Waivers of Consent

Regulatory Criteria for a Waiver or Alteration of Informed Consent

If requesting a waiver or alteration of informed consent, it is the responsibility of the investigator to justify (provide rationale) how each criterion are met. For research studies in which participants are prospectively enrolled, it’s generally assumed that participants are available and prospective consent is feasible. If requesting a waiver in this type of situation, the IRB requires thorough rationale for a waiver.

1. The research involves no more than minimal risk to subjects

   Research procedures for which a waiver is requested must meet the regulatory definition of minimal risk, meaning: the “probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” If this criterion is not met, the waiver cannot be granted by the IRB.

2. The research could not be carried out practicably without the waiver or alteration

   It is not a question as to whether it is possible to obtain consent from the subject or their LAR, but whether the study itself would be feasible to conduct without a waiver or alteration. Informed consent should never be waived for convenience, nor waived solely for reasons of cost or speed, if doing so dilutes the protection of subjects’ rights and welfare. The IRB may consider any of the following in relation to this criterion: a) Scientific validity would be compromised if consent was required; b) Ethical concerns would be raised if consent were required; c) There is a scientifically and ethically justifiable rationale why the research could not be conducted with a population from whom consent can be obtained.

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;

   It must be explained why the study itself would be infeasible to conduct without using identifiable information / biospecimens.

4. The waiver or alteration will not adversely affect the rights and welfare of the subjects

   The IRB may consider any of the following in relation to this criterion: a) Consider other Federal, state, or local laws that safeguard rights; b) Whether the subject population, in general, would consider that their rights were violated if they knew of the waiver/alteration; and c) Whether the subject population, in general, would consider that the waiver/ alteration has the potential to cause adverse consequences for their welfare or general well-being.

5. Where appropriate, the subjects or legally authorized representative will be provided with additional information about their participation.

   The intent of this criterion is to require debriefing for participants in research that involves deception, misinformation, etc. The IRB may consider whether: A subject is included in research that exposes them to situations or conditions to provoke a response for research purposes, and the situation would not have ordinarily occurred; or Information is obtained during the course of the research that directly impacts on the safety or welfare of the subject.

HIPAA Regulated Research with a Waiver of Informed Consent

If the research involves PHI, then the investigator must also request a waiver of Written Authorization. Click below to access the HIPAA Waiver submission form.

Waivers for FDA Regulated Clinical Investigations

While FDA regulations currently do not permit a waiver or alteration of consent for FDA-regulated clinical investigations, FDA guidance allows IRBs to waive or alter the informed consent requirements for minimal risk clinical investigations using the Common Rule criteria.

For greater than minimal risk research governed by FDA regulations (21 CFR 50.23), informed consent may be waived in an individual circumstance only if deemed “infeasible” for ALL of the following reasons:

• a life-threatening situation exists, necessitating the use of the test article;
• the potential subject is unable to consent due to his or her inability to communicate;
• there is insufficient time to obtain the consent of a legally authorized representative; AND
• no alternative approved therapy exists that is equally or more effective at saving the life of the subject.

The test article may be a drug (including a biological product), medical device, or electronic device. Within five working days of the use of the test article, both the investigator and a non-participating physician (i.e., one not involved in the research) must certify in writing that all of the conditions described above existed prior to the treatment, procedure, or intervention. This written documentation must be submitted to the IRB, within five working days.

FDA regulations (21 CFR 50.24) permit exempting certain planned emergency research from informed consent requirements [Exception from Informed Consent (EFIC)]. Please consult with the Penn IRB Directors for further information regarding this type of research.