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FDA Proposes Changes to Clinical Trial Informed Consent Rules

On November 15, 2018, the Food and Drug Administration (FDA) published a Proposed Rule, which, if finalized, will allow an institutional review board (IRB) to waive or alter certain informed consent requirements if a clinical trial poses minimal risk to human subjects and includes appropriate safeguards to protect the rights, safety, and welfare of those human subjects.  

FDA’s Proposed Rule is a significant deviation from current IRB informed consent requirements and could improve clinical trial efficiency for IRBs and clinical investigators involved in minimally risky clinical trials.  However, despite FDA’s expansion of the informed consent waiver and alteration requirements, it remains unclear whether IRBs, clinical investigators, and clinical trial sponsors will actually realize efficiencies where informed consent could be waived or altered.

IRBs are legally responsible for the review, approval, and continuing review of clinical investigations. Of many responsibilities, IRBs must ensure clinical investigators appropriately obtain a study subject’s legally effective informed consent prior to the subject’s participation in a clinical trial.  Currently, FDA permits IRBs to waive or alter informed consent requirements in only the following limited circumstances:

  1. Emergency Use – Applies when human subjects: (i) have a life-threatening situation; (ii) have a severely debilitating condition; (iii) there is no standard acceptable treatment available for the subject’s condition; and (iv) there is insufficient time to obtain IRB approval;

  2. Planned Emergency Research – Applies when human subjects: (i) have a life-threatening medical condition that necessitates urgent intervention; and (ii) cannot provide informed consent because of their condition.  Additionally, the research must: (i) involve an investigational product that has the prospect of direct benefit to the patient and must be administered before informed consent can be obtained; and (ii) show there is no reasonable way to identify individuals eligible for participation;

  3. In Vitro Diagnostic Device Studies Using Leftover Human Specimens who are not Individually Identifiable – This informed consent waiver process is subject to numerous requirements aimed at preserving the anonymity of the individual from whom the specimen was obtained; or

  4. Armed Forces Personnel – Applies only if the President of the United States waives informed consent for military personnel for administration of an investigational product to members of the armed forces.

As a result of Congress’ passage of the 21st Century Cures Act (the Cures Act), FDA is now authorized to promulgate regulations that simplify and help facilitate compliance with various regulations governing clinical trials.  With respect to informed consent, the Cures Act mandates that FDA promulgate exceptions to the clinical trial informed consent process in accordance with the following:

  1. With respect to medical device clinical trials, an IRB may waive informed consent requirements when the clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject or the investigator; and

  2. With respect to drug clinical trials, an IRB may waive informed consent requirements if obtaining informed consent is not feasible, is contrary to the best interests of human subjects, or the proposed clinical testing poses no more than minimal risk to human subjects.  Further, the clinical trial process must include appropriate safeguards as prescribed to protect the rights, safety, and welfare of human subjects.

In response to its Cures Act mandates, FDA’s Proposed Rule could permit IRBs to waive or alter clinical trial informed consent requirements for drug and device studies if the IRB finds and documents the following: 

  1. The clinical trial involves no more than minimal risk to the subjects;

  2. The waiver or alteration of informed consent will not adversely affect the rights and welfare of the subjects;

  3. The clinical trial could not practicably be carried out without the waiver or alteration of informed consent; and

  4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation in the clinical trial.

FDA’s Proposed Rule also provides that if an IRB merely alters informed consent requirements, the IRB may not approve an informed consent document that does not include a statement informing the subject about clinical trial-related information that must be reported to and published on www.ClinicalTrials.gov.

Should FDA’s Proposed Rule be finalized, there are other restrictions IRBs, clinical investigators, and clinical trial sponsors must consider.  For example, states may have informed consent laws that create additional informed consent obligations, or IRBs may have research protocol requirements requiring the subject be given information regarding use of their medical information in compliance with applicable law. 

Moreover, FDA’s Proposed Rule does not permit any and all minimal risk clinical trials to be conducted without informed consent.  In effect, clinical investigators and clinical trial sponsors must not only show the clinical trial involves minimal risk but the subject’s welfare and legal rights are not adversely affected by any informed consent waiver or alteration. 

When determining whether the subject’s welfare and legal rights are not adversely affected, the Proposed Rule advises IRBs to consider whether the waiver or alteration has the potential to negatively affect the subjects' well-being, or whether the subject population in general would likely object to a waiver or alteration being granted.  IRBs, clinical trial sponsors, and clinical investigators may find these considerations difficult to explain and document.  Further, the review process may result in additional delays while the IRB sorts out, for example, whether a subject population would object to a waiver of the general informed consent requirement. 

As a result, while FDA’s Proposed Rule may assist clinical trial sponsors and investigators to more efficiently engage in clinical research, it is not without its challenges. Clinical investigators, IRBs, and clinical trial sponsors should thoughtfully approach informed consent issues and determine whether other legal constraints impact their use of informed consent documents.

© 2021 Dinsmore & Shohl LLP. All rights reserved.National Law Review, Volume VIII, Number 319



About this Author

Brian Murray, healthcare lawyer, Dinsmore

Bryan focuses his practice on health care law and provides legal counsel to health care industry clients on a range of issues, such as specialty and mail-order pharmacy operations, provider networks and reimbursement, regulatory compliance, contract review and preparation and 340B programming. He has experience analyzing pharmaceutical trade issues affected by state and federal regulatory frameworks, including pharmacy practice acts, the anti-Kickback Statute, the Drug Supply Chain Security Act, the Stark Law and the Health Insurance Probability and Accountability Act. ...

(412) 339-5603
Jennifer Mitchell, health care practice group partner, Dinsmore Shohl, law firm,

Jennifer is a Partner in the Health Care Practice Group and leads the firm’s HIPAA Privacy and Security practice and initiatives. In her HIPAA practice, she works with clients to minimize the risk of privacy and data security issues, assisting with all aspects of HIPAA privacy and security compliance, governance, audits/investigations, breach analyses, training and strategic planning. She has a thorough understanding of federal and state privacy and confidentiality laws and has served as a health care privacy expert witness. 

Within the...

Eric J. Plinke, Dinsmore Law, Health Care Lawyer, Corporate Attorney

Eric Plinke is a Partner in the Corporate Department and Health Law Practice Group, and he routinely advises corporate and individual clients regarding a wide-range of health care industry legal issues. He has counseled clients in practice formation and acquisition, hospital and joint venture transactions, hospital and medical practice affiliations, contract review and preparation, compliance programs, HIPAA regulations, scope of practice issues, telemedicine and Stark law and Anti-kickback statutes, as well as significant experience counseling in ambulatory surgery centers and other joint...