By Haley Griffin, Program Associate, CCC
In December, the CCC, in collaboration with CRA-Industry (CRA-I), responded to a Request for Information released by the National Institutes of Health (NIH) on Developing Consent Language for Research Using Digital Health Technologies. The following CCC Council Members and CCC staff authored the response: David Danks (University of California, San Diego), Haley Griffin (Computing Community Consortium), Katie A. Siek (Indiana University), and Pamela Wisniewski (Vanderbilt University). CRA-I Council Member Tammy Toscos (Parkview Health) is also a co-author of the report.
NIH provided informed consent sample language that they plan to release as a voluntary guide for researchers that use digital health technologies, and sought feedback from the community not only on gaps or additional concepts that should be included or clarified in the language itself, but also on any barriers the community could identify that would inhibit its widespread use.
CCC and CRA-I’s response proposed several improvements to their recommended language, including:
- Identifying who is responsible for paying for cellular data/internet connection.
- Explaining what constitutes a “medical device” versus what does not.
- Providing more specificity and/or customization for each item, as technology should not be voted as a monolith.
- Describing in more detail on how AI is used in the system, and how inferences from the data may be used/shared.
- Creating a brief training for establishing baseline competencies.
- Explaining how their data is going to be tracked, transformed, cleaned, and processed.
- Differentiate between treatment/intervention versus data tracking/monitoring.
- Handling with care the different consent and procedures for children.
- Addressing “dark patterns” (e.g., Opt Out, nudges to consent) for obtaining consent for research as a prerequisite to receiving medical treatment.
- Clarifying whether and how the data is protected by HIPAA.
- Noting explicitly what data participants can ask to be removed and what data they can not (and what data the researchers own vs. a 3rd party).
- Explaining risks related to child mandated reporting status of the reseachers (e.g., child abuse, sexual abuse, imminent risk of harm).
- Providing an external and unbiased point of contact in case of harm.
- Clarifying that the research team may withdraw them from the study if the participant no longer qualifies.
- Explaining that withdrawal will not adversely impact their standard medical care as provided prior to entry into the study.
The authors of the CRA response also noted that sometimes template language like this can manifest into required protocol without care being put into making sure it works for the study, and it is important to not require it as a blanket statement if it does not apply directly to the research.
Read the full CCC/CRA-I response here.