Tuesday, April 22, 2014

Research Ethics Roundup: Chimpanzee living space, bans on genetic testing, and more!

Did you catch the blood moon and the first lunar eclipse of the year? We hope so, but now it’s time to turn your gaze from the sky to the screen and catch up on what’s been going on in the field of research ethics!

In Landmark Vote, EU Passes New Clinical Trial Regulation, Including Data Transparency Measures: On April 2, 2014, the European Parliament passed new rules that require pharmaceutical companies to make public the results of clinical trials. The vote repeals Directive 2001/20/EC, the clinical trials directive (CTD), and replaces it with an amended rule. The new rule contains hundreds of changes from the original CTD, the most significant of which are the clinical data transparency measures that require companies to publish a detailed summary of findings in a publicly accessible database as well as release all study data at the time of a drug’s approval.

Crowdsourcing Medical Decisions: Ethicists Worry Josh Hardy Case May Set Bad Precedent: Social media supporters of Josh Hardy, a dying seven-year old, pressured a biotech company into giving him an experimental medication to treat an infection he contracted after a bone marrow transplant, although similar requests were turned down by the company. This situation highlights the ethical dilemmas that doctors, companies, and regulators face in the era of online social networking.

How Mouse Studies Lead Medical Research Down Dead Ends: Drugs based on poorly constructed studies are making it fairly far along the pathway toward approval before being proven ineffective or unsafe. Journalist Richard Harris examines how this happens and considers improvements in the drug development process in this piece for NPR.

NIH Puts Squeeze on Chimpanzee Living Space: To confirm a 2011 recommendation from an advisory committee, which critics cited as costly and difficult to implement, NIH solicited input from experts on animal care and commissioned a literature review in order to determine the minimum space density for captive chimpanzees. The agency concluded that the minimum living space for captive research chimpanzees is 250 square feet per animal, one-fourth of the area recommended by the advisory committee.

Wednesday, April 16, 2014

A research ethics pilgrimage: My experience at the 2013 AER Conference

by Patrick Okonta, MD, FWACS, FMCOG, MPH, research ethics committee chair and senior lecturer in the department of obstetrics and gynecology at Delta State University Teaching Hospital

I attended PRIM&R’s Advancing Ethical Research (AER) Conference this past November for the first time. I was one of ten attendees who were fortunate to receive international an scholarships from PRIM&R to attend the meeting, which took place in Boston from November 7-9, 2013.

During my training in research ethics at the University of Pretoria under the South African Research Ethics Training Initiative (SARETI), a National Institutes of Health-funded project to increase capacity for research ethics in Africa, I had heard about the AER Conference as being a kind of “mecca” for ethicists. I anxiously looked forward to the year that I would have an opportunity to embark on a pilgrimage to the conference. My opportunity came in 2013 when I received one of PRIM&R’s Global Research Scholarships, and the reality more than exceeded my expectations. I learned about ethical challenges in groundbreaking research being conducted in  developed countries, as well as resource-scarce settings. I also had the opportunity to make new friends and share ideas.

As a scholarship recipient, I was invited to participate in a site visit to Partners HealthCare and Boston Children’s Hospital the day before the conference began. Our hosts, PRIM&R Board Members P. Pearl O’Rourke, MD, and Susan Z. Kornetsky, MPH, gave us a warm welcome. During our time at Partners, we observed the deliberations of a preparatory IRB meeting, which made me appreciate the amount of work that occurs before a full board meeting. The tour of Boston Children’s Hospital was also quite revealing. I marveled at the amount of resources—human and infrastructure—that were dedicated to research. I couldn’t help but contrast it with the virtually nonexistent research infrastructure found in most developing countries. The day ended with a reception to welcome the scholarship recipients, and I was particularly delighted to meet Joan Rachlin, JD, MPH, PRIM&R’s executive director emerita, who personally welcomed all of us to the event.

The following day, I attend a pre-conference program titled Ethical Issues in Global Research, which set the stage for what would be a robust and intensive scientific conference. I found the panel discussion on Ethical Considerations for HIV and Infectious Disease Research and Prevention very interesting and something that I could relate to given the research setting in which I work.  

The sessions during the main conference were also fantastic. I found Atul Gawande’s keynote address to be captivating. He is a master storyteller, and he managed to keep the audience engaged without the use of audiovisual aids. Dr. Gawande encouraged the audience to think about health care delivery and building systems that work seamlessly to produce excellent results even in cases where the possibility of a good outcome may seem remote. The didactic sessions and workshops were equally interesting and informative. I particularly enjoyed the presentation by Sara Lavinia Brair, MBBS, MD, during the plenary session titled Applying the Belmont Principles Across Borders and Cultures.

I was also pleased to be able to share my work in a poster presentation titled Scientific Misconduct: Attitudes, Perceptions and Related Factors in a Developing Country. I enjoyed fruitful discussions with those who showed interest in my work.

After returning to my home country, Nigeria, I shared my experience at the conference with my colleagues on my research ethics committee and with the chief medical director of our institution. My experience served to deepen their interest in research ethics.

I am immensely grateful to PRIM&R for giving me the opportunity to attend the 2013 AER Conference in Boston, and, hopefully, I will be able to return one day soon.

Monday, April 14, 2014

We need more education about psychiatric IRB processes: An interview with David H. Strauss

by Avery Avrakotos, education and policy manager

In January, PRIM&R welcomed three new members to its Board of Directors, including David H. Strauss, MD. Dr. Strauss is director of research at the New York State Psychiatric Institute and is vice chair for research administration, ethics, and policy at the Columbia University Department of Psychiatry. Dr. Strauss has been actively involved with PRIM&R for 10 years, and was Co-chair of the Core Conference Planning Committee (CCPC) for the 2012 and 2013 AER Conference. He is also be Co-chair of the CCPC for the 2014 AER Conference. 

I recently connected with Dr. Strauss to discuss why he chose to become involved with PRIM&R, as well as his perspective on some issues facing human subjects research.

Avery Avrakotos (AA): When and how did you first become involved with human subjects research?
David Strauss (DS): I started doing research with human subjects in medical school. Recently, I was looking back and realized I wrote a paper in medical school on patient rights and the right to refuse treatment—ideas about consent were part of what I was interested in even as early as medical school. Following residency, I was asked to be the attending psychiatrist for a dedicated research service. My daily life and administrative responsibilities were to construct a service that promoted patient and family involvement in decision-making while accomplishing research goals. It was at that point that I really began working with the institutional review board (IRB) as an investigator, and I became more familiar with the whole concept of human subjects protections.

AA: What challenges do you see ahead for medical research in general? Any ethical challenges in particular?
DS: There is a swinging back and forth of the pendulum in terms of the tension between the protection of subjects and the needs of research. In the late 1990s and early 2000s, we witnessed a clamp down by many institutions as a result of compliance actions by the Office for Human Research Protections. For the first time, institutions started investing in appropriate resources for human subjects protections, which laid the groundwork for the professionalization of IRB administrators. Subsequently, the world of research has grown in sophistication, and there has been an educated pushback by the academic and research community. For example, we hear complaints that an overly conservative approach to research protection hampers research and therefore progress. The pendulum is swinging back in the other direction in such a way that it seems we may be liberalizing our approach to certain aspects of research protections.

AA: What is one thing you wish the general public knew about human subjects research?
DS: My work is primarily in psychiatry and neuroscience, and I think there is a longstanding stigma associated with the conditions involved in those disciplines, but also with research in those areas. Historically, some of the most egregious examples of exploitation involved individuals in psychiatric facilities. I think what people need to understand about human research protections and human subjects research is that we can’t move the field forward without research, and that there is a sophisticated and careful institutional process involved in ensuring that people’s rights and welfare are supported when they choose to take part in research.

I recently had an opportunity to speak with a New York state based family advocacy group for individuals with mental illnesses. At their annual meeting, they are used to hearing from scientists; they are very interested in finding answers to the problems that impact their family members. However, while they want change, they are quite nervous about research. It was a great opportunity for me to talk about the changes that have occurred in human subjects protections and to tell them the stories that we’ve all learned from. I think that more public education about IRB processes would be a very good thing. Of course, as with everything else, we only hear about the occasional screw up—when there has been a deficiency in the process—but there is relatively little education about human subjects protections when it works well. There are many stories about when something goes wrong in research, but we haven’t done a really good job of promoting human subjects protections being done well.

AA: Why did you agree to serve on PRIM&R’s Board of Directors?
DS: Over the years, and throughout my involvement with the planning for PRIM&R’s annual Advancing Ethical Research Conference, I have been very impressed with the organization and its leadership. I feel honored to have been asked, and I feel honored to be among the luminaries that sit on the board. I don’t consider myself a luminary, but the individuals that sit on PRIM&R’s Board of Directors are all well known in the field. Of course, I also believe in the cause, and I am happy to contribute to serving the mission of the organization.

AA: Can you tell me about one or more articles, books, or documents that have influenced your professional life?
DS: I often recommend  easy and compelling reads to students. One book that is very interesting and that tells great stories is Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision Making by David J. Rothman. More recently, for people outside of psychiatry and for patients, I refer them to Elyn R. Saks’ memoir, The Center Cannot Hold: My Journey Through Madness.

AA: What advice do you have for young professionals interested in pursuing a career in research ethics?
DS: My advice is, like anything else career wise, don’t pursue it unless you feel that you love it. Of course, the only way to know if you love it is to go and do it in any way that you can. At my institution, we open our doors to let people sit in on our meetings. It is a way to encourage people to get involved. I was talking with a young nurse practitioner recently, and it was obvious to me that people who are involved in clinical practice care about patient’s rights, but they still need to learn about the differences between patient care and research. I invited this individual to come to our meetings. She was excited, and she is now serving as a member of our IRB.

It is really a fantastic field—it is a field for people that want to do good, and that want intellectual opportunities and challenges. There are lots of opportunities for individuals from all different backgrounds, but the first step is to learn more about it, quite frankly, through becoming a PRIM&R member, visiting their website, and attending the annual meetings.

Friday, April 4, 2014

The Role of the Public in Scientific Research

by Derek Fong, VMD, DACLAM, clinical veterinarian at the University of Colorado Denver

Throughout the 2014 Institutional Animal Care and Use Committee (IACUC) Conference, the relationship between the scientific community and general public was a common theme that was addressed on both broad and practical levels. During the 2014 Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International Conference, which took place on April 1, one of the findings noted was a lack of participation by community members on the IACUC. I have been on IACUCs with both active and inactive community members, and have seen the important role they can play. Hence, I was happy to note that AAALAC emphasized the importance of the community member, and actually tried to measure their participation versus simply note their presence for a properly constituted committee.

In addition, a poster was presented that addressed the composition of IACUCs in the United States. I am always eager to compare notes, whether it is across institutions or across oceans, to find best practices, and it was interesting to learn that Sweden and Australia require that one-half and one-third of the committee is composed of community members, respectively. This fact highlighted for me the issue of increasing the participation of community members on IACUCs. During the AAALAC conference, it was mentioned that IACUCs can certainly have more than one community member to help rectify a lack of involvement. While I agree with this assertion, it is also worth noting that community members can be difficult to recruit. I also think the IACUC leadership should proactively engage the community members.

This theme was also addressed more broadly during a panel on harm-benefit analysis. Janet Stemwedel, PhD, an associate professor of philosophy at San Jose State University, noted that the benefits from animal research may be viewed quite differently by scientists and the public. Scientists may see benefit in scientific knowledge, but the public may ask more difficult questions such as when they will see the benefit, especially for basic science research. A common theme was the significant disconnect between the scientific community and the public. On the same panel, Thomas D. Albright, PhD, a professor in the systems neurobiology laboratories at the Salk Institute for Biological Studies, noted that this disconnect was due to the reticence of scientists as well as a lack of scientific literacy in our society. I agree with both these assertions, but think the former assertion is more noteworthy to this audience. Rather than hiding in our researching buildings, we need to actively engage the public to help increase scientific literacy. In the same vein, Dr. Stemwedel addressed the need for further transparency with the public about the research process.  

Lastly, I was impressed that conference organizers not only reached out to the public, but to the opposite end of the public spectrum with a workshop, titled Identifying Common Ground Between the Animal Protection and Research Communities, that featured representatives from animal protection organizations. I was pleasantly surprised by the constructive dialogue and ability to find common ground to move the field forward.

Thursday, April 3, 2014

Ethics: Is it the Thought That Counts?

by Derek Fong, VMD, DACLAM, clinical veterinarian at the University of Colorado Denver

John P. Gluck, PhD, professor emeritus of psychology and senior advisor to the president on animal research ethics and welfare at the University of New Mexico and research professor at the Kennedy Institute of Ethics at Georgetown University, painted a broad overview of animal research and ethics during his talk yesterday at the 2014 Institutional Animal Care and Use Committee (IACUC) Conference.

Dr. Gluck highlighted numerous historical events where concern about progress may have outstripped ethical reflection. For example, he noted that J. Robert Oppenheimer, the father of the atomic bomb, expressed regret over his role in its development. He described his own work as a graduate student in the Harlow Primate Laboratory during the 1960s and 1970s, where ethics was considered basic husbandry, such as clean cages. He recalled the surprise he and others felt when a colleague raised an ethical question about the use of animals in research.

While emphasizing the importance of the historical perspective, Dr. Gluck was clear that the role of ethics in science has improved, but is still not ideal. He shared an example of a bone marrow transplant patient who had undergone numerous procedures and clinical trials and wanted to leave the hospital, knowing she would likely die from infection, but would spend her remaining time with her family at home. However, the doctor running the clinical trial persuaded her to stay in the hospital, where she ended up dying two weeks later. This example struck home with me—my wife is a clinical psychologist on a bone marrow transplant unit and addresses these issues commonly. It also reinforced the need for more research to find better treatments and cures.

Dr. Gluck expressed the need for scientists to be professional ethicists. I’m not an ethicist and will likely never call myself one. I have taken classes in ethics, but always seem to walk away unsatisfied with the lack of concrete answers. Ultimately, my novice and, likely provincial, view is that ethics provides guidelines for thought, but does not generally provide a right or wrong answer at the time a choice has to be made. It is my personal belief that when confronted with an ethical question, it is the thought process, not the actual answer, which is most important.

The historical perspective provided by Dr. Gluck demonstrated how our ethical viewpoints continuously and significantly evolve.  Perhaps these ethical thought processes contribute and are necessary to spur larger changes observed over time. I often wonder how people will look back upon our field and our practices in 20, 50, or 100 years. What will seem arcane and what will seem prescient? I strongly believe in our work, but I also know that only time will tell how it is viewed when we, too, are a part of history.