Don't forget - Become a part of PRIM&R's pod in June!

PRIM&R is thrilled to be celebrating 35 years of advancing ethical research! In honor of this milestone, those who join the organization in June will be entered into a drawing for a $100 American Express Gift Card. But there are other reasons to join PRIM&R’s “pod”! PRIM&R membership will help you to:

1. Do more with less.
   PRIM&R members receive discounts on PRIM&R educational programs, including conferences, regional programs, and webinars.
2. Stay informed.
   Our monthly e-Newsletter and bi-monthly Research Ethics Digest (RED) will keep you up to date on all the latest news and research in the field.
3. Expand your knowledge.
   View more than 130 presentations from seven of PRIM&R’s world-renowned conferences from your own desktop with PRIM&R On Demand. Peruse members-only online resources, such as best practices, standard operating procedures (SOPs), and recent headlines.
4. Advance your career.
   Take the CIP or CPIA exam at a discount.
5. Get connected.
   Find colleagues in your neighborhood using PRIM&R’s online membership directory. Build a relationship with a fellow member and get the answers you need through PRIM&R’s Mentoring Program. Share ideas, best practices, and information with peers through PRIM&R’s Online Communities.Build a local community and network of resources by hosting a PRIM&R Regional Connections event.

Join us today! You can join online, or by completing and returning a membership application. If you’d like more information about membership, please contact our membership team.

Season of celebrations

Posted by Joan Rachlin, executive director

It’s always a glorious occasion when we celebrate someone who has played a significant role in PRIM&R’s history. One such individual is Robert Levine, who has been a staple on our Board of Directors, in our program planning process, and at our podium for more than 30 years.

Bob is one of the most recognized and respected teachers, writers, and thinkers in the research ethics field, and it was thus fitting that he should be honored by Yale University, his academic home for over 40 years. The Center for Bioethics at Yale organized a lecture, dinner, and seminar in Bob’s honor June 8-9, and I was fortunate to be among those “feting” him.

The lecture was given by Tom Beauchamp of Georgetown University, another giant in bioethics, and focused on the Belmont Report, of which Tom was one of the drafters. His talk was a thoughtful, candid, and elegant recounting of the philosophical and ethical underpinnings of Belmont.

Tom posed the broader question as to whether there should be a “Belmont II,” and, if so, what it would look like. For example, some have cited “Belmont I” as being too protectionist and not representative enough. (Among other things, there is no explicit role for research subjects.) Tom indicated that he did not favor a “Belmont II,” although he did note that there was likely to be another national bioethics commission, and that it might take up some of the same issues the Belmont drafters raised. He felt, though, that any such commission’s first task was likely to be stem cells.

Another area at which a future bioethics body might look is the advisability of giving a more formal role to the community, but Tom stated that he did not favor such a process; his opposition originates from his concern that community consultation would dilute, or otherwise compromise, the primacy of an individual subject’s right to consent to participation in research.

Many of Tom’s comments loudly and strongly resonated given the fact that we are putting the finishing touches on PRIM&R’s 2009 Advancing Ethical Research Conference, November 14-16, 2009 (pre-conference programs will be held on November 13), coincidentally titled “Navigating the Future Using the Belmont Compass.” Tom’s powerful talk acknowledged that many cite Belmont as being too abstract to provide a sufficiently practical guiding force for those working in today’s highly complex research environment. He opined that Belmont has been “more revered than understood, studied, or practiced,” and noted that Belmont needs constant tending to and updating, as it is a evolving document and a “work in progress.”

What could be a better segue into my thanking our November conference planning committees for their vision and leadership in creating a program that will give all of us a chance to provide Belmont with the collective “tending to and updating” it deserves?

Bob sits on one of the planning committees and is one of the visionaries, and this posting ends as it begins, with warm felicitations to him for a brilliant and purpose-filled career-to-date.

Organizations Earn AAHRPP Accreditation

The following is press release issued on June 18 by Association for the Accreditation of Human Research Protection Programs (AAHRPP)

13 Organizations Earn AAHRPP Accreditation
The Universities of Texas and California add Organizations

Washington, D.C., June 18, 2009—Thirteen new Organizations earned accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP) a week ago, including two that joined others from their university systems.

The University of Texas Health Science Center at Houston and The University of Texas Health Science Center at San Antonio are joining the University of Texas at Austin as newly Accredited Organizations. And the University of California, Los Angeles, joins three others in the University of California System—Irvine, San Francisco, and Riverside—on the accredited roster as well.

In addition, one major teaching hospital and another independent children’s hospital joined the ranks of Organizations like theirs at AAHRPP, which has now accredited 188 Organizations with more than 900 entities.

The Organizations, all awarded Full Accreditation, are:

• Beth Israel Deaconess Medical Center, Boston, MA
• G.V. (Sonny) Montgomery VAMC, Jackson, MS
• Louisiana State University Health Sciences Center – Shreveport, Shreveport, LA
• Nationwide Children’s Hospital, Columbus, OH
• Overton Brooks VA Medical Center, Shreveport, LA
• South Texas Veterans Health Care System, San Antonio, TX
• Southeast Louisiana Veterans Healthcare System, New Orleans, LA
• Syracuse VA Medical Center, Syracuse, NY
• The University of Colorado Denver, Denver, CO
• The University of Texas Health Science Center at Houston, Houston, TX
• The University of Texas Health Science Center at San Antonio, San Antonio, TX
• University of California, Los Angeles, Los Angeles, CA
• VA Eastern Colorado Health Care System, Denver, CO

AAHRPP is a non-profit organization that works with Organizations that conduct human research to raise the level of protection for research participants. AAHRPP accredits Organizations that can demonstrate they provide participant safeguards that surpass the threshold of state and federal requirements. The accreditation program utilizes a voluntary, peer-driven educational model. For organizations interested in learning more about accreditation, visit http://www.aahrpp.org/.

Through the rigorous accreditation process, Organizations must demonstrate that they have built extensive safeguards into every level of their research operation and that they adhere to the highest standards for research. AAHRPP’s standards exceed federal regulations by requiring Organizations to address conflict of interest, to provide community outreach and education and to apply the same stringent protections to all research involving human participants. (Under federal regulations, such protections are mandated only for federally sponsored or regulated research.) The accreditation process typically results in system-wide improvements that enhance protections for research participants and promote high-quality research.

Accreditation is available to Organizations worldwide that conduct biomedical, behavioral or social sciences research involving human participants. Decisions on accreditation are announced quarterly, and accreditation is valid for three years.

OBOS Endorses Single Payer Healthcare

Our Bodies Ourselves' executive director, Judy Norsigian, has been a longstanding member of PRIM&R's Board of Directors. We felt the following press release might be of interest to our readers.

Our Bodies Ourselves Endorses Single Payer Healthcare
Single-Payer Models Are the Best Option for Women, Says OBOS Executive Director Judy Norsigian

06.15.2009 – Boston – Our Bodies Ourselves today endorsed the single-payer healthcare model as the most effective approach for solving the United States' health and medical care crisis.

In a comprehensive position paper, the nonprofit women's health organization argues that a single-payer model is best positioned to control costs and to reduce financial incentives that have led to both inadequate and excessive medical treatment.

Our Bodies Ourselves outlines exactly what women stand to gain from a single-payer system. The benefits are also the subject of an op-ed published Monday, June 15, in the Boston Globe, co-written by Judy Norsigian, OBOS executive director, and Jennifer Potter, MD, director of the Women's Health Center at Beth Israel Deaconess Medical Center and director of Women's Health at Fenway Health.

"The only national plan for healthcare reform that explicitly includes women's reproductive health services, including abortion, is one sponsored by Rep. Barbara Lee, a California Democrat," they write. "Other sponsors of single-payer plans are also amenable to including women's reproductive health services."

Lee is expected to re-introduce H.R. 3000, the United States Universal Health Service Act, this legislative session.

More than 10 benefits for women are discussed in detail in the position paper. Among them:

• Coverage is independent from employment.


• Coverage is independent from marriage.


• Single-payer system would encourage better care for chronic illnesses.


• Single-payer system would eliminate the need for Medicaid.


• Single-payer system would address the cost issues that send women into debt and bankruptcy.

Advocating for single payer is an uphill battle, but not a losing cause, said Norsigian, citing the current organizing efforts around single payer that are drawing congressional and media attention.

"Our efforts could also assist those now seeking to strengthen so-called public health insurance options designed to compete with private insurance companies," said Norsigian. "Though such government-sponsored health care plans are likely doomed to fail, they may ultimately be the only compromise solutions that could succeed in Congress."

The American Medical Association, which President Obama addressed on Monday, objects to a shift away from private insurance coverage, but Norsigian said that's to be expected.

"The AMA now represents fewer than 25 percent of all doctors, about 250,000. Although some doctors, mostly specialists, will have greater income under a private insurance system, most doctors view a single-payer solution as the best approach to health care reform. In fact, the second largest physician group, the American College of Physicians, which represents about 126,000 doctors, is on record in support of single payer," said Norsigian.

Polls indicate that a substantial majority of Americans would support a universal health insurance system based on Medicare. For example, a 2007 AP-Yahoo poll found 65 percent of respondents agreed with this statement: "The United States should adopt a universal health insurance program in which everyone is covered under a program like Medicare that is run by the government and financed by taxpayers."

"That this option has been so categorically rejected or ignored by most legislators in Washington, when the majority of the public clearly supports this approach, is reflective of a weakened democratic process that should be great cause for concern," said Norsigian. "Single payer is the best option for women and the best option for this country."

Just launched: PRIM&R’s new Career Center!

A lot of PRIM&R’s online initiatives have evolved over time, and our job board—now known as the Career Center—is no exception.

This self-service, one-stop shop allows employers to search a resume database, and lets job seekers create a profile containing their resume information. PRIM&R’s new alliance with the National Healthcare Career Network also grants access to job boards from more than 155 top healthcare associations, as well as 7,000-plus resumes from job seekers.

In times like these, efficiency is key. Whether you’re filling a vacancy or finding a job, the Career Center, in conjunction with the NHCN, targets highly qualified candidates or pinpoint the job that’s right for you. Check it out today! And be sure to bookmark http://careers.primr.org so that the newest applicants and the latest openings are never far from your fingertips.

If you have any questions or comments, please contact Anne Meade.

Doorsteps we’ve crossed in 2009

When your mission is to advance ethical research, it’s of tantamount importance to know that one’s work doesn’t exist in a bubble. Research—from the bud of an idea to a full-grown harvest of results—has widespread effects on those conducting it, those who review protocols, the communities who participate, and science at large.

"People conducting research need to understand the wider perspective on how their research proposals are evaluated," said a research professional who recently completed IRB 101^sm, one of PRIM&R’s At Your Doorstep programs, at the University of Wisconsin-Eau Claire.

Awareness of research’s impact must begin at the… well… beginning. And that’s just what participants of IRB 101^sm, and its follow-up program, IRB 250, learn. Participants from the University of Wisconsin-Eau Claire did just that: They reviewed the development of the US federally mandated system, then the underlying principles and procedures for reviewing research, and finally, the key components of the regulations that govern IRB operations.

While the Eau Claire attendees mostly conduct research for clinical trials or social, behavioral, and educational research, other At Your Doorstep participants conduct drug and device research; student and investigator initiated research; and research with populations who do not speak English. Still others oversee research efforts outside of the US and others maintain databases and registries. Such was the case with the Allina Health System, which hosted an IRB 250 program in April.

The benefit of courses that can be customized to an institution’s needs was immediately apparent to this group: One veteran IRB member with a 10-year affiliation appreciated that the content was tapered to her needs, and said she found the information very pertinent to her work. Many other institutions have been very pleased with the quality of learning included in these courses; you can learn who they are on our website.

We frequently hear about the benefits that refresher courses like IRB 101^sm and IRB 250 offer. If you could use a review of the federal regulations, and are interested in hosting an At Your Doorstep program, please contact Emily Hayden, program coordinator, via e-mail or at 617.423.4112, ext. 26, or complete the institutional survey for IRB 101^sm and/or IRB 250 and fax it to PRIM&R at 617.423.1185.

Interested in co-hosting an At Your Doorstep program with another institution? Please contact Emily Hayden, program coordinator, via e-mail or by phone at 617.423.4112, ext. 26. We encourage you to team up with institutions in your area to host a program.

(Photo Credit: WizardofWellness.com)

Monday Memories - 1981

What a view! This photo was taken in 1981 during a small meeting gathering of PRIM&R members and board members. Our records indicate the meeting took place inside, but these people couldn't seem to resist the gorgeous seascape. And who can blame them? If you are one of these cliffhangers, if you took the photo, or know anything about this little get-together, please let us know by leaving a comment below! We're continually digging through our archives, and look forward to hearing whatever details you're able to provide.

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.

Virtual Twins to End Animal Testing

Yesterday, New Scientist published the winning article from the New Scientist/NC3Rs’ "Beyond animal research" essay competition, "Virtual twins could bring the end of animal research" by Natalia Alexandrov. In this article, Alexandrov offers the notion of a computer-generated “virtual twin” that is developed as soon as a baby is born and updated throughout his/her life. Such a model would be created by combining historical averages and things like sex, ethnicity, and basic genetic makeup.

Alexandrov offers the following scenario to elaborate on some of the benefits of a virtual twin:

"When the boy is 10, flu leaves him with a complication - severe bronchitis. Which antibiotic to prescribe? The family doctor downloads Peter's virtual twin, updates it with the latest tests, and runs simulations for the range of available antibiotics to anticipate short-term and long-term effects. This identifies both the perfect drug and one that would have had a life-threatening, long-term effect on Peter's blood-clotting ability, possibly leading to a future stroke."

She also suggests that these virtual twins could mean an end to animal research. “There would no longer be a need to identify a population for a drug trial, nor would years go by in tests while desperate patients are waiting for a new drug.” Some of those who have commented on Alexandrov’s article disagree.

"No matter how far along this project comes along a computer model would not be able to PREDICT the reaction to a drug that has not been tested."

"The problem with using computer simulations is that they are only as good as the data that are used to construct them. We do not fully understand our own genome."

What do you think about the idea of a “virtual twin”? Read the entire article, and then let us know by leaving a comment below.

Come grow with us...Join our pod in June and win!

You’ve told us that you want advice when challenges arise; you’re looking for ways to stretch your budget; you crave substantive resources but don’t have time to look for them; and you want to be part of a professional community. Hear what current members have to say about how PRIM&R membership has helped to provide solutions to their most pressing problems….

You want advice when challenges arise.

"PRIM&R has been instrumental to my experience in the field. It has been invaluable to meet others who have the same goals and dilemmas. I have never left a meeting without benefiting from the knowledge shared by others."

You’re looking for ways to stretch your budget.

PRIM&R membership offers discounts on:

• Registration fees for most PRIM&R educational events;
• Exam fees for the Certified Professional IACUC Administrator (CPIA) and the Certified IRB Professional (CIP®) examination;
• Subscriptions to JERHRE; and
• Posting to the PRIM&R Job Board.

You crave substantive resources but don’t have time to look for them.

"I maintain my membership because of the 'one-stop shopping' concept with PRIM&R, networking, and the connection to other organizations and resources in this profession."

You want to be part of a professional community.

"[PRIM&R] is one of the few organizations where you can learn what is likely to be in the pipeline before it actually happens. It’s wonderful to be around people who speak the same language you do."

Join our pod in June and immediately begin taking advantage of our membership benefits, including early registration for the 2009 Advancing Ethical Research Conference!

Additionally, PRIM&R is thrilled to be celebrating 35 years of advancing ethical research! In honor of this milestone, everyone who joins in June will be entered into a drawing for a $100 American Express Gift Card. We offer two easy ways to join: online or via fax/mail.

Thank you for furthering our shared goal of advancing ethical research!

In May's Newsletter...

The most recent issue of the PRIM&R Newsletter (members only) was distributed on Friday, May 29.

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

• Notice of the last chance to register for two upcoming webinars;
• A summary of a conference call held between the Northwest Association for Biomedical Research (NWABR), representatives from the Office of General Accounting and Oversight (GAO), and members of NWABR about the investigation of Coast IRB following the GAO’s sting operation;
• A recap of Strategies for Institutional Officials: Addressing Conflicts of Interest and Quality Control, a webinar held on April 30, 2009;
• This month’s website feature of the month, the new PRIM&R video;
• A featured talk from PRIM&R Through the Years, a 532-page compilation of presentations delivered by internationally esteemed experts in the field of research ethics at PRIM&R's past annual meetings. This month’s feature is a panel from the 1990 Conflicts of Interest in Biomedical and Biotechnology Research conference, titled “Introduction to Conflict of Interest”;
• Information about “Gene Talk: What do we expect from Families and their Doctors?,” a US national study sponsored and funded by the National Institute of Health; and
• A list of those individuals who passed the CPIA exam in April 2009.

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

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