今回はめちゃくちゃにニッチな話です。
とある業務で臨床試験で用いるアプリを開発する必要があり、iOS・Androidそれぞれで申請をしました。
iOS・Androidそれぞれ数日でレビュー結果が来ましたが、iOSのレビュー結果を見ていると、
Guideline 5.1.3 – Legal – Privacy – Health and Health Research
The app is conducting health-related human subject research, but we were unable to locate all of the required consent disclosures and you have not demonstrated approval from an independent ethics review board.
Next Steps
You must obtain consent from research participants or, in the case of minors, their parent or guardian. The consent form must disclose:
– The nature, purpose, and duration of the research
– Procedures, risks, and benefits to the participants
– Information about confidentiality and handling of data (including any sharing with third parties)
– A point of contact for participant questions
– The withdrawal processIf consent from research participants is secured outside of the app, you must:
– Attach a copy of the consent form. If it does not include the required information listed above, update it to include this information.
– Include a login feature in the app so only participants who’ve previously given their consent can participate in the research.Apps conducting health-related human subject research must secure approval from an independent ethics review board. Please provide proof of such approval. You can attach proof in the App Review Notes section of App Store Connect.
Resources
Learn more about requirements for health and health research apps in guideline 5.1.3.
なんとAppleは、IRB（CRB）にて当該臨床試験が承認されたことを示す書類を求めているのです。
IRBやCRBが通過後、各施設との契約が終わればすぐにでも試験を開始したい、、、！という要望が多いので、アプリ申請が律速にならないようIRBに先んじてアプリを審査に提出したのですが、なかなかしっかりしていますよね。
https://www.ncc.go.jp/jp/ncch/division/clinical_trial/patient/about/index.html
↑にもあるように、臨床試験はその性質上、極めて厳格な手続きを経て実施されるべきものです。Appleはそれを理解しているのでしょうね。
※なおAndroid（Google）の審査では上記に関して何の指摘もなかった模様。