臨床調査を行う場合は、a〜e(期間、目的、手順、利点、データの利用目的、連絡先、やめる手順、等)の同意を得ること。未成年の場合は、親や保護者の同意が必要。
原文
(iii) 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.