Northwestern University Research

Northwestern University - Office for Research

Waiver or Alteration of the Requirements for Obtaining Informed Consent

Description

This waiver applies when the IRB determines that investigators need not obtain the subjects’ informed consent to participate in research in special circumstances.

The IRB may approve research where investigators leave out or alter elements of informed consent, so long as the research meets all applicable regulations.

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. See details.

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

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 subjects may be granted a waiver of consent.  With compelling reason, a waiver of consent may be granted for studies where secondary subjects may be involved and it would either be prohibitive or potentially dangerous to obtain a consent, as in the case where parent 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 subjects be left unaware of the particular purpose of the research, because the subjects’ responses might be biased if they know in advance what the investigators are seeking. Such research designs do not preclude offering potential subjects some information about the research and giving them the opportunity to decide whether to participate.

Additional provision for CHILDREN who are subjects

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 subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (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 waiver

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 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; and
    4. whenever appropriate, the subjects 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 subject 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 waiver

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

  1. Emergency Exemption from Prospective IRB approval for Investigational Drug, Biologics, and Devices
  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 you plan to use or share protected health information (PHI) when conducting your research, you must conduct your study in accordance with the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA).

This means that when applying for a waiver of documentation of consent, you will also have to request a waiver or alteration of HIPAA Authorization.  The IRB can grant the waiver of alteration if it deems the following criteria are met:

  1. An adequate plan to destroy identifiers at the earliest opportunity absent a health or research justification or legal requirement to retain them, and
    1. An adequate plan to protect health information identifiers from improper use or disclosure,
    2. An adequate plan to destroy identifiers at the earliest opportunity absent a health or research justification or legal requirement to retain them, and
    3. Adequate written assurances that the PHI will not be used or disclosed to a third party except as required by law, for authorized oversight of the research study, or for other research uses and disclosures permitted by the Privacy Rule;
  2. Research could not practicably be conducted without the waiver or alteration; and
  3. Research could not practicably be conducted without access to and use of PHI.
Contact :
Chicago
Arthur Rubloff Building, 7th Floor
750 N. Lake Shore Dr.
Phone: (312) 503-9338
Fax: (312) 503-0555
irb@northwestern.edu
Evanston
Chambers Hall, 2nd Floor
600 Foster St.
Phone: (847) 467-1723
irb@northwestern.edu

 

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