This app is specifically intended for the Investigator Team in the Aeon ABP-20002 EXT study only. The application uses HealthKit and Apples ResearchKit library to conduct clinical trials.
The Clinical Research Organization has received approval from the IRB to publish this content to the patients involved in this study. Each patient signs a consent form prior to enrolling in the study.
- Does the human subject research conducted in your app have the approval of an ethics review board or institutional review board?
- Do research participants sign a consent form that includes all of the following information:
(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
(e) the withdrawal process
- If the developer of this app is different than the organization conducting the human subject research, please clarify the relationship between the developer and the organization conducting the research.