If IOM report suggests chimpanzees are not necessary in research, will their use become a thing of the past?

by Andrew N Rowan, PhD, Chief Scientific Officer of The Humane Society of the United States, PRIM&R Board Member, 1985-2010

The use of chimpanzees in invasive experiments has been a controversial issue for decades with proponents arguing that chimpanzee use is necessary to advance human health and opponents arguing that the practice is both unnecessary and unethical. Recent developments could lead to a possible resolution of this issue.

A National Academies’ Institute of Medicine (IOM) committee spent approximately eight months last year examining the necessity of using chimpanzees in biomedical and behavioral research. The final report, which was released in December, did not identify any area of biomedical research for which chimpanzees are critically necessary. In fact, the report was very clear in saying that most of the biomedical research that chimpanzees are currently being used for is unnecessary and their use should be curtailed.

According to the IOM report, the only areas in question are (1) pipeline monoclonal antibody studies—which are expected to conclude in the next year or so and (2) prophylactic hepatitis C vaccine efficacy studies—though the committee was evenly split on whether chimpanzees are necessary for this purpose. In addition, the committee, driven in part by its inability to predict future research needs, laid out a set of strict criteria that any biomedical study using chimpanzees should meet. As a result of the report, the National Institutes of Health immediately suspended new projects involving chimpanzees, and is currently working to implement the IOM recommendations.

The public clamor over the 1,000 or so chimpanzees remaining in laboratories led to the IOM’s critical examination of the relevance and necessity of their use in laboratory studies. The IOM findings, when combined with economic and ethical considerations, lead to the conclusion that society should focus on the further development of alternatives rather than keeping a tight grip on an increasingly irrelevant and ethically costly model. Invasive research on chimpanzees should come to an end and the animals should be given the retirement they deserve.

The IOM findings are in sharp contrast to recent claims (over the past two years) by biomedical research interests that laboratory chimpanzees still provide a vital research model. There are many other instances where the importance of animal research for biomedical advancement is trumpeted in the absence of any systematic and careful examination of the science. As biomedical research technology continues its meteoric advance, how many other types of animal research may be found to be superfluous? In 1969, Nobel Prize-winning immunologist, Sir Peter Medawar stated that “we must grapple with the paradox that nothing but research on animals will provide us with the knowledge that will make it possible for us, one day, to dispense with the use of them altogether.” We are approaching a period where animal research studies will become less common and less essential. Care should be taken not to continue to press for laboratory animal studies just because they may have been important in the past.

WHO publishes standards for human subjects research

by Avery Avrakotos, Education and Policy Coordinator

When not serving as a member of the faculty at PRIM&R’s Advancing Ethical Research Conference, Nancy Kass, ScD, deputy director for public health at the Johns Hopkins Berman Institute of Bioethics, plays an integral role in the development of research policies for human subjects research.

As a member of the World Health Organization (WHO) Research Ethics Secretariat in Geneva (2009-2010), Kass served on a team tasked with preparing a new set of ethical guidelines for research with human participants. 

“Our goal was to provide global guidance and a minimum set of standards that research ethics committees (RECs) throughout the world are expected to follow,” said Kass. The team’s efforts resulted in the publication of “Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants.”

The document, a compilation of 10 standards for ethics review, outlines standards and guidance for RECs members, committee staff, and the institutions that constitute and oversee such committees. It is based on existing international guidance documents and was created in response to recommendations that the WHO provide benchmarks by which RECs could measure performance and procedures.

“It is important that countries, researchers, and collaborators know the expected standards for high-quality research ethics committees and have guidance on how to create and maintain them,” said Kass.

What is your take? Have you reviewed the WHO guidance? Does the document meet its stated aims?

Thank you to Nancy Kass and the Media Relations Office of the Johns Hopkins Berman Institute of Bioethics for providing the content for this post.

“Science Times” synthesis

If your sweet tooth is wishing those Valentine’s Day chocolates had lasted just a little bit longer, there is good news for you in this week’s “Science Times” synthesis! This week’s round-up is filled with “sweet” stories—from a dessert triumph to a tale of altruism—so grab some dessert and read on!

Week of February 21, 2012

Despite safety worries, work on deadly flu to be released: Following a World Health Organization meeting with public health and flu experts, research, which some feared could be used to start epidemics by terrorists, will be released.

Dessert at breakfast may help dieters: A recent study found that dieters provided a high-carbohydrate, protein-enriched breakfast with dessert were more likely to lose additional weight and keep it off over a 32-week period.

Sixty lives, 30 kidneys, all linked: A Good Samaritan and technological advances set off a chain of 30 kidney donations in this heartwarming and inspiring piece.  

Microchip implanted to deliver drug shows promise in trial: The first human trial of a microchip drug-delivery system, led by scientists from Harvard, MIT, and Case Western Reserve University, yields positive results.

Week of February 14, 2012

What’s new? Exuberance for novelty has benefits: Long thought to be a negative attribute, new research suggests novelty-seekers may be healthier and happier as they age.

From 9/11, a lesson on whales, noise, and stress: Research that was ongoing during the September 11 attacks suggests that noise from ships increases the level of stress in whales.

Solutions in Budgeting: An IRB Process

by Mindy Reeter

It’s that time again. No, not tax time, but institutional review board (IRB) budget-writing time! My university’s fiscal year begins July 1, and preparation always starts early.

As a community IRB, we are supported financially by community partners. Many years ago, when the research volume was much less, such support came at a standard flat rate. In 2006, however, the need for a new way to calculate the cost for services became apparent as the research volume fluctuated among each partner,.

That year, we developed and initiated a method called the Agenda Scoring Method. Each item that appeared on our IRB’s agenda in the previous year was counted as an individual action. On IRB forms, one participating community partner is designated as the active research site. This helps to ensure that we know who to allocate the points to. Points are then assigned to each item based on the staffing and resources required to provide substantive and meaningful review.

The scale used to assign points is shown below:

• New Full Board Protocols = 4 points [1 IRB specialist for pre-review, IRB chair review, secondary reviewer, convened board]
• Full Board Changes in Research and Continuing Reviews = 3 points [1 IRB specialist for pre-review, primary reviewer, convened board]
• Unanticipated Problems Involving Risks to Subjects or Others, Expedited and Exempt New Studies = 2 points [1 IRB specialist for pre-review, IRB chair review and approval]
• All Others  = 1 point [1 IRB specialist, IRB chair review and acknowledgement]

Points are assigned, and tallied for each community partner. Percentages of research volume based on these numbers are presented to the Liaison Committee, an IRB advisory committee made up of community partners, in March.

Community partners are known as variable-fee partners or non-variable fee partners. Variable-fee partners are invoiced for IRB services based on the percentage of their usage in the past year. Non-variable fee partners are invoiced at a set rate for IRB services regardless of their usage.

The variable fee partners’ contribution is determined by the difference between the projected expenses for our IRB and the revenue generated from the non-variable affiliates’ set rate. This difference is then divided among the variable fee affiliates according to as the weights calculated by the Agenda Scoring Method.

Budget numbers for the variable fee affiliates are presented to the Liaison Committee in June for acknowledgement before the university’s budget deadline of July 1.

This method of cost allocation has worked well for our IRB. IRB expenses have remained relatively constant—salaries and benefits, IRBNet fees (electronic submission solution), food for meetings, and PRIM&R membership and conference fees.  Our portfolio of community partners has remained stable and committed to our vision of being an exemplary and innovative IRB that aims to respect and protect people in the Central Illinois region who participate in human subjects research.

Connecting with PRIM&R’s support

by Susie Hoffman

I’m writing to tell you about one of PRIM&R’s little-known membership benefits:  PRIM&R Regional Connections.

I first took advantage of this benefit in 2007 to convene the inaugural Virginia Institutional Review Board (IRB) Consortium conference. My goal was to provide a low-cost education and networking opportunity to IRBs throughout Virginia. The Virginia IRB Consortium conference has blossomed into an annual event. I cherish the sense of community that this event brings. It is always wonderful to make connections with new colleagues and to watch their eyes light up as they realize they have found others that actually know what an IRB is all about! The growth of the event over the past five years has, in part, been sustained by support from PRIM&R Regional Connections. 

PRIM&R Regional Connections aims to foster connections among PRIM&R members and their colleagues. In order to meet this goal, the program encourages individuals to plan regional events. The events can be as simple as a networking gathering or as complex as a full day conference. To help along the way, PRIM&R provides planning resources such as checklists, timelines, and helpful tips. The most amazing aspect, however, is that PRIM&R can provide up to $1,000 in funding to help defray costs! In these tough economic times, this funding can be the lifeline institutions and individuals need to create new educational and/or networking opportunities. PRIM&R will also work with the host to connect them with an individual who has already hosted a PRIM&R Regional Connections event and who can help you think through the process and provide insight into possibilities. 

The only requirement to take advantage of PRIM&R Regional Connections is that you must be a PRIM&R member and you must apply. PRIM&R can help you plan, market, and execute your event. Based on my own experience, I would encourage you to get started today by learning more on the PRIM&R website. As funding is limited, please don’t delay! Complete the PRIM&R Regional Connections Application for Funding today!

Many thanks, Susie, for making sure your fellow members are aware of this way to connect with one another! PRIM&R has been proud to support the Virginia IRB Consortium and congratulate you and your colleagues on its continued growth.

'Science Times' synthesis

Can you believe that February is already here? As the months of winter continue to fly by, let’s take a moment to see the latest happenings in the world of research in this week’s ‘Science Times’ synthesis. Drop us a comment and share your thoughts on the articles below.

Week of February 7, 2012

Fallout from fatigue syndrome retraction: Sufferers of chronic fatigue syndrome are dismayed as a study linking and mouse retroviruses is retracted.

Cancer-deterring drug found to harm bones: Scientists were hopeful that extemestane could be used to prevent breast cancer, but new studies link the drug to significant bone loss.

Sloan-Kettering chief accused of taking research: Accusations bring the question of intellectual property to light as a former University of Pennsylvania employee allegedly used research conducted there to create a new, valuable biotechnology. 

Week of January 31, 2012
Don’t censor influenza research: An op-ed piece argues that by censoring research on a highly transmissible, deadly form of influenza we are thwarting our ability to combat the virus should a pandemic occur.
DNA turning human story into a tell-all: As genetic sequencing technology continues to advance, a new and complex portrait of human origins is emerging.

The perils of ‘bite-size’ science: Increasingly, in the behavioral sciences, academics are publishing shorter articles. Two researchers argue that the shift should be worrisome.

More fun than Disney? Being a blogger at the 2011 AER Conference

Dawnett Watkins was a member of the PRIM&R Blog Squad at the 2011 Advancing Ethical Research Conference. In the post below, she reflects on her experience.

It’s the middle of winter (if you can call 70-degree temperatures winter!), but I can’t stop my mind from drifting to visions of next December and San Diego, where the 2012 Advancing Ethical Research (AER) Conference will be held. Why am I thinking about the conference now? Because I know that in just a couple of months, I will be receiving an email encouraging me to make my reservation at the conference hotel, and just like that I will be booking my room for next year’s conference (even if I don’t have approval to attend the conference yet)!

Why am I always so excited for PRIM&R’s annual conference? I always learn something new; after eight or nine years of attending, I have yet to repeat a session. There are always more sessions than I can possibly attend (outside of cloning myself, which I’m pretty sure is against the rules). In addition to having an opportunity to attend engaging workshops and plenary presentations, I have met so many interesting people and found answers to questions answered that I didn’t even know I was looking for.

Sure, there are times that I walk away completely overwhelmed, like the first year I attended and found out how incredibly important having written policies and procedures was. By the next year was patting myself on the back for having created and implemented written policies and procedures at my institution.

The 2011 AER Conference was by far the most fun I’ve had at conference. More fun than Disney? Well, okay, more fun DURING the conference than ever before. Why? Being a member of the PRIM&R Blog Squad was a lot of fun. The only negative aspect was having to wear a red PRIM&R Blog Squad shirt the whole week—my alma mater (Oklahoma State University) was scheduled to play their in-state rival, the University of Oklahoma, in what was to be one of the best football games ever (from an OSU fan’s perspective anyway). I was being asked to wear the color of the rival team all week! Never fear, I had a solution, I planned ahead and brought plenty of orange shirts to wear underneath the bright red. And, in the end, I didn’t get burned by the red, and I still had fun with the whole blogger thing. So, if you’re reading this and thinking maybe, just maybe you’ll apply for the blog squad this year— go for it! I never dreamed that I would be one of the lucky ones to be picked for the PRIM&R Blog Squad, and yet here you are reading my blog! Who says learning can’t be fun? See you in sunny San Diego!