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If My Study Includes Approved Drugs, When Do the Risks of Those Drugs Need to Be Disclosed in the Consent Form?


If my study includes approved drugs, when do the risks of those drugs need to be disclosed in the consent form?


The United States Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) regulations require that the study participant is provided with a “description of any reasonably foreseeable risks or discomforts to the subject;” (45CFR 46.116(a)(2)) (21 CFR 50.25(a)(2)) within the consent form.

Therefore, when the protocol “requires” a participant to begin taking a drug while on-study, even if it is an approved drug and/or is standard of care (SOC), the reasonably foreseeable risks of that drug are required to be disclosed in the consent form. The IRB typically defines “requires” based on how the protocol is written.

If a specific drug and dose is required by the protocol, the risks must be disclosed to participants. If the protocol requires a drug “or equivalent” to be administered (e.g., “prednisone or equivalent corticosteroid”), then the risks that would cover the equivalent drugs (e.g., corticosteroid drugs) should be described. If the protocol design includes “Investigator choice” but that choice is limited by the protocol, then the risks are required.

It is important to note that when the risks are required to be disclosed, they must be disclosed within the consent form [45 CFR 46.117(b)(1), 21 CFR 50.27(a)(1)]. It is not sufficient to direct participants to the package labeling for a drug instead of adding the risks to the consent form.

Study designs often compare SOC drugs with investigational drugs. In a design where participants will be placed in one group or the other as part of the research, the risks of the drugs in each group must be disclosed in the consent form. Other study designs require that all participants start on SOC for research purposes, and then some of the participants are administered an investigational drug. Because the SOC is a requirement of the protocol, the risks must be disclosed. However, if participants will just continue the SOC they already started prior to the research and the SOC is maintained independent of the research, then the risks of the SOC are not research risks and not required to be disclosed.

According to Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors (Aug 2023), “For clinical investigations involving the comparison of an investigational product to one or more standards of care, it may be acceptable to describe the more common and significant risks and discomforts of the standard of care in the informed consent form and provide additional risk information, as appropriate, as part of the consent discussion.”

Other studies are designed to evaluate one or more SOCs (“comparative effectiveness”). Even in these studies, the risks of a specific SOC being evaluated are risks of research if (1) a standard of care that at least some of the individual participants will be assigned to receive will be different from the standard of care that they would have received if they were not participating in the study, and (2) there might be different risks associated with those standards of care. Therefore, in such studies, the risks of each SOC being evaluated are considered risks of the research and must be disclosed in the consent form.

Finally, in addition to evaluating drugs as comparators, many study designs often also include pre-medications, prophylaxis, and rescue medications as part of the protocol. If they are required, even for a limited period, the risks should be described in the consent form. If they are not required, and are only recommended, optional, or given at the discretion of the research staff, then the risks are not required.

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