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
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From research being conducted by Facebook to questions raised by a study on public opinion of same-sex marriage, this week's Research Ethics Roundup delves into the world of social and behavioral research. Read on to learn more about these and other stories in the world of research ethics and oversight.
Do You Consent?: In this piece for Slate, James Grimmelmann, JD, considers questions raised by studies conducted by Facebook and other entities outside of the traditional research realm, and considers the role of research oversight in those contexts.
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In this week's Research Ethics Roundup, we explore some of the ethical and practical questions posed by new innovations in the research enterprise, as well as some age old concerns, such as the recruitment of subjects for clinical trials. Read on:
FDA, Sponsors Look to Expand Patient Input to Clinical Trials: The involvement of patient groups in the design of clinical trials is becoming increasingly common. In this article for Applied Clinical Trials, Jill Wechsler reports on this shift, as well as the Food and Drug Administration's efforts to foster patient-focused drug development.