On Aug. 15, 2023, the FDA released a guidance for informed consent which states that a medical device clinical trial may not proceed until the sponsor addresses the agency’s concerns regarding the informed consent forms and procedures. The guidance may be subject to revision in the next year or two, due to an ongoing rulemaking process for alignment of FDA’s requirements with the Common Rule by the Department of Health and Human Services (HHS).
The new FDA guidance supersedes the previous guidance issued in September 1998, and finalizes the draft guidance released July 15, 2014. That draft guidance was still in process when HHS released the 2018 version of the Common Rule, which applies across all agencies that are part of the department, including the National Institutes of Health. In its current form, the Common Rule applies to all research that commenced on or after Jan. 21, 2019, although there are exceptions to the scope of the rule, such as studies undertaken as public health surveillance.
One of the impending changes to the FDA’s requirements for clinical trials is stipulated by a provision of the 21st Century Cures Act regarding minimal risk studies. Section 3024 of the Cures Act allows researchers to waive the requirements for informed consent if the study poses no more than a minimal risk to the subjects. Another instance in which informed consent might be waived is when it is not feasible to obtain informed consent for each potential study subject, in which case the sponsor of the study may be required to obtain community consent.
While this new FDA guidance is applicable to the agency’s centers for devices, drugs and biologics, the FDA is engaged in the rulemaking process that would harmonize its approach to informed consent with the Common Rule’s requirements. At present, the FDA guidance requires that any advertisement used for clinical trial recruitment provide no more information than is needed for potential recruits to determine their interest in and eligibility for the study.
Once a potential recruit has been identified, the sponsor of the study must conduct a consent discussion prior to attempting to obtain consent from the individual. This discussion must include the alternative treatments the recruit might receive if they choose not to take part in the clinical trial. The consent process is continuous, and includes activities such as updating the participant with information about any safety data that has emerged since the subject first signed the consent form.
The consent form must disclose whether compensation will be provided along with information on how any compensation would be determined. Any costs that would be incurred by the study subject and/or the subject’s insurance should also be disclosed, including potential out-of-pocket expenses not covered by the participant’s insurance plan.
The consent form must discuss the potential for unforeseeable risks, including any risks that were not identified due to the absence of completed animal and/or bench testing of the product. The FDA stated that there are instances in which the cost of the investigational product may be charged directly to the study participants, which also must be disclosed.
Study subjects must be made aware of the circumstances in which the investigator may unilaterally discharge the subject from the study without the consent of the subject. Study participants should also be advised of the consequences of voluntarily withdrawal from the trial. There are circumstances in which the study drug or biologic should be withdrawn gradually to minimize any ill effects.
Informed consent need not be conducted on a face-to-face basis in some circumstances, such as when the patient has legally authorized a representative to manage such matters. The informed consent process can be conducted by telephone and/or videoconferencing, with documentation requirements handled by forms using electronic signatures or forms that can be printed out, signed, scanned, and returned electronically to the investigator. The guidance also provides details about informed consent that are specific to studies of medical devices versus studies of pharmaceuticals, as well as information on enrolling minors and those who do not speak English. It is important to consult with an attorney to ensure that you remain compliant with FDA rules and regulations when conducting clinical trials.