India Releases New Rules on Clinical Trial Injury

Last week, the Indian government issued revised rules governing “compensation in case of injury or death during clinical trial.”  You’ve really got to read the whole thing, but some of the provisions are pretty remarkable:

  • “In the case of an injury occurring to the clinical trial subject, he or she shall be given free medical management as long as required.”  Note that this doesn’t say anything about the injury being study-related.
  • If an injury is related, then the subject is also entitled to financial compensation above any medical expenses.
  • If the subject dies as a result of clinical trial participation, his or her “nominees” would be entitled to financial compensation.
  • Injury or death will be considered related to trial participation in a variety of usual circumstances, including adverse effects of the investigational product and protocol violation or negligence.  But here’s the kicker: injury or death will be deemed trial-related, and therefore eligible for care/compensation, if it results from “failure of investigational product to provide intended therapeutic effect” or “use of placebo in a placebo-controlled trial”.  Read that again – if an investigational product doesn’t work, the sponsor will be liable for free medical care and further financial compensation.
Like all of the presidential bioethics commissions and many others that have considered this issue, I’m all for the adoption of reasonable and appropriate compensation systems to make subjects whole in the event of study-related injury.  And I think US policy is woefully inadequate on this score.  But the pendulum can also swing too far in the other direction.  Will sponsors take their trials elsewhere or will research in India still be worth it?
[H/T to Rebecca Li for the head's up re: publication of the new rules.]

Reducing Gun Violence in America

Typically, we would avoid such a shameless plug for our researchers — we’d be a little more subtle. But, we can’t help it this time. This book is the best $10 you’ll spend all year.

A little less than a month ago, Johns Hopkins University convened more than 20 of the world’s leading experts on gun violence and policy to summarize their research and recommend policy changes. This 282-page book features empirical research from the leading experts in the field covering the topics of mental health and gun violence, gun law enforcement, high-risk guns, international case studies of responses to gun violence, the Second Amendment, public opinion on gun policy, and concludes with a summary of the recommendations for reforms to Federal policies.

Chapter 3, “Preventing Gun Violence Involving People with Serious Mental Illness,” features research conducted by Jeffrey Swanson, PhD, and his team of researchers based at Duke University. The research presented was funded by PHLR and the National Science Foundation.

Seriously. Check it out.

Upcoming Event with Jonathan Lazar

Jonathan Lazar on Locked Out: Investigating Societal Discrimination Against People with Disabilities Due to Inaccessible Websites

Wednesday, February 13, 2013 | 4:00 pm

Sheerr Room, Fay House, 10 Garden Street, Cambridge

Jonathan Lazar is a professor of Computer and Information Sciences, director of the undergraduate program inInformation Systems, and founder and director of the Universal Usability Laboratory, all at Towson University. His research in human-computer interaction focuses on understanding how people with disabilities interact with technologies, how improved interface design can change the quality of life for people with disabilities, and how human-computer interaction and public policy influence each other.

With his fellowship project as a Radcliffe Fellow, Lazar seeks to improve understanding of the relationship between web-based interfaces that are inaccessible to people with disabilities, and how those inaccessible interfaces lead to forms of discrimination that are illegal under US law. As part of the project, he is writing a book about the topic and collaborating on research with the Harvard Law School Project on Disability. For his fellowship presentation, he will discuss equal access to web-based information and societal discrimination in five areas: federal government, state government, county-level emergency alert information, airline reservations, and employment applications.

Lazar has published more than 120 refereed articles in journals, books, and conference proceedings. He has also authored three books and edited three, including Research Methods in Human-Computer Interaction (Wiley, 2010), Universal Usability: Designing Computer Interfaces for Diverse User Populations (Wiley, 2007), and Web Usability: A User-Centered Design Approach (Addison Wesley, 2006). He was awarded a 2011 University System of Maryland Board of Regents Faculty Award for Public Service, a 2010 Dr. Jacob Bolotin Award from the National Federation of the Blind for working towards achieving the full integration of the blind into society on a basis of equality, and a 2009 Innovator of the Year Award from the Maryland Daily Record for his work on improving the accessibility of web-based security features. He earned MS and PhD degrees in Information Systems from the University of Maryland, Baltimore County, and a BBA degree in Management Information Systems from Loyola University Maryland, where he received the Rev. Daniel McGuire SJ Alumni Association Service Award. He currently serves as chair of public policy for ACM SIGCHI (the Association for Computing Machinery Special Interest Group on Computer-Human Interaction).

This event is free and open to the public. ASL interpretation will be provided. Please forward this notice to anyone who may be interested in attending. 

For more information or to request any disability-related accommodations, please visit www.radcliffe.harvard.edu or call (617) 495 – 8212.