Researchkit: IRB Approval for your Study App in Four Steps

by Priya Menon

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Two weeks after Apple’s ResearchKit was made available to researchers everywhere in March 2015, getting approval from an independent ethics board was made mandatory for all apps made using this open-source software platform. 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.

The relevant section of the guidance in the App Store submission guidelines reads:

27.9 Apps conducting health-related human subject research must obtain consent from participants or, in the case of minors, their parent or guardian. Such consent must include the (a) nature, purpose, and duration of the research; (b) procedures, risks, and benefits to the participant; (c) information about confidentiality and handling of data (including any sharing with third parties); (d) a point of contact for participant questions; and (e) the withdrawal process.

27.10 Apps conducting health-related human subject research must secure approval from an independent ethics review board. Proof of such approval must be provided upon request.

An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a type of committee designated to approve, monitor, and review biomedical and behavioral research involving humans. This process involves conducting a risk-benefit analysis aimed at determining whether the research should be conducted at all. The IRB ensures that the rights and welfare of human participants of a trial/research study are protected.

Let’s get started on the IRB approval process.

Step 1 : Have you chosen your IRB?

Under FDA regulations, an IRB is an appropriately constituted group that formally reviews and monitors biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. Make sure that the IRB of your choice is registered with the FDA. Our client TrialX chose WIRB for their IRB.

Step 2: What about human research participant training?

All members of research team must complete Protecting Human Research  Participants Training before submitting protocol for IRB review. The certificate received on completing this has to be submitted to the IRB as proof. Refer to certificate of Dr. Chintan Patel, PI of America Walks Study:  PI_PatelChintan_GCP.

Step 3: Get ready with documents for Submission!

Prepare for submission to the IRB office, protocol package including the following based on your research:

  • Initial Review Submission Form  / Application Form :  

This is mostly available on chosen IRB’s website and can be filled in online or can be downloaded, filled (typed in) and then sent. This is a comprehensive form and has to be filled in very diligently with details about sponsors, principal investigator, federal funding, type of study, study phase, research site location, and sections on consent, subject payment and participant recruitment. The form has to be duly signed by the Principal Investigator of the study and submitted with a copy of the following documents (explained below) for review.

 

IRB for Researchkit App study

  • Informed Consent Form:

    Text of the Informed Consent pages of the app which will be used while recruiting participants is one of the most important documents as far as IRB approval is concerned. The submission of this text and the language to be used is is very specific and any deviation from this may require resubmissions.

    Please keep the following points in mind while drafting the Informed Consent of your study:

    • Name of study and other submitted protocol details should be in conformation with federal regulations, ICH guidelines and state/local laws.
    • Each section of the consent should be accurate and in accordance with the protocol.
    • Please avoid duplication of information in various sections of the consent.
    • Use clear language in the section detailing subject protection and safety.

    Informed Consent document contains detailed sections of the study starting from introduction of the study to purpose, duration, participants the study is aimed at and risks involved. It is necessary to outline methods of data gathering, use of this data, benefits to the participants, and study commitments. Tasks and surveys outlined in the study as well as privacy and information on how a participant can withdraw also has to be mentioned. The text used in the app on successful completion of informed consent process and exiting the informed consent process without completing it are other sections that would be needed.

    Below are screenshots of Informed Consent from America Walks Study.

 

Informed Consent IRB Researchkit

 

HIPAA data security researchkit

HIPAA Researchkit withdrawal

 

You can refer to the reviewed and approved Informed Consent document submitted by TrialX for America Walks Study, to get a complete idea of the document – AmericaWalks IRB Consent

  • Professional License and Curriculum Vitae of PI:

Professional license of Principal Investigator showing expiration date has to be submitted.  Detailed CVs of PI as well as all Sub-Investigators have to be enclosed with the application form.

  • Materials to be provided to participants:

These would include advertisements, questionnaires, subject diaries etc. All materials which will be used in the study and given to subjects are to be submitted.

Below are samples of FaceBook ads that were approved by IRB for TrialX:

 

Researchkit IRB approval

Step 4: Awaiting review results?

Essentially, an IRB verifies the following during protocol review,

  • If the medical study creates any risk to participants.
  • Whether the measures taken to ensure privacy and confidentiality are sufficient.
  • Informed consent taken remotely is acceptable for the study under review.

The board may get back with corrections and required resubmissions. A notification via email of the IRB action on submitted protocol as either Approved, Exempted, Declined will be sent.

Please find here IRB approval of TrialX’s America Walks Study: CertificateofApprovalforStudy_AWS.

Proof of IRB approval may have to be submitted on request, prior to the app being available for download in the play stores. Mandatory IRB approval would certainly protect users from taking part in dubious trials.

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