At PRIM&R's 2019 Advancing Ethical Research Conference, Ivor Pritchard, PhD, discussed the relation between public, private, and social information in his session, The Secrets of Big Data: Public, Private or What? (B15). Dr. Pritchard asked, what are the risks and confidentiality provisions for social information?
First, the concept of social information can be described as neither publicly nor privately available, but information provided in controlled settings. As an example, data gathered from a classroom or an online chatroom are neither public nor private in that the subject is a) not alone and b) not everyone has access to that environment. Then, what are the risks to subjects in social experiments (experiments conducted in public settings like [...] Read more
In April, the Food and Drug Administration (FDA) issued a discussion paper, "Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD).” The paper represents FDA’s response to the growing number of medical device manufacturers who are utilizing artificial intelligence and machine learning technologies to continuously improve their products. On June 3, PRIM&R submitted comments in response to the discussion paper, thanking the FDA for their consideration of the public health implications of the use of these technologies, but also cautioning that any new regulatory approach in this area must address the protection of individuals whose personal information and data are being used in the creation and ongoing testing of these technologies. Read more
data-rich networked information technologies are unique in that they represent people’s lives and activities, bridge multiple dimensions of a person’s life, and are often collected, aggregated, exchanged, and mined without them knowing. We call this data “pervasive data,” and the increased scale, scope, speed, and depth of pervasive data available to researchers require that we confront the ethical frameworks that guide such research activities. Read more
At PRIM&R’s 2017 SBER conference, I had the opportunity to sit in on the excellent didactic session, “Certificates of Confidentiality (CoCs) and National Institute of Justice (NIJ) Privacy Certificates,” given by Petrice Brown-Longenecker, PhD, CIP (Extramural Human Research Protection Officer, NIH); Elonna Ekweani, JD (Public Health Analyst, NIH); Mary Ramirez, MA, CIP (Assistant Director, Health Sciences and Behavioral Sciences IRB, University of Michigan); and Leslie E. Wolf, JD, MPH (Professor; Director, Center for Law, Health, and Society, Georgia State University College of Law). Read more
On March 1, 2017, PRIM&R held a day-long Ethics of Data Access, Use, and Sharing for Human Subjects Research Workshop in partnership with the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University (MRCT Center). I am pleased to announce that the proceedings and other information from the day are now available on PRIM&R’s website. Read more