Clinical trial participation as a career?

by Emily Butler, content coordinator

Early phase clinical trials depend on the enrollment of healthy volunteers, who usually receive compensation for participation. Those in the research community, with input from bioethicists, have spent a great deal of time trying to determine what constitutes “fair” and “appropriate” compensation for subjects.

Researchers, sponsors, and IRBs/HRPPs are rightly concerned that excessive or otherwise “inappropriate” payments could constitute an undue inducement, thereby interfering with the prospective subject’s judgment and decision-making. In fact, some normal volunteers have come to regard clinical trials participation as a job, and, in those cases, the compensation they receive becomes their primary source of income.

A new book by Roberto Abadie uses an anthropological lens to examine the lives of paid research subjects. In The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects, Abadie documents the experiences of several repeat research participants in Philadelphia.

This recently released Time video highlights one subject’s story.

Repeat trial participation exposes participants to a multitude of risks, which raises concerns not only for the subjects’ health, but also for the reliability of the research data. We are curious to hear your thoughts on this issue. How do you think researchers and IRBs/HRPPs might address these concerns?

Fortunately, the NIH has been collecting survey data on the issue of payment for participation, and we will let you know when those results are made public.

Featured Member Interview: Lynn Penrod

As an extension of our Member Appreciation Month series of member interviews, 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 Lynn Penrod, director of human research protections and the research ethics office at the University of Alberta in Canada.

When and why did you join the field?
When the Canadian Tri-Council Policy Statement on Ethics in Human Research was in its gestation period, I was serving as president of SSHRC. When I returned to my home institution, the University of Alberta, I simply stayed involved, first as a member, then as chair of the arts science law research ethics board (we call them REBs in Canada), and for the past three years as director of the research ethics office.

My own academic career (I'm a professor of French and a lecturer in law) has allowed the combination of theory and practice we see in the world of research ethics to keep my interest in the work very high.

What is your favorite part of your job?
Meeting all the various people involved (investigators, other administrators) not only at the University of Alberta, but across Canada through the Canadian Association of Research Ethics Boards (CAREB), the US, and internationally, too (through PRIM&R, for example!).

What is playing on your iPod right now?
My iPod is currently playing James Taylor and Carole King Live at the Troubadour, Martha Wainwright's Piaf album, YoYo Ma, Bach Brandenburg Concertos, Etta James, and the various soundtracks from Glee. I grew up in Piqua, OH, just south of Lima on I-75!

What is the last movie you saw?
Just saw The Girl with the Dragon Tattoo.

What are you reading?
Currently reading George Sand's Indiana for a paper I'm writing and just finished Margaret Atwood's The Year of the Flood.

What is your after-hours guilty pleasure?
Love soap operas and shopping.

Why did you join PRIM&R?
I joined PRIM&R to learn how others tackled the same issues I was facing in my position. Organizations like PRIM&R are really important for professional development (and basic training, too) in ethics research.

What is your favorite member benefit?
Various Newsletter items, the website, and, of course, the annual meetings. My very first meeting was a special one on SBER and it certainly convinced me to come back.

What would you say to someone who is considering PRIM&R membership?
I'd tell anyone considering joining PRIM&R that it's a must for professional development. It really broadens your view of the ethics world you live in on a daily basis and provides a network of people and organizations to help out with difficult issues. I wish there were more interaction between Americans and Canadians at PRIM&R meetings—we really do have a lot in common and could learn more from each other than we currently do.

What do you believe is a key challenge facing the field of research ethics?
The biggest challenges faced today are the rapid advances being made in science that are not necessarily being met with appropriate ethical standards and procedures. Multi-site research and the extraordinary difficulties with reciprocity in reviewing research protocols as well.

Thank you for being part of the membership community and sharing your story, Lynn. Let us know what you think of Glee’s next season!

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

Upcoming OLAW meeting reviews history, glimpses future

By Catherine Rogers

This week, PRIM&R chatted with Susan Silk, director, Division of Policy and Education, at the National Institutes of Health Office of Laboratory Animal Welfare (NIH OLAW) about the upcoming symposium titled Animal Welfare and Scientific Research: 1985 to 2010. PRIM&R is proud to support this meeting, which will be held October 25-26, with pre-conference educational workshops on October 24, in Bethesda, MD. This symposium presents a unique learning opportunity for animal care and use professionals.

Thank you for agreeing to talk with us today, Susan. For those who are new to the field, or who just need a reminder, please explain OLAW’s mission. OLAW provides guidance and interpretation of the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training, thereby contributing to the quality of PHS-supported activities.

What does that mean? The office oversees the welfare of research animal subjects in activities, including research, training and testing, that are funded by the PHS. This includes training people, such as institutional animal care and use committee (IACUC) members, institutional officials, veterinarians, and people who work with the animals.

How does OLAW carry out this mission?
We have a system of local oversight where institutional animal care and use committees (IACUCs) oversee animal programs at their Assured institutions, and they are the eyes, heads, and feet on the ground. In that regard, OLAW provides guidance and interpretation of PHS policy to IACUCs and support through educational programs. NIH and OLAW look at the relationship with Assured institutions as a partnership. Each organization shares the need to assure compliance, and along with that goes responsibilities for stewardship of public funds and self-governance

This is a system based on a long standing history of education and selfless work on the part of members of the IACUC. We think it’s a good system, and so we’re excited to be having this symposium on the occasion of the 25th anniversary of the policies, laws and regulations that guide us in this animal welfare oversight.

That certainly is exciting—please tell me some more about the meeting.
The symposium will be preceded by pre-conference educational workshops, IACUC 101 and Meeting the Information Requirements of the Animal Welfare Act: AWIC Workshop.

From there, the meeting’s agenda highlights the past, present, and future in recognition of the original meeting, with the same title, which was held 25 years ago.

The meeting is sponsored by the NIH OLAW; United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Animal Care; and IACUC 101. The meeting is supported by a host of NIH institutes and centers; the Food and Drug Administration; Centers for Disease Control (CDC); the Department of Veterans Affairs; PRIM&R; and a growing group of for- and non-profit organizations.

What kind of content does the program feature?
On the first day, we’ll be discussing the past, present and future of the way we manage and care for our research animals. We’ll explore how we have improved the quality of care for these animals, and how we have, in turn, empowered more complex research and further refined the animal models.

That evening, Charles McCarthy, PhD, also a member of PRIM&R’s Board of Directors, will give a keynote address. He served as the director of the former Office for Protection from Research Risks, and will tell us about the early beginnings of animal welfare policy at NIH. He will be joined by Robert Whitney, DVM, and Thomas Wolfle DVM, PhD who will share their reflections on the development of the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training and the Inter-Agency Research Animal Committee who crafted the principles.

The second day of the symposium is about scientific research. We’ll start that morning with discussions about policy by the NIH, CDC, FDA and USDA. From there, attendees will hear from leading biomedical researchers, why they use animals, why they use the models they do, and how animals are essential to their work. We’ll also cover a range of animal models, including mice, fish, nonhuman primates, and some more exotic research animals, such as song birds and voles.

Which speakers are you most looking forward to hearing?
I’m looking forward to the gathering because it will allow us to discuss animal welfare and scientific research with the statesmen of our field who were responsible for crafting the guidance and policies that govern our research.

I’m also very eager to hear from the research scientists including Dr. Cendales (Emory) who will describe the use of animal models in transplant medicine; Dr. Kurilla (NIAID) who will discuss the importance of animal models in vaccine development; Dr. Zola (Yerkes) who will explain the use of nonhuman primates in exploring the challenges of the aging brain. We will learn about the use of fish models in cancer and aging from Dr. Hopkins (MIT); and about the use of voles in understanding depression, schizophrenia, and autism from Dr. Young (Emory); and Dr. Jarvis (Duke) will explain how he uses song bird models to explore brain development.

I’m also very excited about Dr. Susan Lederer, PhD, a science historian. She will talk about the increasing NIH support of animal models in biomedical research, from WWII to the present. She’ll be included in a session with professors Jentsch and Ringach from the University of California, Los Angeles, who are involved in the ProTest movement; they’ll describe how they explain to the public why animals are essential as scientists make advances that will lead to safe and useful drugs, therapies, and cures.

Of course I am also very excited to hear from the veterinarians, animal program operations people and the national level policy folks. But if you want to hear more details about the agenda, you can find a complete program on the OLAW website.

Why is it important to review the history of animal care and use? What does this accomplish?
As the care and use of animal research models has become increasingly sophisticated and advanced, better, more complex research has been empowered.

We’ve made a special effort to include laboratory animal medicine fellows and veterinary students by offering “Next Generation” travel awards to nine stellar candidates. We’re also encouraging other young professionals to attend so everyone can better understand how—and why—the field developed.

Any closing thoughts?
The whole idea of using animals in research is a hot-button issue right now. We’re a government in which everybody has the right to voice an opinion, especially about how the government spends its money. While we welcome all points of view, we’d like the opportunity to explain to the public that we’re a responsible community; that we have guidelines, rules, and regulations that were developed by thoughtful people; that we never use animals when it’s not imperative; and that the animals are handled with a concern for their welfare.

Thank you, Susan, for this insight. Best of luck with your meeting!

A gold mine for lifelong learners

by Joan Rachlin, executive director

Reading the Sunday New York Times is one of my greatest pleasures and I never regret the time spent thumbing through its always packed pages. Yesterday’s edition was no exception; in fact, if anything, it was even more of a feast than usual. Two of the items that caught my eye were so exciting that I wanted to pass them on to you.

First, there was an article about TED (Technology, Education, Design) Talks, which has been one of my favorite internet destinations for the past year since first hearing about it from a young cousin who said that his college professors require many of the talks as an integral part of their curricula. I took a look at some of these “ideas worth sharing” and found them fascinating and addictive.

I’ve summarized a few of my favorite talks below, and hope that they will be a worthy introduction for those of you who have not yet discovered the pleasures of this incredible site. For those who have a favorite TED Talk, please share yours by leaving a comment on this post.

The first is a talk by Dan Ariely, who is a well known behavioral economist, author, and NPR commentator. Dan was also one of the 2009 Advancing Ethical Research Conference keynote speakers, and generated higher marks than almost any of the speakers I can remember. Have a look/listen to his TED Talk and see why.

The next talk is by Dan Gilbert who, similarly, is a crossover researcher, in that his work has made it into the mainstream, most notably via his book Stumbling Upon Happiness, and his PBS series This Emotional Life. You can enjoy this talk here.

In an effort to find a talk that would interest our many instutional animal care and use committee (IACUC) members and other members of the PRIM&R community, I listened to Laurie Santos, a primate researcher at Yale, and found her talk fun and fascinating. When’s the last time you heard a primate talk that included references to Shakespeare, Stephen Colbert, and the “monkey marketplace” (including notes about economists and financial advisors)? Watch this talk here.

Finally, my friend Alan Wertheimer, another fan of the site, told me about the fourth talk that I’ve included, which was given by Esther Duflo, a professor at the Poverty Action Lab at MIT. Professor Duflo is using traditional research methods to more systematically and reliably determine what interventions work in programs seeking to reduce poverty. Watch hers here.

Trust me, you’ll enjoy these, and will hopefully find your own favorites as I have.

The other “WOW!” moment during my Sunday Times perusal was an article on “An Introduction to Op Ed at 40”. Visit this section, browse the left-hand section of the page, and see who has written letters over these past four decades and what they had to say. I found this to be a short but spectacular refresher course in politics, history, literature, and more.

In short, for those of us who are ardent believers in the need for lifelong learning, here are two gold mines. I hope that you enjoy them as much as I, and please let me know what you think.

OHRP releases new "withdrawal of subjects from research" document

The Office for Human Research Protections (OHRP) has released a new document titled Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues.

The document offers answers to important questions about the meaning of subject withdrawal from research, as well as associated procedures. The OHRP also examines how this document may interact with similar FDA and HIPAA recommendations. What do you think of this new federal guidance? How might it apply to your work?

Cancer drugs raise further questions in ongoing ethical debate

An article in a recent edition of the New York Times examines the struggle between treating patients responsibly, and gathering scientific knowledge through research.

Controlled testing of a melanoma drug called PLX4032 is at the center of this most recent debate. The study was designed as a traditional, randomized, controlled trial that enrolled half of the patients in the group to receive the study drug and half of the patients in the group to receive the standard chemotherapy treatment. The problem was that "the standard chemotherapy used in melanoma, dacarbazine, slowed tumor growth in 15 percent of patients for an average of two months," while the study drug "had halted tumor growth in 81 percent of patients for an average of eight [months]."

Although considered the gold standard for proving a drug’s efficacy, such controlled trials raise many ethical questions. Is it researchers’ responsibility to collect accurate data, look out for patients’ best interests, or both? Is there a way that researchers can benefit the greater good and gather accurate, reliable data without submitting a large number of patients to a treatment that is considered unsatisfactory? What is the IRB’s role in reviewing this research and its consequences on subjects?

Featured Member Interview: Lisa Shaner

As an extension of our Member Appreciation Month series of member interviews, 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 Lisa Shaner, IRB analyst at MetroHealth System in Cleveland, OH.

When and why did you join the field?

After I graduated from college in 1999 with a pre-medicine degree, I worked on three research projects. In 2004, while working on one of the projects I obtained my masters of public health degree. I joined the field in March 2008 because I knew I could use my background and my concern for the health and well-being of people to assist the IRB in its mission to protect human subjects.

What is your favorite part of your job?

I enjoy helping the research coordinators and principal investigators fill out the IRB electronic applications and guide them through writing their consents, assents, verbal scripts, and any documents that might be handed to the subject.

What is the last movie you saw?

Dodgeball

What's for dinner tonight?

Pizza

What are you reading?

Institutional Review Board Management and Function 2nd Edition by Elizabeth A, Bankert and Robert J, Amdur because I will be taking the CIP® exam in September.

What are three websites you visit on a daily basis?

Travel, World News, and Health, all on msn.com.

Why did you join PRIM&R?

I joined because my boss told me I needed to join.

What is your favorite member benefit?

I've enjoyed discounted fees for conferences and a discounted fee for my CIP exam. I also like the Newsletters I receive via e-mail.

If you were planning our next conference, who would you select as a keynote speaker?

As keynote speaker I would like to hear the FDA's Center for Biologics Evaluation and Research acting director Karen Midthun, MD.

What motivates you to maintain your commitment to advancing ethical research?

My concern for the health and well-being of people is what motivates me to maintain my commitment to advancing ethical research. There will always be people wanting to enroll in research studies, and I think I am part of a team that is responsible for their safety.

What do you believe is a key challenge facing the field of research ethics?

Since patient data is readily available with the electronic medical record and the computer has become the favorite storage device of investigators, I think the key challenge facing the field of research ethics is data security.

Thank you for being part of the membership community and sharing your story, Lisa. Good luck on your CIP exam!

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

The Immortal Life of Henrietta Lacks

PRIM&R is looking forward to hearing Rebecca Skloot, author of The Immortal Life of Henrietta Lacks, deliver a keynote address and facilitate a book group luncheon at the 2010 AER Conference. Rebecca's book continues to receive praise, such as this post, reprinted from the Our Bodies, Ourselves blog.

The Immortal Life of Henrietta Lacks

by Rachel Walden

Blogger, Our Bodies, Our Blog

Earlier this week, I had the privilege of attending a talk by Rebecca Skloot, author of recently published book, The Immortal Life of Henrietta Lacks.

Henrietta Lacks was a poor, black woman whose cervical cancer cells were taken in the course of her treatment for cervical cancer at Johns Hopkins in the 1950s. Her cells were the first “immortal” cells—cells kept alive in culture—and went on to be widely used in medical research.
Henrietta’s cells were used in the development of the polio vaccine, were sent up in early space missions, and are mentioned in tens of thousands of research papers.

Rebecca Skloot’s book chronicles the history of Henrietta Lacks and her cells (dubbed “HeLa” cells), as well as Skloot’s journey uncovering the story.

Lacks and her family never knew about the vast body of research that was being conducted using the cells, or even that the cells had been taken and used for research at all. She and her family never benefited financially from the selling of HeLa cells. While Henrietta is long dead, her children and grandchildren still struggle to get medical care, and do not have health insurance.

In the course of her talk, Skloot read snippets of the book and discussed questions of ethics, race and class raised by the story. She talked about whether the family should be compensated, the kind of medical care Henrietta received in John Hopkins’s “colored” ward, and the past and current use of cells and tissue from people’s biopsies and other procedures for later medical research (which may make money for biotechnology corporations). It was really interesting, and I highly recommend the book to anyone interested in these issues.

Skloot has established the Henrietta Lacks Foundation to fund scholarships and medical care for members of the Lacks family. She also blogs about her work. The text of an interview earlier this year with Skloot on NPR’s Fresh Air is available here.

Contribute to the conversation!

Whether it’s a blog we write, a news story we post, or a program we announce, we always want to hear from you. There are many ways that you can contribute to the conversation.

• Comment on Ampersand. React to posts by hitting the “comments” link at the bottom of any post. Fill out the form, and select from the “Comment as” drop-down menu. Most commenters choose “Name/URL,” and enter their name, but you may also choose to comment as “Anonymous.”


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• Link in! We’re all about networking, and encourage you to connect with PRIM&R on LinkedIn. Join ongoing threads about ideas, questions, and suggestions for yourself and others in your position.

Have another way you’d like to be heard? Let us know—just write to info@primr.org with your suggestions and we’ll be happy to chat with you.

Federal stem cell funding allowed to resume

This afternoon, a federal appeals court temporarily restored federal funding for stem cell research pending appeal of a U.S. District Court ruling of August 23 that halted such funding. The temporary lift of the injunction allows researchers to proceed with projects while the Obama administration prepares an appeal. To view the order and learn more about the case, see the Washington Post article published earlier today.

Many of our readers are involved in stem cell research, either as investigators or as members of an institutional review board (IRB). We are curious to hear what impact this case has had on your work. Are you involved in stem cell research? And if so, how have these recent developments affected your work?

Introducing: PRIM&R’s first online course for IRB members!

by Emily Butler, content coordinator

PRIM&R is excited to introduce the Ethical Oversight of Human Subjects Research Course (EO Course), a four-hour, in-depth exploration of the functions and purposes of institutional review boards (IRBs). Through an interactive, animated interface that includes audio narration, progress checks and case studies, the course focuses on the roles of IRB members who tackle challenging ethical and regulatory issues.

The course has eight modules that cover the key ethical principles and regulations that govern human subjects research. A unique feature of the course is its approach to teaching the application of these rules and principles. Learners will observe the deliberations of a virtual IRB as it reviews specific elements of both a biomedical and a behavioral research proposal in connection with the issues presented in each module. The course is accessible on the internet so may be viewed at any time of day, and from any computer or location, allowing course participants to incorporate ongoing education into a busy work schedule.

Based on years of feedback from professionals working in the field of human research protections, we know there’s a need for reliable, affordable research ethics education geared to the IRB member. As the field of human subjects protections becomes more complex, the need for courses that encourage the application of rules to factual scenarios becomes increasingly valuable. We hope that you will find that this course meets that need.

Learn more about the EO Course, or subscribe now! If you have any questions, please e-mail, or call 617.423.4112, ext. 0. We look forward to seeing you online!

Featured Member Interview: Jillian Gardner

As an extension of our Member Appreciation Month series of member interviews, 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 Jillian Gardner, a lecturer at the Steve Biko Centre for Bioethics in Johannesburg, South Africa.

When and why did you join the field?
I joined this field in 2007, after taking up my current job as a lecturer in the Steve Biko Centre for Bioethics. Prior to that I worked for a research institute as a coordinator, so it almost seemed like a natural progression.

What is your favorite part of your job?
Assisting researchers to make their research proposals more ethical; the opportunity to meet and jointly evaluate research proposals with colleagues from other departments; and teaching.

What is the last movie you saw?
The last movie I saw was Shutter Island.

Why did you join PRIM&R?
I was referred to join PRIM&R by a colleague. I was awarded a scholarship to attend PRIM&R’s 2008 Advancing Ethical Research Conference, and membership was part of the package.

What is your favorite member benefit?
Access to a number of educational resources and up-to-date information.

What would you say to someone who is considering PRIM&R membership?
This is a great opportunity to meet and network with staff and members of IRBs throughout the world, to share experiences, and to discuss issues of common concern.

What motivates you to maintain your commitment to advancing ethical research?
Part of what motivates me is a commitment to social justice.

Thank you for being part of the membership community and sharing your story, Jillian. We hope you liked Shutter Island!

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