Dear Apple App Store Team, I am reaching out to seek clarity and guidance specifically regarding the documentation requirements for submitting a research-based healthcare application on the App Store. Our development team is committed to ensuring compliance with all relevant guidelines, and we would appreciate your assistance in understanding the specific documentation needed for these applications. As our application involves collecting data from patients for research purposes, we want to ensure that we provide the necessary documentation to support our submission. Here are the key areas for which we are seeking clarification:
- Consent Documentation:
- Any specific forms or templates required to demonstrate the obtaining of informed consent, especially for minors where parental consent is involved.
- Research Nature, Purpose, and Duration:
- Guidance on documenting and communicating the nature, purpose, and expected duration of the research to the participants.
- Procedures, Risks, and Benefits:
- Clarity on the documentation needed to communicate the research procedures, potential risks, and expected benefits to the participants or users.
- Confidentiality and Data Handling:
- Any specific documentation or information required demonstrating how confidentiality will be maintained and how data collected during the research will be handled, including any sharing with third parties.
- Participant Contact Information:
- Guidance on providing a point of contact for participant questions and inquiries.
- Withdrawal Process Information:
- Documentation needed to explain the withdrawal process for participants who choose to discontinue their involvement in the research.
- Ethics Review Board Approval:
- Specific requirements for providing proof of approval from an independent ethics review board, including any templates or forms that may be necessary.
Understanding these specific requirements will enable us to compile a comprehensive submission package tailored to the expectations of the App Store review process for research-based applications. We appreciate your attention to this matter and look forward to your guidance. If there are any specific forms or templates that should accompany our submission, kindly let us know. Thank you for your time and assistance. Best regards, Youcef Barkat