On September 25, 2019, ORI issued revised Medical and Nonmedical Informed Consent Templates including the Spanish Translation.
In addition to minor edits, substantive changes include:
- Statements for research regulated under the European General Data Protection Regulations (GDPR) [see the UK GDPR guidance on when this rule applies];
- Notification applicable to subjects under the supervision of the Kentucky Department of Corrections (DOC) [prisoners, parolees, etc.]; and
- Expanded Future Use & Sharing Options [described below].
The revised Common Rule regulations require informed consent documents to let subjects know whether their information or specimens collected during a study might be used for additional future research. However, the two future use statements provided in the regulation only cover two scenarios:
- No storage for future use and sharing; or
- Removal of identifiers, after which information or specimens could be used or shared for future research without the subject’s additional consent.
The current update includes language for storing information/specimens with identifiers or code links for the investigator’s future use and removing identifiers before sharing with other researchers. If a secondary researcher requests information/specimen(s) with identifiable information, subjects are informed that an IRB will review the request and determine if the research may be conducted with or without the subject’s additional consent. The additional option is provided in effort to prevent future use sections that include conflicting and inconsistent messages regarding storage, use, and sharing.