App Store Reject

Guideline 5.1.3

Guideline 5.1.3 - Privacy: Health Research App Without Informed Consent

High RiskHardTypical Fix: 1-3 days0 Reports
Also known as:App conducts health research without informed consentMissing informed consent flow for human subject researchHealth research app lacks IRB/ERB approval documentationResearchKit study does not include proper consent moduleParticipants cannot withdraw from health research study

Our Take

Apple is rejecting your app because it conducts health-related human subject research without obtaining proper informed consent from participants or without evidence of ethics board (IRB/ERB) approval. Apps that use HealthKit, CareKit, or ResearchKit to collect health data for research purposes must comply with applicable laws and institutional guidelines, including obtaining informed consent. This rejection covers two main scenarios: (1) the app collects health data for research but does not include a proper informed consent flow — a screen that explains the study, risks, benefits, data usage, and allows the participant to agree or decline, or (2) the app conducts research that requires ethics board oversight but cannot demonstrate that approval was obtained. Apple takes this seriously because health research with human subjects is heavily regulated worldwide. The informed consent must be embedded in the app (not just a website link), must be understandable to a layperson, and must be completable before any data collection begins. If your app uses ResearchKit, the framework includes built-in informed consent components that satisfy Apple's requirements.

Resolution Guide

01

**Implement informed consent** — Use ResearchKit's ORKConsentDocument and ORKVisualConsentStep to build a compliant consent flow. It must cover: study purpose, procedures, time commitment, risks, benefits, data handling, confidentiality, and the right to withdraw.


02

**Make consent mandatory before data collection** — No health data collection or study participation can begin until the user completes the consent flow and affirmatively agrees.


03

**Include withdrawal mechanism** — Add a clear way for participants to withdraw from the study at any time (e.g., a 'Leave Study' button in settings) and stop all data collection when they do.


04

**Obtain IRB/ERB approval** — If your research involves human subjects, obtain ethics board approval. This is typically required by law, not just Apple policy.


05

**Document approval in review notes** — Upload the IRB approval letter and protocol number in the App Review Notes. Include the approving institution's name and approval date.

Prevention

  • Use ResearchKit's built-in consent framework
  • Obtain IRB approval before beginning development
  • Include consent documentation in every submission's review notes
  • Partner with a research institution if you lack IRB access

    • Example Rejection Email

    From:Apple App Review Team
    Subject:Guideline 5.1.3 - Privacy: Health Research App Without Inf
    Guideline 5.1.3 - Legal - Privacy - Health and Health Research Your app conducts health-related human subject research but does not include an adequate informed consent process. Specifically, your app collects health data from users for research purposes but does not: - Present an informed consent form that explains the study purpose, procedures, risks, and benefits. - Provide participants with the ability to withdraw from the study at any time. - Demonstrate ethics board (IRB) approval for the research. Next Steps: Please update your app to include a complete informed consent process before collecting any health research data. If your research requires IRB approval, please provide documentation of the approval in your review notes.

    Consider Appealing

    Appeal if IRB approval exists and was not submitted with the review. Provide the IRB approval letter and protocol number in the review notes. If the consent flow exists but was missed by the reviewer, provide step-by-step instructions to reach it.

    Generate Appeal

    Before & After

    Before — Rejected

    App collects heart rate and sleep data for a university study with only a checkbox saying 'I agree to participate'

    After — Approved

    App includes a full ResearchKit consent flow with visual slides explaining the study, a PDF consent document for review, a signature step, and a 'Leave Study' button in settings; IRB approval letter attached to review notes

    What changed: A single checkbox is not informed consent. Apple expects a comprehensive, multi-step process that mirrors clinical research standards.

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