- "This seems, at first glance, to be an extremely serious potential breach of research ethics. It also is a pretty monumental medical story — a clinical trial resulting in deaths and serious morbidity. Yet I haven't been able to find any sources, other than HuffPo, that have corroborated this story. The blogs and newsgroups I note above each cite the HuffPo story only. The story has not been picked up by mainstream media. Documents supporting the story, such as the letter to Columbia from OHRP, are not publicly available."
Friday, October 30, 2009
The most recent issue of the PRIM&R Newsletter (members only) was distributed today, October 30.
In addition to our regular features, such as Recent Headlines, Government and Legal News, and Public Policy, this issue included…
- A reminder that Friday, November 6 is the LAST CHANCE to register for the 2009 AER Conference and pre-conference programs;
- A request for those attending the 2009 AER Conference to bring an unwrapped book or toy with them to benefit a local Nashville shelter;
- An invitation to contribute to the program development for the 2010 IACUC Conference;
- A thank you to October’s volunteer of the month, Susan Delano;
- This month’s website feature of the month, the members only icon () that you see dispersed around the PRIM&R website;
- A featured talk from PRIM&R Through the Years. This month’s feature is a session from the 1994 panel Changes and Choices for IRBs: The Inclusion of Women and Minorities, and Other Emerging Issues in Research conference, titled “Risk Assessment”; and
- A reminder about the special offer for PRIM&R’s Career Center – only good until November 6!
Can’t find the Newsletter in your inbox? Check out the Newsletter Archives.
Want to become a PRIM&R member? Learn more.
Wednesday, October 28, 2009
by Jen Levine-Fried, Membership Specialist
From 2003 to 2005, I participated in an HIV vaccine trial. I visited the research department at Fenway Community Health in Boston nearly a dozen times over the course of a year, spending up to two hours at a time giving blood, answering questions, and wincing through countless injections of an experimental vaccine.
Given my substantial investment of time and energy, I was happy to read news in September that a vaccine trial similar to the one I participated in had finally produced modest success in preventing HIV infection. Reading the article opened a floodgate of memories about "my" trial, which, due to my subsequent experience working for PRIM&R, I now view through a new lens.
I've thought a lot about the informed consent process. Don't get me wrong—I was very well informed about the potential short- and long-term risks of the study. I think that the researchers did an excellent job ensuring I made my choice freely.
But as I think about risks now, especially the long-term ones, I wonder if I would have made the same decision. For example, I'm not HIV positive, but due to the experimental vaccine I received, I would appear to test positive using standard HIV tests.
If I want to document that I am HIV negative, I have to be tested at Fenway, which I can do at any time, free of charge. The researchers did not know how long my false-positive status might last, a minor concern to a single twenty-something (which I was, at the start of the trial). But now I am a married mother of two, and I have had to specifically decline HIV tests during both of my pregnancies. It gave me pause.
There's also the question of whether the vaccine could have been passed to my children in some way, a question for which the researchers did not have a definitive or compelling answer (although they suggested any risk was minimal). It makes me wonder whether I should have had more consideration at the time for my future self—and my future, hypothetical, children.
On the other hand, I recall the outrage that stemmed from federal guidelines announced in 2006 suggesting that all women of child-bearing age be treated as "pre-pregnant." (Essentially, the guidelines suggest that all women of childbearing age should follow the same sorts of health guidelines as pregnant women.) As a feminist and, at the time, newly pregnant woman, I shared (and still share!) that outrage. And I wonder, even if I had been pushed to consider myself in that light, would it have been possible for me to do so, since it was so far out of my mindset at the time?
One thing is clear: there are no easy answers to this question. But I would love to hear your thoughts on this aspect of informed consent.
Tuesday, October 27, 2009
The planning process for the 2010 IACUC Conference is underway, and to develop the conference you want, we need your help generating ideas for the program's content. That's why we're extending this Invitation to Contribute to Program Development, so that the Conference Planning Committee may consider a broad and rich spectrum of topics and speakers.
Feedback from the community is invaluable when it comes to gathering and fleshing out ideas. For that reason, we're hoping you will post your thoughts—whether they're full-grown or just seedlings—to the conference discussion forum, where a wide variety of past and future attendees will come together to sow the seeds of another exciting program. Or, if you already have an idea, submit it directly to the PRIM&R staff using this online form.
The Conference Planning Committee will consider all submissions received by November 25, 2009. Please note that this process is not related to the Call for Poster Abstracts, which will begin in November.
Please consider participating in this process, as hearing from a large and professionally diverse chorus of voices will immeasurably enrich our conference program. If you have questions, please e-mail us, or call 617.423.4112, ext. 0.
Monday, October 26, 2009
Did you write these lyrics? Maybe you were on stage singing them? Either way, we hope you have a laugh—and let us know if you were involved!
That’s what they say
In short, no way.
They said I might as well root for the Mets
Sent me to see some guy named Schwetz
He told me to bail
Or end up in jail
That what I thought
If I get caught
Wish I’d stayed in that refresher course
Paula Zahn did quite a tour de force
Maybe I’ll be
Thursday, October 22, 2009
Posted by Catherine Rogers, marketing coordinator
Take one look at the photos from last year’s Institutional Animal Care and Use Committee (IACUC) Conference and you’ll notice a few visual cues that speak to the meeting’s intrinsic value: A vibrant community. A diverse faculty. Smiling faces. Raised hands. Ah-ha moments.
But the pictures tell only part of the story...
To fully grasp the impact of the IACUC Conference, though, it’s necessary to immerse yourself in the experience. That’s why I wanted to share some preliminary details about PRIM&R’s 2010 IACUC Conference, which will be held March 22-23, with pre-conference programs being held on March 21, in Baltimore, MD, at the Baltimore Marriott Waterfront Hotel.
Based on the feedback we’ve received about last year’s IACUC Conference, our meetings continue to expand and improve, and 2010 will be no exception:
- We’re expecting 700 attendees from 30 countries worldwide.
- Our faculty has grown to nearly 125, including almost 20 federal representatives.
- The conference program is composed of 20 tracks and 80 sessions designed to improve communication and collaboration, foster programmatic integration, and achieve convergence throughout an institution’s animal care and use program.
In addition, attendees will have greater access to networking with peers, colleagues, experts, thought-leaders, and federal government representatives! We know it’s not always easy to find a space to continue a discussion, reconnect with old friends, or engage in a thoughtful discussion with new ones. That’s why we have done the work for you! Once you’re onsite at the Marriott, look for signs directing you to a series of hand-picked Alternative Networking Depots—aka AmpersAND Lounges—where you’ll find comfy couches and cozy nooks, perfect for coffee and conversation.
General registration will open this winter, and we will continually update our website with information about the program and faculty, so please be sure to check back for the latest developments.
Hope to see you in Baltimore!
Monday, October 19, 2009
If you have any questions, please contact Anne Meade, web and e-learning manager.
Friday, October 16, 2009
I just wanted to remind you that we are less than a week away from the deadline for the regular registration rate for the 2009 Advancing Ethical Research Conference. The late rate starts October 23, which is also the last day you can book a room in PRIM&R’s block at the Gaylord Opryland Hotel. Make your reservation online to ensure you will pay the special conference rate of only $185 per night.
If you’re still on the fence about attending the 2009 AER Conference, consider this:
As research becomes increasingly complex, competitive, and "conflicted," your responsibilities shift, as well. You can fully adapt to our ever-changing world, and you can learn what you need to know to do your job better. By attending the 2009 AER Conference, you will play an active role in raising the caliber of research at your institution.
Creating a culture of ethics and compliance takes vigilance, and that’s where PRIM&R comes in. Your mission is to protect human subjects and advance ethical research. Ours is to help you find the best ways to do that. Register now!
Where do conference planners go for fun? Well, at least this one goes to other conferences! Some might call it a “buswoman’s” holiday , but I call it a chance to sit, listen, and learn—something I cannot easily do at PRIM&R meetings given the fact that there’s always a task that needs tending.
So here I am at the American Society of Bioethics and Humanities meeting in Washington, D.C., and there I was in the second row center yesterday during the opening session. Ezekiel Emanuel was the initial speaker, and his speech was titled "The Future of Bioethics: Policy, Politics, or Mush."
In his inimitable way, Zeke asked those in the audience to assess and reassess our professional principles, purposes, and practices.
Zeke mused about the early days of his work in the bioethics field when giants like Erich Heller taught and wrote about a range of probative issues: "Reality was being eviscerated of deeper meaning in the course of being 'explained' by modern science." Heller also noted that scientific explanations deprive things of their "individual being as entities and reduce them to the position of mere links in a much more broadly conceived chain."
Zeke also discussed the need for more empirical work in the bioethics field, as, he said,"public engagement is important, but it should not be the main focus of our discipline." Zeke was also quick to name reasons why it is important for the bioethics field to shift:
Loose lips sink ships.
In other words, much of what bioethicists observe is neither neutral nor benign, and their pronouncements are instead often perceived as a call to action. He therefore urges bioethicists to judiciously wield their power to “sink ships.” One way to do so would be to clarify the difference between statements of general condemnation versus those with a more “I am uncomfortable with this” tone.
One example he gives of this “loose lips” concern is that many bioethicists cannot precisely define injustice, exploitation, coercion, involuntariness, manipulation, etc., and yet there is a tone of certainty that pervades their work on these topics.
Zeke referred to the Willowbrook coercion case, which has stood for 40 years as an example of unethical research, until Walter Robinson’s recent work questioned whether there was an ethical violation. Zeke’s point is that bioethicists must be more precise about distinguishing these things, versus using loaded ethical terms.
"Data" is not the plural of anecdote.
But, according to Zeke, some bioethicists have nonetheless drawn conclusions despite the lack of data. Empirical data is sorely needed on bioethical and IRB-related questions, and yet it rarely exists. “We can’t say anything about risks and benefits or about the quality of informed consent with an anecdote,” he said. “A story is a story, but the hard questions require data,” he said, citing both the TeGenero experience in the United Kingdom, and ACTG O76 mother-to-child transmission studies, to illustrate this point.
Where’s the beef in bioethics?
He lamented that many of the fundamental ethical issues discussed today have been around for ages and ages, and we still have not solved them as there is no empirical knowledge. Among the examples are the lack of data on informed consent, surrogate decision-making at the end of life, and the ethics of using financial incentives to encourage healthy decision-making.
In closing, Zeke restated his desire to increase the intellectual rigor of the discipline so that the work of bioethicists will be important for the biomedical research field at large.
Thursday, October 8, 2009
“I am coping through action. It is the only thing I know.” Amy Farber
Hello and happy autumn, everyone. This is a season of transition for most of us as we migrate from the calmer days of summer, where we were lucky enough to have a break from the workaday world, to fresh stores of new projects to tackle and new problems to solve.
Problem-solving is something all of us face, but how would you react if the problem you wanted to solve was how to save your own life? My dear friend and shero, Amy Farber, is doing just that.
Amy has a Ph.D. in medical anthropology from Harvard and was pursuing a law degree when she was diagnosed with Lymphangioleiomyomatosis (LAM), a rare, fatal, multi-system disease affecting women in their childbearing years. LAM causes destruction throughout the body, often in the lungs, kidneys, and lymph nodes. This destruction is attributed to cellular abnormalities, and eventually leads to respiratory failure as cysts and nodules take over normal lung tissue. LAM affects 30,000-50,000 women worldwide, and there is no known cure or treatment.
In fact, before Amy came along, the mechanisms of destruction of lung and other tissues in LAM were poorly understood. When Amy realized that there was not only no cure, but no treatment, either, she decided to try to change all that by taking Ralph Waldo Emerson’s advice to heart. Emerson said, “Do not go where the path leads; rather, go where there is no path and leave a trail." And so, Amy has begun blazing a trail that will hopefully produce effective therapies for LAM.
Before explaining how she has done that, I want to disclose some facts: I sit on the Board of Directors of the LAM Treatment Alliance (LTA), the organization Amy founded and now runs. I met her about two years before she was diagnosed with LAM and was immediately struck by her brilliance, fearlessness, principled thinking, commitment to being a true citizen of the world, and outsized spirit. All of those qualities have served her well as she races against the clock to unlock the mysteries of LAM so that she and her sister sufferers can have long and healthy lives.
So what exactly has she done? Amy’s accomplishments compose a long and impressive list, a summary of which can be found on the LTA website, but there is so much more.
Most recently, for example, Amy forged a collaboration called LAMsight between LTA and the MIT Media Lab. According to a recent New York Times article, this web site “allows patients to report information about their health, then turns those reports into databases that can be mined for observations about the disease.”
As noted in the article, “online communities have the potential to transform medical research—especially into rare diseases [like Amy’s] that lack the number of patients needed for large-scale studies and rarely attract research financing from the drug industry.”
Her MIT collaborator, Frank Moss, seconds that sense by noting that “patients’ everyday experiences in living with an illness are an enormous source of untapped data. When aggregated, those data could generate new hypotheses and avenues for research. We’re really turning patients into scientists and changing the balance of power between clinicians and scientists and patients.”
I had not heard of this “crowdsourcing” or “open-source research” until reading this article. Of course wherever there’s a new technology, you’re sure to find a debate brewing, and this is no exception. While advocates like Amy and her colleagues believe that these new models have the potential to alter previously conceived notions of how to build bridges between researchers, patients and their doctors, others cite the risks of self-reported data (i.e. the “garbage in, garbage out” problem).
While those working on LAMsight believe that these methods are far cheaper and faster than traditional research, the detractors point out that patient privacy cannot be guaranteed, and that informed consent may be more problematic than ever given the complexities of such a high-stakes and experimental venture. The LTA/MIT team acknowledges the problems with this pioneering use of technology and plans only to use the data generated for exploratory analysis and hypothesis generation.
So what do you think of patient-driven research? How would you tackle the problems of privacy protections and consent? Extraordinary Amy Farber and her dedicated and determined scientific colleagues are working hard to do just that. Join me in wishing them luck, and in wishing Amy good luck and good health!
P.S. If you know someone who might be interested in helping Amy find a cure for LAM, please pass this on.
Wednesday, October 7, 2009
This is Part II of a two-part series. Read Part I here.
The Draft OMS [Office of Medical Services] Guidelines on Medical and Psychological Support to Detainee Interrogation, (the Guidelines), from Appendix F of the CIA Inspector General Special Review of Counterterrorism Detention and Interrogation Activities (IG Report) mention medical dimensions that need to be monitored to ensure the safety of the detainees, but redact the following paragraph[s] that presumably detail the role of physicians and psychologists in that task fundamental to the ethical conduct of human research (F:9).
Unlike trainees in other U.S. government programs subjected to a single waterboard application, the subject detainees did not volunteer nor were they engaged in an informed consent process. The IG Report cites the Office of Medical Services’ opinion that the waterboard training experience is so different from the subsequent CIA use as to make it almost irrelevant (¶43fn26).
The IG Report details the evolution of the international, multi-site Detention and Interrogation Program, over a two-year period, including distinct roles for interrogators, debriefers and analysts (¶15fn6 and ¶204). In interrogation sessions where the waterboard is applied, an unresponsive subject should be righted immediately and the interrogator should deliver a sub-xyphoid thrust to expel the water. It is the interrogator who is tasked with the application of first aid to an unresponsive subject detainee. Only if the interrogator’s intervention fails to restore normal breathing is aggressive medical intervention required, administered, presumably, by the physician observing and documenting the use of the waterboard. The physician’s primarily role in waterboard interrogation is observation and documentation for research purposes and medical intervention only in extremis.
Is the risk-to-benefit analysis socially beneficial? No.
The IG Report points to on-site medical oversight as evidence that all the enhanced interrogation techniques pose risk. It identified concerns about whether the risks of the use of the waterboard were justified by the results and whether it has been unnecessarily used in some instances (¶220). The IG Report documents, according to the Chief of Medical Services:
- OMS was neither consulted nor involved in the initial analysis of the risk and benefits of enhanced interrogation techniques (EITs) . . . OMS contends that the reported sophistication of the preliminary EIT review was exaggerated, at least as it related to the waterboard, and that the power of this EIT was appreciably overstated . . . Consequently, according to OMS, there was no a priori reason to believe that applying the waterboard with the frequency and intensity with which it was used by the psychologist/interrogators was either efficacious or medically safe. (¶43fn26)
Whether the authors were making a point, or due to proofreading oversight, ¶266 repeats, word-for-word, the warning raised in ¶19:
- The Agency faces potentially serious long-term political and legal challenges as a result of the CTC Detention and Interrogation Program, particularly its use of EITs and the inability of the U.S. Government to decide what it will ultimately do with terrorists detained by the Agency.
The idea that an agency of the federal government engaged in human research on torture is an appalling thing to contemplate. This post hoc exercise in research ethics setting aside the legal and moral issues has been dizzying and, as the Spanish say, like trying to block out the sun with your hand.
Tuesday, October 6, 2009
The comments and opinions in this post reflect only those of Renée LLanusa-Cestero, director of La Cesta Consultants, LLC, and do not necessarily represent the opinion of PRIM&R or its Board of Directors.
The release of the CIA Inspector General Special Review of Counterterrorism Detention and Interrogation Activities (IG Report) has prompted a call from Physicians for Human Rights (PHR) for health professionals who have violated ethical standards, as detailed in the IG Report, to be held accountable through criminal prosecution, loss of license, and loss of professional society membership, where appropriate.
This two-part post series focuses on a previously unknown category of ethical violation identified by PHR and of particular concern to PRIM&R members: unethical human experimentation and the development of research to assess and refine the use of the waterboard.
The IG Report (¶266) anticipated the appointment of a special prosecutor to investigate torture and the PHR call for a full investigation of the role of medical and psychological professionals for war crimes (¶231). Setting aside the crucially important legal and moral issues for a moment, I propose a post hoc review of the IG Report to examine the PHR concern that data collection and analysis on the use of the waterboard may have amounted to unethical human experimentation by addressing the fundamental questions posed by IRBs.
Does the Common Rule apply? Yes.
Pursuant to Executive Order 12333, the CIA is one of 17 federal departments and agencies that have adopted the Common Rule. The Common Rule stipulates department or agency heads retain final judgment as to whether a particular activity is covered by this policy (45CFR46.101(c)). The IG Report reveals no documentation of an exemption from the Common Rule.
Is it human research? Yes.
Did the development of the Detention and Interrogation Program include human experimentation; that is, was it research? The Common Rule definitions of “research,” “human subject,” and “intervention” appear to apply (45CFR46.102(e) and (f), respectively).
For example, Appendix F of the IG Report, Draft OMS [Office of Medical Services] Guidelines on Medical and Psychological Support to Detainee Interrogation, (the Guidelines) provide chilling, clinically descriptive standard and enhanced interrogation techniques in ascending degree of intensity culminating with the waterboard, the most traumatic of the enhanced interrogation techniques (F:1). The Guidelines conclude with the following Note:
- NOTE: In order to best inform future medical judgments and recommendations, it is important that every application of the waterboard be thoroughly documented: how long each application (and the entire procedure) lasted, how much water was used in the process (realizing that much splashes off), how exactly the water was applied, if a seal was achieved, if the naso- or oropharynx was filled, what sort of volume was expelled, how long was the break between applications, and how the subject looked between each treatment. (F:10 italics in the original)
Check back tomorrow for the second part of this two-part series!
Friday, October 2, 2009
- "As research ethics board members, we tend to be inundated with negative stories that are often fraught with problems, wrongdoing, and concerns. Realistically, it is our job to look at research with a critical eye. Nevertheless, this story reminds me of the excitement, the possibility, and promise of research, and why it's so satisfying to be a collaborative and integral part of the facilitation of research."
Read the entire post here.