Common Rule Bulletin #4: The "Reasonable Person" Standard in ICF

NIH OFFICE OF HUMAN SUBJECTS RESEARCH PROTECTIONS (OHSRP) GUIDANCE ON THE REVISED COMMON RULE

The revised Common Rule (rCR), referred to as the “2018 requirements” or sometimes as “the Final Rule”, contains several new provisions that take effect for all new research reviewed on and after January 21, 2019. Note: This guidance is intended for use by the NIH Intramural Research Program (IRP) and may be superseded by future NIH guidance or policy, or guidance issued by the Office for Human Research Protections (OHRP).

What is the Reasonable Person Standard and how does it apply to the informed consent process?

The revised Common Rule (rCR) introduces the reasonable person standard when judging what information should be provided to potential study subjects.

The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information. (§46.116(a)(4))

However, the regulations do not define the reasonable person standard. In the context of the information provided during the consent process, it is being interpreted to mean the relevant information that a hypothetical ordinary person with average knowledge, skill and judgement would need to decide on participation. The reasonable person standard is distinct from the professional standard which holds that professional practices determine adequate disclosure. The reasonable person standard shifts the decision about what information should be provided to the potential subject away from what the physician believes should be disclosed, based on professional standard, to information that a reasonable, ordinary person would want in order to decide whether to participate in the research or not. This standard for disclosure is generally considered more ethical than the professional standard.

In applying this to the consent form, investigators with knowledge of their subject population should include information that they know will likely be important to this group of individuals in deciding whether they want to participate in the research or not. This should also include reasons why the subject might not want to participate. During the consent process, and with knowledge of the potential specific subject’s values and goals, the investigator should provide additional information that would be tailored to the individual’s decision-making process. For example, if the subject is a professional concert pianist or soccer player and the proposed study drug intervention has a risk of peripheral neuropathy, the investigator should provide specific information regarding the likelihood and potential severity of this side effect.