by Avery Avrakotos, Education and Policy Manager, and Meryn Robinson, Educational Program and Membership Services
Technological advances, the growing need for comparative effectiveness research, an increasing demand for data transparency, and the continued globalization of the research enterprise were among some of the issues that human subjects protections professionals grappled with in 2013. For those involved in animal care and use, the year marked a continuation of efforts to educate the public about the value of animal research. As we reflect on 2013, and look ahead to what 2014 will bring, we are pleased to share with you a collection of Ampersand posts that reflect some of the year’s major events, both for PRIM&R and for the field of research ethics:
The Impact of Sequestration Looms for Biomedical Research by Avery Avrakotos—The start of 2013 was marked by great uncertainty as the US government faced sequester. In this post, PRIM&R’s education and policy manager examines the impact of sequestration on biomedical research in the United States.
Looking Forward and Looking Back by Joan Rachlin, JD, MPH—In April, PRIM&R’s founding executive director, Joan Rachlin, announced her intention to step down from her position in early 2014. In this post, she reflects on her decision.
Digging into the HIPAA/HITECH Act Omnibus Final Rule by Alexandra Shlimovich—In March, PRIM&R hosted a webinar during which Emily Chi Fogler, JD, and Jennifer Geetter, JD, reviewed the sections of the new Health Insurance Portability and Accountability Act (HIPAA) Rule of particular relevance to IRBs and HRPPs at HIPAA-covered entities. In this follow-up blog post, Emily Chi Fogler answers questions from webinar participants.
The SUPPORT Study and the Future of Comparative Effectiveness Research by Elisa A. Hurley, PhD and Avery Avrakotos—The Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) was the source of much controversy within the human subjects protections community this past year. Two members of the PRIM&R staff outline some of the early debate generated by the study.
In Memoriam: Harry Rozmiarek, DVM, PhD by Joan Rachlin, JD, MPH—In June, Harry Rozmiarek, a cherished member of the PRIM&R Board of Directors, passed away. In this heartfelt tribute, PRIM&R’s executive director looks back at Dr. Rozmiarek’s life, accomplishments, and how he will be remembered by his friends and colleagues in the PRIM&R community.
Open and Respectful Dialogue on the Use of Animals in Research is Essential by Joan Rachlin, JD, MPH—People for the Ethical Treatment of Animals released a violent video game, Cage Fight, which allows players to assume the role of a mixed martial arts fighter as they attempt to free animals and take on researchers in a university lab, military installation, and pharmaceutical company lab. Executive director Joan Rachlin considers the potential effect of such a game in this thought-provoking piece.
Publishing Clinical Trial Data: The Who, What, When, Where, and Why by Joan Rachlin, JD, MPH—In June, The New York Times published a piece on Peter Doshi, PhD, a post-doctoral fellow at Johns Hopkins University who advocates for pharmaceutical companies making their clinical trial data public. PRIM&R’s founding executive director outlines Doshi’s story as well as several other breakthroughs in the push for data transparency.
Will the Supreme Court’s Decision in the Myriad Case Discourage Innovation? by Maeve Luthin, JD—In June, the US Supreme Court determined that human genes fall within the “laws of nature” exception to patentable material. PRIM&R’s professional development manager discusses how this decision may impact biomedical research in this post.
Justice Delayed is Not Always Justice Denied: The Lacks Family and the National Institutes of Health by Joan Rachlin, JD, MPH—In August, the National Institutes of Health established the HeLa Genome Data Access Working Group of the Advisory Committee to the Director, which will oversee requests for access to the HeLa genome data. PRIM&R’s executive director highlights how the fundamental concept of respect for persons was successfully modeled in the creation of this entity.
Institutions and Central IRBs: It’s Different Work by Stephanie Pyle, MFA—A member of the PRIM&R Blog Squad from the 2013 Advancing Ethical Research (AER) Conference summarizes the lessons and discussions from the pre-conference workshop Central IRB Models: Benefits, Challenges, and Role in Clinical Research.
Introducing “Anticipate and Communicate” by the staff of the Presidential Commission for the Study of Bioethical Issues—This piece, reposted with permission from the blog of the Presidential Commission for the Study of Bioethical Issues, details the release of the Commission’s report titled Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts, which makes recommendations about how to handle incidental and secondary findings.
Reflecting on Therapeutic Misconception by László M. Szabó, Esq.—A member of PRIM&R’s Blog Squad from the 2013 AER Conference reflects on the wisdom shared by Paul Appelbaum during his keynote address, Therapeutic Misconception in Clinical Research: A 30-Year Retrospective.
What’s in a Name? Research “Participant” Versus Research “Subject” by Ali Hall—PRIM&R’s educational programs assistant discusses the significance and the reasoning behind PRIM&R’s decision to use the term “subject” as opposed to “participant” in reference to those who enroll in research.
Many newsworthy events happened during the past year—what did you find most intriguing, most thought-provoking?