This recently-issued Request for Information (RFI) invites stakeholder input on the utility and useability of sample language developed for use in informed consent documents for data and biospecimen sharing. The RFI is open until September 29, 2021.
Research studies with human participants can often involve the collection of information: this can include surveys, images, electronic health records, wearable device information, as well as human material (e.g., blood, tissue, urine, extracted DNA). In responsible research, these “data and biospecimens” need informed consent practices that provide prospective research participants with accessible and accurate information about the collection of these data and biospecimens, as well as their future use.
NIH stakeholders have voiced a strong interest in developing clear and efficient communication strategies related to information sharing. To assist in this endeavor, NIH developed sample language that may be used in informed consent when data and biospecimen sharing may occur, as well as “points to consider" for investigators and Institutional Review Boards (IRB).
With this Request for Information (RFI), NIH encourages your input to help refine this draft sample language. NIH welcomes input from research investigators, institutional review board members, study participants, professional organizations, associations with a focus on research oversight, and other interested members of the public.
The sample language and components include providing prospective research participants with:
- An introduction to and description of the storage and sharing of data and biospecimens in the study;
- The voluntary nature of data and biospecimen storage and sharing;
- What happens if a participant changes their mind about storage and sharing;
- Reasonably foreseeable risks/discomforts related to storage and sharing, and any benefits related to storage and sharing that prospective participants may receive; and
- Whether data and biospecimens collected from participants may contribute to products with commercial value.
The RFI also includes these general points to consider:
- Distinct storage and/or sharing procedures for data and biospecimens that may require separate consent language;
- Creating understandable language that conveys the necessary information in the entire informed consent form;
- Additional considerations when studies involve participants who may be considered vulnerable to coercion or undue influence;
- Cultural preferences or requirements regarding how data and biospecimens are handled;
- Additional considerations when studies include the storage and sharing of genomic data;
- Specific consent language if the future use of data and biospecimens will be limited; and
- Implications for privacy and confidentiality as technology advances for coding and deidentifying data and biospecimens.