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Describes when it may be appropriate for a U-M IRB to approve a waiver to document informed consent or a waiver of informed consent for human subjects research.

On December 21, 2023, the U.S. Food and Drug Administration (“FDA”) published a final rule to allow institutional review boards (“IRBs”) to waive or alter informed consent for certain clinical investigations that pose no more than minimal risk to human subjects and include appropriate safeguards to protect the rights, safety, and welfare of human subjects (the “Final Rule”).1 The Final Rule follows a proposed rule issued in November 2018,2 which we discussed in a previous Alert. It is one of several steps that FDA has taken to harmonize its requirements with those of the “Federal Policy for the Protection of Human Subjects,” known as the “Common Rule,”3 as required under the 21st Century Cures Act (the “Cures Act”) enacted in 2016.4 Other steps FDA has taken include publication of two proposed rules in September 2022 to harmonize FDA regulations pertaining to human subjects research and review of cooperative research by a single IRB with the Common Rule,5 which we discussed in an earlier Alert. To complete the harmonization process, which the Cures Act had required FDA to complete by December 13, 2019, FDA must still finalize these proposed rules. Additionally, FDA has said that it is also considering how certain other provisions in the Common Rule that are potentially relevant for FDA-regulated research, such as provisions on the posting of informed consent forms, broad consent, limited IRB review, exempt research, and public health surveillance activities, could be applied to FDA-regulated research.6

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On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) issued a new guidance document on informed consent (the “Final Guidance”).1 This guidance finalizes the draft “Informed Consent Information Sheet” from 2014 (the “Draft Guidance”) and supersedes FDA’s guidance from 1998, “A Guide to Informed Consent.”2 FDA’s issuance of the Final Guidance follows FDA’s continuing efforts in recent years to modernize and streamline the clinical trial enterprise.

The Institutional Review Board (IRB) may consider a waiver or alteration of the requirement for obtaining informed consent if all of the conditions are met.

The revised Common Rule, which goes into effect January 21, 2019, includes changes to the requirements for informed consent. These changes only apply to studies reviewed and approved on or after January 21, 2019 under the revised rule. The goal of the changes is to facilitate the understanding of a prospective subject or legally authorized representative in regards to the reasons why one might or might not want to participate in the research. The primary changes include:

The COVID-19 pandemic poses distinct challenges for the conduct of minimal-risk clinical research, including the very definition of “minimal risk,” heterogeneity of risk among potential study parti...

Waiver of the Requirement to Obtain a Signed Informed Consent (45 CFR 46.117) - Regulatory Requirements Following expedited or full-board review, the IRB may waive the requirement to obtain a signed

340. Informed Consent for Exempt and Minimal Risk Research | Research Integrity | University of Nevada, Reno

Investigators are required to obtain informed consent as a legal and ethical obligation. This chapter discusses the process of consent, the elements of consent, and legal requirements involved when obtaining informed consent from subjects.

Public Citizen is deeply concerned that once the Food and Drug (FDA) finalizes the proposed rule, clinical investigators inappropriately will seek, and IRBs inappropriately will grant, waivers of informed consent for clinical investigations that involve greater than minimal risk to the subjects.

There are two components to the informed consent process: information and documentation. The first occurs when you convey pertinent information to potential subjects so t

UTHealth is a comprehensive academic health university in Texas, uniting schools of dentistry, medicine, nursing, public health, biomedical sciences and biomedical informatics.

For more information on Informed Consent see IRB Policies and Procedures. “Informed consent is more than just providing a prospective participant with a for ...

1. Can consent or parental permission ever be “passive” or “implied”?

Obtaining written informed consent from a potential participant is more than just a signature on a form.

Except as provided in ß50.23, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.