Blog Share: Post from the Research Ethics Blog

On her blog yesterday, Nancy Walton discusses a research disaster that occurred over nine years ago and is just now coming to light. It concerned a cardiac surgery trial conducted at Columbia University that may have resulted in the deaths of at least two subjects and caused severe adverse reactions in many others. In her blog, Walton wonders why the only media outlet that she found to have covered the story is the Huffington Post. Why hasn’t the mainstream media picked up on it, she asks?

"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."

Read the entire post here.

In October's Newsletter...

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.

My time as a study participant

A PRIM&R staff member recalls her experience as a research subject and questions the value of informed consent for long-term risks.

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.

Photo credit: dbtechno.com

Contribute to the 2010 IACUC Conference

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.

An 'unforgettable' Monday Memory...

This week’s Monday Memory is a bit different… Can you tell why? Instead of an image, this time, we’ve chosen a spoof—from the IRB Follies of yore—of Nat King Cole’s “Unforgettable.”

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!

Unapprovable

Unnnn-approvable
That’s what they say
It’s un-doable
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

Expeditable
That what I thought
I’m indictable
If I get caught
Wish I’d stayed in that refresher course
Paula Zahn did quite a tour de force
Maybe I’ll be
Unforgettable too

Mark Your Calendars for IACUC 2010!

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!

Post positions and resumes in Nashville

Recruit for open positions, or take the next step in your career! Employment opportunities in the field of human subjects research will be displayed on the 2009 Advancing Ethical Research Conference job board. To post a job opening on the conference job board, please fill out this form and return it to PRIM&R by November 6, 2009. Please note that onsite submissions will not be accepted. Any job that is posted to our online job board between October 1 and November 6 will be included in a full-color print-out on the conference job board for no additional charge.

If you have any questions, please contact Anne Meade, web and e-learning manager.

Why pay more? Register today and save!

Posted by Anne Meade, web and e-learning manager

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!

Notes from the field

Posted by Joan Rachlin, executive director

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.

Coping through action

Posted by Joan Rachlin, executive director

“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.