Informed consent
Informed consent is a standard practice for health providers and clinical researchers in providing health care or conducting clinical research; it is not a concept specific to ResearchKit. Obtaining informed consent from participants, prior to enrolling them in a clinical study, is to ensure that the permission has been given and the participant has a clear understanding of the facts, implications, and consequences of their participation in the study. As such, informed consent and its constituents are a vast topic that is beyond the scope of this book.
ResearchKit provides the mechanism that is necessary to present the informed consent document to the participant as an animated sequence of pages as well as the document in its totality. Each page may have more information that presents more details on the page's topic. ResearchKit comes with a number of predefined sections, as shown in the following:
- Overview
- Data gathering
- Privacy
- Data use
- Time commitment
- Surveys
- Tasks
- Withdrawal
The informed consent module includes the ability to record the participant's signature if that is required by a study's informed consent process. This is not a digital signature (that is, verifiable and irrevocable) and ResearchKit has no provisions to collect such signatures. It's the application developer's responsibility to provide support for digital signature, if required by the study protocol.
Informed consent is a ResearchKit task. As such, it may be extended in order to comply with the requirements of the study. For example, the consent process for some of the initial ResearchKit applications presents a comprehension quiz that the participants were required to pass in order to be deemed consented.
