Research Ethics Roundup: GM rice, cancer trials, treatment of subject injury, and more!

Autumn officially begins tomorrow, so whether you spend your weekend watching football, picking apples, or indulging in some pumpkin pie, make sure you leave room for our Research Ethics Roundup. This week’s installment features articles on recent protests over genetically modified organisms (GMOs) in China, the human side of clinical trials, and more!

Greenpeace out to sea on GM rice issue, bioethicist says: Greenpeace has been extremely critical of a US Department of Agriculture (USDA)- and National Institutes of Health (NIH)-funded study in China, which sought to examine the effects of genetically modified rice on a population of children with historically low levels of vitamin A. The author of this article argues that Greenpeace’s protestations have stigmatized a successful research study that could help prevent death or blindness in thousands of children, over a categorically negative perception of genetically modified foods as a whole.

Treatment of subject injury: Fair is fair: In this post from Bill of Heath, a blog from the Petrie-Flom Center at Harvard University, PRIM&R faculty member Suzanne Rivera, PhD, highlights the lack of clarity surrounding who is financially responsible for treatment when a research subject is harmed as a result of his or her participation in a study. Dr. Rivera also discusses the complications that can arise when an institutional review board (IRB), sponsor, or institution attempts to limn the details of liability relating to injury of a participant.

Vets and physicians find research parallels: A trend of collaboration and cooperation has emerged between the fields of human and animal medicine. This interdisciplinary approach has led to stunning advances on both sides, and has helped to narrow what has traditionally been a decades-long gap between animal and human medicine.

The trials of cancer trials: In this personal essay, Susan Gubar details the complexity and uncertainty of cancer research trials from a subject’s perspective. From daunting consent forms to the disappointment of disqualification, Ms. Gubar deftly illuminates the emotional toll of participation in scientific research.

Looking for more news? PRIM&R members can visit our Knowledge Center to find more recent scholarly journal and popular media articles pertaining to research ethics. Not yet a member? Learn more about becoming a member by visiting our website.

Want to do research ethics well? Go beyond compliance.

 by Alexandra Shlimovich, Online Learning and Certification Coordinator

This week, I sat down with Elisa Hurley, PRIM&R’s education director and presenter of last week’s Research Ethics Beyond Respect, Beneficence, and Justice webinar. We discussed what it takes to do research ethics well, ways to become involved in human subjects protections, and key resources in the field.

Alexandra Shlimovich (AS): What does someone need to understand to do research ethics well?
Elisa Hurley (EH): I come at this question from the perspective of someone who teaches research ethics, and not as a human research protections professional.  From my perspective, to do research ethics well, it’s important to first and foremost understand that it goes beyond compliance. As I mentioned during the webinar, compliance is about following the rules; it’s about dotting the I’s and crossing the T’s. Ethics goes beyond compliance. Ethics is about making judgments about what is right, based on reflection and reasoning. And to reflect and reason well, it is imperative to understand some of the key concepts of research ethics—not just respect, beneficence, and justice, but also concepts such as undue influence, coercion, vulnerability, reasonable risk-benefit ratio, and informed consent. We also have to understand that what makes influence undue, or what constitutes a reasonable risk-benefit ratio, or what counts as sufficiently informed consent is itself a matter for argument and reasoning. In fact, I think it’s pretty clear that our regulations are precisely set up so that we can’t just follow them; rather, the regulations call for the judgment, the deliberation, of a group—namely, the institutional review board (IRB).

AS: What are some ways people can obtain the experience necessary to enter this field?
EH: This is an interesting question, because there really isn’t a clearly defined path into the research ethics professions.  My own view is that a master’s degree in bioethics that includes courses or a specialization in research ethics can never hurt for those interested in the theoretical foundations of the ethics of research with human subjects (as of course I am).

However, an advanced degree isn’t necessary. Probably one of the best ways to gain useful experience for anyone interested in entering the human research protections field is to serve on an IRB as an unaffiliated/community member.  Most IRB offices have publicly accessible websites that include contact information for the administrator/manager and other staff.  Searching online for local IRBs and making calls to administrators about their needs for unaffiliated members might be a way to get a foot in the door. Once there, don’t be shy about talking to the IRB staff about their roles, how they got there, etc.

I also think meeting people in the field who can not only share their stories but provide contacts is key. Joining a professional organization, such as PRIM&R, can provide those invaluable networking opportunities. In fact, PRIM&R’s mentoring program matches mentees and mentors based on needs and interests and is a wonderful resource for our members.

AS: What follow up readings or resources would you suggest to the attendees of this webinar?
EH: If people are interested in becoming more familiar with the concepts that are at the heart of research ethics, the best resource I can recommend is The Oxford Textbook of Clinical Research Ethics, published in 2008 and edited by Zeke Emanuel et al.  It’s an unparalleled collection of original articles on just about every aspect of ethical research with human subjects, from the history of the field and its seminal documents, to issues in research design, subject selection, informed consent, risk-benefit analysis, to ethical issues unique to social science and behavioral research, and much more.  I also can’t say enough about the value of reading and re-reading The Belmont Report. Every time I go back to it, I am surprised to find some new nuance or point that I hadn’t noticed before. It’s by no means perfect—for instance, it seems to universally advocate protecting research subjects, including the vulnerable, rather than empowering them in the research enterprise. Nevertheless, it remains such an impressive document—elegant, clear, insightful, and instructive, and all the more powerful for its brevity.

If you’re interested in learning more about the fundamentals of research ethics and did not have a chance to participate in last week’s webinar, the archive is available for purchase. PRIM&R members can also access additional research ethics readings on our Knowledge Center.

Book review: Patchett offers insight into the work of IRBs

I was excited to read State of Wonder by Ann Patchett for Ampersand’s Summer Reading List. Having thoroughly enjoyed two of Patchett’s previous books (The Magician’s Assistant and Bel Canto), I looked forward to her most recent New York Times bestseller, especially as she took on several issues critical for those of us in the research ethics field, including respect, justice, beneficence, informed consent, coercion, and more. As I can find it challenging to explain the work of an institutional review board (IRB) to lay people, finding a popular novel that can do so is refreshing and helpful.

Marina Singh, the heroine of State of Wonder, is a doctor working for Vogel, a drug company, whose colleague and friend dies while on a business trip to the Amazon in Brazil. The purpose of his trip was to obtain an update on the research efforts of the elusive Annick Swenson, an investigator funded by Vogel who is seeking to develop what could be a very valuable drug. When Marina volunteers to go to the Amazon to pick up where her colleague left off, she is thrust into a world far from the safety of her laboratory, where the ethical precepts that guide research  have been left behind, and where the roles of researcher and research participant have become blurred.

From the outset, Dr. Swenson’s approach to research is revealed as troubling. No one is aware of the details of her work—not even her exact location—and she is not required to provide regular progress reports. While the secrecy of this elusive researcher is grounded in altruism, her distrust of her funders, her fellow researchers, the research oversight system, and even the subjects of her research threatens to destabilize her work. While Patchett does not provide an in-depth exploration of the research issues IRBs grapple with, she does, through Marina’s story, examine the real-life dilemma of holding tight to our ethical center in the face of the tantalizing prospect of scientific discovery. 

Patchett is a gifted and dazzling storyteller, and this book is a terrific launching pad to engage those in our field in a discussion about the questions of right and wrong, as well to help family and friends more fully understand the purpose and work of the IRB.

I recommend adding State of Wonder to your summer-quickly-becoming-autumn reading list and hope you will let us know here at Ampersand what you think of this and the other books on our Summer Reading List.

Research Ethics Roundup: Questioning post-market trials, stem cell research, and more!

Though summer may be nearly over, the world of research ethics is still heating up. From the ethical implications of post-market research, to the protection of children in clinical trials, this week’s Research Ethics Roundup is full of stories you won’t want to miss.

Additional protections for children who participate in clinical research: In this powerful opinion piece, pediatric ethicist and PRIM&R faculty member, Robert “Skip” Nelson, MD, PhD, argues that children are especially vulnerable to exploitation and exposure to unnecessary risks due both to the high level of emotion and urgency often associated with childhood illness and the limited amount of information available about pediatric treatments. 

Genes now tell doctors secrets they can’t utter: This article in The New York Times discusses the procedural and ethical issues surrounding the return of genetic results to research participants or their families. Special attention is given to cases in which the results were not envisioned as part of the initial protocol or consent process and for which treatment options exist.

Appeals court panel says federally funded embryonic stem cell research can continue: The U.S. Circuit Court of Appeals for the District of Columbia has upheld the decision of a lower court to dismiss a case that challenged federal funding for embryonic stem cell research.

Do post-market drug trials need a higher dose of ethics?: While clinical trials with experimental treatments require doctors to provide extensive counseling before a participant can give his or her informed consent, post-market trials do not. As a result, participants often lack a clear picture of the risks and benefits of enrolling in post-market trials.

Book review: Skloot deftly explores issues of race, ethics, and medicine

 by Alysa Perry, program coordinator

When The Immortal Life of Henrietta Lacks was published in 2010, it became a New York Times Best Seller. Once you start reading, it’s easy to see why.  Rebecca Skloot masterfully tells a story that is simultaneously entertaining, scientific, informative, and historical.

Skloot shares the biography of Henrietta Lacks, a poor black woman whose cells—taken without her consent when she was dying of cervical cancer in 1951—became one of the most transformative tools in medicine. Known as the HeLa cell line to medical professionals, Lacks’ cells have contributed to some of the most important advances in history: cloning, the polio vaccine, chemotherapy, in vitro fertilization, and more.

Lacks’ cells were unique because of their immortality. Until George Gey, a researcher at Johns Hopkins University, propagated the cells shortly after Lack’s death, no one had successfully kept cells alive for more than a few days—a major hindrance to medical research. Knowing how significant this discovery was, Gey went on to share the cells with his friends and fellow researchers, who then shared them with their colleagues. Today, HeLa cells are bought and sold by the billions, and are widely used around the world.

What is most impressive about Skloot’s telling of the story is her detective work. For decades the source of the HeLa cells remained a mystery. Even Lacks’ family and descendants were unaware of the cells’ existence until 25 years after her death. Skloot spent 10 years researching, reading, traveling, and winning the trust of the Lacks family in order to write the book. She poured over hundreds of resources and interviewed dozens of people who knew Lacks in order to accurately portray her.

Lacks’ story raises a number of complex ethical issues. The book traces not only the lives of the Lacks family, but also the history of informed consent—a concept that wasn’t salient until the latter half of the 20th century.  When The Immortal Life of Henrietta Lacks was first published, Skloot was asked what lessons could be learned from her book. She responded, “the story of HeLa cells and what happened with Henrietta has often been held up as an example of a racist white scientist doing something malicious to a black woman. But that’s not accurate. The real story is much more subtle and complicated. What is very true about science is that there are human beings behind it and sometimes even with the best of intentions things go wrong.”  

PRIM&R had the privilege of hosting Rebecca Skloot as a keynote speaker at the 2010 Advancing Ethical Research (AER) Conference in San Diego. Skloot shared stories about her writing and research process, and attendees described her talk as riveting and inspirational.

The Immortal Life of Henrietta Lacks is a must read for anyone new to the field of research ethics. It is extremely valuable as an introduction to many of the federal regulations and ethical considerations that are at the core of human subjects protections and it has become a classic text in the field. Most importantly, however, it gives Lacks the recognition and homage she deserves for her incredible contribution to modern medicine.