HIPAA authorization from prospective participants for the use or disclosure of their PHI which is done in the same document. 

Please see HRP-314 WORKSHEET Criteria for Approval, Item 7 and SOP HRP-091 for more information.

Situations When It Is Used

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 (Verbal or Online Consent)

Description

Potential participants, or the parents of children who are potential participants, are presented (either verbally or in writing) with the same information required in a written consent document, but documentation of the process (signing of the consent form) has been waived by the IRB.

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.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide participants with a written statement regarding the research.

Conditions for Approval

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.

Situations When It Is Used

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.

Waiver or Alteration of Informed Consent

Description

Complete Waiver of Consent

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.

This waiver applies in the special circumstances when the IRB determines that it is not necessary to obtain the participants’ consent to conduct the research.

Alteration of Consent

The IRB may approve research where investigators leave out or alter elements of informed consent, provided the research meets all applicable regulations. This falls under the category of "Deception" or "Incomplete Disclosure" and more information can be found on the Guidelines for Research Involving Deception and Incomplete Disclosure webpage.

HHS regulations allow the IRB to waive the requirement for obtaining informed consent or parental permission or to approve a consent procedure that leaves out or alters some or all of the elements of informed consent otherwise required under the regulations.

The FDA does not allow a waiver or alteration of the requirements for obtaining informed consent except in special circumstances. 

Situations When It Is Used

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

HIPAA Requirements

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