News | Cardiovascular Clinical Studies | November 19, 2018

New FDA Proposed Rule Alters Informed Consent for Clinical Studies

Proposed rule would allow Institutional Review Boards to waive or alter informed consent requirements for clinical studies that pose minimal risk to human participants under limited conditions

New FDA Proposed Rule Alters Informed Consent for Clinical Studies

November 19, 2018 — The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for certain FDA-regulated clinical investigations that present no more than minimal risk to human research participants.

If finalized, the proposed rule — an amendment of FDA’s regulations to implement a provision of the 21st Century Cures Act — would allow the Institutional Review Board (IRB) responsible for the review and approval of the research to waive or alter certain elements of informed consent, or to waive the requirement entirely, under limited conditions. To waive or alter informed consent under the proposal, the IRB would need to make findings that have been included in a Common Rule waiver provision for minimal risk research for decades. The Common Rule provision has provided appropriate safeguards to protect the rights, safety and welfare of individuals participating in certain minimal risk research for more than 25 years.

The FDA intends to withdraw its related 2017 guidance if this proposed rule becomes final. The agency is also seeking input on the types of minimal-risk clinical investigations for which sponsors or investigators would anticipate requesting a waiver or alteration of informed consent from the IRB.

The full proposed rule can be read here.

“Obtaining informed consent from those who volunteer to participate in research is a fundamentally important principle of human subject protection. The quality and integrity of clinical research is something the agency takes very seriously and the protection of research individuals is paramount. Over the years, we’ve received feedback from sponsors and investigators that they were not able to move forward in conducting important clinical investigations where there would be minimal risk as these trials involved situations where obtaining informed consent wasn’t possible, and the agency lacked the authority to permit a waiver of informed consent for that research. With the passage of the 21st Century Cures Act, the FDA’s authorities were changed, allowing greater flexibility. That’s why today, we’re proposing a change to our informed consent regulations in a way that maintains safeguards to protect study participants, while allowing important research to proceed where there is minimal risk to patients,” said FDA Commissioner Scott Gottlieb, M.D. “This change would facilitate the conduct of certain minimal risk clinical investigations that may be important to addressing significant public health needs without compromising the rights, safety, or welfare of human subjects.”

For more information: www.fda.gov

Related Content

Videos | Cardiovascular Business | April 16, 2019
A discussion with Ruth Fisher, MBA, vice president of the...
Foreign-trained doctors now make up one-third of cardiologists in the United States and help make up for the U.S. overall shortage of physicians. Pictured here is co-author of this article Mandeep R. Mehra, MBBS, MSc, FRCP, who is an example of the contribution international physicians have made in the U.S. He is medical director of the Brigham and Women’s Hospital Heart and Vascular Center.

Foreign-trained doctors now make up one-third of cardiologists in the United States and help make up for the overall shortage of physicians. Pictured here is co-author of this article Mandeep R. Mehra, MBBS, MSc, FRCP, who is an example of the contribution international physicians have made in the U.S. He is medical director of the Brigham and Women’s Hospital Heart and Vascular Center, The William Harvey Distinguished Chair in Advanced Cardiovascular Medicine, and a professor of medicine at Harvard Medical School. He is past-president of both the Heart Failure Society of America and the International Society of Heart and Lung Transplantation. 

Feature | Cardiovascular Business | April 15, 2019 | William W. Pinsky, M.D., FAAP, FACC, and Mandeep R. Mehra, MBBS, MSc , FRCP
As we strive to process today’s successive news cycles involving negative reports about immigration, it is easy for m
ACC Combines NCDR, Accreditation Into New Quality Summit
News | Cardiovascular Business | March 15, 2019
The American College of Cardiology’s first annual ACC Quality Summit, held March 13-15 in New Orleans, merges the NCDR...
Diagnostic and Interventional Cardiology Named 2019 Azbee Awards Finalist for Social Media
News | Cardiovascular Business | March 08, 2019 | Jeff Zagoudis, Associate Editor
Diagnostic and Interventional Cardiology (DAIC) was named a finalist in the Social Media Presence category for the 2019...
 FDA Commissioner Scott Gottlieb Announces Resignation
News | Cardiovascular Business | March 05, 2019 | Jeff Zagoudis, Associate Editor
U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., resigned from his position March 5 after two...
Diagnostic and Interventional Cardiology Honored as Jesse H. Neal Awards Finalist

An example of the new transesophageal echo (TEE) visualization technology called TrueVue was shown at TCT 2018 for the first time. Philips’ new photo-realistic rendering is designed to offer a surgical view of cardiac structures to aid transcatheter procedural navigation.

News | Cardiovascular Business | February 25, 2019
Diagnostic and Interventional Cardiology has been recognized as a finalist in the Jesse H. Neal Awards for the third...
GE to Postpone Healthcare IPO Following Biopharmaceutical Business Sale
News | Cardiovascular Business | February 25, 2019 | Jeff Zagoudis, Associate Editor
GE Healthcare announced Feb. 25 the sale of its biopharmaceutical business to Danaher, and GE Chairman and CEO Larry...
Medical Bills Financially Burden Almost Half of Cardiovascular Disease Patients
News | Cardiovascular Business | February 11, 2019
Over 45 percent of adult atherosclerotic cardiovascular disease (ASCVD) patients suffer financial hardship related to...
Researchers raised the question whether an economic benefit should be assessed in FDA reviews. A large amount of the bill for atrial fibrillation catheter ablation procedures is the cost of the mapping and ablation catheters.

A large amount of the bill for atrial fibrillation catheter ablation procedures is the cost of the mapping and ablation catheters. Researchers raised the question whether an economic benefit should be assessed in FDA reviews. 

Feature | Cardiovascular Business | January 14, 2019 | Philip Jacobs, DPhil, Ilke Akpinar, M.D., Thanh Nguyen, M.D., Ph.D., Rupinder Sandhu, M.D., and Lars Thording Ph.D.
In an age when everything in medicine is now looked at though a cost vs. benefit analysis and U.S.
Overlay Init