At its outset, the agency defines informed consent as not only the form which patients must sign to enroll in a trial, but also how to facilitate the potential subject's comprehension of the information on the form and the trial, as well as how to adequately provide an opportunity for the potential subject to ask questions and to consider whether to participate.
In addition to the basic elements of what should be included in the consent form, the FDA focuses on how careful the wording and how delicate clinical investigators need to be to avoid coercion or any undue influence on a prospective patient.
“For example, in a clinical investigation involving the surgical insertion of an investigational device, waiting to obtain informed consent until the potential subject is in the preoperative area may fail to minimize the possibility of undue influence,” the FDA says.
The agency also prohibits any language “that claim investigational test articles are safe or effective for the purposes for which they are being investigated...Likewise, statements that inappropriately overstate the possibility of benefit should be avoided because they may unduly influence potential subjects. Careful wording is needed in order to avoid overstating potential benefits that may contribute to a subject's therapeutic misconception.”
These statements of caution seem to align with a petition filed earlier this month from the Center for Responsible Science , which called on the agency to ensure patients understand that experimental drugs may be unsafe or ineffective.
Furthermore, the agency would like to outlaw statements such as: "FDA has given permission for the clinical investigation to proceed" or "FDA has approved the clinical investigation" because they may contribute to the misimpression that an investigation has the agency's endorsement.
The FDA even goes so far as to recommend that potential subjects “first be informed of the care a patient would likely receive if not part of the research and then be provided with information about the research.
“The description should identify tests or procedures that would be part of usual care that will not be performed as well as those required by the protocol that would not be part of their care outside of the research, for example, drawing blood samples for a pharmacokinetic study,” the agency says.
The explanation of potential risks of the test article and control, if any, and an assessment of the likelihood of these risks occurring should be presented to potential subjects and be based on information presented in the protocol, investigator's brochure, package labeling, and previous research reports, according to the FDA.
Payments to Subjects
In addition to describing the extent to which records identifying subjects will be confidential, sponsors must also describe how medical costs to research-related injuries will be paid.
If no compensation is available, the FDA says the consent process should include statements such as:
- Because of hospital policy, the hospital is not able to offer financial compensation should you be injured as a result of participating in this research. However, you are not precluded from seeking to collect compensation for injury related to malpractice, fault, or blame on the part of those involved in the research, including the hospital; or
- Because of hospital policy, the hospital makes no commitment to provide free medical care or payment for any unfavorable outcomes resulting from participation in this research. Medical services will be offered at the usual charge. However, you are not precluded from seeking to collect compensation for injury related to malpractice, fault, or blame on the part of those involved in the research, including the hospital.
The FDA also recommends that the cost of any tests, procedures and/or products that may be charged to the subject or the subject's insurance be explained as part of the informed consent process.
“Subjects should be made aware that insurance or other reimbursement mechanisms might not fund the medical care they receive because they are participating in a clinical investigation even when the care is the standard care they would otherwise receive if not participating in a clinical investigation,” the agency says.