PRIM&R Website Maintenance Occurring this Weekend

PRIM&R is moving its servers to the cloud! As such, our website will be down from Friday, July 27, at 9:00 AM ET until the morning of Monday, July 30.

In the meantime, we encourage you to explore Ampersand to find out more about PRIM&R members, receive updates on the latest in research ethics news, and more. If while reading Ampersand you find yourself inspired, please do not hesitate to contact us. We welcome guest contributions and we would be honored to showcase your voice!

Please note that PRIMR will still be accessible by email and phone during normal business hours during this period. If you have any questions or need to contact someone, please email info@primr.org or call us at 617.423.4112.  Thank you for your patience.

Research Ethics Roundup: Free access to research, new policies in Europe, and more!

Recent changes to clinical trial rules in Europe, an emerging controversy over Food and Drug Administration (FDA)-approved anemia drugs, and heated debate over the bird flu moratorium are all in the mix in this week’s Research Ethics Roundup.

Europe proposes revision of clinical trial rules: The European Commission has formally adopted proposals for new rules to replace the controversial Clinical Trials Directive. Experts predict that these changes will reduce some of the red tape that has resulted in bloated insurance costs and a reduction in the number of clinical trials being conducted in the EU since the inception of the directive.

Free access to British scientific research within two years: According to The Guardian, the British government plans to make “research papers that describe work paid for by the British taxpayer free online for universities, companies and individuals to use for any purpose, wherever they are in the world." The goal is to implement this policy by 2014.

Anemia drugs made billions, but at what cost?: Researchers have uncovered a growing body of evidence that indicates that FDA approval for several popular anemia drugs may have resulted from the drugs’ benefits being overstated and their potentially lethal side effects being downplayed. According to The Washington Post, “the multibillion-dollar rise and fall of the anemia drugs illustrates how the economic incentives embedded in the U.S. health-care system can make it not only inefficient but also potentially deadly.”

Bird flu researchers to meet about research moratorium: What was to be a 60-day, voluntary moratorium on work with contagious, lab-altered forms of bird flu has now reached its sixth month anniversary. Researchers will meet in New York next week to discuss whether the high risk of a bird flu epidemic should impact scientists’ decision to conduct research in order to minimize the chance of an outbreak, or if it should motivate researchers to learn more about the virus in general. Concerns have also been raised over the limited involvement of nonscientific stakeholders, and the lack of transparency of these risks in the media.

Featured Member Profile: Darcy Hammar

Welcome to another installment of our featured member profiles where we will continue to introduce you to more of our members—individuals who work to advance ethical research on a daily basis. Please read on to learn more about their professional experiences, how membership helps connect them to a larger community, and what goes on behind-the-scenes in their lives!

Today we’d like to introduce you to Darcy Hammar, institutional review board (IRB) manager at Rocky Mountain University of Health Professions in Annapolis, MD.

When and why did you join the field?

I started as a non-scientist, unaffiliated IRB committee member in 2001. A former colleague was serving as the academic dean at a new institution and she thought I’d be a good fit given my academic background in the history of medicine and professional experience at several health-related associations. She was right, and in 2008 I became the IRB manager at the same institution.

What is your favorite part of your job?
The challenge of working in the “grey area,” where medical and social/behavioral studies intersect.

What is your idea of perfect happiness?
Summers in the Pacific Northwest with my family.

What are you reading?
I am reading Please Look After Mom by Kyung-Sook Shin.

What’s your after-hours guilty pleasure?
I’m not sure it’s a guilty pleasure, but I’m a knitter with a capital “K”. I have more than 30 years of experience knitting.

Why did you join PRIM&R?
To gain access to member resources! I’m not currently in a position to travel to PRIM&R conferences, so webinars and members-only resources are the next best thing.

What is your favorite member benefit?
The publications (Newsletter, Research Ethics Digest, and Ampersand) that help keep me up to date in the field.
What would you say to someone who is considering PRIM&R membership?
The benefits are well worth the investment.
What advice do you have for young professionals interested in pursuing a career in ethical research?
Every day is interesting, challenging, and rewarding.
Thank you for being part of the membership community and sharing your story, Darcy. We hope you are having a terrific summer out west with your family!
If you’d like to learn more about becoming a member, please visit our website today.

A Few Thoughts about Washington and Research on a Hot Summer’s Day

by Joan Rachlin, JD, MPH, Executive Director

Last week’s Food and Drug Administration approval of Truvada, the first drug to help prevent HIV infection in high-risk populations, was extraordinary, and extraordinarily well-timed. The announcement coincided with the opening of the 2012 International AIDS Conference, which was held in the US for the first time since President Obama lifted a travel and immigration ban on HIV-positive people in October 2009.

National Public Radio’s (NPR’s) coverage of the story included a rebroadcast of Magic Johnson’s announcement, some 20 years ago, that he had HIV and was thus retiring from the NBA. The presumed subtext of his retirement was that he would be “getting his affairs in order,” but today he is alive, well, and leading a very active life. This news, which has been mirrored in the experiences of millions, is thanks to biomedical research. Truvada is but the latest in a long and strong line of antiretroviral drugs that have turned AIDS into a chronic disease and not a death sentence.

Yet, as the 100 day run-up to the November election approaches, I’m left wondering whether other drugs and therapeutics will be developed should the political landscape in Washington change come January.

Just last week the House Appropriations Committee released the draft fiscal year 2012 Labor, Health and Human Services funding bill, which was quickly passed by the committee’s Labor, Health and Human Services, Education and Related Services sub-committee. As was reported last week by several of our collegial organizations, the House appropriations sub-committee bill places the well-being of Americans in jeopardy. This bill would require a “zero out” (i.e. termination) of funding for the Agency for Healthcare Research and Quality (AHRQ), effectively eliminating patient-centered outcomes research. In an email publication, the Association of American Medical Colleges (AAMC) described the key provisions of the bill:

• The bill "terminates" the AHRQ, effective October 1 (page 90-92).
• The bill contains a provision (page 84, section 217): "Notwithstanding any other provision of law, none of the discretionary funds appropriated by this Act may be used to support any patient-centered outcomes research."
• The bill rescinds funding for the Affordable Care Act (ACA)-created Prevention Fund and contains numerous other provisions intended to repeal health care reform efforts.
• The bill flat-funds the National Institutes of Health and cuts the Centers for Disease Control and Prevention budget by 10 percent.

Although this bill has virtually no chance of becoming law, given the current composition of the Senate and President Obama’s opposition to any decimation of the research enterprise, its mere introduction and sub-committee passage is a reminder that each of us can become active in this participatory democracy of ours by letting our congressional representatives know how we feel about research and the incalculable benefits it produces.

It’s also a good time to reflect on the meaning of ethics, which is commonly defined as “the discipline of what is good and what is bad, and moral duty and obligation.” Each of you reading this is steeped in the world of ethics and knows what the imperative to uphold high ethical standards requires. Thus, in addition to wishing you a lot of rest and relaxation with friends and family in the pre-election days, I also ask that you think about dashing off an email to your representatives and senators and to let them know what you think about this proposed spending bill, and about any similar attempts to hijack the health of Americans for political gain.

Stay well, stay cool, and always, onward in ethics and fairness.   

Research Ethics Roundup: Considering the 3Rs in the UK and more!

In this week’s Research Ethics Roundup, the 3Rs, bias in research, and compensation for research participants serve as food for thought.

What does the increase in numbers of animals used in research mean?: Statistics indicating that the use of animals in scientific research in the United Kingdom (UK) increased in 2011 were recently released. While some are concerned that this trend may indicate deviation from the 3Rs –reduction, refinement, and replacement– others believe the implications of these statistics may be more benign.

Why do we allow poor science to guide policy?: In this eye-opening piece on the relationship between research and policy, concerns are raised over whether scientific publishing, the basis for many policy decisions, is as objective and valid as it ought to be.

Guatemalans used in experiments deserve compensation: In the late 1940s, researchers from the United States Public Health Service exposed Guatemalan citizens to sexually transmitted diseases without their consent. Today, those citizens and their descendents are seeking financial retribution, and the authors of this opinion piece from The New York Times are on their side.

2012 IACUC Conference: What You Liked

By Maeve Luthin, Project Coordinator

Yesterday, we shared with you a list of items that we will work on to ensure that our 2013 Institutional Animal Care and Use Committee (IACUC) Conference surpasses your expectations. Today, we welcome you to join us as we relish some of the successes of 2012. Below are the top five successes that we hope to repeat in 2013:

1. Dazzling Speakers – Many of you enjoyed the opportunity to hear keynote speaker Bernard Rollin, PhD, speak and answer questions about his memoir, Putting the Horse Before Descartes. At the 2013 conference, we plan to line up a similarly dynamic speaker who will also be available to entertain questions and sign books.
   


2. Make New Friends, but Keep the Old – Whether it was while walking between sessions, eating lunch, or munching on hors d’oeuvres during receptions, you enjoyed meeting and mingling with one another. We will certainly continue to facilitate these informal opportunities in the future!



3. Marvelous Mentoring – Participants raved about Speed Mentoring. Not only were you able to get answers to specific questions, but you gained insight that you might not have otherwise received. Of course, mentoring was not just confined to this event—you reported that it was easy to find faculty members and attendees who were happy to answer your questions and offer you guidance.


4. Mixing it Up – There was something for everyone at the 2012 IACUC Conference! You attended content-rich sessions in a variety of formats. Some sessions were about the facilitators’ research, others provided guidance on best practices, and many gave you the opportunity to voice your questions and concerns. We aim to preserve this diversity when crafting the 2013 program, and urge you to participate in this process by answering our 2013 IACUC Conference Call for Program Contributions.
   


5. You Didn’t Curb Your Enthusiasm – The 2012 IACUC Conference would never have been a success if it wasn’t for your enthusiasm. You didn’t just travel to Boston to attend the program—you participated in the conference by asking speakers your questions, by networking with your colleagues, by signing up for special events, and by introducing yourself to others. This high level of interaction amongst attendees is what makes PRIM&R events so unique!

Thanks to all who attended the 2012 IACUC Conference—and a special thank you to those who shared feedback in the conference evaluation. We’re grateful to be part of your professional life!

Please mark your calendars for the 2013 IACUC Conference, to be held March 18-19 (with pre-conference programs on March 16-17) in Baltimore, MD.  We hope to see you then! Please don’t hesitate to contact us if you have any questions.

2012 IACUC Conference: What You Asked Us to Improve

by Maeve Luthin, Project Coordinator

Thanks to everyone who took the time to complete the 2012 IACUC Conference evaluation, we have tons of feedback on various aspects of the conference. As we continue to plan ahead, we promise to work hard to correct things those that did not go right this time around. We wanted to share with you our strategies in tackling the five items that you deemed most in need of improvement. 

1. Information Overload…and Disconnect - Yes, we do have two websites that require different usernames and passwords. Yes, you register for the conference on one, but all of the handouts are on the other. And, yes, we know that this can get a bit confusing. So, we’re going to step up our efforts to make users transition between the Conference Passport and www.primr.org more seamless. We’ll feature the link to the Passport more prominently on our website, and we’ll make sure that attendees get access to the Passport at an earlier date prior to the conference. We’ll also do better in making sure that posted copies of the program, attendee lists, and handouts are continuously updated. 
   


2. Short ‘n Sweet - Many of you expressed that you found the information in our Conference Attendee Newsletters to be extremely helpful...once you had the time to read them, and once you were able to find what you were looking for. We understand that you are busy, especially when preparing to leave the office for several days to attend an offsite meeting. We’ll continue our efforts to make our Newsletters full of clear, concise information, and we’ll be better about posting them on our website so they can be easily accessible at a later date.


3. Going Digital or Bust? - You loved it! You hated it! You liked a digital Conference Guide in theory but would hate to see the hard copy go! We hear you, and for the time being, we will continue to publish a paper version of the Conference Guide to meet your onsite conference needs. However, we will also be making a digital version available, as those of you with smartphones and tablets indicated it was a helpful resource.


4. Food, Glorious Food! - There wasn’t enough breakfast, and lunches went quickly. It was never our intention to transform our attendees into Olivers and Olivias during their time onsite! We’re working on making sure that this situation does not repeat itself next year.
   
   
5. Where’s Waldo? Where Am I? - The session descriptors that accompany each of the breakout sessions in the conference program are a collaborative effort between planning committee members and the faculty. Some attendees shared that they found the subject of conversation in their breakout sessions to differ from what was written in the session descriptors printed in the conference program. We’re working on ways to ensure that this no longer happens.

We’re extremely gratified that you attended the 2012 IACUC Conference, and that you took the time to share your thoughts about the meeting with us. We hope you’ll join us next year in Baltimore, where the 2013 IACUC Conference will be held March 18-19, with pre-conference programs on March 16-17. Thanks again!