Monday, March 30, 2015

Smart New Guidance Gives Institutions the Opportunity to Be More Efficient

By Shannon Reynolds, BA, CPIA, RLAT

Shannon Reynolds, regulatory compliance specialist at the Allen Institute for Brain Science, recently shared her experience at the Northwest Association for Biomedical Research (NWABR) 2015 IACUC Conference on NWABR’s official blog, "Thank Research!". We are pleased to share her thoughts and observations about a recent OLAW Notice Number NOT-OD-14-126, which was a topic of discussion at the conference. 

The Office of Laboratory Animal Welfare (OLAW) oversees the care and use of animals in research funded by the National Institutes of Health (NIH). IACUCs are responsible for oversight at the institutional level, which includes the review of research protocols and their compliance.

This past summer, OLAW issued guidance formally known as "Notice Number NOT-OD-14-126" (in government-speak), and it was a hot topic during the 2015 NWABR IACUC Conference.

In short, now some changes to an original research plan (or protocol) submitted by a researcher can be approved by a more efficient process. Instead of researchers resubmitting to the IACUC from scratch, a select group of changes can be reviewed against policies previously approved by the IACUC, through a process called Veterinary Verification and Consultation (VVC), with caveats.

Why would institutions want to do this? Mainly because it offers a new, more efficient method for IACUCs to approve small changes in the researcher’s roadmap that would otherwise need to be submitted to the IACUC for a lengthier review. This change will increase efficiency for IACUCs and researchers. VVC is a common sense approach to support the forward motion of research, while continuing to protect animals involved.

So, "This guidance sounds great, but how can I USE it?" Well, if you’re a researcher or administrator looking to escape red tape, you’re in luck.

OLAW has done its part to open the door to make compliance easier. Dr. Brent Morse, an Animal Welfare Program Specialist with the Division of Compliance Oversight at OLAW, recently provided a practical overview of the new guidance at the 2015 NWABR IACUC Conference, along with an explanation of the various options that IACUCs have for approving the supporting policies. The bottom line – institutions will need to do their part.

Your institution’s preparation of clear and specific policies will determine the extent to which this new guidance can be leveraged. While the guidance is fairly straightforward, the extent to which it can be implemented is not. It’s a move both respectful and smart. The veterinarian performing VVC is only verifying that the requested change is consistent with your existing IACUC-approved policies. It’s up to your individual institution working with your IACUC to support making the process easier still.

If you missed Dr. Morse’s talk, or if you still have questions about this guidance, I would encourage you to review the transcript of the OLAW Online Seminar on this topic which originally aired on August 21, 2014.

Of note for the strictly administrative among us, certain types of significant changes are still required to go through the "classic" IACUC review and approval methods (i.e., FCR or DMR). A subset of specific significant changes may now be administratively "handled" (not approved) through VVC. In addition, the description of the changes that qualify for administrative review has been expanded to include increases in animal numbers when the institution’s IACUC has supporting policies in place.

We’d like to thank Shannon for allowing us to share her thoughts from the 2015 NWABR Conference.

The 2016 NWABR Conference will be held in conjunction with PRIM&R’s 2016 IACUC Conference , March 30-April 2, 2016, in Bellevue, WA.

Friday, March 27, 2015

PAM: It's more than Post-Approval Monitoring; It's also Personality And Management "Style"

By Kathy Banks, BSc, MSc, continuing review coordinator, animal ethics, University of British Columbia 

PRIM&R is pleased to share a post from Kathy Banks, a member of the PRIM&R Blog Squad for the 2015 Institutional Animal Care and Use Committee (IACUC) Conference. The PRIM&R Blog Squad is composed of PRIM&R members who blog here, on Ampersand, to give our readers an inside peek of what happened during the conference in Boston, MA.

As the PAM Coordinator at the University of British Columbia (UBC), the session I was most looking forward to at the 2015 IACUC Conference was C11: Attaining a New Performance Plateau Through Post-Approval Monitoring (PAM). I was hoping to glean some insight from the presenters and make connections with PAM personnel from other institutions. I was eager to learn of everyone's successes and failures, how they set up their programs, how they handle non-compliance issues, how their reporting structure works, and more. Frankly, I wanted to pick everyone's brains (networking at its finest!) and use their good ideas to make the UBC program better.

I was not disappointed, to say the least.

The three presenters, Christina Nascimento, CPIA, MS, Sandra L. Wilkins, LVT, RLATG, CPIA, and Jon D. Reuter, DVM, MPVM, DACLAM, were fantastic. They brought their unique perspectives on all things PAM at their institutions (which ranged from large to small, public to private), openly sharing their ideas with us. I have to extend my thanks for all of their insight during their presentations and during the question/answer period. Many of the issues they faced setting up their programs (such as principal investigator (PI) buy-in, communication tips, strategies for resistance to the PAM process, etc.), UBC has faced. Much of the evolution their programs have undergone, UBC is/has undergone (including selecting the best number of PAM personnel, defining and redefining what the program is, and developing procedures for how PAM visits work). It was also reassuring to hear from them, and several others in the audience, that we're all doing very similar things to ensure PAM compliance within our institutions, regardless of the governing bodies to which we report.

The predominant messages/issues of this session were all very familiar to me – you need researcher/PI buy-in (if nothing else, you "kill them with kindness"), you need good communication (both ways, in whatever form works for you and them), you need people who have the right personality (to keep things positive even when they're not) and skill set (ideally a history in animal research), and you need trust (both ways). But the biggest discussion point, reiterated by everyone (and something I will hold in my back pocket), was the emphasis on the fact that PAM personnel are NOT the "police." Everyone in the room— from the speakers to the PAM personnel in the audience who hailed from all over the United States (and elsewhere)—emphasized how PAM should be seen as a resource, an educational tool, and a point of contact. This is the principle the UBC PAM team has been using since it started, and will continue to use as we move forward.

I came out of this session with a new found sense of purpose, several new ideas, and a new network of colleagues. the 2015 IACUC Conference was a long few days, but I was glad to be here, and I am already planning for the 2016 IACUC Conference meeting in Bellevue, WA (which is on my side of the continent this time, making it even more enticing). See you in 2016!

Thursday, March 26, 2015

I Am What I Am: How That Makes Me Successful in the Field of Research Ethics

By Anne Meade, MS, PMP, senior manager for website and social media

What makes you successful in your research ethics work? Is it a particular personality trait?  A set of skills you've developed? A combination of both? For the March Question of the Month, our People & Perspectives oral history project wants to know what you think about this question.

In this People & Perspectives compilation, Jeffrey Botkin, MD, MPH, and Kristina Borror, PhD, illustrate the traits they feel help them succeed in their careers:
"[it is] the ability to do…practical, collaborative decision making…so much of it is the ability to engage in practical problem solving and collaborative solutions that has served me well." – Jeffrey Botkin, MD, MPH
"Compassion, empathy for people who are hurting…not giving up when things get hard, and of course the boring analytical skills." – Kristina Borror, PhD
What traits or skills do you see in yourself or your colleagues that make you successful? Respond to the Question of the Month on the People & Perspectives website, or share a comment below.

Meeting the Challenges in Oversight of Wildlife Research

By Alexandra Shlimovich, webinar and publications specialist

PRIM&R recently hosted a webinar on Meeting the Challenges in Oversight of Wildlife Research. Afterwards, the presenters, John A. Bryan, II, DVM, MS , and Robert S. Sikes, PhD, answered questions submitted by webinar attendees for us to share with Ampersand readers. 

1. Can you share strategies for handling post-approval reviews of wildlife protocols?

Robert S. Sikes (RSS): Post-approval monitoring (PAM) can be accomplished in many ways. Although travel to remote sites might not be feasible, today's technology opens up many options not possible even a few years back. Digital recording is often easily accomplished if there are enough team members to ensure that actual procedures or animal safety are not compromised. Even a simple conversation with team members regarding procedures and any unexpected outcomes might meet the needs of the IACUC. Real-time communication can assist with unexpected events and has been used by many teams.

John A. Bryan (JAB): Indeed, there are many ways to get this done and technology is key in this day and age. We've had principal investigators (PIs) send in photographs, videos (some posted on YouTube), and written reports, along with telephone calls. Sending IACUC members out to observe field work is always great, and PIs are often receptive to this. Another recommendation (as shared by the USDA, APHIS, Animal Care) is to have designated individuals who may not be voting members of the IACUC, but who can observe and report back to the IACUC.

2. What are some examples of "management actions" that would be outside the scope of IACUC review? Could long-term population monitoring (that might even involve handling of animals) be considered a management action?

JAB: The analogy I often use here is the same that I gave during the webinar: you may have a graduate student whose dissertation involves the study of white-tailed deer (WtD) population densities in the context of habitat carrying capacity (whether or not WtD are eating themselves out of house and home) and involving lethal capture. The completed and published dissertation may state that there are indeed too many WtD in a given area, and that their overall herd health would be improved by culling. This may prompt the state agency that administers/manages that overpopulated area to do just that: cull some WtD. The culling action would be a management action, and would not necessarily require IACUC oversight. It would, however, need to be conducted with the utmost care and attention toward "best practices". Other management actions that would not require IACUC oversight might include spot interventions needed to ensure the health and/or well-being of an animal (e.g., a WtD caught in a fence). In some instances, relocation efforts may not fall under IACUC oversight (e.g., moving a species from one area to another for the sole purposes of re-establishing a population, with no intended research component).

3. Our occupation health physician is contracted through a local urgent care center and has little to no expertise regarding wildlife studies. Other than seeking out a specialist, how do other institutes deal with this issue?

RSS: It's unclear whether this question pertains to risk assessment or to treatment. If treatment, the most important step is to inform the health care provider of recent field work and animal exposure so that they can start thinking of zoonoses if necessary. If treatment is required, this situation warrants serious considerations of potential agents and perhaps consultation with specialists.

JAB: I agree. With risk assessment, the IACUC can do its best to inform collaborating physicians about the potential risks associated with patients coming in from the field; with treatment, that is the purview of the physician(s).

4. About half of our IACUC protocols have field research components. Periodically our investigators encounter a diseased or injured animal that is a non-target species and wish to give treatment or euthanize the animal. Investigators may not be trained in recognizing disease states or in euthanasia techniques for an off-target species. As an IACUC we recommend investigators leave the animal alone and contact appropriate state or federal agencies. Do you have any additional thoughts on encountering injured/diseased non-target species?

RSS: Injuries and diseases happen in nature. Some of these animals live and even breed long after an injury that an investigator might think warrants euthanasia. There are many accounts of three-legged wild animals doing fine. This is a situation where I would let nature take its course. This is true also for injured target animals where the injury was not a result of investigator actions.

JAB: Biologists and veterinarians keep more of an ecological perspective on their efforts, and are apt to let nature run its course (e.g., we don't airlift an elk with a broken leg to a vet hospital). Mountain lions and/or other predators will more appropriately take care of that situation. A dead deer in the forest has just as important a role to play in the health of that ecosystem as does a live deer.

Dr. Bryan and Dr. Sikes also shared a list of resources, which you can find here.

PRIM&R would like to thank Dr. Bryan and Dr. Sikes for sharing their expertise on this important topic. Do you have an idea for an IACUC-themed webinar? Share it with us at webinars@primr.org.

If you were unable to attend this webinar and are interested in purchasing the archive, you may do so here.

Wednesday, March 25, 2015

Key Notes From a Keynote: 20+ years Living in My Genes

By Kathy Banks, BSc, MSc, continuing review coordinator, animal ethics, University of British Columbia 

PRIM&R is pleased to share a post from Kathy Banks, a member of the PRIM&R Blog Squad for the 2015 Institutional Animal Care and Use Committee (IACUC) Conference. The PRIM&R Blog Squad is composed of PRIM&R members who blog here, on Ampersand, to give our readers an inside peek of what happened at the conference in Boston, MA.

Gene therapy! We can cure ALL the diseases! More than 20 years ago, this was (and still is, honestly) a fanciful notion, but targeted therapeutics was one of the newest advances in genetics. At the time, it was a field of study that found me (instead of me finding it), and I was smitten. The first gene therapy treatment was done in 1990, and it was HUGE news. When I started graduate school in 1996 (at University of British Columbia, in the Department of Medical Genetics), I was immediately plunged into this "new field" of research. One of my graduate classes was about gene mutations that result in diseases with classic genetic inheritance patterns, including cystic fibrosis (CF) caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

When I read that David K. Meyerholz, DVM, PhD, was one of the keynote speakers at the 2015 IACUC Conference, I knew his talk was something I could not miss. He studies lung diseases (asthma runs in my family), including CF. CF is a disease which has become much more personal for me as the daughter of a friend has it. With two scientists as parents, they know her prognosis, but they also know how science can change things. Dr. Meyerholz's keynote and the preceding interview with Avery Avrakotos, PRIM&R's education and policy manager, solidified my decision to attend.

Dr. Meyerholz showed us data from his research on CF and his insights from these studies. One of the main things he and his team have studied is a "chicken or the egg" question: what comes first in CF, inflammation or infection? This was a key insight that had been studied by many for a long time, but there were no means to answer the question as the existing genetic models were insufficient. By creating a workable and human-like equivalent model to study CF as it develops, they have shown that newborn CF lungs lack inflammatory cells, but are already prone to infection by bacteria. They found that CF neonates are born with airway defects that can enhance contamination of the lungs.They identified abnormal mucus in CF airways that gets "stuck", preventing cilia from sweeping the mucus and debris out of the lungs. Furthermore, they have shown that multiple "hits" to the defenses of the CF lung make the lung prone to infection to propagate the "cycle of destruction" in CF lungs. These breakthroughs came about because the science evolved, which created the possibility of the model, which in turn allowed the studies to take place.

In 1980, the life expectancy for a CF patient was 14. Thirty-five years later it has almost tripled to 37 years. Who knows where we will be in another ten or fifteen years? Based on the advances being made in understanding the disease and on my scientific background, my expectations are that the life expectancy will be extended even longer. So, maybe the thought that with gene therapy, we CAN cure all the diseases isn't so fanciful after all?