Thursday Apr. 21, 2016: Impact of Patenting and Financial Interests in Academic Research
What is the mandate of publicly funded research institutions? What are the legal, practical, and ethical implications of universities retaining control of their inventions?
5pm in L-206 (BU medical campus), led by Mike Quintin.
Thursday Mar. 24, 2016: A Science Policy Career Discussion
4pm on the Charles River Campus, led by our advisor Dr. Sarah Hokanson
Thursday Feb. 25, 2016: Personalized Medicine
How heavily should companies offering genetic testing for disease-related biomarkers be regulated by the FDA?
The subject of personalized medicine is rich with public and science policy issues, including regulation of data use and establishing test standards. We could return to the subject to discuss any of these nuances, but for this particular discussion I would like to talk about FDA oversight and regulation of consumer genomics. The overarching question we will be discussing is: How heavily should companies offering genetic testing for disease-related biomarkers be regulated by the FDA?
- The article that shows how popular Y chromosome genealogy databases can lend themselves to locating specific male individuals using simple online searches (this touches on the issue of privacy).
- The white paper for the senate subcommittee on the FDA proposal to tighten its regulation on LTDs (laboratory developed tests). As a reminder, the FDA can (and has on multiple occasions) issue warning letters to direct-to-consumer genetic testing companies about their claims to test for disease biomarkers. Since many of these companies claim their tests are LTDs rather than medical devices, the FDA can only issue a sternly worded letter. The FDA wants to change that, hence the proposed changes to their regulation protocols.
- A summary of the medical device section of the 21st Century Cures act, particularly the note regarding the removal of a “placeholder” for LDTs.
- The paper in which it is stated that IRB determined that data collected from DTC testing does not constitute human subject research (in terms of regulation). The cohort section (in Methods) summarizes 23andMe’s policy toward data sharing for research purposes.
Wednesday, Jan. 20, 2016: Artificial Intelligence
2 Cummington Mall, Rm109 at 5pm
- Computational Rationality (Gershman et al., 2015; Science)
- Robot Weapons– What’s the Harm? (New York Times)
- Robotics and the law– When software can harm you (New York Times)
- The Air Force Wants You to Trust Robots–Should You? (Scientific American)
- Why Self-Driving Cars Must Be Programmed to Kill (MIT Technology Review)