Friday, April 24, 2015

Research Ethics Roundup: Reconsidering the Placebo Effect, the Disclosure of Clinical Trial Data, and More

In this week’s Research Ethics Roundup, we explore how shifting conceptions of research—from the growing demand for the sharing of clinical trial data to a renewed emphasis on statistical power in animal research—are challenging current thinking. Read on and share your thoughts on these pieces and other research ethics and oversight news in the comments.

Is the Placebo Effect in Some People’s Genes?:  A recent study published in Trends in Molecular Biology found that an individual’s response to a placebo may be affected by his or her genetics. This article from Reuters provides an overview of the research, as well as the potential implications of this finding for clinical research.

NIH Research: Think Globally: Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, and Francis S. Collins, MD, PhD, director of the National Institutes of Health, advocate for US investment in research aimed at addressing global health issues in this editorial from Science.

UK Funders Demand Strong Statistics for Animal Studies: Concerns about studies that lack statistical power have resulted in changes to the guidelines put forward by United Kingdom bodies responsible for distributing funding for research involving animals. In this article for Nature, Daniel Cressey provides background on the change, including the role of the 3Rs.

US Societies Push Back Against NIH Reproducibility Guidelines: In November, the National Institutes of Health developed guidelines intended to “improve the reproducibility of preclinical research.” However, some groups are concerned that the guidelines, which have been adopted by many journals, need further refinement. Monya Baker explores the issue in this piece from Nature.

WHO Joins the Push for Greater Disclosure of Clinical Trial Data: Last week, the World Health Organization (WHO) issued a new position statement that calls for companies to release the results—both negative and positive—of all clinical trials of medical products. In this piece for The Wall Street Journal’s Pharmalot, Ed Silverman summarizes the WHO’s position, as well as the reaction from the research community.

Wednesday, April 22, 2015

Beyond the Results: Context is Key

By Anne Meade, senior manager for website and social media

Not that long ago, genome sequencing was something most people did not have as an option available to them. Fast-forward 13 years later from when the human genome was first sequenced for $3 billion, and companies have announced that that they have machines available that "can sequence the genetic code of a human cell for $1,000." As genome sequencing has become more affordable and accessible, an ethical challenge becomes helping people interpret what their results mean to them, their health, and their futures.

In her interview for People and Perspectives, Carol Weil, program director for ethical and regulatory affairs at the National Cancer Institute, discusses the importance of context when assessing the risk of returning research results to participants. If people take part in research and want to be informed of the results garnered during the course of that research, one could argue they have that right. But the lack of understanding they possess about the information—and its current applicability to known diseases and conditions—can be anxiety-producing. Weil explains that advancements in technology mean it is not complicated to provide the information, but the value of the information and its interpretation can be difficult – "Is there a way to tell someone something that doesn't provoke more anxiety and cause more harm?"

Weil admits that there are various schools of thought about this and that there is no single answer applicable to every situation. You are going to find different answers in different contexts.
"The kinds of things that you would do in an observational cohort study in terms of collecting biospecimens and returning research results might be very different than the kinds of things you would do in a, say, a targeted genetic study where you have a rare disease population…I don't think it’s such a bad thing that you have different answers in different contexts…context is key." [Emphasis added]
Often, thinking about risk and research might focus on the actual study itself, but there can be risks beyond that. In the example above, researchers risk creating greater fear or stress by providing results that may not have documented relevance to a participant's current health or future well-being. The answers are going to be different for different populations and different studies. Standards of care as they are defined in medical practice can be difficult to apply to some ethical dilemmas. As Weil notes, "The key is to ensure that the participants that are involved in the research in the study understand what the choices are, and have accepted them if they've enrolled in the research."

Watch Carol's five-minute excerpt where she discusses this topic or watch her full video, which outlines her belief in the need for comprehensive discussions about research ethics and regulatory oversight.

Friday, April 17, 2015

Remembering Alan Wertheimer

Alan P. Wertheimer, PhD, senior research scholar in the Department of Bioethics at the National Institutes of Health (NIH) and professor emeritus of political science at the University of Vermont (UVM), passed away on April 10, 2015.

Dr. Wertheimer was a respected leader and philosopher who made significant contributions to the field of research ethics. Much of his career, however, was spent in the field of political science. As an undergraduate student at New York University (NYU), Dr. Wertheimer took his first course in political philosophy, an experience that served as inspiration for his career. He completed his bachelor's degree at NYU in 1964, and went on to receive his PhD from Case Western Reserve University in 1968. From there, he took a position teaching political science at UVM, where he continued to teach until 2005. He also served as visiting professor of public policy at the John F. Kennedy School of Government at Harvard University and professor of law at the University of San Diego.

Throughout his tenure at UVM, Dr. Wertheimer explored topics related to the political philosophy of law. Of particular interest were the topics of coercion, exploitation, and consent. He published numerous articles on these topics, as well as several books, including: Coercion (Princeton University Press, 1987) and Exploitation (Princeton University Press, 1996). Upon his retirement from teaching in 2005, Dr. Wertheimer was invited by Ezekiel Emanuel, MD, PhD, who served as chief of the Department of Bioethics at the NIH Clinical Center at the time, to become a visiting scholar in the department. Through this experience, Dr. Wertheimer discovered that coercion and exploitation—topics that he had previously studied in the political science realm—also had a place in research ethics. Though it was originally a year-long engagement, Dr. Wertheimer continued to work with the NIH Clinical Center exploring topics related to research ethics until he passed away.

Dr. Wertheimer's most recent work at the NIH focused on ethics of clinical research with particular emphasis on issues of coercion, exploitation, and consent. Chief of the NIH Clinical Center's Department of Bioethics and PRIM&R board member Christine Grady, MSN, PhD, was a colleague of Dr. Wertheimer's. She shared: "Alan was a well-known and accomplished scholar in political philosophy before coming to bioethics. After he joined the NIH Clinical Center Department of Bioethics, he did some of the finest work the field has ever seen, challenging received wisdom on many important topics in research ethics. Alan was an incredible colleague, teacher, mentor, and friend. His humility, humor, generosity, and kindness touched so many people. We will miss him tremendously."

In 2012, Dr. Wertheimer sat down with Gigi McMillan for an interview for PRIM&R's People and Perspectives initiative. During his interview, Dr. Wertheimer talked about his start in the field and shared insights on the topics of coercion and consent, as applied to research ethics.


In addition to his scholarly work, Dr. Wertheimer also demonstrated a commitment to teaching throughout his career. He was an active participant in PRIM&R's Advancing Ethical Research (AER) Conference for many years, serving as both a breakout session facilitator and panelist. He also served on the Core Conference Planning Committee from 2009 to 2014. David A. Borasky, Jr., MPH, CIP, vice president of quality management at Copernicus Group IRB and PRIM&R board member, had the opportunity to work closely with Dr. Wertheimer during a number of AER Conferences. He reflected on the experience: "It was always such a treat to interact with Alan. I learned a lot by working with him. He was a phenomenal – and patient – teacher. I will miss [the moments] when Alan would ask a provocative question, and as you thought about it (and he could see you thinking about it), a mischievous grin would appear on his face."

Dr. Wertheimer's vast contributions to research ethics scholarship have enriched the field and helped challenge conventional wisdom. His commitment to exploring challenging topics, his willingness to teach, and his always kind and generous nature made him a true leader. He will be deeply missed.

Thursday, April 16, 2015

Meet the 2014-15 Pillars of PRIM&R Award Winner: Francis Kombe

We are pleased to introduce you to the 2014-15 Pillars of PRIM&R Award recipient, Francis Kazungu Kombe. Francis currently serves as a senior community facilitator in charge of training at the Kenya Medical Research Institute/Wellcome Trust Research Programme (KWTRP). Over the next year, he will be using his award for a project that explores strengthening fieldworkers’ capacity to address practical and ethical challenges in international research settings. Read on to learn more about Francis' background and his project.

At the heart of my Pillars of PRIM&R project are fieldworkers—the front line staff who engage with prospective or actual study participants to collect data or seek consent. Fieldworkers play a vital role in maintaining a strong link between research institutions and the communities they serve.

A growing number of publications highlight the ethical dilemmas associated with fieldworkers' involvement in studies, including the potential for them to exploit community trust in order to meet recruitment quotas, the challenges they face in maintaining privacy and confidentiality in the community, and the possibility of being exploited through unfair employment practices.1 Fieldworkers are often residents within the community in which they are employed, and their insider knowledge about the community's socio-cultural, geographic, and leadership structures can help inform sensitivities around research implementation. However, fieldworkers can experience tension between professional expectations to adhere to ethical guidelines in the conduct of research, and the need to remain responsive and sensitive to ethical issues raised by members of their community. At worst, this tension can undermine data quality and, ultimately, the ethical standards of the research.

Support and training of fieldworkers to address complex ethical questions is so crucial to their work, but it varies between institutions. As well, standard curriculum for training fieldworkers is not available, making it difficult to compare the quality of training that fieldworkers receive.

As a former fieldworker, I have experienced firsthand the struggle to get already willing community members to understand the most basic concepts of research before getting them to consent to community-based and clinical research studies. In these communities, therapeutic misconception is common, while the concept of research remains alien. It is through this unique experience that I developed a passion for research ethics and capacity building, a skill-mix that I use to empower the community and staff, and enhance their understanding about research. This is what is at the core of my current work, which seeks to understand the impact of different pedagogies, support structures, and trainings in strengthening the capacity of field workers to address the moral and ethical dilemmas they face in their daily activities.

Throughout the next year, and with the help of my Pillars of PRIM&R award, I plan to explore ways in which fieldworkers at international health research institutions in Sub-Saharan Africa can be effectively supported to handle practical and ethical challenges. Specifically, I plan to:

  • Map out current practices in relation to training, support, and performance management of fieldworkers in the region
  • Conduct telephone surveys of fieldworkers and fieldworker managers in an effort to compare experiences and lessons learned in supporting fieldworkers
  • Convene a group of fieldworkers' managers and supervisors for a consultative workshop where participants will discuss standard approaches that could be developed to strengthen support of fieldworkers in research activities

Long-term, I hope that the outcomes of this project will feed into ongoing work at research institutions across the region, informing appropriate and consistent support systems for fieldworkers. I also hope to develop a generic approach and broad curriculum for fieldworker capacity building. I look forward to sharing my experiences and outcomes with you, and thank PRIM&R for their support through their Pillars of PRIM&R award.

The Pillars of PRIM&R Award recognizes professionals whose scholarship in the field of human subject protections and/or animal care and use reflects PRIM&R's mission and core values, and who demonstrate exceptional potential for leadership in the field of research ethics. To learn more about the Pillars of PRIM&R, please visit our website.

1. S. Molyneux, D. Kamuya, P.A. Madiega, T. Chantler, V. Angwenyi & P.W. Geissler. Field workers at the interface. Dev World Bioeth 2013; 13: ii-iv, D.M. Kamuya, S.J. Theobald, P.K. Munywoki, D. Koech, W.P. Geissler & S.C. Molyneux. Evolving friendships and shifting ethical dilemmas: fieldworkers' experiences in a short term community based study in Kenya. Dev World Bioeth 2013; 13: 1-9.

Tuesday, April 14, 2015

Work to Ensure the Safety and Wellbeing of the Animals: An Interview with Candace Beiler

By Megan Frame, membership manager

Welcome to another installment of our featured member interviews where we will introduce you to PRIM&R's members—individuals who work to advance ethical research on a daily basis. This member interview is especially fitting because April 12-18 is National Volunteer Week, a time when we celebrate the time and talent our volunteers dedicate to PRIM&R.

Please read on to learn more about Candace Beiler, one of our valuable volunteers, and IACUC Administrator at Schepens Eye Research Institute in Boston, MA.

Megan Frame (MF): When and why did you join the field?
Candace Beiler (CB): I joined the field in 2005 because I have a strong love for animals, as well as science, and I wanted to be able to pursue my interests, learn new things, and challenge myself in new ways.

MF: What's one specific challenge that you have faced during your career, and how did you overcome it?
CB: I started my career as a veterinary technologist and loved every minute that I spent with the animals, ensuring that their health and care needs were met. After obtaining my master's degree, I started thinking I wanted to see a bigger picture of animal research and decided to move into an IACUC role and learn the regulatory aspects of the field. This was a big challenge for me because as a veterinary technologist (in my mind), I was the person providing direct care to the animals, and therefore felt confident they were being well cared for. Moving away from that position was difficult.

I overcame that feeling by realizing that, from the IACUC and regulatory side of things, I can still work to ensure the safety and wellbeing of the animals, and further advance animal care by educating laboratories and members of the community of the importance of the humane care and welfare of the animals in research.

MF: What is one thing you wish the general public knew about animal research?
CB: Mainly, I wish that the general public knew how well animals are treated in research. I have worked with so many different people in the field, and have seen the care, love, and sensitivity that everyone provides. I wish the public better understood that every animal in research is so well cared for throughout their lives and that each animal whose life is being sacrificed is saving the life of a loved one out there.

MF: What motivates you to maintain your commitment to advancing ethical research?
CB: My father was diagnosed with lung cancer in 2007, and passed away from this horrific disease in 2009. He and all other people suffering from currently incurable diseases are my motivation to maintain my commitment to advancing ethical research. Continued research is what is going to save the lives of others. My father could not be saved, but there are plenty of others out there whose lives can be improved or saved through new treatment methods discovered through research.

MF: Have there been any PRIM&R events or talks that you have attended that have made a significant impact on your approach to your work? If so, what were they and how did they influence you?
CB: PRIM&R's IACUC Conferences always make a significant impact on my approach to my work. There have been many influential talks and discussions that I have attended that inspire me to bring new ideas and concepts back to my job. I attended a talk at the 2014 IACUC Conference in Denver that discussed harm/benefit for balancing ethics, compliance, and science when performing reviews of protocols. After attending this discussion, it made me pay closer attention when reviewing protocols as to whether there is both institutional compliance and ethical responsibility, while still enabling research. The different views that other attendees had regarding this topic were also influential to me and my approach to work.

MF: How has membership in PRIM&R's community of research ethics professionals helped you to advance in your career or do your job better?
CB: There are many ways that my PRIM&R membership has helped me advance in my career and also do my job better. Obtaining the CPIA® credential through PRIM&R allowed me to advance in my job, as well as improve my job performance. Preparing for the exam and reviewing all of the materials taught me a lot that I now apply to my job every day.

My experiences at PRIM&R's IACUC Conferences have not only supported me in my job, but they have also introduced me to people within the field. There are many people whom I have met through PRIM&R that I reach out to for advice on a specific topic, or just to see how they do certain things at their institutions. I have also made personal friendships with many people whom I have met at the conferences.

One of the more recent benefits I have taken advantage of through my PRIM&R membership is the Mentoring Program. I have been a mentor for two mentees and have been able to guide them with my knowledge and experiences, and have also learned a lot from them as well.

Thank you for being part of the membership community and volunteering your time with us as a mentor, Candace! Our community wouldn't be as strong without the support of members like you.

If you'd like to learn more about becoming a member, please visit our website today.