For the first time, the proposed rule would allow ethics boards known as institutional review boards (IRBs) to waive the requirement for researchers to obtain informed consent from participants. IRBs could also alter the strict set of FDA requirements for research involving human volunteers (21 CFR parts 50 and 56).
Currently, IRBs can only waive informed consent requirements in life-threatening situations or for emergency research, when a patient population has no capacity to consent.
The proposed change would better align FDA’s regulations with the Common Rule (45 CFR 46), which is a separate but similar group of human research protection regulations that govern federally funded research that uses human subjects. The regulations apply to the Department of Health and Human Services (HHS) and nearly 20 other federal agencies.
It is part of a larger effort by both FDA and HHS to decrease red tape around research administration, thereby allowing IRBs to spend more time on the ethics of riskier research instead of allocating minimal resources to lower-risk studies.
FDA said the proposed change would save IRBs around $237,600 a year, with a range from $59,400 to up to $950,500. It also fulfills part of a 21st Century Cures law requirement for FDA and the HHS to harmonize their human subjects regulations to the extent possible.
The Common Rule underwent a major overhaul that came out in 2017, and those changes take effect Jan. 21. The overhaul marked the first time the federal government updated the rule since it came out in 1991, and included a new criterion on what is allowed for informed consent to be waived.
Four of Five Changes
The waiver specially applies to minimal risk research, a threshold FDA sets as the level of risk or harm encountered in daily life or anything that would happen during the course of a routine doctor’s visit. The current Common Rule already allows a waiver if:
- the research involves no more than minimal risk;
- the waiver or alteration will not adversely affect the rights and welfare of the study volunteers;
- the research could not realistically happen without the waiver or alteration; and
- the subjects will be provided with additional pertinent information after participation, when appropriate.
FDA plans to adopt all four of these changes.
It is not adopting a fifth condition from the revised Common Rule which states, “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.”
The prepublication notice did not elaborate why FDA is not adopting the fifth condition but said it welcomes comments on the proposal.
In a statement issued Nov. 13, FDA Commissioner Scott Gottlieb, M.D., indicated that the decision not to adopt the fifth condition pertains to safety and the rights of the research volunteers.
“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,” Gottlieb said.
Selected information in the "Pharmaceutical Science Update" is compiled from summaries and articles from Bloomberg BNA.