The Office of Human Research Protections (OHRP) has issued draft guidance on “Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.” As more and more comparative effectiveness research is conducted to evaluate different treatments commonly used by medical practitioners (“standards of care”), the guidance is an attempt to assist researchers in determining how to disclose potential risks of the different treatments they are studying. As the Office notes:
“Where multiple ‘standard of care’ options are available for a given disease or condition, the use of the term does not imply that the options will produce similar benefits or incur similar risks. Furthermore, patients may not find those options equally acceptable, nor do physicians always use them interchangeably. Importantly there is not necessarily a limit on how different the risks from two versions of a standard of care might be.”
The guidance aims to address confusion over whether the risks of “standard of care” treatments patients might have undergone regardless of their study participation counted as “risks of research” (and would thus need to be disclosed as part of the informed consent process). It comes in the wake of an OHRP investigation into a clinical trial studying differing levels of oxygenation in premature infants (all within the “standard of care” range), which found that participants had not been adequately informed of the risks of different treatments. The guidance holds:
“In standard of care studies, OHRP generally considers the risks of a specific standard of care being evaluated to be risks of research if (1) a standard of care that at least some of the individual subjects 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 possible differences in risk being evaluated are considered risks of the research.”
OHRP will accept comments on the draft guidance through December 23, 2014. Comments may be submitted directly from the Federal Register Notice, via regulations.gov (using docket ID number HHS-OPHS-2014-0005), or by mail. More detailed instructions are in the Federal Register.