On March 12, 2015 Apple Inc. released ResearchKit™, an open source application for iOS devices such as the iPhone and iPad, to assist investigators and sponsors in the conduct of human subjects research. One of the components of ResearchKit is an interactive interface for electronic informed consent (“eIC”).
Apple’s ResearchKit shows incorporation of concepts from FDA’s March 2015 Draft Guidance on Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers (“Draft Guidance”). In the Draft Guidance, FDA clarifies requirements set forth in 21 CFR parts 11, 50, and 56 as they pertain to eIC. Highlighted concepts from the Draft Guidance include the following.
- When FDA evaluates a system utilizing electronic signatures, FDA requires “at least two distinct identification components such as an identification code and password.”[1] Biometric signatures are accepted as well, an example of which is the fingerprint reader incorporated on many Apple devices.[2]
- Interactive ease of use for research participants is of paramount importance.[3] The Draft Guidance explains that participants should be able to navigate forward and backward, stop, continue at a later time, and ask questions about their role in the study.[4]
- Participants’ reading comprehension of the informed consent document may be enhanced through the use of visual aids such as diagrams and graphics.[5]
- Capabilities should exist that allow informed consent documentation to be made available to the participant in physical form and eIC applications must be able to push notifications to participants if the consent form has been amended.
- An IRB “must review and approve the eIC and any amendments to the eIC.” FDA also urges investigators and developers to work with and consult the IRB before finalizing the project development to ensure that the format and contents of the application are ethically sound.[6]
Github, an online coding website for ResearchKit, references eIC in its Best Practices section. Github stresses that primary guidance for the design of the informed consent component of ResearchKit should come from an IRB, stating that “the consent functionality in the Research Kit framework is only intended as a tool; the details of the Consent functionality in your application are your responsibility.” Even within the informed consent template on the developer site, IRB review of the application before dissemination is stressed. The Best Practices on Github are merely guideposts for developers; the requirements of a reviewing IRB may exceed those detailed on the site. An application to be used for human subjects research is allowed on the App Store only if the application has been approved by an IRB beforehand. While Apple supplies code for ResearchKit, the company does not maintain an IRB to review ResearchKit apps.
New research-related developments like ResearchKit can improve the research participant’s experience while decreasing administrative challenges for sponsors and investigators. Sterling IRB has experience with review of eICs and has helped researchers ensure that applicable regulatory requirements are met as studies transition from using traditional paper-based informed consent processes to use of eIC. Sterling IRB would be happy to work with you to explore how using eIC can benefit your study’s subjects and your study team. If you would like to learn more about Sterling services, please contact the IRB.
Article submitted by Royce DuBiner, JD, LLM
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[1] 21 CFR 11.200 (a)(1).
[2] 21 CFR 11.200 (b)
[3] Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers Guidance for Industry, FDA Draft Guidance, March (2015), at 3.
[4] Id., at 4.
[5] Id., at 6.
[6] Id., at 7.