What is GetResearchSmart LLC (GRSSM) and how might it and its website benefit prospective research subjects (prospects)?
18) What if a prospective subject is or may become insufficiently capable to make his or her own research-related decisions? A: Federal regulations do not currently exist that specifically apply to persons with diminished capacity (sometimes referred to as those who are decisionally impaired) to make research decisions. Therefore, special alertness is warranted in connection with such decisions and participation. In addition, there may be state laws that offer some, but not complete protections. Existing federal regulations do mention the need for additional safeguards to protect the interests of varied vulnerable populations. Specifically included, by example, are “mentally disabled persons” (i.e., 45 CFR 46.111[b]). Therefore, IRBs are expected to ensure that study plans adequately account for issues of diminished capacity. However, the lack of specific regulations results in the absence of a uniform approach upon which investigators and IRBs may confidently rely. This absence makes
