# Guideline 5.1.3 - Privacy: Health Research App Without Informed Consent

**Guideline:** 5.1.3 · **Store:** Apple App Store · **Risk:** high · **Difficulty:** hard · **Typical turnaround:** 1-3 days

Canonical URL: https://appstorereject.com/rejections/apple/5/guideline-513-privacy-health-research-app-without-informed-consent

## Description

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.

## Common variations

- App conducts health research without informed consent
- Missing informed consent flow for human subject research
- Health research app lacks IRB/ERB approval documentation
- ResearchKit study does not include proper consent module
- Participants cannot withdraw from health research study

## Example rejection email

```
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.
```

## Resolution steps

## Quick Assessment
- **Risk level:** High
- **Resolution path:** Fix & Resubmit (may require significant timeline if IRB approval is needed)
- **Typical turnaround:** 1-3 days (if IRB exists) to weeks (if IRB process needed)

## The Fix

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

## Appeal guidance

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.

## Before / after examples

**Before:** App collects heart rate and sleep data for a university study with only a checkbox saying 'I agree to participate'
**After:** 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
**Why it works:** A single checkbox is not informed consent. Apple expects a comprehensive, multi-step process that mirrors clinical research standards.

## Common questions

**Can you appeal a 5.1.3 rejection?**

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.

**How long does this typically take to fix?**

Typical turnaround is 1-3 days (difficulty: hard). After resubmission, most re-reviews complete within 24-48 hours.

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*Machine-readable source: https://api.appstorereject.com/api/rejections/detail?slug=guideline-513-privacy-health-research-app-without-informed-consent*