PRIM&R hosts event in conjunction with "Deadly Medicine" traveling exhibition

George Santayana famously remarked: "Those who cannot remember the past are condemned to repeat it." The fields of research ethics and human subjects protections were built from the ashes of the Holocaust, and PRIM&R's mission has been to help ensure that "never again" means "never again."

It was toward this end that PRIM&R held an event at the Francis A. Countway Library on the campus of Harvard Medical School on Wednesday, May 18, in conjunction with the United States Holocaust Memorial Museum's traveling exhibition, Deadly Medicine: Creating the Master Race. This powerful exhibition examines Nazi Germany's campaign to "cleanse" German society of individuals viewed as threats to the nation's health. Enlisting the help of physicians and geneticists, psychiatrists, and medically trained anthropologists, the Nazis developed racial health policies that began with the mass sterilization of genetically diseased people, and ended with the near annihilation of European Jewry, more than six million by the time the war ended.

The evening began with self-guided tours of the exhibition, followed by conversations with three extraordinary Holocaust survivors, Marika Barnett, Marion Katz, and Fred Manasse, who each shared their story. The moving event ended with a powerful lecture by Michael A. Grodin, MD, who is the director of the Project on Medicine and the Holocaust and senior faculty at the Elie Wiesel Center for Judaic Studies and the Division of Religious and Theological Studies at Boston University where he is also a professor of bioethics, human rights, family medicine and psychiatry. Dr. Grodin is one of the foremost authorities in the world on these topics and wrote several books and articles, including one called The Nazi Doctors and The Nuremberg Code: Human Rights in Human Experimentation.

We would like to take this opportunity to thank Marika, Marion, and Fred for sharing their stories of loss, courage, survival, and hope with us. All who heard these three remarkable individuals were inspired and humbled. We'd also like to thank Dr. Grodin for his impressive and stirring lecture. The attendees at this unique gathering left with a deeper understanding of why the work they do matters and with a renewed commitment to ensuring that ethics is always at the forefront of that work.

If you are interested in seeing this exhibition for yourself, please review the Traveling Exhibitions section of the United States Holocaust Memorial Museum website. Deadly Medicine: Creating the Master Race is scheduled to be in the following cities:

• February 20, 2011 through August 7, 2011
  Museum of Texas Tech University, Lubbock, TX

• August 9, 2011 through October 30, 2011
  Washington University in St. Louis Bernard Becker Medical Library, St. Louis, MO

• September 15, 2011 through January 7, 2012
  Museum of Jewish Heritage—A Living Memorial to the Holocaust, New York, NY

• February 3, 2012 through April 13, 2012
  University of Michigan Taubman Health Sciences Library, Ann Arbor, MI
  

Additionally, we encourage you to consider hosting a PRIM&R Regional Connections event in conjunction with Deadly Medicine: Creating the Master Race. PRIM&R can help with both some funding and some technical assistance (please contact Jen Levine-Fried if you'd like to find out more about PRIM&R Regional Connections) in planning the event, so please consider making sure that those in your city or region "remember the past."

Images © United States Holocaust Memorial Museum

Featured Member Profile: Kimberly Volarcik

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 Kimberly Volarcik, RN, executive director of research compliance at Case Western Reserve University in Cleveland, OH.

When and why did you join the field?
I joined the office of research compliance at Case Western Reserve University (CWRU) in November 2004. I previously worked in the department of genetics at University Hospitals of Cleveland/CWRU assisting two researchers, coordinating their human research programs. Both investigators decided to leave the university in 2004. Since I wanted to stay in Cleveland, I looked at my career opportunities and decided to make the transition from clinical research coordination to research administration.

What is your favorite part of your job?
As CWRU’s research compliance officer, I enjoy helping investigators and their study teams move their research forward. I also enjoy collaborating with the two CWRU-based institutional review boards (IRBs) and the four CWRU-affiliated hospital IRBs.

What are you reading?
I am currently reading The Immortal Life of Henrietta Lacks. I was very moved by Rebecca Skloot’s keynote address at the 2010 Advancing Ethical Research Conference in December. I ordered the book so I could find out first-hand about the multitude of ethical issues that confronted the researchers who took Henrietta’s cells and the industry that profited from them for more than 20 years.

Why did you join PRIM&R?
I joined PRIM&R because it is such a strong and independent organization within the research administration community. It is important for me to be a part of a dedicated organization, to continue my professional growth, and to keep up with changes in regulations and ethical issues that arise in human subject research and recombinant DNA studies.

What is your favorite member benefit?
The monthly Newsletter and e-mails that PRIM&R sends to its members. This correspondence helps me stay up to date on changing regulations and be exposed to new ideas and ethical issues.

What would you say to someone who is considering PRIM&R membership?
To those pondering joining PRIM&R, I would strongly urge them to do so. PRIM&R is a wonderful organization that not only helps administrators train investigators and research teams, but also takes a great stance on education, and maintains a high level of ethical debates and concepts.

What motivates you to maintain your commitment to advancing ethical research?
I am motivated to maintain my commitment to advancing ethical research because of my background as a registered nurse and my work in the field of genetics. These experiences have taught me not only the importance of advancing science and medical technology, but of doing so in a safe and compassionate manner.

Thank you for being part of the membership community and sharing your story, Kimberly. If you would like to be re-inspired by the 2010 AER Conference, you can watch select sessions via our online Conference Portal. If you’d like to learn more about becoming a member, please visit our website today.

That’s why they call them “trials”

PRIM&R is pleased to introduce you to Barbara Brenner, author of the blog, Healthy Barbs. Barbara is the former executive director of Breast Cancer Action, and is living with amyotrophic lateral sclerosis (ALS). Having spent the past 15 years working on topics related to healthcare and illness, Barbara continues to stimulate critical conversations, and to encourage critical thinking about mainstream coverage of health care and medical issues. Today, we are pleased to share with you an excerpt from her blog:

Given the times we seem to be in, maybe you’re thinking you’re about to read a blog about the trials and tribulations of Donald Trump, who can’t seem to tear himself away from the big bucks of an NBC contract to run for president, or the upcoming trial of Dominique Strauss-Kahn, managing director of the International Monetary Fund, on sexual assault charges, or the struggles of Maria Shriver, who turns out to have been married to another adulterous male politician.

While those topics are undoubtedly more fun to explore, they are not my subject today. I want to address the serious topic of drug clinical trials, a topic that most people who aren’t doctors—and, tragically, some who are—don’t understand.

What is a drug clinical trial? Clinical trials are used to advance scientific research into the treatment of illnesses.

A clinical trial is a medical research process used to determine if a drug is safe for humans to take and effective to treat the medical condition that it is intended to address. The drug under investigation—called the treatment—is compared to what is called a “control,” which is either a placebo (a pill or infusion that looks like the drug under investigation, but that has no biological properties) or an existing treatment for the condition, so that researchers can determine whether the drug under investigation is more effective than the alternative to which it’s being compared. The treatment group of patients and the control group of patients have to be balanced in number so that the results of the trial are meaningful.

Drug trials are necessary because without them, there is no way of knowing whether the treatment drug that is the subject of the trial will work for the patients in the trial.
Two other features of well-designed trials, randomization and blindness, are important to ensure that the trial reflects how the drug works, rather than a bias on the part of those administering the trial.

Randomization is the process by which patients in the trial are assigned to receive either the drug under investigation or the control. By assigning to patients at random, researchers avoid any bias that might creep into trial results by choosing, for example, the apparently healthier patients to receive the drug, or the less-healthy patients to receive the control.

Blindness refers to who knows what about which patients are in the treatment group or the control group. Ideally, drug trials are “double blind,” meaning that neither the researchers nor the patients know which group the patient is in. Double-blind trials keep researchers from making judgments about how patients are doing based on what they are known to be taking. They may also keep patients from deciding to drop out of trials because they didn’t get into the treatment group. (Open-label trials – where both the patients and the researchers know what drug is—have become much more common in breast cancer than double-blind trials.)

A drug trial is considered a success if the patients getting the treatment drug do better than patients in the control group by a statistically significant percentage. A successful trial tells nothing about whether the treatment drug actually worked in an individual patient. After all, it’s possible that the patient would have improved without the drug in question. Miracles do sometimes happen in medicine, and not necessarily because doctors make them happen.

Clinical trials in the abstract

I know a lot about clinical trials from my work as a breast cancer activist. From that work, I have come to believe that trials should demonstrate that the drug being tested can do at least one of three things before it is marketed to the public:

• Improve survival
• Improve quality of life
• Cost less than existing, equally effective treatments

These ideas about the goals and structures of clinical trials are fine in the abstract. It’s harder when they have very personal implications, either for you or for someone you love. While no promises are ever made to patients entering clinical trials, it’s hard for the patients or the people who love them not to believe at some level that the drug under investigation will improve their lives. People often enter trials believing this, no matter what they are told about the purpose of the trial.

The personal side

That my friends share this belief was evident when I told them that I am being screened to see if I’m eligible to be in a clinical trial. Many have hoped that, if I was eligible for the trial, I would get the drug being investigated, not the control, which in this case is a placebo. That hope seems to convey the belief that the drug will work. Whether it will or not is, in fact, what the trial is intended to test.

I know that participating in a clinical trial means taking a chance that I won’t get the drug under investigation, as well as the chance that that drug won’t work anyway. I know that it’s impossible to know from a clinical trial whether the drug under investigation will help me, even if it shows benefit for a significant percentage of people in the trial.

At the same time, I know there is only one approved treatment for ALS, the disease I have. At best, that treatment only delays progression. Better treatments are needed: ones that will extend patients’ lives or improve the quality of the lives they live with this devastating illness. I know that only through clinical trials can better drugs be found, and I hope that this trial—and other trials—will advance the knowledge of what does and doesn’t work to treat ALS.

And I’ll also keep in mind, as I enter the trial that placebos also work sometimes.

The following piece has been reprinted from the blog, Healthy Barbs, with permission from Barbara Brenner. To continue reading and follow Barbara’s journey, please visit Healthy Barbs.

“Science Times” synthesis

School might (almost!) be out for the summer, but research, innovation, and discovery are always in session. So before you head out to a Memorial Day barbecue, brush up on this week’s “Science Times” synthesis and learn about video games, leeches, neural circuits, and more!

Week of May 10, 2011

Hazy recall as a signal foretelling depression: An “overgeneral” memory has been identified as an indicator of depression and post-traumatic stress disorder.

Fixated by screens, but seemingly nothing else: A growing body of research on attention deficit hyperactivity disorder suggests that it is not uncharacteristic for sufferers to find video games more gratifying than non-sufferers.

In digestion, leeches show sophisticated side: New research indicates that leeches actively seek out environments with temperatures that aid digestion.

Regimens: Looking twice at supplements for infants: Research into infant feeding practices determined that nearly one in 10 babies are given unproven supplements or plant-based teas during the first year of life.

Week of May 17, 2011

A new gauge to see what’s beyond happiness: In a new take on well-being, some researchers believe the desire for accomplishment overrides the desire for happiness.

Control desk for the neural switchboard: Using the emerging technology of optogenetics, researchers are gaining control over neural circuits and making advances into disorders such as anxiety and Parkinson’s disease.

A blood test offers clues to longevity: Controversy surrounds a new blood test that promises to reveal an individual’s biological age by measuring telomere length.

Featured Member Profile: Sherry Baierl

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 Sherry Baierl, human research protections manager for Memorial Health Care System.

When and why did you join the field?
I have been interested in research since my high school days. During college, I was interested in behavioral research and choose to major in psychology. I have also witnessed first-hand how advances in research have impacted the medical field and patient care. Without research we would not have the knowledge we have today. We should always question if there is another way, or, more importantly, a better and safer way to do what we do. We need to make strides in achieving this.

What is your favorite part of your job?
My favorite part of my job is the knowledge that what I do everyday influences patient care for the better. We have found through research which drugs and devices have the ability to prolong life or give someone a better quality of life.

What is your current state of mind?
Contentment.

What is the last movie you saw?
Fast and Furious 5.

What is your idea of perfect happiness?
Being with family and friends.

What are you reading?
When God Whispers Your Name, by Max Lucado.

What's your after-hours guilty pleasure?
Watching movies with my family.

Why did you join PRIM&R?
To stay abreast of the latest research information out there, and to network with others who work in the research field. Networking provides you with access to researchers who can assist you in any changes that you might implement at your research site. I also joined in order to increase my knowledge of best practices and gain access to the resources that are available to me as a member. I love going to the conferences to hear updates, stay current on the latest research news, and gather any tools that will assist all of us along the way.

What is your favorite member benefit?
Staying informed of all the latest changes and, of course, increasing my knowledge in an ever-expanding field.

What would you say to someone who is considering PRIM&R membership?
I would say they need to join to stay abreast of the latest research information, connect with peers in the field of research, and to attend the conferences, which are so valuable. You never walk away without new knowledge.

What motivates you to maintain your commitment to advancing ethical research? The knowledge that we are doing our best to keep research participants safe, and that research is making an impact on people and their quality of life. We do this by implementing rigorous requirements to safeguard the population and by making sure that what we do is ethical. I feel that all research should be sent through a research review board in order to ensure all of the ethical and required elements of the study are accounted for.

Thank you for being part of the membership community and sharing your story, Sherry. Let us know what you think of When God Whispers Your Name!

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

Featured Member Profile: Jeffrey Kretsch

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 Jeffrey Kretsch, technical director at Raytheon BBN Technologies in Virginia.

When and why did you join the field?
I got into this field in 2005 when my work required the use of human subjects. I knew nothing about this; it was a real eye-opener for me that these types of issues existed. After I retired, I decided I liked the work and chose to continue with it.

What is your favorite part of your job?
I enjoy taking a research task and seeing what the balance is between what the researchers were attempting to accomplish and the costs to the subjects who participated. Even in the short time that I have worked in this field, I have seen an apparent shift toward making sure research isn’t stifled by maintaining human subjects protections. I enjoy finding a proper balance between protecting human subjects and allowing work to go on that provides useful benefits.

What are you reading?
I like history—I am reading The Great Influenza: The Story of the Deadliest Pandemic in History by John M. Barry. He does such a good job of bringing to life the people who created our modern system of medicine and how they tried to address the pandemic. Experiments were routinely done on prisoners and service personnel that would never be allowed today. The book demonstrates how two conflicting goals, protecting the population and conducting a war, resulted in a bad situation becoming much worse.

Why did you join PRIM&R?
I like the conferences PRIM&R puts together, especially the keynote speaker presentations. These speeches always highlight what is at stake in this field.

What is your favorite member benefit?
Reading the publications and bulking up my library with the books I purchase at all of the conferences!

What would you say to someone who is considering PRIM&R membership?
I have actually encouraged one of my sisters to get into this field, and one of the things I was thinking of doing was offering her a membership to PRIM&R to help her get her started in the field.

What motivates you to maintain your commitment to advancing ethical research?
I think this is a debt we owe to the human subjects who suffered or died because researchers could not or would not respect their rights. It is a small thing compared to all that these subjects lost, but at least they can know that our work is a result of a difference they made to the world, and in that sense they are not forgotten.

Thank you for being part of the membership community and sharing your story, Jeffrey. We hope you take advantage of the rewards offered in our Refer a Colleague Program should your sister become a member.

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

“Science Times” synthesis

This Sunday will be devoted to celebrating mothers, and this week’s “Science Times” synthesis is your mother lode of new research on the decreasing height of women in resource poor countries, the impact of exercise, and the function of the placenta. Share your knowledge, and Mom will surely be impressed.

Week of April 26

A new generation’s vanity, heard through hit lyrics: Researchers, seeking to define the personality of a generation through music, have reported a recent trend toward narcissism.

Hippos, warts, and other thugs of the genetic realm: Recent discoveries in cardiac research have spurred interest in understanding the gene, Hippo, which inhibits heart growth.

Study of vision tackles a philosophy riddle: Examining an age-old question, scientists discover that vision-impaired individuals whose vision is restored are not automatically able to connect what they see with objects previously known only through touch.

Height: Very poor women are shrinking, as are their changes at a better life: Height—an indicator of childhood nutrition, disease, and poverty—is declining among women in Africa and South America according to an analysis of demographic data.

Week of May 3

Does exercise really boost your mood?: In addition to releasing hormones, exercise also allows for neurogenesis to occur. Recent research on neurogenesis is mixed in regard to these processes’ impacts on anxiety.

Job description grows for our utility hormone: A recent discovery links the placenta to the development of a hormone with an increasingly complex role in our body’s function: serotonin.

Monkeys’ memories can stretch beyond what’s in front of them: Using rhesus monkeys, researchers demonstrated that monkeys can hold an object in their mind without actually seeing it.

Featured Member Profile: Heather Pixley

Welcome to another installment of our featured member interviews where we will continue to introduce you to 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 Heather Pixley, program leader and scientific writer at the Center for Aging Research at the Dartmouth Institute in Lebanon, New Hampshire.

When and why did you join the field?
I joined in 2003 when I was promoted to laboratory coordinator for a research group at Dartmouth. Much of my position involved writing and updating institutional review board (IRB) materials, and I soon became an IRB member and the administrative manager for our group. IRB duties are the most fulfilling part of my position.

What is your favorite part of your job?
My favorite part is helping others learn about human subjects and ethical issues. I also enjoy serving as a consultant for research groups that are less experienced.

What's playing on your iPod?
I might be the last person who doesn't have an iPod or other MP3 player.

What is the last movie you saw?
I recently saw Paranormal Activity 2.

What are you reading?
I'm currently reading Middlesex by Jeffrey Eugenides.

Why did you join PRIM&R?
My institution's IRB provided funding for my initial membership and attendance at a meeting. It was a very worthwhile experience.

What is your favorite member benefit?
I really enjoy the Newsletters and complimentary access to webinars.

If you were planning our next conference, who would you select as a keynote speaker?
I would choose Stephen Bartels, MD, MS, as a keynote speaker. The aging population is growing, and therefore so are treatment and research programs. I would consider him to be an expert on ethics, research, and older adults with serious mental illness. He is an excellent speaker.

What motivates you to maintain your commitment to advancing ethical research?
I have been a research subject in the past, recruited subjects to research studies at my institution, and served as an IRB committee member to review the research of others. At each point, I have gained a different perspective and also seen that not everyone is well versed in the best policies and procedures. It is important to continue offering guidance to researchers as techniques change and advance.

Thank you for being part of the membership community and sharing your story, Heather. If you’d like to learn more about becoming a member, please visit our website today.

The buck stops at the PI

by Wendy Tate, PSP, CIP

Just this year, a mere four months since the start of the year, the United States Food and Drug Administration (FDA) has issued seven warning letters to clinical investigators. Four of these letters cite investigators for failure to personally supervise their human subjects research. This is a violation of FDA regulation 21 CFR 312.60, which specifically states that:

“An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation. An investigator shall, in accordance with the provisions of part 50 of this chapter, obtain the informed consent of each human subject to whom the drug is administered, except as provided in 50.23 or 50.24 of this chapter. Additional specific responsibilities of clinical investigators are set forth in this part and in parts 50 and 56 of this chapter.”

The FDA outlines their expectations in two guidance documents, The Use of Clinical Holds Following Clinical Investigator Misconduct and FDA Inspections of Clinical Investigators, and requires documentation of the responsible party on FDA Form 1572. The Office for Human Research Protections (OHRP) shares the FDA’s perspective and discusses the investigator’s ultimate responsibility in its Frequently Asked Questions.

Delegation of tasks is not investigator negligence; in fact, it is almost always required to complete a clinical trial properly. It is not the intent of the FDA to have a busy medical doctor personally execute all aspects of a study alone. When done properly, delegation can significantly improve subject safety by assigning qualified people to complete complex tasks.

However, the investigator must be aware of what is being delegated, to whom, and how the designee(s) are completing the assigned tasks. The people delegated to execute the tasks must be qualified to do so, with appropriate credentials and experience. Designees must receive appropriate, thorough training, and have expectations set out that must be met. Ongoing oversight by the investigator must be a priority throughout the life of the project through regular communication and meetings.

Resources are available to help investigators. Some institutions have clinical research offices that provide support. Investigators must be cautious when using such a service, though, so that they do not lose sight of their responsibilities. Many institutions have quality assurance/quality improvement (QA/QI) programs designed to give investigators tools to run their research effectively while ensuring compliance. Such programs also perform site visits to evaluate and educate investigators on FDA expectations. Institutions that do not have a QA/QI program may instead offer these services through their IRB office.

Being an investigator is a complex and high-stakes line of work. It is about adequately protecting human subjects by ensuring appropriate conduct of a study. The FDA Form 1572 summarizes the requirements an investigator promises to uphold when leading a clinical trial. The FDA will hold investigators responsible to every one of these requirements. The duties are broad and the penalties can be severe. It is important for compliance programs to reach out to investigators before the FDA comes auditing, and for investigators to seek out help and appropriately delegate duties to ensure compliance with all of the regulations.

When May Expedited Procedures Be Used ?

PRIM&R is pleased to bring you a blog post from PRIM&R Blog Squad member, Christine Scheuring. The PRIM&R Blog Squad is composed of PRIM&R members who are devoted to blogging from and about our conferences. Christine was the PRIM&R Blog Squad member for the 2011 SBER Conference.

On the last day of the 2011 Social, Behavioral, and Educational Research (SBER) Conference, I attended When May Expedited Procedures Be Used? Part I: Initial Review. During the session, attendees were asked to consider whether research that audio taped married couples discussing their financial situations could be expedited. Session facilitator Dean Gallant assistant dean for research administration and policy at Harvard University, further explained that the recordings would be kept confidential and would not be shared with anyone, including the spouse. After some discussion, we all concluded that this study could be reviewed using the expedited procedure.

Following our conclusion, Mr. Gallant went on explain that a study of a similar description had, in fact, been expedited at Harvard. During the course of the study, one of the husbands passed away and the man’s wife asked the researchers for a copy of the audio tape as it was one of the last recordings she had of his voice.

Hearing her story, the sympathetic side of me immediately wanted to give her the tape—no questions asked. However, after further discussion the group came to the consensus that it would not have been the right thing to do, even though the husband was deceased. During the course of our discussion, one attendee suggested he or she would have given the woman an edited version of the tape. After much deliberation, Harvard ultimately ended up erasing the data completely.

If I learned one thing from attending the 2011 SBER Conference it's that we, as human subjects protections professionals, face a lot of gray area. We confront difficult decisions on a daily basis, and this example was a reminder that the challenges we encounter may not always be those we expect, but it is in those moments that we must rely on one another.

Not only do we have the support of our own institution’s institutional review board chairs and members and fellow staff and administrators, but now we have the vast network of colleagues that we met in Boston, and it's comforting to know that when tough situations arise, we have each other to consult.

Human embryonic stem cell research: Court victory, but challenges remain

We are pleased to welcome guest blogger Melinda Abelman, MSc, CIP, Embryonic Stem Cell Research Oversight manager at Partners HealthCare System, to Ampersand. Below, Ms. Abelman shares her view on the most recent federal decision regarding stem cell research.

As the embryonic stem cell research oversight (ESCRO) manager for an academic institution, I routinely monitor local, national, and international developments in the field. Last week, a United States Court of Appeals decision was heralded as a victory for human embryonic stem cell (hESC) researchers who wish to pursue this research. While good news, some legal hurdles remain.

To understand the significance of this ruling, some background is helpful.

• In August 2010, two researchers working with adult stem cells filed a lawsuit alleging that the current National Institutes of Health (NIH) policy that allows use of federal money for hESC research violates the 1996 law against using federal funds for the destruction or harming of human embryos.

• Current NIH guidelines allow taxpayers’ dollars to be spent for research use of hESCs that have been derived from in-vitro fertilization embryos in excess of clinical need, but do not allow federal funding for the destruction of embryos to obtain the hESCs.


• This lawsuit went to a US district court judge who agreed and issued an injunction to halt NIH funding for hESC research pending a decision on the case.


• In September 2010, a temporary stay was placed on the injunction which allowed NIH to continue funding this research as two lawsuits proceeded through the courts: (1) the original suit brought forward by the researchers, and (2) the appeal by the US Department of Justice to reverse the injunction.

On April 29, 2011, a three-judge appeals court panel permanently lifted the injunction in a 2-1 vote. The majority opinion stated that the law is ambiguous and the NIH’s interpretation is reasonable. The dissenting opinion asserted that the federal law is clear about banning funding for hESC research and that the court majority is using "linguistic jujitsu" to justify its position.

While the decision is good news for academic researchers that rely on federal funding, I am cautious in my optimism. It is still uncertain how the original lawsuit will proceed. In addition, as long as the current law banning federal funding for the destruction or harm of embryos is in effect, there will be those who will attempt to challenge the current federal approach to hESC research. To lay this issue to rest, a legislative fix is needed.

In a recent article, pioneering stem cell researcher, Dr. Alan Trouson, was cautious as well. His response to the news: "While this recent Court of Appeals decision is very welcome, it is simply one step toward US researchers being able to feel they can proceed with this groundbreaking research."

May is Member Appreciation Month at PRIM&R!

Thirty-one days is not enough to thank you for all that you do…



















But it’s a start! Please allow us to appreciate you during Member Appreciation Month!