The AAMC appreciates that the proposed principles move in a direction that is fitting of a new research model based on openness, transparency, data sharing, and participant engagement. However, the letter stresses that addressing privacy and building trust must reflect three overarching goals: engaging all populations, setting reasonable expectations, and planning for effective dissemination.
The letter also expresses support for updated regulatory requirements that facilitate the activities of the PMI, as well as the exploration of novel forms of information sharing and consent. Finally, the AAMC notes that there are inherent risks in large-scale data collection that participants should be made aware of, and additionally that “there may be privacy issues that have not yet been anticipated, and the structure of the PMI should be able to accommodate and respond to those emerging concerns.”
The White House is currently reviewing public feedback and is soliciting further information on ongoing activities and initiatives in precision medicine.