On October 11, the National Institutes of Health (“NIH”) issued a request for information (“RFI”), which proposes sample language regarding the use of digital health technologies in research for inclusion in informed consent documents and requests public feedback on the utility and usability of the proposed language. Comments on the RFI are due by December 12, 2023.
In the RFI, NIH recognizes that digital health technologies have increasingly been deployed in biomedical and behavioral research and that incorporating these technologies into traditional research frameworks may pose new considerations for potential participants. NIH explains that potential participants may be concerned about data ownership and other proprietary issues, which may limit participant control over how their data is used. NIH states that the purpose of the RFI is to inform investigators, including research teams and Institutional Review Board (“IRB”) members, who are conducting research that studies or uses digital health technologies and support investigators’ efforts to increase transparency and understanding for potential research participants. NIH also states that the sample language was designed to ensure readability and comprehension with language that conveys the necessary information to research participants.
NIH outlines a variety of considerations and provides optional sample language designed to be modified and incorporated into informed consent documents for a study which will collect participants’ data. Specifically, NIH proposes sample language and addresses considerations for each of the following components:
- Introduction: NIH states that the introduction component should provide prospective participants with a description of the digital health technologies used in the study and the purpose of their inclusion. This description should include a clear statement about how the technology is being used to address the study aims, if the technology has been approved by U.S. Food and Drug Administration (“FDA”) for its intended use, and if the efficacy of the technology is being studied. Investigators should also indicate whether the study team will provide the digital health technology, if the participant will be asked to connect hardware or install software on a personal digital device, and if the participant must return study-provided devices or discontinue any subscription services at the conclusion of the study.
- Procedures: NIH states that investigators should provide prospective participants with a description of how, when, and under what conditions the digital health technologies will be used in the study. Specifically, NIH states that participants should be provided with a clear description of how the digital health technology will be used (e.g., data collection, data management and sharing) and how the technology may impact daily activities. NIH states that investigators should inform participants if their personal health care providers will receive information collected by the digital health technology and provide participants with the names of all third parties along with the frequency and level of access they may have to participant data.
- Data sharing and ownership: NIH states that investigators should provide prospective participants with a clear understanding of data ownership and how participant data is collected, stored, and shared. Investigators should inform participants of whether the data collected by digital health technologies is sensitive or identifiable (e.g., if the data is associated with possible stigma, or contains confidential or identifiable information); the length of time their data will be retained for the study; and purposes for which data could be used during and after the study (i.e., repositories or future studies). Investigators should also indicate whether the data collected by the digital health technology is owned by the company and whether the data may be sold or shared to third parties without explicit participant consent.
- Potential risks: NIH states that investigators using digital health technologies are expected to assess and identify the reasonably foreseeable risks and/or discomforts that may be associated with digital health technologies being used in the study. These include possible privacy and security risks (e.g., location data), along with physical or psychosocial discomforts (e.g., skin irritation, allergic reaction, broken skin, anxiety). Investigators are expected to provide participants with a clear understanding of how their study data is being protected; the steps being taken to minimize possible privacy risks that could arise; and address the potential risks for breaches of participant study data.
- Benefits: NIH states investigators should inform prospective participants about any anticipated direct benefits related to their use of digital health technologies during the research study.
- Costs: NIH states investigators should also inform prospective participants of any potential costs to them related to use of digital health technologies in the study. Consent forms should clearly state who will be responsible for which costs related to the use of the digital health technology (whether study-provided or a personal device).
- Withdrawal: NIH states that investigators should clearly address the limitations of data removal when a participant withdraws from a study using digital health technologies and specify any collection of data beyond the withdrawal point or study conclusion. For example, NIH states that investigators conducting studies that use personal devices should clarify if software must be uninstalled when leaving or ending participation in the study.
Organizations that use or test digital health technologies, such as wearable devices, sensor technologies, and mobile apps, in clinical trials and studies should review the proposed consent language and consider submitting comments addressing all or several of the considerations outlined above. NIH welcomes input from research investigators, IRB members, study participants, professional organizations, associations with a focus on research oversight, and other interested members of the public. NIH instructs organizations to submit comments electronically on its website (see here).
NIH explains that the proposed sample language does not take the place of an informed consent, but rather is intended to be incorporated into written and oral consents as appropriate. It also does not alone satisfy the regulatory requirements for informed consent as described in the 2018 revised Common Rule or the FDA’s regulations governing the protection of human participants. NIH notes that the RFI provides issues to consider for informed consent of research studies which plan to use digital health technologies (i.e., for both research-grade and commercial digital health technologies) and does not address future use of data collected from digital health devices. NIH also notes that it may update the document or develop new resources to address additional considerations as digital health technologies continue to evolve.
For more information about the NIH RFI, please contact the professionals listed below, or your regular Crowell contact.