Posted by:Ranjani Rao September 18th, 2015

How ResearchKit Can Help

Informed Consent is required from your research participants. And the term “informed” means that your participant has to be given all information on the study beforehand.

This is a pain point for both researchers and participants. Researchers generally have to provide voluminous documents to educate the potential participant on the study. Participants have to wade through those documents, understand them and consent to the study.

This process is time consuming to say the least.

But there is a way for both the researcher and the participant to better navigate this process.

Researchers can replace these documents with more engaging and interactive methods of providing study information for consent. They can use videos, animations, images, text and FAQs instead. They can have quiz questions set up to measure the participant’s knowledge of the material. Think of it as an eLearning course. And all these in a mobile app that the participant can download and peruse at their convenience. Apple’s ResearchKit has modules that simplify and streamline the process of building dynamic content and the workflows required for the consent process. These can be incorporated in an iOS mobile app.

An effective, efficient consent process that provides better protection for human subjects is the direction in which regulations are going. The Notice of Proposed Rulemaking (NPRM) recommended by the U.S. Department of Health and Human Services and other federal agencies is in favor of streamlining the consent process to make it easier for the participant. Some of the recommendations that are relevant to what we are discussing are:

Clearly define the purpose of the study in such a way that critical information such as risks and benefits are apparent and navigable The ICF should be designed and presented in a manner that the information that is crucial to the patient making the decision is called out and easy to find An app offers easy ways to provide the participant with structured information for quick access and navigation. All the critical information is presented upfront and tailored to what the participant wants to know. To conform with regulations, the IRB-mandated informed consent documents can be presented in the app for the final review.

The mobile app could be extended for use in situations where the researchers actually sit down and explain the consent information to participants. The researcher could use the mobile app as a means to present the information for maximum impact and enhanced understanding. This app could be further used to check participant eligibility and to sign up participants.

If informed consent is required to happen in person, as often is the case, then at least researchers have a prepped, truly informed participant who can come to the study site and finish up the consent process by getting any remaining questions answered and signing the documents in a much shorter amount of time.

A win-win for both parties.

How else can ResearchKit benefit your research? Click below to learn more and to get started on YOUR ResearchKit app today !

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