In contrast to the return of general or individual study results to subjects, incidental findings are discoveries of individual-level findings that are unrelated to the goals of the study. While there is overlap among the concepts, as shown above in the linear Venn diagram, SACHRP believes that each topic is best addressed individually for clarity. This final recommendation addresses the return of incidental findings to research subjects. SACHRP then released a recommendation on the return of individual study results to research subjects on May 19, 2016. SACHRP next released a recommendation on Septemon recent changes to HIPAA and CLIA regulations that potentially affect the return of individual research laboratory results. On MaSACHRP released a recommendation on the return of general study results to research subjects. While this commentary was focused on the issues presented in the FDA request for comment, it also addressed some of the broader issues associated with the public release of study data.

SACHRP partially addressed the issue of public release of data in December of 2013 by providing commentary in response to the June 4, 2013, Food and Drug Administration (FDA) Request for Comment relating to the availability of masked and de-identified non-summary safety and efficacy data. SACHRP has issued four previous recommendations on this matter.

Incidental findings