Remembering Ted Kennedy - a post from Pearl O'Rourke

P. Pearl O’Rourke, director of human research affairs at Partners Healthcare System, has been a longstanding member of PRIM&R's Board of Directors. We asked if she would share her thoughts with our readers on Senator Edward M. Kennedy’s recent passing.

In the mid-1990’s, I was a staff member in Senator Kennedy’s office. In the years following, our paths crossed several times and he always greeted me as if I had never left. Last Thursday, I stood on Cambridge Street in Boston as his motorcade traveled through Boston streets, I stood in line at the JFK Library, and I watched the television coverage of his funeral for hours. It seemed the least I could do.

He was large in his largesse—my first day on the job well before I had done an iota of work, he welcomed me with a booming voice and heartily thanked me in advance for my help, my expertise, my yet-to-be-defined contributions.

As a staff member, I summarized issues, wrote memos, participated in briefings, staffed him at hearings. Most exciting were the work meetings with Senator Kennedy himself – when called to the office and asked to present facts and defend suggestions and opinions. One did not go in ill-prepared.

But best memories are more personal.

Going with him to NIH where he met with patients and families and displayed the most amazing mixture of compassion, respect, interest. He thanked them for their time and he humbly said that he needed their help and the insight of their life-experience.

Walking down a corridor with him as he burst into song.

Rushing out of the Capitol with him as he hurried to a waiting car. He was running late…but on the way to the car, in his peripheral vision he spied a sixth-grade field trip with a number of the kids shyly waving. He stopped—and like a magnet he was drawn to the kids. He wanted to know who they were, where they were from, what they had visited in DC. And then—how he would love to get some pictures with them. Kennedy assigned me as photographer and in an instant there was a puddle of 20 cameras at my feet. I took the same picture 20 times—Kennedy’s smile and esprit was the same in photo number 20 as it was on the first click. The kids loved it… the Senator loved it… I loved it. It was an honor being a part of his team.

Remembering Ted Kennedy...

Posted by Joan Rachlin, executive director

I wrote a short preface in this space yesterday about the profound sense of loss that so many of us are feeling upon learning of Senator Kennedy's death.

As these pictures suggest, I have been a long time admirer of Ted Kennedy and a bit of a groupie as well. One photo shows my then 7 year old son sitting on his lap at a 1994 benefit for one of our favorite non-profits (besides PRIM&R, of course!).

The other shows Senator Kennedy, his wife, Vickie Reggie Kennedy, and me at an outdoor community event about 7 years ago.

I've now dutifully disclosed my potential conflicts of interest, but nothing dilutes or diminishes the fact that Ted Kennedy was a champion of so many issues affecting research, health care, disabilities, maternal/child health, and so much more. His contributions are deep and wide, and, as you all by now know, he was the third longest serving senator in the history of the Senate. He had his hand—and heart—in every important piece of legislation in the past 46+ years, and authored or co-authored 2,500 bills.

Ted Kennedy was widely respected by friend and foe alike, and was legendary for his ability to reach across the aisle and hammer out compromises on issues that were important to the working women, men, and families, whom he represented with a ferocity that earned him the sobriquet "lion of the Senate." He was a master of the art of compromise, owing perhaps to his having grown up in a family of nine children, but, as so many commentators have noted, he never compromised on his principles. The tributes are pouring in, and one report that I found to be a succinct account of a larger-than-life man came from NPR.

In recognition of his extraordinary public service and his legendary legislative achievements, the PRIM&R Board voted at its June 2009 meeting to bestow a “Special Lifetime Public Service Award” upon Senator Kennedy and there will be a posthumous tribute to him at the November conference. During the June Board discussion, two members, Charles McCarthy and Alex Capron, recounted Senator Kennedy’s seminal role (along with Representative Paul Rogers) in the passage of the National Research Act of 1974. He served as Chairman of the Senate Health Subcommittee, which held hearings and drafted the legislation that led to the National Research Act, which in turn created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. As most of our blog's readers know, the National Commission served as the foundation for the Belmont Report and the federal regulations as we know them today.

Senator Kennedy's commitment to strengthening the system for human subject protections stemmed from his obvious anger over the U.S. Public Health Service Study of Untreated Syphilis in the Negro Male, and he was thus determined to move quickly in response to calls for regulation of medical research following those tragic abuses. In fact my friend and colleague, Moira Keane, reminded me yesterday that OPRR (the Office for the Protection from Research Risks), the predecessor of OHRP (the Office for Human Research Protections), produced a series of video tapes in the 1990's and Senator Kennedy was featured on one of them.

Among the Senator's other related activities were his leadership on issues in healthcare and health insurance affordability, privacy in medical treatment, research issues with populations requiring special protection, such as minorities, incarcerated individuals, persons with disabilities, children, and individuals suffering from mental disorders. Senator Kennedy was also concerned with issues in cancer research, working on the National Cancer Act and other issues affecting the formation and funding of the National Cancer Institute.

His legislative skills are well known to all, but his kindness, compassion, and devotion to his constituents made him someone who, in Rudyard Kipling's words, "never lost the common touch." Here in Boston, it was always said that Ted Kennedy was "more Irish than Harvard," i.e., he never lost touch with his family’s roots or culture, and that he would take a call from "Mrs. McGillicuddy" over one from the President of Harvard. Stories of the many ways in which he helped constituents are ubiquitous, and everyone with whom I spoke yesterday all had the same comment, to wit, that he is irreplaceable in the Senate. Massachusetts has its fair share of talented politicians, but no one can fill Teddy Kennedy's shoes…ever.

There is a poem by Maya Angelou that I love, but that I rarely quote, as it applies to so few among us. I last quoted it when the father of the research ethics field, Jay Katz, passed away last November, and I share it with you now in memory of someone who never stopped fighting to make life better for the most vulnerable Americans.

May Senator Edward Kennedy rest in peace. He has earned it. May we not rest, though, until quality health care is accessible to all, and not just to those fortunate enough to be wealthy or employed. As the Senator said "...the work goes on, the cause endures, the hope still lives, and the dream lives on."

Ailey, Baldwin, Floyd, Killens, and Mayfield
By Dr. Maya Angelou

From her collection, I Shall Not be Moved

When great trees fall,
rocks on distant hills shudder,
lions hunker down
in tall grasses,
and even elephants
lumber after safety.

When great trees fall
in forests,
small things recoil into silence,
their senses
eroded beyond fear.

When great souls die,
the air around us becomes
light, rare, sterile.
We breathe briefly.
Our eyes, briefly,
see with a hurtful clarity.
Our memory, suddenly sharpened,
examines,
gnaws on kind words
unsaid,
promised walks
never taken.

Great souls die and
our reality, bound to
them, takes leave of us.
Our souls,
dependent upon their
nurture,
now shrink, wizened.
Our minds, formed
and informed by their
radiance,
fall away.
We are not so much maddened
as reduced to the unutterable ignorance
of dark, cold caves.

And when great souls die,
after a period peace blooms,
slowly and always
irregularly. Spaces fill
with a kind of
soothing electric vibration.
Our senses, restored, never
to be the same, whisper to us
They existed. They existed.
We can be. Be and be
better. For they existed.

P.S. As with all of the blogs posted in this space, the views shared are those of the writer and not the organization.

Maximize your professional development!

Posted by Emily Hayden, program coordinator

We’ve all had an experience where putting in that extra bit of effort made all the difference: The early-morning study group that brought that B up to an A. The extra hour after practice that earned you a spot on the team. Volunteering on Saturdays to ease the burden for someone less fortunate.

I’ve found that the most fulfilling activities usually require a little extra time and effort, but are worth it in the end because I can look back and be satisfied, knowing that I maximized my available resources.

The same idea applies to professional development. We all know it is important, but our busy schedules and multiple commitments prevent us from taking advantage of these opportunities. At PRIM&R, we want to make it easy to make the most of your time and energy—that’s why we’re hosting a full day of 10 pre-conference programs as a lead-in to the 2009 Advancing Ethical Research (AER) Conference!

These full-day programs will be held on November 13 and are designed to meet the needs of those who are involved in the field of human subjects research, such as IRB members, chairs, and staff; researchers and investigators; institutional officials; and community members and community research advisory board members.

Not only will these programs provide information that will keep you current in the high-stakes and ever-changing field of research ethics and compliance, but these smaller sessions will provide you with valuable networking opportunities and advice from peers who face the same challenges that you do.

Some things require extra effort, but not registration! You can register for a pre-conference program at the same time as the 2009 AER Conference. Or, if you have already registered for the conference and would like to extend your stay in Nashville, please call us at 617.423.4112, ext. 0 and we will gladly assist you.

If you have questions regarding the pre-conference programs, please contact me via e-mail, or at 617.423.4112, ext. 26.

The "Lion of the Senate" and Massachusetts’ favorite son is no more...

It’s a sad day in Massachusetts, the Senate, the country, and around much of the world. One of my greatest heroes is gone, and I am feeling the loss as I remember one who improved the lives of so many millions.

I’m in the process of writing a blog about Ted Kennedy, but it won’t be posted until tomorrow. Until then, I wanted to share one written by Judy Norsigian, executive director of Our Bodies, Ourselves, and a PRIM&R Board member. Judy posted this blog on her organization’s website and I wanted to share it with you. Onward in hope…

Joan Rachlin, JD, MPH
PRIM&R Executive Director

(Originally posted by Judy Norsigian, executive director of Our Bodies, Ourselves and PRIM&R Board Member, on Our Bodies, Our Blog)

Remembering Senator Kennedy’s Work on Behalf of All

It is with heavy heart that so many of us receive the news of Sen. Ted Kennedy’s death. Although I have been anticipating this moment for weeks now, the reality is still such a shock.

I know that for so many women’s health activists, Kennedy’s passing will only strengthen our resolve to continue his valiant fight for meaningful health care reform. I have started writing letters to several more liberal Republicans, beseeching them to honor his memory by breaking ranks with the Republican Party and its current efforts to eliminate the public health insurance option from any bill coming out of Congress.

As a tribute to this tireless advocate for the millions who had no political power, each of us can think of one gesture we can carry out in the coming weeks.

In 2002, I testified before the Senate HELP Committee on the topic of somatic cell nuclear transfer (which involves creating cloned human embryos to serve as a source of embryonic stem cells for scientific research; it poses health risks for women who provide eggs for such research). Kennedy, who was co-chairing that particular HELP Committee hearing, was ever so gracious, even though I knew he did not agree with the position of Our Bodies Ourselves at that time.

And when my late husband, Irving Kenneth Zola, died in 1994, shortly after he was appointed to the National Council on Disability, Kennedy’s remarks at a special memorial service for Irv in Washington, D.C., brought tears to everyone’s eyes. His compassion, tenacity and commitment to the needs of all remain an inspiration to me both personally and professionally.

We will miss you terribly, Ted, and we will all fight even harder for the causes you championed for more decades than some of us have even been alive.

Pillars of PRIM&R: Advancing Ethical Research in Sudan

Posted by Shaquanna Philip, conference coordinator

Since we first introduced you to him, last year’s Pillars of PRIM&R Award recipient, Dr. Dya Eldin Elsayed has been working diligently to contribute to the advancement of ethical practices in the conduct of research in Sudan and, more specifically, at Alzaiem Alazhari University (AAU), where he is the Assistant Professor in the Department of Community Medicine. In his initial application, he explained that:

“Lack of education in bioethics, lack of resources, lack of trained personnel and ineffective ethics review process are some of the challenges faced by the national research system in [Sudan]. These deficiencies are compounded by less developed health system[s] and health services, [a] high illiteracy rate, ignorance of human right[s] including [a] right to health care. These facts raised the questions of potential exploitation of research participants and poor communities.”

The Pillars of PRIM&R award has supported his development of a bioethics curriculum for undergraduate students, as well as an ethics training program for both undergraduate and postgraduate students in the school of Medicine and Health Studies. Below Dr. Elsayed explains his motivation to develop the program and how earning the Pillars of PRIM&R award has impacted his professional development.

Developing a curriculum in research ethics
Dya Eldin M. Elsayed



The idea to develop a curriculum in research ethics came into my view from the fact that knowledge about research ethics is deficient among Sudanese researchers. Bioethics is not taught in most of medical and health-related schools in our country. However, where it is taught, the teaching is very insufficient. As bioethics is still, in our country, in its early stage of development, there are few experts (some scholars and professionals) in the field of bioethics. Therefore we lack both experts to undertake the teaching matters and the teaching materials.

I am involved in, and interested in, teaching of medical practices as well as research ethics. I recognized the need for capacity building in research ethics and human protection. I heard of PRIM&R and its commitment to support and enhance development of research ethics across the world. I applied for [the] PRIM&R fellowship program with a proposal “to develop research ethics curriculum for graduate students in Sudan”. Most of [the] graduate students in the schools of medicine and other health related schools involve human subjects in their graduate research. They are the potential researchers, so I decided to place this teaching program in graduate faculty. Fortunately enough my application was accepted by the review committee of the PRIM&R award.

The award was highly appreciated by my colleagues in the department of community medicine, by the Dean faculty and the Vice Chancellor of Alzaiem Alazhari University (AAU). They were very exalted and congratulated me and availed themselves to help.

Developing the research ethics curriculum was an excellent learning opportunity for me. I made a thorough literature review and extensive consultation process. Consultations involved many experts in the field, interested organizations and individuals, a wide range of researchers and colleagues. Finally the draft was submitted to PRIM&R.

The curriculum now is submitted to the scientific committee of the Graduate Faculty at AAU for review and approval and introduction to students in the next academic year which will start in October.

I owe PRIM&R great gratitude not only for accepting my application, but also for giving me the opportunity to search and develop this training program. The award gave me the opportunity, the enthusiasm and potential to work hard and to move from just [an] interested person in bioethics to a professional in research ethics teaching. I believe that this newly developed research ethics curriculum will provide substantial opportunities for contribution to the development of medical and research ethics education in all of the areas where deficits exist.

Since its inception in 1974, PRIM&R has been infused with the wisdom, devotion, and vision of a number of highly respected and uncommonly committed directors, members, and volunteers. When two such revered board members, Louis Lasagna and Herman Wigodsky, passed away, their colleagues on the board established the Pillars of PRIM&R Memorial Fund to honor them and other longstanding PRIM&R contributors by making a small annual grant to one person who is working to advance ethical research.

Who is Sally Satel and why is she saying those things about IRBs?

Posted by Joan Rachlin, executive director

Anyone happen to catch Sally Satel’s Op-Ed in the New York Times about two weeks ago?

In case you didn't, you might want to know that the piece, by Dr. Satel of the American Enterprise Institute, repeats some oft-heard allegations about IRBs, including that the "current regulations have become so stringent and unwieldy that the ethics oversight system often impedes the kind of careful research we should be promoting."

Quoting Robert Levine and Norman Fost's assertion that "the system regulating the use of human subjects is increasingly dysfunctional,” Dr. Satel concludes that "the lengthy approval process cuts into scientific productivity." She then cites the Johns Hopkins/University of Michigan "checklist" case as due proof that "although some boards are flexible, many are too risk-averse, narrowly interpreting each word in research protocols lest they be second-guessed by Washington regulators."

Noting that "Stanford University researchers estimated that it cost them about $56,000 in administrative wages, 18 months of delay, and 10,000 pages of paper to make a small change to an already approved research program that simply compared the progress made by patients attending different types of addiction-treatment programs," Dr. Satel goes on to describe how these types of experiences are causing many researchers to turn to commercial IRBs for faster and cheaper reviews, although she does mention that some commercial IRBs have “dangerously lax” standards.

So who is Sally Satel? I heard her speak at the American Society of Bioethics and Humanities meeting two years ago, and, while I vehemently disagreed with most of her positions, I found her to be thoughtful, articulate, and certainly provocative. She is someone who my typical knee-jerk reactions would, in the past, oblige me to dismiss with a wave of the hand.

Dr. Satel, for example, opposes the need for medical ethicists, is a proponent of the legalized sale of donated organs, and is one whose views about medicine, research, and public health have earned her the sobriquet of "right wing pundit." For example, she has long maintained that "incorporating social justice into the mission of medicine diverts attention and resources from the effort to prevent and combat disease for everyone."

But I have previously written in this space about the importance of "respectful listening" and of not harshly judging the opinions of others, two qualities I tend to preach more than practice. I'm trying harder these days to aim for balance and fairness, and, in that spirit, decided to try to find out more about Dr. Satel. I turned to trusty ol’ Google and learned that she suffered from chronic renal failure and underwent a kidney transplant, that she works part-time at a drug treatment clinic and is admired and appreciated by her patients, and that she holds some views I find temperate, even persuasive (maybe I'll blog another day about which those might be, but, until then, my lips are sealed ☺).

So although I take issue with many of her broad-brush allegations in the NYT Op-Ed piece, and although I generally resent and resist any efforts to treat, no less slam, the HRPP/IRB world as a monolithic one, I'm trying harder these days to respectfully listen to—and understand—the opinions of those with whom I would normally disagree. In fact, much of what Dr. Satel is saying is little more than a summary of the opinions that have been making their way around the media for quite some time now. IRBs are getting a bad rap in a lot of places these days, and I'm hoping that our community will gather at the PRIM&R conference in November and work together to figure out what's working, what's not, and how to ethically, effectively, and efficiently meet our obligations to research subjects.

Until then, though, I'd like to hear from those of you who have opinions about Dr. Satel's opinions. I suspect that there would be a wide spectrum of responses, and I sure would like to hear at least some of them. Thanks for reading Ampersand, and happy homestretch of August!

Monday Memories - Break out the party hats!

Where’dya get that hat?! This Monday Memory comes straight from the archives of our executive director. If you know who any of these ladies are, please post a comment. We’d love to hear about YOUR memory of this event. (Looks like fun!)

As part of our 35th anniversary, we'd like to remind you (and ourselves) of PRIM&R's journey, so we will periodically post interesting photos and ask that YOU to jog our memories and fill in the details.

Show what you know in IACUC administration

In addition to the CIP® credential we highlighted recently, PRIM&R also wants you to know about the Certification for Professional IACUC Administrators. This credential helps advance the quality of animal research protection programs by formally recognizing an IACUC professionals’ knowledge.

Back in February, we had the pleasure of speaking with Susan Kallay, BS, LATg, CPIA, about her experience preparing for and earning the credential (See PRIM&R Newsletter, February 2009 . During that conversation, Susan expressed her belief that “[t]he CPIA credential demonstrates a degree of professionalism and knowledge that [is] very useful for this work. “ While the full-text version of the interview is available only to members in the Newsletter Archive, we wanted to share this sentiment with everyone to illustrate just how beneficial the credential is.

If you’re not yet a PRIM&R member, but would like to read the interview in its entirety, please contact us, and we will send you a copy of the February edition.

Susan is a post approval monitoring administrator in the Center for Comparative Medicine at Northwestern University. In this position she reviews approves animal protocols, and visits labs to ensure that the research is conducted in accordance with the approved protocol. Once a veterinarian technician, Susan has a bachelors degree in biology and is pursuing her masters in quality assurance and regulatory affairs.

PRIM&R Staff (PS): Do you think your institution might begin to recruit and favor new employees with the CPIA credential?

Susan Kallay (SK): Yes, I could see that happening within this department. The CPIA credential demonstrates a degree of professionalism and knowledge that would be very useful for this work.

PS: Now I would like to ask you a couple of questions about how you prepared for the test. How long before the test did you start studying?

SK: I started studying about two and a half months before the test date. My preference is to study alone. I like do learn in my own way. I read all of the materials several times. All of the information that you need is in the materials. You just need to take the time to absorb it all. I suppose that if you do know someone else who is preparing for the exam, and you are the kind of person who likes to study that way, forming a study group could be helpful. I am also in school for my masters, so I would grab whatever time I could find to read and reread the materials.

To learn more about the eligibility requirements and the exam itself, please download the CPIA Handbook or visit our website. Don’t delay – the deadline to apply for the October exam period is September 1, 2009.

Pssst! Did you know you can save $100 on exam fees as a PRIM&R member? Join today and take advantage of ALL the benefits of PRIM&R membership.

PRIM&R Membership Awards

PRIM&R members are engaged everyday in important work that advances the ethical conduct of research. PRIM&R is proud to periodically recognize those who have made outstanding and valuable contributions to this field. Since 1996 and 2006, respectively, PRIM&R has presented the Distinguished Service Award (DSA) and the ARENA Legacy Award (ALA) to honor our members’ exceptional accomplishments.

The DSA honors “an individual(s) who has made a valuable contribution to the ethical conduct of research and to enhanced compliance with federal regulations.” In addition, recipients of the DSA are members who have made long-standing contributions to PRIM&R.

Past recipients of the DSA include:

2008 - Jeremy Sugarman
2006 - Bonnie M. Lee
2005 - Ernest Prentice
2003 - Gary Chadwick and Susan Kornetsky
2002 - Joan Rachlin
2001 - Karen Hansen
2000 - Robert Nelson
1999 - Marky Pitts and Molly Greene
1998 - Ada Sue Selwitz
1997 - David Bernhardt
1996 - Helen McGough

The ALA recognizes individuals who have made an outstanding contribution to the goals of PRIM&R by significantly promoting the ethical conduct of research through mentoring, teaching, and leadership. From 1986 to 2005, the Applied Research Ethics National Association (ARENA) was the membership division of PRIM&R. One of the many important contributions that ARENA made to the field of research ethics was to encourage the professional advancement of those who work in the field of subject protections, as that, in turn, promotes excellence in the field and ultimately contributes to a more ethical research enterprise. This award is intended to honor individuals who embody these ideals by consistently fostering professional development through leadership, education, and mentoring.

Past recipients of the ALA include:

2008 - William Freeman
2007 - Elizabeth Bankert
2006 - Marky Pitts

Please take the opportunity to learn more about each recipient on our website.

It is time, once again, to recognize leaders in the field. If you are a PRIM&R member, you received an e-mail with details on how to nominate your colleagues on August 6. If you missed it, please visit our website to nominate a fellow member today! The deadline for nominations is Thursday, September 10, 2009.

Leading the way at the 2009 AER Conference

Preparations for the 2009 Advancing Ethical Research Conference are moving forward at full force. We are excited to announce that a few folks are “penned” into the program already, and promise to deliver insightful, inspiring keynote addresses!

Dr. Joshua Sharfstein, MD, principal deputy commissioner at the FDA, will kick off the conference on Saturday, November 14.

Then, on Sunday, November 15, we will hold concurrent keynotes: Dr. Ellen Wright Clayton, MD, JD Rosalind E. Franklin Professor of Genetics and Health Policy and director of the Center for Biomedical Ethics and Society at Vanderbilt University; and Dan Ariely, PhD, James B. Duke Professor of Behavioral Economics at Duke University. If you haven’t yet registered for the conference, you can pick which keynote you would like to attend during the registration process. If you have registered, please e-mail us to let us know which keynote you plan to attend.

Finally, Dr. Keith Norris, professor of medicine and executive vice president of Research and Health Affairs at Charles Drew University of Medicine, will deliver the final keynote speech on Monday, November 16.

We are very excited to have all of our keynote speakers join us, and we hope you will register today you can see each of their speeches in person in Nashville.