The terms “Commercial Purpose” and “Non-Commercial Purpose” seem confusing. Are they named for an intended purpose or for the type of investigators that are eligible to receive them?
The terminology is based on what the participant indicated on the informed consent. A participant indicating on the informed consent that his or her data may be shared with investigators developing commercial products will be included in the commercial purpose data set. Therefore, the commercial purpose data set may be used by either academic or commercial entities developing commercially viable products. If a participant indicated that his or her data may not be shared with investigators developing commercial products, then that data will not appear in the commercial purpose data set, but will be in the non-commercial purpose data set providing the informed consent does not prohibit sharing of data beyond the study itself. Investigators from both academic and commercial institutions may receive the non-commercial data set; however, the investigator must indicate a non-commercial use of the data in the data distribution agreement.