Posted by:Shyam Deval May 21st, 2015

In my blog last week, I started taking a high level look at what is included under the hood in newly introduced Apple ResearchKit. I also touched upon functional details on one of the three out of box modules provided in the ResearchKit software framework – Surveys. Today we will look in depth at the second module – Informed Consent. As I did last week,I will touch upon the functional feature set of this module rather than many technical details. Of course you can get into more implementation level details here.

Almost all medical research studies requires the researcher to inform the participants about the details of the study as part of signing up the user into the study and many require a signed consent from each participant.The Informed Consent module provides the basic pieces to display the consent document in the app and obtain participant signature though it does not provide digital signature support.

As with the Survey module, Informed Consent module uses the concept of tasks and steps to allow app developer to create a model (structure) of a consent document with customized content,display it for visual consent and allow for review and signature by the user.The module also provides a step to obtain user consent for sharing the study data with other researchers.

ResearchKit framework provides some of the core sections that are usually included in most of the consent documents.Some of these sections are:

  • Overview – provide users an overview of the study at a high level
  • Data Gathering – explain how the study gathers the needed data from participants
  • Privacy – very critical section that provides users information about how their privacy and identity is protected
  • Data Use – details on how the data collected by the study is used.This also speaks to the privacy and identify concerns users may have about the study data provided by them
  • Time Commitment – users need to know at the outset the amount of time they are required to give to the study process and how long does that commitment last
  • Withdrawing – explains the process to the users if they want to withdraw from the study at some point during the study

There is also an option to create custom sections for the consent document if the framework provided sections are not adequate for the user consent needed in the study.

Once the users have stepped through the different information sections, they are ready to review and signoff on the consent.This consent review content could be just a collection of all the information sections or entirely different review content presented as a page.Depending on the requirements there are options to ask users to enter their name and also write a signature on the screen.

The Informed Consent module does provide a lot of out of box functionality but one area where it does need to be supplemented is when the consent signature needs to be ‘verifiable and irrevocable’,the app developers are responsible for producing that digital signature or to generate a PDF document that will allow to attest the identity of the study participant and capture the time of the signature.

In my next blog post,I will touch upon the last of the three modules provided by ResearchKit – Active Tasks.

Is your company building apps using ResearchKit? If yes,I would love to hear about your experience.

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