Thursday, December 31, 2009

A Love Story

Posted by Joan Rachlin, executive director

On the eve of the New Year, I wanted to share with you a story of love, devotion, courage, and character that has inspired and motivated me.

The story actually begins over 30 years ago when, as a young attorney working to improve the health and mental health care for those incarcerated in Massachusetts, I had a client who was experiencing life-threatening kidney problems. Not surprisingly, my efforts to find a doctor who would see an inmate were turning up empty due to the biases confronting most prisoners, no matter how desperate their medical conditions.

I had called at least six specialists in hopes of finding someone who would not hang up as soon as I mentioned the word "prisoner." Both my hopes, and, more importantly, my client’s kidney function, were fading fast. In fairness, treating an inmate is no cakewalk, as armed correctional officers accompany the shackled prisoner to each appointment, and what was formerly a calm medical office is thereby transformed into a makeshift prison.

I then met a young nephrologist named Andy Levey at the Tufts Medical Center and, from our very first conversation, he was kind, helpful, non-judgmental, and unafraid. Andy is a gentle man with a seemingly permanent smile on his face and a heart that could overflow the Grand Canyon. He treated my client over a period of years and became a true hero to both of us.

I had not seen Andy for well over a dozen years, but then saw him again when I took my son, Micah, to his first day of kindergarten in 1993. My anxiety about Micah’s starting school dissolved in a burst of pleasure at seeing Andy, whose son was in the same class. I told Micah that Andy was one of my heroes, and proceeded to explain why. Since that day, Andy, his equally extraordinary wife, Roberta, and son, Isaac, have been friends and neighbors.

Flash forward to 2009 when Roberta, a beloved and respected oncologist, was in need of a new kidney. Andy was not a match for his wife, but, on December 15, he donated his kidney to a "stranger" as part of a three-way swap. If this were a newspaper article instead of a blog, the headline might read "kidney doctor donates kidney."

I have been thinking about Andy and Roberta for the past two weeks, and so rather than write this New Year’s Eve post about something trite or clichéd, I decided to share their story with you, as it is the story of the greatest gift one person can give to another. My words are wholly inadequate, and, it turns out, wholly unnecessary, too, as Andy, Roberta, and Isaac have sent e-mails that tell their own story in their own words.

Upon returning home from the hospital on December 19, Andy wrote that "Roberta and I had a chance to meet one of the two other donor recipient pairs in our exchange. They are both doing well. We also hear that the third pair is doing well. It was awe-inspiring to hear the story of the other Tufts pair that brought them, from completely different backgrounds and medical circumstances, to the same kidney exchange program as us. What a miracle that we could help each other do what we could not do for ourselves! I feel great every time I think about what I’ve had a chance to do. This is a great start to a holiday season for celebrating miracles."

Roberta joined him at home on December 21, and wrote that she feels "triumphant and very optimistic," and that "it is a very special holiday season for us."

Finally, having met Isaac on his first day of kindergarten, I was awed by reading his e-mail, which demonstrated uncommon maturity, sensitivity, and wisdom. He noted that "the world can be a pretty grim place sometimes, but today, three people, including my mom, woke up with kidney failure in their immediate future and went to sleep at night with new kidneys and, hopefully, clear paths where that organ is concerned for decades to come. Three people today committed a deeply selfless act and donated a part of their body for someone they loved. We should all hope that if we are ever called on to make such a sacrifice, we can follow the example of my dad and two other kidney donors. And when we are in need, let’s hope circumstances and the generosity of our friends and family are on our side."

Roberta and Andy are such caring, humble, and brave individuals, and their story is what I am holding on to as we enter the New Year. It's easy to become organ donors (by ensuring that our driver's licenses reflects our wishes; it's not so easy to become a living donor, which is why this story warranted telling), but being there – really being there – for those you love, is not so easy.

I’m going to try, though, and I’m going to think of Andy and Roberta each time I am presented with an opportunity to make both my small, and the larger, world a better place.

Here’s to good health and safety for each of you in 2010 and beyond, and may each of us find the strength, courage, and compassion to give to others in need, whether they be spouses or strangers.

In December's Newsletter...

Happy New Year! The most recent issue of PRIM&R’s Newsletter (members only) was distributed today, December 31.

In addition to our regular features, such as Recent Headlines, Government and Legal News, and Public Policy, this issue included…
  • Abstract information for the 2010 IACUC Conference;
  • A link to the 2009 Workload and Salary Reports (members only);
  • Information about PRIM&R’s current Career Center promotion (get $50 off using code NY121450 at checkout);
  • A profile of PRIM&R Board Member, Marky Pitts;
  • Our final featured talk from PRIM&R Through the Years. This month’s feature is a session titled “Recovering the Ethics of IRB Decision Making,” from the 1996 IRB conference,

Can’t find the Newsletter in your inbox? Check out the Newsletter Archives.

Want to become a PRIM&R member? Learn more.

Wednesday, December 30, 2009

AER Conference Proceedings

For the first time, the 2009 Advancing Ethical Research (AER) Conference Proceedings include video and audio components of four keynote addresses, 12 panel discussions, three debates, two living room conversations, and one town hall meeting. This means you can see and hear the speakers while their slides are up on the screen as you access the inspiring, vibrant, and in-depth content of the meeting. Not sure what we mean? Here’s an example.

If you attended the conference, please visit www.conferenceproceedings.com/2009AERC.htm and enter your individual code, which you can retrieve using this link. If you need assistance, please e-mail PRIM&R.

If you did not attend the conference and would like to buy full access to the proceedings, please fill out this form and return it to PRIM&R via e-mail or via fax, at 617.423.1185.

If you have questions about the Conference Portal, please contact Shaquanna Philip, program coordinator, by e-mail or by phone at 617.423.4112, ext. 22.

Monday, December 28, 2009

Monday Memories: Final Installment

For the past year, we have posted old photos from our archives in hopes of gaining some insight into PRIM&R's vibrant history. However, for the last installment of this series, we've decided to step outside of the archives a bit, and instead look to more recent history.

This photo was taken at PRIM&R's 35th Anniversary Birthday Party in Nashville, TN, at the 2009 Advancing Ethical Research Conference. Are you one of the talented, foot-stompin' singers on stage with New South? Let us know!


Even if you weren't able to join us there, though, we want to extend our gratitude to you, our cherished community, for helping us reach this milestone.

Wednesday, December 23, 2009

Happy Holidays from PRIM&R!

As our 35th anniversary draws to a close, we are warmed by the memories of this year-long celebration.

At the core of PRIM&R’s culture is an unwavering commitment to ensuring that research is ethical and that research subjects are protected. Looking forward to 2010 and beyond, we rededicate ourselves to these basic principles and to the work of advancing ethical research.

We hope you’ll join us in looking back with pride at what has already been accomplished, and in looking forward with energy and renewed purpose to a continuation of our shared work.

Thank you for being part of the PRIM&R community. We are proud to share common cause with so many principled and hard-working individuals.

Wishing you a joyous season and good health in the New Year and always!

Your pals at PRIM&R

Tuesday, December 15, 2009

Engage in the Exchange of Ideas and Strategies for IACUCs


PRIM&R is now accepting abstracts for the 2010 IACUC Conference Poster Presentations. The goal of the annual poster presentations is to provide a platform for members of the IACUC community to share ideas, information, and practical strategies that solve the many challenges faced by IACUC professionals. A poster presentation is your opportunity to showcase your research or innovative projects to stimulate informal discussion among presenters and conference attendees.

Last year, three of the accepted abstracts were selected for both a poster and oral presentation. These abstracts included:


  • Meeting Responsibilities: the Institutional Animal User Education and Training Program at the University of Saskatchewan, which was presented by Amanda Plante, UCACS Education and Training Committee, University of Saskatchewan.

    This abstract describes the University of Saskatchewan’s newly implemented training program that “consists of an on-line UCACS animal care course, practical skills training, one-on-one training, documenting education and training, [and] monitoring procedures.” The program was so successful that “effective January 1, 2009, approval of an animal use protocol (new or annual review), by the AREB requires (or is conditional upon) successful completion of the UCACS Animal Care Course by all personnel listed on the protocol, including the principal investigator. Any new personnel added to a currently approved protocol must complete the on-line course before beginning any work with animals[…] Currently, the UCACS Education and Training Committee (ETC) is developing a shortened version of the on-line course that can be completed by licensed veterinarians.” Complete Abstract Available Here

  • Random Source (Class B) Dealer Activities: October 31, 2007- November 1, 2008, which was presented by Gary P. Goldberg DVM, DACLAM, USDA/APHIS/Animal Care. This study was implemented in response to an inquiry from the Institute of Laboratory Animal Resources.

    “This review included sources of acquisition such as from private individuals, municipal pounds or shelters, and from other licensee or registrants. The disposition of these animals was categorized as to individuals, other licensee/registrants, or to research facilities[...] In order to estimate the teaching use of the random source animals, the records of random source dogs and cats were surveyed for campuses where U.S. Medical Colleges, U.S. Veterinary Colleges, and U.S. Veterinary Technician Schools were located. Complete Abstract Available Here

  • MONiTOR: Monitoring Of Novartis’ in vivo Techniques, Operations, & Research, which was presented by David DeOrnellis, BS, RLATg, CPIA and Colleen Cody, BS, Novartis Institutes for BioMedical Research, Inc.

    This abstract describes the “dynamic and comprehensive program for monitoring compliance of NIBR Cambridge in vivo research. MONiTOR is unique due to the incorporation of all aspects of in vivo research in its scope, including the conductance of technical animal procedures, the operational aspects of vivarium management, and experimental procedures. MONiTOR is a fully integrated system that recognizes the importance of compliance at all levels of in vivo research in ensuring the welfare of the animals used for research at NIBR Cambridge, from husbandry to research-related procedures.” Complete Abstract Available Here

Have you recently pursued an innovative approach to improving the management, function, and operations of IACUCs? Or, perhaps you have conducted empirical research on research ethics as it relates to the care and use of laboratory animals?

We encourage you to share your ideas and experiences with your colleagues via a programmatic or scientific poster presentation.

Please visit our website
for more information, including guidelines, important dates, and frequently asked questions, and to submit your abstract online.

Wednesday, December 9, 2009

Awards recap from the 2009 AER Conference

PRIM&R was proud to present three awards at the 2009 Advancing Ethical Research Conference in Nashville.

Designed to honor PRIM&R members who have made valuable contributions to the ethical conduct of research and to enhanced compliance with federal regulations, the Distinguished Service Award was presented to Charlotte Coley, MACT, CIP.

Jeffrey Cohen, PhD, CIP received the ARENA Legacy Award, which was established in 2006 to recognize members who have made outstanding contributions to the goals of PRIM&R by significantly promoting the ethical conduct of research through mentoring, teaching, and leadership.

PRIM&R honored Albert R. Jonsen, MA, with the Lifetime Achievement Award for Excellence in Research Ethics, presented to those whose work has been seminal, exemplary, and the embodiment of a commitment to advancing research ethics.

Read more about PRIM&R's awards, and our award winners, on our website.

Monday, December 7, 2009

A New Lesson from the Old "Tuskegee" Study


Susan Reverby generously agreed to let us reprint the below Op Ed piece, which was originally published on Race-Talk on December 3, 2009.

"Don’t take the swine flu vaccine. Remember the Tuskegee Experiment Syphilis Vaccine," a recent post on Twitter warns. The message is simple: "Tuskegee," America’s notorious medical research study, is still considered as our own equivalent to Nazi experimentation that links state power to scientific fervor. Nearly forty years after the study ended, the name “Tuskegee” evokes fears of the dangers of government involvement in medical care. But as Congress debates how to provide health coverage for everyone and fear of the swine flu vaccine runs rampant, there is a different critical lesson to take from the infamous medical research project which targeted poor rural African American men and ran unabated for decades.

The accompanying photograph (taken in 1953) shows PHS physicians drawing blood from, not infecting, the Study's unwitting participants.

From 1932 to 1972, the U.S. Public Health Service (PHS) conducted a study on "untreated syphilis in the male Negro" in Macon County, Alabama in and around the city of Tuskegee. 439 African American men with late stage syphilis were selected as research subjects, and 185 without the disease became the study’s control group. A mostly sexually transmitted disease, syphilis left untreated can cause fatal heart and neurological problems. The men thought of themselves as patients obtaining needed medical care for what was known as “bad blood” from the government’s doctors. The PHS physicians never told these men they were actually research subjects being followed in a "no treatment" study.

Instead, the researchers explained that the aspirins, tonics, and diagnostic spinal taps given were "free treatment." In a county with only 16 doctors whose prices the men could rarely afford, a government program of free care enticed them. The study’s nurse kept visiting the men’s homes and helping them to get medical care for other ills. The study’s subjects and controls were also promised money for decent burials in exchange for the use of their bodies for autopsy after their deaths.

The study was not kept secret. Medical articles charting its progress appeared over the decades, while several health professionals questioned the study’s ethics. In 1972 the research experiment came to an end in a storm of media coverage that brought in federal investigators, a Senate hearing, and a subsequent lawsuit against the PHS, the state of Alabama, and many of the doctors involved.

In "Tuskegee’s" wake, major changes in federal rules governing medical research were established, including written informed consent and the creation of institutional review boards to oversee human subject research. The study also created another legacy—it became the metaphor for the distrust of scientific research, the risks of government provision of medical care, and the exploitation of poor patients.

Rumors and myths about what happened continue to circulate in whispers, blogs and media coverage. Most egregious in the face of the need for H1N1 vaccine is the erroneous claim that the government’s doctors intentionally infected the men with syphilis. But no “Tuskegee experiment syphilis vaccine” was ever created; no shots of the bacteria that cause syphilis were put into the men’s veins.

As the Obama administration takes on the huge task of reforming how we organize and pay for health care for all Americans and we line up for our shots, "Tuskegee" can offer another perhaps less obvious, if ironic, lesson. These men living in rural Alabama came forward for treatment not because they were uneducated and easily duped by their government, but because they needed health care for themselves and their families. They, as with increasing numbers of Americans, had no real access to the medical care they required, could not pay for what was available, and had to find it where possible.

Perhaps as the debate over health care reform winds its way through the Congress, a new post on Twitter should read: "Don’t forget the 'Tuskegee' syphilis study. Everyone deserves the right to affordable health care and this is what our government should and must provide."

Susan M. Reverby is the Marion Butler McLean Professor in the History of Ideas and Professor of Women's and Gender Studies at Wellesley College and an historian of American women, medicine and nursing. She became interested in researching the Tuskegee Syphilis Study after seeing a performance of “Miss Evers’ Boys,” the play by David Feldshuh that tells the story of the study from the perspective of its nurse. In 2000, Dr. Reverby edited Tuskegee Truths: Rethinking the Tuskegee Syphilis Study, a book of articles and primary documents on the study. Her new book, Examining Tuskegee: The Infamous Syphilis Study and its Legacy is now available. Please see the following website for more information. http://www.examiningtuskegee.com.

Thursday, December 3, 2009

Want to be a CIP or CPIA? Mark your Calendars!

Posted by Emily Butler, program assistant

PRIM&R helps to educate those involved in the administration of human research protection and animal use and welfare programs through two certification programs: Certified Institutional Review Board (IRB) Professional (CIP®) and Certified Professional Institutional Animal Care and Use Committee (IACUC) Administrator (CPIA). These two programs improve the quality of human research protection programs and animal care and use programs by promoting ethical practices and advanced knowledge of regulations.

The CIP and CPIA exams will be offered during the following testing periods:

CIP 2010 Exam Dates

Spring Testing Period
Application deadline: January 15, 2010
Exam dates: March 6 through March 20, 2010

Fall Testing Period
Application deadline: August 1, 2010
Exam dates: September 11 through September 25, 2010

CPIA 2010 Exam Dates

Spring Testing Period

Application deadline: March 1, 2010
Exam dates: April 10 through April 24, 2010

Fall Testing Period
Application deadline: September 1, 2010
Exam dates: October 16 through October 30, 2010

Both exams are administered by the Professional Testing Corporation, and are offered at least twice yearly at testing sites across the U.S. and Canada. Locate the testing center nearest to you. For more information, and to determine if you are eligible to sit for an exam, please visit the CIP or CPIA eligibility pages of our website.

Monday, November 30, 2009

In November's Newsletter

The most recent issue of the PRIM&R Newsletter (members only) was distributed yesterday, November 30.

In addition to our regular features, such as Recent Headlines, Government and Legal News, and Public Policy, this issue included…

Can’t find the Newsletter in your inbox? Check out the Newsletter Archives.


Want to become a PRIM&R member? Learn more.

Tuesday, November 24, 2009

Happy Thanksgiving!

by Joan Rachlin

“Gratitude is not only the greatest of virtues, but the parent of all the others.” Cicero

Everyone’s talkin’ turkey these days, and I can’t seem to avoid being besieged by information regarding hot cooking tips. Did you know that:

- Brining is back (it locks in the moisture)?

- Frozen birds often taste better than a fresh one, depending on transit time for the latter?

- The tofurkey craze is not a craze at all? In fact, it’s celebrating its 15th birthday and sales are skyrocketing.

But who am I fooling? I don’t want to avoid this inundation of turkey tips, because like so many others, I love Thanksgiving! I relish the colorful and delicious meal, enjoy being with family and friends, endure the football watchers who commandeer the living room, and generally appreciate the non-denominational come-on-come-all inclusivity of the day. I wish, though, that the media were as interested in the true meaning of the holiday as they are in the food.

Then again, the questionable symbolism of this holiday goes back to the original Thanksgiving feast when, as the story goes, tolerant and eager-to-learn pilgrims were hosted by the American Indians, who welcomed the newcomers. When myths underlie the meaning of any tradition, the foundations tend to be shaky, and so it is with the rosier-than-real message of Thanksgiving.

But how do we begin to change the message and expand the meaning of this day? We each must decide what the holiday means to us as individuals, but we can rely on some old and trusted guideposts to help show us the way. Would you believe that the Belmont principles are apt here, too? They really do have wide application, no?

First, we can respect the hardships and losses of both the pilgrims and the American Indians, as well as those of the many other immigrants and indigenous people the world over. We can similarly honor and respect the courage of President Abraham Lincoln, who declared Thanksgiving to be a national holiday in the midst of the Civil War; he understood that healing and reconciliation could best be advanced through an expression of gratitude for blessings large and small.

Beneficence is the second Belmont principle, and in its simplest form, means “being kind” and “doing good.” This is where the “thanks” come in, as each of us has benefitted from people who have “done good” on our behalf. In human subjects research, I have been struck by the manner in which some institutions and individuals actively care about and for the subjects. Similarly, some of PRIM&R’s IACUC professionals have told me about their annual ceremonies honoring the animals that make research possible.

Justice is the final principle, and this is the easiest one to apply to Thanksgiving. One of the most iconic Thanksgiving symbols is the horn of plenty, which symbolizes abundance of the harvest, and we can best embody the meaning of justice by ensuring that our abundance and wealth, both as individuals and as a society, are shared with those who are less fortunate.

The core principles that underlie the Belmont Report are rooted in the human condition. We are all connected, and can only get by with a lot of help from our friends and family (apologies to the Beatles).

So I end this Thanksgiving missive as I end so many of my thoughts and writings… I am grateful, really, really grateful, for this community of ours. I am grateful for the fact that you are committed to living your professional lives with ethics as the guiding star. I am grateful for my family, my friends, my co-workers, my neighbors, my healthcare-givers, and for those unseen, unheard individuals who do the things that make my comfort and joy possible.

We all have so much to be thankful for. They say that one of the secrets of life is wanting what you have, rather than having what you want, and a corollary of that truism is that what we want is not always what we need. I hope to work ever harder to give thanks for blessings large and small in my life and in PRIM&R’s organizational life. Each of you is on our list of people for whom we are thankful at this season of thanks giving and always!

Enjoy every morsel and mouthful!

Council Announces CPIA Recertification Guidelines

In 2007, PRIM&R launched its certification program for IACUC professionals known as the Certified Professional IACUC Administrator (CPIA) credential. The certification process was developed to improve the quality of animal care and use programs by promoting ethical practices and advanced knowledge of IACUC administration.

Since its inception, CPIA has grown steadily. There are currently 164 CPIAs in the country and the number of exam applicants rises steadily. Since the CPIA certification period is five years, early CPIA-certified individuals have been asking about the requirements for recertification. After a thoughtful deliberation process, the CPIA Council, the committee that oversees the CPIA credential standards, released the CPIA Recertification Guidelines.

To maintain certification, a CPIA must recertify every five years from the time of the most recent certification. Recertification may always be achieved by successfully retaking the CPIA examination. However, CPIAs also have the option to recertify by completing certain professional development and continuing education activities as described in the Recertification Guidelines.

Why recertify or sit for the CPIA exam for the first time?

The CPIA credential…

  • Demonstrates the certified IACUC professional’s high level of dedication to IACUC administration as a profession.
  • Provides potential career advancement opportunities.
  • Validates the holder’s knowledge of his or her field.
  • Strengthens the profession by providing an established body of relevant knowledge and national standards of practice in IACUC administration.

For more detailed information, please download the CPIA Recertification Guidelines or the CCPIA Policies and Procedures Manual.

Friday, November 20, 2009

PRIM&R exhibits at the 2009 AALAS National Meeting

Posted by Emily Butler, program assistant

The Denver Convention Center’s 40-foot tall blue bear!

Alongside 4,000 excited professionals, I arrived at the Denver Convention Center to exhibit at the American Association for Laboratory Animal Science (AALAS) 60th National Meeting. I quickly learned that the “National” in the title doesn’t fully describe the scope of this meeting, as the conference is the world’s largest gathering of both national and international laboratory animal professionals. The AALAS National Meeting is known as the event to attend for cutting-edge training and networking in all aspects of laboratory animal production, care, and use.

I quickly got to work, setting up a booth stocked with information about PRIM&R’s animal research related programs. While my station in the row of affiliate organizations was dwarfed by the glitz and shine of the laboratory animal vendors’ displays, it was gratifying to welcome a steady flow of attendees, whose experience levels ranged from novice to veteran.

For each curious glance cast on the PRIM&R display, I offered a quick overview of our mission and offerings. I spoke with a wide array of attendees, including local high school students, directors of AALAS-equivalent associations in Taiwan and India, and young lab animal technicians with aspirations to join the ranks of their institution’s institutional animal care and use committee (IACUC).

While some visitors were quick to exclaim their familiarity (“I love PRIM&R!”) with our organization, about two thirds had never heard of PRIM&R. My goal was to acquaint those attendees with PRIM&R’s mission and programs as quickly as I could, and felt successful when an attendee walked away with the expressed intention to visit our website, attend a conference, or become a member. I kindled interest in both the 2010 IACUC Conference and the Certified Professional IACUC Administrator (CPIA), and encouraged attendees who lacked the ability to travel to visit the website for webinar and member networking opportunities.

On November 11th, I packed up the booth with a long list of follow-up questions and the satisfaction of having introduced PRIM&R to hundreds of new professionals.

Monday, November 16, 2009

Day 3 at the 2009 AER Conference

Here’s what’s happening today at the 2009 AER Conference. (Please refer to your program for full titles and descriptions.)

*Registration for those events that are marked "Pre-Registration Required" has closed.

6:45 – 7:45 AM
Yoga (Governor’s Chamber A)

7:00 AM
Registration Opens (Delta Foyer)

7:00 – 8:00 AM
Continental Breakfast (Ryman Exhibit Hall B4-5)
CIP® continental breakfast - Pre-registration required (Governor’s AE)

8:00 – 8:15 AM
Welcome, tribute to Sen. Edward M. Kennedy, and membership news (Delta A)

8:15 – 9:15 AM
Keynote Address – Keith Norris, MD (Delta A)

9:15 – 9:30 AM
Break

9:30 – 10:45 AM
Panel IX (Delta B)
Panel X (Delta CD)
A Great Debate (Delta A)

10:45 – 11:15 AM
Break

11:15 AM – 12:30 PM
Didactic Sessions and Workshop Series E
(Please see program or daily schedule for room assignments.)

12:30 – 1:30 PM
Lunch (Ryman Exhibit Hall B4-5)
NCI CIRB Lunch – Pre-registration required (Governor’s AE)
AAHRPP Lunch – First come, first serve (Delta Island ABC)

1:30 – 1:45 PM
Break

1:45 – 3:00 PM
Town Hall Meeting (Governor’s B)
Panel XI (Delta B)
Panel XII (Delta CD)

3:15 – 4:30 PM

The Grand Finale! Eight Learning Sessions
(Please see program or daily schedule for room assignments.)

4:30 – 5:30 PM
Closing Reception (President's Ballroom)

Sunday, November 15, 2009

Opening Day at the 2009 AER Conference!

Posted by Joan Rachlin, executive director

Thanks for joining us if you’re here in Nashville, and, if you’re not, we miss you! We’re off and running, and what a first day it was.

The day began with a therapeutic dose of stand-up comedy, compliments of Conference Co-Chairs Michele Russell-Einhorn and Bruce Gordon. Things quickly got serious, though, as three awards were presented to three very deserving individuals: Jeffrey Cohen, PhD, CIP, founder and principal partner of HRP Associates, received the ARENA Legacy Award, which recognizes a PRIM&R member who has made an exemplary contribution to the mission and goals of PRIM&R by significantly promoting the ethical conduct of research through mentoring, teaching, and leadership.
Jeff is a former ARENA (Applied Research Ethics National Association) president who has made many “exemplary contributions” to PRIM&R. He has co-chaired multiple PRIM&R and ARENA meetings, and has taught at every kind of educational forum we offer – conferences, At Your Doorstep courses, regional meetings, and webinars.

Following the presentation, Jeff cited the fact that he has only missed two PRIM&R meetings in 30 years, and that the information gained at those meetings, along with the networking that took place there, were central to the success of his career.

Bob Levine presented the PRIM&R Distinguished Service Award to Charlotte Coley, MACT, CIP, Director of IRB Educational Programs at Duke University. The DSA honors the member who has made valuable and unique contributions to the field of research ethics, and who has attained distinction in promoting the purpose and ideals of this organization through writing, teaching, and writing. Charlotte has made many contributions to PRIM&R, among them co-chairing the Workshop/Didactic Sub-Committee for the past two years, teaching at several conferences, and by sharing her deep and wide knowledge of IRB ethics and regulations with the PRIM&R community.

The final honoree was Albert Jonsen, who was the recipient of PRIM&R’s Lifetime Achievement Award for Excellence in Research Ethics. This award is intended to recognize and honor individuals who have made a major and sustained contribution to the development or dissemination of the ethical principles that govern research.

The LTA has only been conferred three prior times… to Jay Katz (who, sadly, passed away last November), Charles McCarthy, and Robert Levine, all giants in the research ethics field. Al Jonsen, a moral philosopher who is widely considered to be one of the pioneers in the research ethics field and who was one of the drafters of the Belmont Report, told some warm anecdotes about the drafting process at the Belmont Conference Center in Maryland in 1978. Al thanked the audience members for translating the three Belmont principles (respect for persons, beneficence, and justice) into their daily work in protecting subjects.

Al also hosted an informal and interactive luncheon for over 100 friends and fans today. Stay tuned, and I’ll tell you more about that when next I have a chance to sit down.

Al, Jeff, and Charlotte are cherished friends of all who work in the subject protections field, and they have honored us by allowing us to honor them.

Three cheers for three spectacular FOPs (“Friends of PRIM&R).

Day 2 at the 2009 AER Conference

Here’s what’s happening today at the 2009 AER Conference. (Please refer to your program for full titles and descriptions.)

*Registration for those events that are marked "Pre-Registration Required" has closed.

6:45 – 7:45 AM
Yoga (Governor’s Chamber A)

7:00 AM
Registration Opens (Delta Foyer)

7:00 – 8:00 AM
Continental Breakfast (Ryman Exhibit Hall B4-6)
Membership Networking Continental Breakfast – Pre-registration Required (Governor’s AE)

8:00 – 8:15 AM
Welcome, updates, and PRIM&R’s 35th anniversary (Delta A)

8:15 – 9:15 AM
Keynote Address – Ellen Wright Clayton (Delta A)
Keynote address – Professor Dan Ariely (Delta CD)

9:15 – 9:30 AM
Break

9:30 – 10:45 AM
Panel III (Delta CD)
Panel IV (Delta A)
Panel V (Delta B)

10:45 – 11:15 AM
Break

11:15 AM – 12:30 PM
Didactic Sessions and Workshop Series C
(Please see program or daily schedule for room assignments.)

12:30 – 1:45 PM
Lunch (Ryman Exhibit Hall B4-6)
CITI Program Lunch - Pre-registration required (Governor’s AE)
NCI CIRB Lunch - Pre-registration required (Delta Island ABC)

1:45 – 2:00 PM
Break

2:00 – 3:15 PM
Living Room Conversation (Delta CD)
Panel VI (Delta A)
Panel VII (Delta B)

3:15 – 3:30 PM
Break

3:30 – 4:45 PM
Town Hall Meeting (Delta CD)
Panel VIII (Delta B)
A Great Debate (Delta A)

4:45 – 5:00 PM
Break

5:00 – 6:15 PM
Didactic Sessions and Workshop Series D
(Please see program or daily schedule for room assignments.)

7:00 PM

PRIM&R's 35th Birthday Party (Delta B)
Don't have a ticket? Stop by the Help Desk to buy one!

Saturday, November 14, 2009

Day 1 at the 2009 AER Conference

Here’s what’s happening today at the 2009 AER Conference. (Please refer to your program for full titles and descriptions.)

*Registration for those events that are marked "Pre-Registration Required" has closed.

7:00 AM
Registration Opens (Delta Foyer)

7:00 – 8:00 AM
Continental Breakfast (Ryman Exhibit Hall B4-6)

8:00 – 8:15 AM
Welcome (Delta A)

8:15 – 9:15 AM
Keynote Address – Joshua Sharfstein, MD (Delta A)

9:15 – 10:30 AM
Panel I (Delta A)

10:30 – 11:00 AM
Break

11:00 AM – 12:15 PM
Living Room Conversation (Delta CD)
Panel II (Delta B)
A Great Debate (Delta A)

12:15 – 1:45 PM
Common Ground Networking Lunch (Ryman Exhibit Hall B4-6)
Research Ethics Brook Group Lunch - Pre-registration Required (Governor’s AE)
Lunch with Albert Jonsen, PhD – Pre-registration Required (Cheekwood ABC)

2:00 – 3:15 PM
Didactic Sessions and Workshop Series A
(Please see program or daily schedule for room assignments.)

3:15 – 3:30 PM
Break

3:30 – 4:45 PM
Didactic Sessions and Workshop Series B
(Please see program or daily schedule for room assignments.)

5:00 – 6:30 PM
Speed Mentoring (Ryman Exhibit Hall B4-6)

5:00 – 7:00 PM
Meet and greet with the exhibitors! (Ryman Exhibit Hall B4-6)

5:30 – 7:00 PM
Moderated abstract discussions (Ryman Exhibit Hall B4-6)

8:00 PM – 10:00 PM
Movie Night – Milk (Delta B)

8:00 PM – 10:00 PM
Poker Night (Delta Island ABC)

Friday, November 13, 2009

35 reasons we love our members!

It’s finally November and we want to give thanks! Starting with Applied Research Ethics National Association’s (ARENA) 61 charter members, PRIM&R members have kept us going through the lean years and helped us grow into an international organization representing nearly 3,500 individuals. We’ve spent the last 35 days revealing a few of the MANY reasons we have to be grateful to our members on Twitter and Facebook. In case you missed it, we’ve compiled the reasons below.

  1. They send us holiday cards- sometimes even personal ones!
  2. They send us lots of local treats, such as pralines, buckeyes, and coffee candies.
  3. They are committed to the field of research ethics.
  4. They embody PRIM&R’s mission.
  5. They’re diverse.
  6. They come from all 50 United States and 36 countries.
  7. They help advance the field by becoming certified CIPs and CPIAs.
  8. They speak many languages.
  9. They get engaged at our conferences!
  10. They contribute to our conference programs.
  11. They pay their membership dues on time.
  12. They become friends, fans, and hopefully followers in the world of social networking!
  13. They let us use their words in our marketing materials and go on camera to help make our movies.
  14. They host networking events and help us network with other organizations.
  15. They send us photos of their grandkids!
  16. They give us honest feedback.
  17. Their phone calls can brighten our day, especially when they tell us jokes or write songs that make us laugh.
  18. They give us nicknames.
  19. They stick with our volunteer positions for decades.
  20. They volunteer at Speed Mentoring!
  21. They solve problems in our Online Communities.
  22. They write blog posts and newsletter articles!
  23. They give us tours of their facilities.
  24. They’re friendly, altruistic, and creative.
  25. They help advance science by ensuring that research is responsible and by protecting human and animal subjects.
  26. They climb Mt. Kilimanjaro!
  27. They’re committed to lifelong learning.
  28. They have interesting hobbies—golf, fly-fishing, rally racing, antiquing…
  29. They help PRIM&R get green, but not with envy!
  30. They love animals.
  31. They’re true card sharks when it comes to playing Texas Hold ‘Em.
  32. They’re ethical.
  33. They know what most of the acronyms in the field stand for.
  34. They sing and dance along to Mamma Mia! and Hairspray.
  35. They’ve brought us to this 35th anniversary milestone and we hope they’ll stick with us for the next 35!

Monday, November 9, 2009

Headed to Nashville?

Headed to Nashville for the 2009 Advancing Ethical Research Conference? We are, too!

Please visit our website for a roundup of whens, wheres, and need-to-know facts before you travel.

Thanks!



Tuesday, November 3, 2009

Where else will you find...

...more than 300 representatives of federal agencies?
...more than 250 subject matter experts on our faculty?
...more than 2,000 subject matter experts in the audience and all around you?
...more than 165 educational sessions?
...and everything else an IRB/HRPP could ever want?


The 2009 Advancing Ethical Research Conference
is quickly approaching, and the PRIM&R office is humming with excitement to bring you all of the above, and more. Your last chance to register for this conference is this Friday, November 6 at 5:00 PM ET.

Among our goals is a determination to educate, energize, and inspire our attendees so that they can in turn educate, energize, and inspire their colleagues back home. We hope that you will be in the audience
when Dr. Josh Sharfstein, the Deputy Commissioner of the FDA, kicks off the program with a keynote address on November 14.

Not yet sure about whether you'll be there? We know that it's an economically challenging time, but as you consider whether you can afford the cost of this conference, please also consider the costs of not attending. The need to stay abreast of regulatory changes and to understand the ever-present and emerging ethical issues don't disappear because resources are scarce.

In this time of diminished resources, we believe that investing in the PRIM&R AER Conference is a low-risk way to increase your staff's knowledge, motivation, and commitment to our shared mission of advancing research and protecting the health and welfare of human subjects.

Friday, October 30, 2009

Blog Share: Post from the Research Ethics Blog

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

    "This seems, at first glance, to be an extremely serious potential breach of research ethics. It also is a pretty monumental medical story — a clinical trial resulting in deaths and serious morbidity. Yet I haven't been able to find any sources, other than HuffPo, that have corroborated this story. The blogs and newsgroups I note above each cite the HuffPo story only. The story has not been picked up by mainstream media. Documents supporting the story, such as the letter to Columbia from OHRP, are not publicly available."
Read the entire post here.

In October's Newsletter...

The most recent issue of the PRIM&R Newsletter (members only) was distributed today, October 30.

In addition to our regular features, such as Recent Headlines, Government and Legal News, and Public Policy, this issue included…

  • A reminder that Friday, November 6 is the LAST CHANCE to register for the 2009 AER Conference and pre-conference programs;
  • A request for those attending the 2009 AER Conference to bring an unwrapped book or toy with them to benefit a local Nashville shelter;
  • An invitation to contribute to the program development for the 2010 IACUC Conference;
  • A thank you to October’s volunteer of the month, Susan Delano;
  • This month’s website feature of the month, the members only icon () that you see dispersed around the PRIM&R website;
  • A featured talk from PRIM&R Through the Years. This month’s feature is a session from the 1994 panel Changes and Choices for IRBs: The Inclusion of Women and Minorities, and Other Emerging Issues in Research conference, titled “Risk Assessment”; and
  • A reminder about the special offer for PRIM&R’s Career Centeronly good until November 6!

Can’t find the Newsletter in your inbox? Check out the Newsletter Archives.

Want to become a PRIM&R member? Learn more.

Wednesday, October 28, 2009

My time as a study participant

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

by Jen Levine-Fried, Membership Specialist

From 2003 to 2005, I participated in an HIV vaccine trial. I visited the research department at Fenway Community Health
in Boston nearly a dozen times over the course of a year, spending up to two hours at a time giving blood, answering questions, and wincing through countless injections of an experimental vaccine.

Given my substantial investment of time and energy, I was happy to read news in September
that a vaccine trial similar to the one I participated in had finally produced modest success in preventing HIV infection. Reading the article opened a floodgate of memories about "my" trial, which, due to my subsequent experience working for PRIM&R, I now view through a new lens.

I've thought a lot about the informed consent process. Don't get me wrong—I was very well informed about the potential short- and long-term risks of the study. I think that the researchers did an excellent job ensuring I made my choice freely.

But as I think about risks now, especially the long-term ones, I wonder if I would have made the same decision. For example, I'm not HIV positive, but due to the experimental vaccine I received, I would appear to test positive using standard HIV tests.

If I want to document that I am HIV negative, I have to be tested at Fenway, which I can do at any time, free of charge. The researchers did not know how long my false-positive status might last, a minor concern to a single twenty-something (which I was, at the start of the trial). But now I am a married mother of two, and I have had to specifically decline HIV tests during both of my pregnancies. It gave me pause.

There's also the question of whether the vaccine could have been passed to my children in some way, a question for which the researchers did not have a definitive or compelling answer (although they suggested any risk was minimal). It makes me wonder whether I should have had more consideration at the time for my future self—and my future, hypothetical, children.

On the other hand, I recall the outrage that stemmed from federal guidelines announced in 2006 suggesting that all women of child-bearing age be treated as "pre-pregnant."
(Essentially, the guidelines suggest that all women of childbearing age should follow the same sorts of health guidelines as pregnant women.) As a feminist and, at the time, newly pregnant woman, I shared (and still share!) that outrage. And I wonder, even if I had been pushed to consider myself in that light, would it have been possible for me to do so, since it was so far out of my mindset at the time?
One thing is clear: there are no easy answers to this question. But I would love to hear your thoughts on this aspect of informed consent.
Photo credit: dbtechno.com

Tuesday, October 27, 2009

Contribute to the 2010 IACUC Conference

The planning process for the 2010 IACUC Conference is underway, and to develop the conference you want, we need your help generating ideas for the program's content. That's why we're extending this Invitation to Contribute to Program Development, so that the Conference Planning Committee may consider a broad and rich spectrum of topics and speakers.

Feedback from the community is invaluable when it comes to gathering and fleshing out ideas. For that reason, we're hoping you will post your thoughts—whether they're full-grown or just seedlings—to the conference discussion forum, where a wide variety of past and future attendees will come together to sow the seeds of another exciting program. Or, if you already have an idea, submit it directly to the PRIM&R staff using this online form.

The Conference Planning Committee will consider all submissions received by November 25, 2009. Please note that this process is not related to the Call for Poster Abstracts, which will begin in November.

Please consider participating in this process, as hearing from a large and professionally diverse chorus of voices will immeasurably enrich our conference program. If you have questions, please e-mail us, or call 617.423.4112, ext. 0.

Monday, October 26, 2009

An 'unforgettable' Monday Memory...

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

Did you write these lyrics? Maybe you were on stage singing them? Either way, we hope you have a laugh—and let us know if you were involved!

Unapprovable

Unnnn-approvable
That’s what they say
It’s un-doable
In short, no way.

They said I might as well root for the Mets
Sent me to see some guy named Schwetz
He told me to bail
Or end up in jail

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

Thursday, October 22, 2009

Mark Your Calendars for IACUC 2010!

Posted by Catherine Rogers, marketing coordinator

Take one look at the photos from last year’s Institutional Animal Care and Use Committee (IACUC) Conference and you’ll notice a few visual cues that speak to the meeting’s intrinsic value: A vibrant community. A diverse faculty. Smiling faces. Raised hands. Ah-ha moments.

But the pictures tell only part of the story...

To fully grasp the impact of the IACUC Conference, though, it’s necessary to immerse yourself in the experience. That’s why I wanted to share some preliminary details about PRIM&R’s 2010 IACUC Conference, which will be held March 22-23, with pre-conference programs being held on March 21, in Baltimore, MD, at the Baltimore Marriott Waterfront Hotel.

Based on the feedback we’ve received about last year’s IACUC Conference, our meetings continue to expand and improve, and 2010 will be no exception:

  • We’re expecting 700 attendees from 30 countries worldwide.
  • Our faculty has grown to nearly 125, including almost 20 federal representatives.
  • The conference program is composed of 20 tracks and 80 sessions designed to improve communication and collaboration, foster programmatic integration, and achieve convergence throughout an institution’s animal care and use program.

In addition, attendees will have greater access to networking with peers, colleagues, experts, thought-leaders, and federal government representatives! We know it’s not always easy to find a space to continue a discussion, reconnect with old friends, or engage in a thoughtful discussion with new ones. That’s why we have done the work for you! Once you’re onsite at the Marriott, look for signs directing you to a series of hand-picked Alternative Networking Depots—aka AmpersAND Lounges—where you’ll find comfy couches and cozy nooks, perfect for coffee and conversation.

General registration will open this winter, and we will continually update our website with information about the program and faculty, so please be sure to check back for the latest developments.

Hope to see you in Baltimore!

Monday, October 19, 2009

Post positions and resumes in Nashville

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

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


Friday, October 16, 2009

Why pay more? Register today and save!

Posted by Anne Meade, web and e-learning manager

I just wanted to remind you that we are less than a week away from the deadline for the regular registration rate for the 2009 Advancing Ethical Research Conference. The late rate starts October 23, which is also the last day you can book a room in PRIM&R’s block at the Gaylord Opryland Hotel. Make your reservation online to ensure you will pay the special conference rate of only $185 per night.

If you’re still on the fence about attending the 2009 AER Conference, consider this:

As research becomes increasingly complex, competitive, and "conflicted," your responsibilities shift, as well. You can fully adapt to our ever-changing world, and you can learn what you need to know to do your job better. By attending the 2009 AER Conference, you will play an active role in raising the caliber of research at your institution.

Creating a culture of ethics and compliance takes vigilance, and that’s where PRIM&R comes in. Your mission is to protect human subjects and advance ethical research. Ours is to help you find the best ways to do that. Register now!

Notes from the field

Posted by Joan Rachlin, executive director

Where do conference planners go for fun? Well, at least this one goes to other conferences! Some might call it a “buswoman’s” holiday , but I call it a chance to sit, listen, and learn—something I cannot easily do at PRIM&R meetings given the fact that there’s always a task that needs tending.

So here I am at the American Society of Bioethics and Humanities meeting in Washington, D.C., and there I was in the second row center yesterday during the opening session. Ezekiel Emanuel was the initial speaker, and his speech was titled "The Future of Bioethics: Policy, Politics, or Mush."

In his inimitable way, Zeke asked those in the audience to assess and reassess our professional principles, purposes, and practices.

Zeke mused about the early days of his work in the bioethics field when giants like Erich Heller taught and wrote about a range of probative issues: "Reality was being eviscerated of deeper meaning in the course of being 'explained' by modern science." Heller also noted that scientific explanations deprive things of their "individual being as entities and reduce them to the position of mere links in a much more broadly conceived chain."

Zeke also discussed the need for more empirical work in the bioethics field, as, he said,"public engagement is important, but it should not be the main focus of our discipline." Zeke was also quick to name reasons why it is important for the bioethics field to shift:


Loose lips sink ships.

In other words, much of what bioethicists observe is neither neutral nor benign, and their pronouncements are instead often perceived as a call to action. He therefore urges bioethicists to judiciously wield their power to “sink ships.” One way to do so would be to clarify the difference between statements of general condemnation versus those with a more “I am uncomfortable with this” tone.

One example he gives of this “loose lips” concern is that many bioethicists cannot precisely define injustice, exploitation, coercion, involuntariness, manipulation, etc., and yet there is a tone of certainty that pervades their work on these topics.

Zeke referred to the Willowbrook coercion case
, which has stood for 40 years as an example of unethical research, until Walter Robinson’s recent work questioned whether there was an ethical violation. Zeke’s point is that bioethicists must be more precise about distinguishing these things, versus using loaded ethical terms.

"Data" is not the plural of anecdote.

But, according to Zeke, some bioethicists have nonetheless drawn conclusions despite the lack of data. Empirical data is sorely needed on bioethical and IRB-related questions, and yet it rarely exists. “We can’t say anything about risks and benefits or about the quality of informed consent with an anecdote,” he said. “A story is a story, but the hard questions require data,” he said, citing both the TeGenero experience in the United Kingdom
, and ACTG O76 mother-to-child transmission studies, to illustrate this point.

Where’s the beef in bioethics?

He lamented that many of the fundamental ethical issues discussed today have been around for ages and ages, and we still have not solved them as there is no empirical knowledge. Among the examples are the lack of data on informed consent, surrogate decision-making at the end of life, and the ethics of using financial incentives to encourage healthy decision-making.

In closing, Zeke restated his desire to increase the intellectual rigor of the discipline so that the work of bioethicists will be important for the biomedical research field at large.
 
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