Existing CoCs issued by NIH prior to the enactment of the 21st Century Cures Act – new requirements!
As Section 2012 of the 21st Century Cures Act (link) mandates, as of June 13, 2017, all persons to whom a CoCs has previously been issued are now subject to the requirements of the CoC provisions in the 21st Century Cures Act, in particular, the new prohibitions on disclosure of identifiable, sensitive research information.
What does this mean?
This means that disclosure of the identifiable, sensitive information is only permitted when:
- Required by Federal, State, or local laws (e.g., as required by the Federal Food, Drug, and Cosmetic Act, or state laws requiring the reporting of communicable diseases to State and local health departments or child abuse to State/local authorities), excluding instances of disclosure in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding;
- Necessary for the medical treatment of the individual to whom the information, document, or biospecimen pertains and made with the consent of such individual;
- Made with the consent of the individual to whom the information, document, or biospecimen pertains; or
- Made for the purposes of other scientific research that is in compliance with applicable Federal regulations governing the protection of human subjects in research.
For more information on CoCs issued under the 21st Century Cures Act, please refer to the following CoC Guidance and
- Policy/Guide Notice (link to both)
- FAQs for non federal funded projects
- Brief Information Sheets
- Training webinar