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Waivers and Alterations of Informed Consent

Waive or alter some or all of the eight required elements of consent in accordance with federal regulations

There are situations for minimal risk research where it may be appropriate and permitted for an IRB to waive the requirement for informed consent or to approve a consent procedure that omits some, or alters some or all, of the required elements of informed consent. A waiver or alteration of informed consent may apply to an entire study or a component of the research, and may apply to written consent forms or to oral consent scripts.

Screening, recruitment, and determining eligibility 

With the revisions to the Common Rule effective as of January 21, 2019, IRBs no longer need to grant waivers or alterations of informed consent for screening, recruitment, and determining eligibility. Under the new version of the Common Rule, IRBs are not required to make a determination that a waiver or alteration of informed consent is required if a study team will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective subjects without the informed consent of the prospective subject or the subject’s legally authorized representative, as long as:
  • The study team will obtain information through oral or written communication with the prospective subject or legally authorized representative, or
  • The study team will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.
Waivers or alterations when broad consent was not obtained 

A “waiver” of informed consent means that the requirement to obtain informed consent is waived in its entirety for an entire study or for a component of the research. 

“Alteration” of informed consent means that the study team must obtain informed consent from subjects, but the consent procedure omits some of the required elements of consent or alters elements of consent. An altered consent process must still meet the following general requirements for informed consent:
  • Informed consent must be obtained before involving the subject in the research.
  • The circumstances in which informed consent is obtained must provide the prospective subject sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence.
  • Information must be in language understandable to the subject.
  • The prospective subject must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate.
  • Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject in understanding why one might or might not want to participate, organized and presented in a way that facilitates comprehension.
  • Informed consent as a whole must present information in sufficient detail relating to the research and must be organized and presented in a way that facilitates understanding of why one might or might not want to participate
  • No informed consent may include any exculpatory language through which the subject is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, sponsor, institution or its agents from liability for negligence. 
An IRB may waive or alter the informed consent requirements, including research that falls under FDA regulations, if it finds and documents all of the following criteria are met:
  1. the research involves no more than minimal risk to the subjects;
  2. the waiver or alteration will not adversely affect the rights and welfare of the subjects;
  3. the research could not practicably be carried out without the waiver or alteration;
  4. and, whenever appropriate, the subjects will be provided with additional information after participation.
If the research involves using identifiable private information or identifiable biospecimens, under the Common Rule, the IRB also must find and document that the research could not practicably be carried out without using such information or biospecimens in an identifiable format. 

Waivers or alterations for public benefit and service programs  

The Common Rule also permits a waiver or alteration of informed consent for research involving public benefit and service programs. The research or demonstration project must be:
  • conducted by or subject to the approval of state or local government officials, and
  • designed to study, evaluate, or otherwise examine:
    • public benefit or service programs;
    • procedures for obtaining benefits or services under those programs;
    • possible changes in or alternatives to those programs or procedures; or
    • possible changes in methods or levels of payment for benefits or services under those programs.
The IRB must find and document that the research could not practicably be carried out without the waiver or alteration of informed consent. 

Broad consent limitation on waivers or alterations  

If an individual was asked to provide broad consent, as defined under the revised Common Rule, for secondary research use of identifiable private information or identifiable biospecimens and refused to consent, an IRB cannot waive consent for the storage, maintenance, or secondary research use of the identifiable private information or identifiable biospecimens. 

ARROW guidance 

A waiver or alteration of informed consent can be requested either for the entire study or for part of the study and should be selected on the Informed Consent: General page in ARROW as appropriate. Depending on the selection, the Waiver of Signed Consent and/or Alteration of Consent page will appear in the application after you save the page. This table below is intended to assist study teams in completing the Waiver of Informed Consent page in ARROW:

 2.1 Are you requesting a waiver of informed consent for all components of the study? This should be answered "yes" or "no" depending on whether the waiver is being sought for all study activities. Note that as of January 21, 2019, study teams no longer need to request a waiver of informed consent for screening activities. 
 2.1.1 If no, list the component(s) of the study for which the waiver is being requested (e.g.retrospective chart review).  If the waiver of informed consent is being sought for only part of the study, please list the study activity (or activities) to which it should apply.
 2.2 If your study enrolls minors, are you requesting a waiver of assent and parental permission  If the study activities for which the waiver of informed consent is requested apply to minor subjects, this question should be answered "yes." If the study does not enroll minors, "not applicable" should be selected
 2.3 Provide a justification for how the following criteria for a waiver of informed consent will be met: 1) The study involves no more than minimal risk to the subjects; 2) The waiver will not adversely affect the rights and welfare of the subjects; 3) The study could not practicably be carried out without the waiver.

If the study team is requesting a waiver of informed consent to use identifiable information or identifiable biospecimens, also provide justification why the research could not be practicable carried out without using identifiable information or identifiable biospecimens.
Explain how the research (or research component for which the waiver is requested) meets each of these criteria.

If the waiver will cover the use of identifiable information or identifiable biospecimens, also address why the research could not could not practicably be carried out without using such information or biospecimens in an identifiable format.

This table below is intended to assist study teams in completing the Alteration of Informed Consent Process page in ARROW:

 3.1 Are you requesting an altered consent process (e.g. oral consent, altered consent document) for all components of the study)? This should be answered "yes" or "no" depending on whether the alteration is being sought for all study activities.

Note that as of January 21, 2019, study teams no longer need to request a waiver of informed consent for screening activities. 
 3.1.1 If no, list the component(s) of the study for which the alteration is being requested (e.g. retrospective chart review).  If the alteration of informed consent is being sought for only part of the study, please list the study activity (or activities) to which it should apply.
 3.2 Provide a justification for how the following criteria for an alteration of informed consent will be met: 1) The study involves no more than minimal risk to the subjects; 2) The waiver will not adversely affect the rights and welfare of the subjects; 3) The study could not practicably be carried out without the waiver.  Explain how the research (or research component for which the alteration is requested) meets each of these criteria.
 3.3 Describe the altered consent process (e.g. oral consent process, altered consent form, altered parental permission).  Specify which elements of informed consent, if any, you are omitting from the consent process, and provide a justification for omitting those elements.

Specify which elements of informed consent, if any, you are altering and provide a justification for altering those elements.
 3.4 If applicable, upload a copy of the altered consent document (e.g. information sheet or oral consent script). Please remember to preview your consent document using the Preview Final Documents activity prior to submitting your application. Additional information about using this activity can be found here  Upload consent documents in only one place in the ARROW application (i.e., any documents related to the altered consent documents should NOT be uploaded on the Informed Consent Overview page as well).




Keywords:waive ICF, alteration, informed consent   Doc ID:41962
Owner:Monica E.Group:Health Sciences IRBs
Created:2014-07-17 14:52 CDTUpdated:2019-01-27 09:47 CDT
Sites:Health Sciences IRBs
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