Industry, Advocacy Groups Seek Clarity on Proposed Changes to Informed Consent Rules

Trade associations representing the medical device and clinical research industries, as well as the nonprofit public advocacy organization Public Citizen, are calling for the US Food and Drug Administration (FDA) to clarify provisions of its proposed rule for institutional review boards (IRBs) to waive or alter requirements for obtaining informed consent for certain clinical trials involving minimal risk to participants.
 
Background
 
Under current FDA regulations, exceptions to obtaining informed consent can only be made in life-threatening situations or when conditions for emergency research are met. Outside those situations, FDA regulations require that subjects provide informed consent before they can participate in a clinical trial.
 
However, in Section 3024 of the 21st Century Cures Act, Congress expanded the exception to obtaining informed consent when there is minimal risk to participants to FDA-regulated studies.
 
In 2017, FDA issued guidance stating it would not object to IRBs waiving or altering informed consent in line with Cures. In November, FDA issued a proposed rule to institute those changes and announced it would withdraw the guidance once the rule is finalized.
 
Comments
 
Medical device trade group AdvaMed says FDA’s proposed rule “appropriately implements the requirements” spelled out in Cures but calls on FDA to provide advice on how patient privacy protections under the Health Insurance Portability and Accountability Act (HIPAA) apply to studies that receive waivers of informed consent.
 
“While retrospective collection of anonymized data or research on anonymized biospecimens obtained in a previous research study, would not typically require consent under the Privacy Rule, many low-risk, retrospective, post-market clinical follow-up studies may require collection of [protected health information] PHI and therefore, may still require subject authorization under the Privacy Rule,” AdvaMed writes.
 
As such, AdvaMed calls on FDA to work with the Department of Health and Human Services (HHS) to harmonize informed consent and privacy requirements for clinical studies in the future.
 
AdvaMed also asks FDA to clarify its interpretation of the term “impracticable” used in the proposal. Currently, one of the requirements to qualify for a waiver of informed consent is that the research “could not practicably be carried out without the waiver,” which AdvaMed says could be interpreted as narrowing the criteria for a waiver of informed consent. “This effectively means that obtaining the subjects’ consent would only be impracticable if the scientific validity of the study would be compromised by asking the subjects to consent,” AdvaMed writes.
 
Additionally, AdvaMed requests that FDA revise the proposed rule to specify that consent requirements can be waived or modified for postapproval studies that collect anonymized standard of care data from medical records and for studies involving existing de-identified biospecimens.
 
Both AdvaMed and the Association of Clinical Research Organizations (ACRO) also say that FDA should not adopt the fifth criteria from the 2017 revision of the Common Rule that states that a waiver of informed consent can be granted “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.”
 
AdvaMed says this criterion is redundant with the Common Rule’s third criterion, while ACRO argues that the criterion would be unnecessary as biospecimen research does not meet FDA’s definition of a clinical investigation.
 
Nonprofit advocacy group Public Citizen, on the other hand, warned that the proposed rule could lead to more clinical trials with inappropriately waived informed consent requirements unless FDA provides “clear guidance … that carefully demarcates the types of clinical investigations that would and would not qualify for the proposed waiver.”
 
“We are deeply concerned that once the FDA finalizes the proposed rule, clinical investigators will inappropriately seek, and IRBs inappropriately will grant, waivers of informed consent for clinical investigations that involve greater than minimal risk,” Public Citizen writes.
 
Public Citizen points to the recent case where informed consent requirements were waived for clinical trials run by the Hennepin County Medical Center in Minneapolis that compared ketamine and other sedatives to manage prehospital agitation in emergency patients. FDA ultimately cited the hospital’s IRB in an inspection report for approving studies for waiving informed consent that did not meet the criteria for exception.
 
Public Docket