Meet the PRIM&R Blog Squad: Andy Burman

PRIM&R is pleased to introduce the members of the inaugural Blog Squad at this year’s 2010 Advancing Ethical Research Conference. The Blog Squad is composed of four PRIM&R members who are devoted to blogging live from the conference.

Today’s Blog Squad member is Andy Burman, IRB coordinator at Genesis Health System in Davenport, Iowa.

Growing up, I never dreamed that my career would support a research program for a community-based health system. I had never heard of an institutional review board, the Code of Federal Regulations, or the Belmont Report. My aspirations were more focused on my dreams of playing professional baseball, being a lead singer in a rock band, forecasting the weather on the Weather Channel, or working at John Deere (I do live in Iowa).

Life has a way of changing all of those things.

My full name is Andrew Carey Burman, but most people call me Andy. I was raised in an area called the Quad-Cities, a metropolitan area with more than 375,000 people. The Quad-Cities encompass space that includes eastern Iowa and western Illinois, and is home to the only place where the Mississippi River flows directly from east to west.

In 1996, when I was 14 years old, my father suddenly became ill. After suffering cardiac arrest and spending 85 days in the local hospital called Genesis, he returned home a much different, and more sick, person with congestive heart failure. In 1998, when his cardiac situation was continuing to deteriorate, he enrolled in a research device project for a biventricular pacemaker-defibrillator that included a wire system that reached to the left ventricle of the heart. The implantation of the device into my father was a first-in-the world procedure.

While the device trial was ultimately successful and is now currently on the market, the damage to my father's heart was beyond what the device could correct. In February 2001, my father was listed for a heart transplant. He was extremely fortunate to receive a heart in April of the same year.

Today, nearly 10 years post-transplant, my father leads an excellent and productive life. Now retired, his days are filled with golf, table tennis, grocery shopping, cooking, yard work, and spending time with the family pet. He has competed for Team Iowa in the 2004, 2006, 2008, and 2010 U.S. Transplant Games, and has been a medalist in table tennis on two occasions.
As for me, I often wonder where I would be without research. I know for sure that I would not have a living Dad. I would not have had a father to witness my wedding, or the upcoming birth of my first child, his first grandchild (hopefully any day!). Additionally, I doubt that I would be a research program coordinator for the community-based health system Genesis, the same health system where my father received much of his care.

These life experiences have led me to be an advocate for the promotion and execution of ethical clinical research. I consider it my small way of giving back to a community that has given me so much.

It is an honor to be selected as a member of the PRIM&R Blog Squad. I look forward to meeting my fellow PRIM&R colleagues at my first AER conference this December.

Featured Member Profile: Natalie Bell

Welcome to another installment of our featured member interviews where we will continue to introduce you to more of our members, individuals who work to advance ethical research on a daily basis. Please read on to learn more about their professional experiences, how membership helps connect them to a larger community, and what goes on behind-the-scenes in their lives!

Today we’d like to introduce you to Natalie Bell, IACUC coordinator at the University of Medicine and Dentistry of New Jersey.

When and why did you join the field?
I joined the biomedical research field in 2000. At that time, I was looking for a career change. I had recently been laid off from a position in the insurance industry. A friend who was working at the University of Medicine and Dentistry of New Jersey (UMDNJ) recommended that I apply for a position there. When I interviewed for the position, I thought maybe it was not for me, but I accepted the position anyway. It was the best decision I ever made.

Although I did not have any experience in this field or a scientific background, the director of the animal facility took a chance on me based on my years of experience with computers. I’ve not stopped learning since I started working in this field almost 10 years ago. Every day there is something new and challenging. I love my job.

What is your favorite part of your job?
My favorite part of the job is the IACUC meetings. I enjoy the meetings and taking the minutes. Listening to the robust discussion provides me with insight into the various studies proposed at my institution.

What's your after-hours guilty pleasure?
My guilty after-hours pleasure is watching my soap operas that I tape via VCR. Yes, I said VCR. I’m still old school.

Why did you join PRIM&R?
I joined PRIM&R to better understand my position as an IACUC coordinator, to network with people in my field who have experience with the complex issues that arise in the day-to-day workflow, and to stay informed on various regulatory issues and updates.

What is your favorite member benefit?
My favorite member benefits are the e-networking opportunities, webinars, discounts for conferences, and certifications, such as CPIA.

What would you say to someone who is considering PRIM&R membership?
I would advise anyone considering PRIM&R membership that it is a great resource for everyone in the biomedical research field. Being a member of PRIM&R allows for learning and networking with like-minded individuals.

Additionally, I would advise attendance at the annual IACUC conference. I can go on for days about the conference and the knowledge I gained from this event. The conference is a perfect venue to learn, discuss issues facing all IACUCs, and find solutions.

What do you believe is a key challenge facing the field of research ethics?
I believe the key challenge facing the field of research ethics is conflict of interest, in that there is more focus on obtaining and/or losing funding as opposed to animal care. Although funding is extremely important, it should not be the only consideration when submitting and/or reviewing a proposal.

Thank you for being part of the membership community and sharing your story, Natalie. Let us know how long your VCR lasts!

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

Question: What do John of Salisbury, Pepper the Dalmatian, and Jeremy Bentham have in common?

by Joan Rachlin, executive director

Answer: They’ve all been prominently referenced at an exciting conference that I’m attending in Bethesda, called 25 Years of Animal Welfare and Scientific Research: 1985 to 2010. The meeting was planned by Susan Silk and Pat Brown of the National Institutes of Health Office of Laboratory Animal Welfare (NIH OLAW). Other sponsors include the US Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS) Animal Care, and IACUC 101. PRIM&R was proud to be a supporter of the meeting.

There have been so many outstanding sessions, but time and space will only permit me to discuss one of them here today. If you’re interested in seeing, hearing, and learning more visit the meeting website for details.

I’d like to share with you a few highlights of a talk given by Charles McCarthy, beloved PRIM&R Board member and former Office for Protection from Research Risks (OPRR) director. Charlie gave a keynote address last night in which he quoted John of Salisbury, who, in 1159, said, “We are like dwarfs sitting on the shoulders of giants. We see more, and things that are more distant, than they did, not because our sight is superior or because we are taller than they, but because they raise us up, and by their great stature add to ours.”

That quote was spot-on for this meeting, as it has featured many of the giants who created and nurtured the lab animal protection system that we now know so well. These giants included Charlie, Bob Whitney, Tom Wolfle, Dale Schwindaman, John Miller, Kathryn Bayne, Chester Gipson, Betty Goldentyer, Nelson Garnett, Ralph Dell, Stuart Zola, and many others who have built and strengthened the available protections for laboratory animals over the past 40+ years.

Charlie talked about the passage of the Animal Welfare Act, which was sparked by the theft, in 1965, of Pepper, the beloved pet Dalmatian of the Lakavage family from Pennsylvania. Pepper was stolen, sold to a dealer in New York, and sold again to Montefiore Hospital where she died on the operating table in the course of a procedure relating to pacemaker implantation.

Before she died during that surgical procedure, though, Mrs. Lakavage saw Pepper in TV news footage of a truck stopped by a state trooper. She tried to get Pepper back, but the dealer was uncooperative, and then was similarly uncooperative when approached by his Congressman. The public outcry that ensued led to the drafting of the Laboratory Animal Welfare Act (LAWA), which was signed by Lyndon B. Johnson in 1966. The initial version of the Act was intended to prevent the use or sale of stolen dogs or cats for research and, toward that end, it required the registration of research facilities and the licensure of dealers. It also required special training for lab animal veterinarians in an effort to improve the quality of veterinary care for animals used in research. Christine Stevens of the Humane Society of the US and Peyton Dunn of WARDS were the individuals and organizations responsible for the Act’s passage. Mrs. Stevens was a constructive and gracious, if uncommonly determined, faculty member at several of PRIM&R’s earliest conferences on animal care and use, and I felt privileged to have known and worked with her.

In addition, another dear and dearly departed friend of PRIM&R, Frank Loew (former PRIM&R Board member, former dean of the Tufts Veterinary School, and former president of Becker College) also played a significant role in the passage of LAWA. Frank was a young lab animal vet at RJ Reynolds when he received a request from the Committee Chair in Congress to assess any problems with the anticipated passage of the LAWA. Frank said no. Had he said yes, it is quite possible the bill would have been shelved.

In any case, Pepper’s death and the passage of LAWA did not solve every problem. Charlie went on to discuss how he had been on a site visit in California in 1983 when he turned on the news and learned of the Silver Spring monkey case. Edward Taub, the principal investigator in whose lab the monkeys lived, conducted research on stroke rehabilitation. Part of his protocol included cutting the ganglia that supplied sensation to the monkeys’ brains from their arms and legs. He then used restraint, electric shock, and withholding of food to force them to use the limbs they could not feel. There was no veterinary care for the monkeys for prolonged periods of time, as Dr. Taub claimed to know more about them than the vets.

Alex Pacheco, the founder of PETA, took photos of Dr. Taub’s lab and arranged for a police raid, while pretending to be an employee. The monkeys were stolen, and eventually returned to the custody of the NIH. The case swelled PETA’s coffers as donations in the millions flooded in, following the repeated broadcasts of these maltreated monkeys. Dr. William Raub handled the case for NIH, and it thus became known as the Raub/Taub case. Dr. Taub was eventually convicted and lost his NIH funding.

There was so much more information in Charlie’s talk, and when you multiply that by 30+ speakers, you can begin to understand how rich a meeting this has been.

I’ve told you about John of Salisbury and Pepper, but what about the Jeremy Bentham reference? Well, it turns out that he wisely noted about animals, “The question is not whether they can talk or reason, but whether they can suffer.” Bob Whitney, a longtime and highly respected vet with the US Public Health Service, quoted Bentham and then added that “we all know that the answer to that question is yes.” He went on to remind us that the goal of the animal protections community is to relieve, minimize, and mitigate their suffering.

Thanks to all of you who are involved in and committed to that very noble endeavor.

And thanks to my good friend and longtime Board member, Andrew Rowan, for helping fill in some of the historical blanks while I was writing this blog.

'Science Times' synthesis

Don’t have time to read the New York Times? We love the NYT science section at PRIM&R, and share with you a twice-monthly digest of all of the most exciting articles we can find. Enjoy!

October 12, 2010

Taking early retirement may retire memory, too: Discover why economists are claiming that there may be a “use it or lose it” risk with regard to keeping one’s mind active after retiring.

Hunting one language, stumbling on another: Read how linguists looking for one distinct language found another “hidden” one in India.

Studying tropical genetic blood diseases: Peruse selections from conversations with Sir David Weatherall, a researcher-physician at Oxford who was among the first to use the tools of molecular biology to understand blood diseases.

Really?: Find out the real facts about “brain freeze”!

October 19, 2010

Hope for human fertility in the study of a worm: Read about a research study that may provide information about how to extend female fertility.

Bringing in family to combat anorexia: Learn about a new method for treating anorexia that may be more effective than therapy alone.

Cracking the mystery of how sloths got long necks: Find out what scientists have learned about sloths’ famously long necks.

An inside look at a widening lens

By Alan Wertheimer, author, senior research scholar in the department of bioethics, clinical center at the US National Institutes of Health, and PRIM&R member

Oxford University Press has just published my most recent, and probably my last, book, Rethinking the Ethics of Clinical Research: Widening the Lens. This is the first extended work of my second career. After teaching political philosophy at the University of Vermont for 37 years, I joined the Department of Bioethics in the Clinical Center at the National Institutes of Health (NIH) in 2005.

My philosophical work had focused on the moral status of dyadic relations: when is one coerced in a way that compromises one’s responsibility for one’s actions? When does someone exploit another? When does a person give valid consent to sexual relations? When I arrived at NIH, I waded into the literature on the ethics of research with human subjects, only to find that the concepts about which I had been obsessing for many years were central to that discourse. Can offers of financial payments to participate in research be coercive? Are researchers exploiting subjects in less developed countries? Do research subjects give valid consent when they do not fully understand or appreciate that they will not be receiving personalized medical care? So, I started working along lines with which I was familiar, but in a context that was entirely new to me, and which has led me to extend and revise my views.

My book is not a systematic treatise on research ethics. Rather, it consists of philosophical reflections on a variety of issues such as the unacknowledged prevalence of paternalism in research ethics, exploitation in international research, the ethics of paying research subjects, and whether researchers have special obligations to those who already benefit from and consent to participate in research.

As a quasi-outsider, I have been struck by the extent to which research ethics adopts a type of “research exceptionalism,” which is the view that participation in research is a distinctive activity that requires moral principles that we do not adopt or reject in other social contexts. For example, research ethics often proceeds as if it is obvious that valid consent must be preceded by an elaborate disclosure of information. Yet, we make no such assumption in many other areas of life, such as marriage, sexual relations, employment, and most commercial transactions.

It is also universally said that subjects have a right to withdraw at virtually any point without penalty, but in some areas of life, people make binding commitments in exchange for benefits. Why not here?

Additionally, it is often said that it is morally problematic to pay subjects to accept risks to their life or health that they would not otherwise accept. On the other hand, we pay people to accept risks all the time, be it as coal miners (I write just after 33 miners in Chile have been rescued), soldiers, loggers, fishermen, fire fighters, structural steel workers, or pizza deliverers. Is there something morally distinct about the risks of research? If so, what is it?

Another issue lies in the “off-shoring” of medical research. Some think that “off-shoring” of manufacturing and services is a net good for countries and workers abroad, and for those who consume those products and services (at lower prices) here. This may mean people believe it is unproblematic to employ those “off-shore” to answer telephones, but morally troublesome to employ them as research subjects for testing drugs. That may be so, but, if so, why is that so?

That is not clear.

The book’s sub-title—widening the lens—reflects my commitment to viewing the principles of research ethics from a broader perspective, and my hope to persuade readers that it is worth looking at the ethics of research from a wider philosophical angle.

To hear more from Alan, please join us at the 2010 AER Conference, where he will be one of the many expert faculty leading over 175 keynotes, panels, and breakout sessions.

Featured Member Interview: Maynard Dyson

Welcome to another installment of our featured member interviews where we introduce you to more of our members, individuals who work to advance ethical research on a daily basis. Please read on to learn more about their professional experiences, how membership helps connect them to a larger community, and what goes on behind-the-scenes in their lives!

Today we’d like to introduce you to Maynard Dyson, IRB chairperson at Cook Children’s Medical Center in Fort Worth, TX.

When and why did you join the field?
I joined the field about six years ago when my institution, Cook Children’s Health Care System, was looking for new leadership as it became more active in pediatric research.

What is your favorite part of your job?
My favorite part of the job of IRB chairperson is helping investigators carry out their goal of advancing pediatric care and, at the same time, informing and protecting the subjects.

What is playing on your iPod right now?
Currently the Ramones are on my iPod. There’s nothing like punk rock to help you push yourself to the max on the elliptical.

Why did you join PRIM&R?
I joined PRIM&R to be part of a community that values protecting subjects while carrying out the highest quality research.

What is your favorite member benefit?
RED (The Research Ethics Digest), with its summary of current articles and events, is my favorite benefit.

What would you say to someone who is considering PRIM&R membership?
I would tell someone considering membership that they will benefit from being part of the community. When the day-to-day pressures and demands begin to make you question the meaning of all the forms and regulations, this community can give you perspective and realize what a contribution you are making.

The reverse side is that only an active and vigorous professional organization can serve as a voice and multiply the influence IRBs and IRB professionals have to shape research in this country.

What do you believe is a key challenge facing the field of research ethics?
I think a major question IRBs will face in the future is the balance between local and central IRBs. Central IRBs can attract individuals with particular expertise and certainly can generate the volume to assure excellent infrastructure. In this era of increasingly large multi-center studies they are also more efficient, but we must remember that efficiency is not one of the goals of an IRB, if it compromises subject protection. Figuring out how to best use the resources of both kinds of IRBs is a major challenge for the future.

Thank you for being part of the membership community and sharing your story, Maynard. Enjoy the punk rock!

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

'Science Times' synthesis

For those of you who have not yet had the pleasure of "meeting" and reading the weekly Science Times section of each Tuesday’s New York Times, we’d like to introduce you. Ampersand will feature a new bi-weekly post that will hopefully be as helpful as it is interesting. We love the Science Times and look forward to sharing its highlights with you.

Thanks for your role in moving the scientific frontier forward ethically and responsibly.
Let us know what you think of these stories, and mostly, enjoy!

September 28, 2010

MacArthur Foundation honors 23 fellows: The MacArthur Foundation announced its annual list of talented, self-directed, creative minds, including 13 scientists.

Mysteries that howl and hunt: Scientists continue to survey coyotes to obtain a better understanding of the species.

October 5, 2010

Aiming to learn as we do, a machine teaches itself: Researchers are perfecting a computer system that mimics human learning to understand the meaning of language.

Pioneer of in vitro fertilization wins Nobel Prize in Medicine or Physiology: Britain’s Robert G. Edwards was awarded for the breakthrough that has helped millions of people have children.

Rediscovering the first miracle drug: Revisit the history and research behind injectable insulin.

Professor unveils history of intentional STD inoculation in Guatemala, secretaries Clinton and Sebelius respond

by Emily Butler, content coordinator

The tale of human subjects abuses committed during the U.S. Public Health Service Syphilis Study at Tuskegee—in which researchers intentionally withheld treatment from hundreds of black men from the 1930s until 1972—reverberates through the research ethics world as a sentinel reminder of why the vigilant protection of human subjects is so essential.

Today, Secretary of State Hillary Rodham Clinton and Secretary of Health and Human Services Kathleen Sebelius issued a joint statement of apology for a scandal that is sadly reminiscent of the abuses that took place at Tuskegee. Between 1946 and 1948, a U.S. Public Health Service physician investigated syphilis and gonorrhea treatment by intentionally inoculating hundreds of Guatemalans with the diseases. These abuses, conducted as part of the U.S. Public Health Service Sexually Transmitted Disease Inoculation Study of 1946-1948, were unknown to the public until Susan M. Reverby, professor of Women’s and Gender Studies at Wellesley College, uncovered the story through her research involving the syphilis study at Tuskegee.

Although historians have spent years trying to correct the misconception that black men were intentionally infected with syphilis at Tuskegee, today’s story serves as a reminder that this type of injustice did occur in some studies.

According to long-time PRIM&R Board member and Yale professor Robert Levine, “Tuskegee has become the leading metaphor for evil in the name of research involving human subjects. When we want to say this research looks as evil as we can get, we say this reminds us of Tuskegee.”

Today’s news story evokes the symbolic power of past studies that Dr. Levine suggests, and is the latest, real reminder of why the work of those in the IRB/HRPP community is so essential.

Learn more by reading Dr. Reverby’s full report on her website, and visit NBC to read an article and watch a short video news story.

We are curious to hear your thoughts regarding this story.