Waiver or Alteration of Consent (Waiver Request Form Reviewer Checklist)

Owner: Vice President of Academic Affairs
Author: CSS IRB
Contact: irb@css.edu
Policy Number: 15
Effective Date: 10/8/2021

Policy

Common Rule regulations (45 CFR 46.116) 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.

Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidance on obtaining and approving requests for a waiver of informed consent at The College of St. Scholastica (CSS).

Definitions

Waiver - An IRB may waive the requirement to obtain informed consent for research provided the IRB satisfies the requirements for waiver and alteration. Waivers of informed consent are primarily requested for projects involving the secondary analysis of existing data or in projects involving deception.

Alteration - An IRB may approve a consent procedure that omits some, or alters some or all, of the elements of informed consent provided the IRB satisfies the requirements for alteration and waiver. An IRB may not omit or alter any of the requirements for informed consent whether written or oral.

Research in General

In order for the IRB to waive or alter consent, the IRB must find and document that:

1. The research involves no more than minimal risk to the subjects;
2. The research could not practicably be carried out without the requested waiver or alteration;
3. If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
4. The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
5. Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.

The first consideration is whether the research is no more than minimal risk. If it is determined to be greater than minimal risk, it cannot be granted a waiver of consent.

The second determination is that the waiver or alteration will not adversely affect the rights and welfare of the participants. This should basically be an evaluation whether the waiver would violate any state or federal laws or regulations, routine medical care, or entitlement. The IRB must be aware of state laws where the research is being conducted and should consult their legal counsel if needed.

The third criterion relates to the impracticability of carrying out the research without the waiver. The word ‘practicable’ means feasible or capable of being carried out. It does not mean possible, or conversely impossible. It may be possible to get consent, but the IRB must decide if it is practicable. For example, a large sample size where the potential subjects are no longer being seen as patients, many may be deceased, many may be lost to follow-up or difficult to contact would be reasons for impracticability – in this case requiring consent might greatly decrease sample size and bias the sample . If not granting the waiver would impact the scientific integrity and validity of the research, this would also be grounds for impracticability. Researcher inconvenience, cost of consent, or speed of completing the research are not valid reasons for granting a waiver.

The last criterion is whenever appropriate, the subject will be provided with additional information after participation. If the research reveals some new information which would be in the best interests of the subject to know, the researcher should have a mechanism to contact the subject and inform him or her. The CSS IRB and researcher need to consider whether the information is important enough to outweigh the privacy interests of the subject. In most retrospective research (e.g. review of existing records) this criterion would not apply.

Screening, Recruiting, or Determining Eligibility

The IRB may approve a research proposal in which an investigator 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, if either of the following conditions are met:

1. The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or
2. The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable bio-specimens*.

*Minnesota law is more restrictive than HIPAA in certain respects regarding access to health records for research purposes. Researchers at The College of St. Scholastica who obtain an IRB waiver of the HIPAA authorization requirement still must meet state law requirements (an authorization signed by patients permitting access to their records for research purposes generally) in order to access health records. It is important to check with the CSS IRB about the differences between Minnesota law and HIPAA in the research context for appropriate research review. (MN Stat. 144.295 DISCLOSURE OF HEALTH RECORDS FOR EXTERNAL RESEARCH.)

FDA and DHHS Guidance

Waiver of informed consent for certain FDA-regulated minimal risk clinical investigations will facilitate investigators’ ability to conduct studies that may contribute substantially to the development of products to diagnose or treat diseases or conditions or address unmet medical needs. The FDA intends to revise its informed consent regulations to add this waiver or alteration under appropriate human subject protection safeguards to the two existing exceptions from informed consent (i.e., in life-threatening situations and for emergency research). The FDA does not intend to object to the IRB approving a consent procedure that does not include, or that alters, some or all of the elements of informed consent set forth in 21 CFR 50.25, or waiving the requirements to obtain informed consent when the IRB finds and documents that:

1. The clinical investigation involves no more than minimal risk (as defined in 21 CFR 50.3(k) or 56.102(i)) to the subjects;
2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
3. The clinical investigation could not practicably be carried out without the waiver or alteration; and
4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

The IRB must be mindful of other issues related to waiver of consent:

• A waiver of parental permission may be approved according to 45 CFR 46;408(c). (See, CSS IRB SOP #16 Informed Consent w/Checklist and Templates.) The regulation has criteria for granting a waiver of parental permission in addition to the DHHS criteria above.
• A waiver of child assent may be approved according to 45 CFR 46:408(a). Even if the IRB determines that the children are capable of assenting the IRB may waive assent under the DHS criteria above.
• For research sponsored by the Department of Education or under the FERPA law, an exception to consent to access student records may be granted for specific education research categories for research carried out on behalf of The College of St. Scholastica. Minnesota law is applicable in addition to the FERPA law.
• NOTE THAT – Waiver of Documentation of Consent (CSS SOP #18 Waiver of Documentation of Consent) is different from a waiver or alteration of consent. In a waiver of documentation there is still a consent process, but written documentation is not required.

References:

21 CFR 50

45 CFR 46.116

45 CFR 46.408

University of Southern California

https://oprs.usc.edu/files/2019/01/Waiver-of-Consent_Reviewer_Checklist_1.15.19.docx

IRB EasyEd. Waiver or Alteration of Consent. Volume 1 Number 2 and Addendum. © 2017 Apex Ethical