Smart New Guidance Gives Institutions the Opportunity to Be More Efficient – Mystery Blogger

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.

A Win – Win Situation! – Guest Blogger Saradha S. (Part 2)

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Furthering my previous post, the 2015 IACUC conference organized by NWABR at Seattle this February left me with this – biomedical study protocols involving animals may not seem to be the most humane choice for many but more often than not, they turn out to be the best available choice.

The conference encompassed many aspects of IACUCs including protocol reviews, reducing regulatory burden, similarities/differences among ‘IACUC’ regulations around the world and much more. Of particular interest to me, though, was a session where researchers shared their experience in using non-primate animals under a research setting; this session showcased ways in which animals were subjects for research, aided research, and were saved by research. The takeaway for me – it’s not just about making use of them but being able to help them in turn. I met many people who not only had the right to work with animals, but felt the responsibility to protect them.

Some of these research teams have had issues such as long turnaround time to get protocols approved (highly disruptive for patients depending on studies like gene therapy) while some others are extremely happy with all the support and assistance they get from the IACUCs.

Such research that aims for the greater good is entrenched in ethical debate, it appears.

Kudos to the IACUCs for their efforts to instill strong ethical standards in every research lab that deals with such fascinating creatures as animals!

Kudos to the biomedical research community for the drive and dedication with which they strive to solve unanswered questions about animal and human health, despite all odds!

Kudos to NWABR for facilitating this great event!  Let’s continue the conversation.

Saradha is a Business development professional with international experience in marketing, inside sales and market research. She brings her MS in Biotechnology with post-graduate studies in business administration and several biotech industry internships to bear as a volunteer in the life sciences

Nothing Like Travel to Broaden A Perspective! – Mystery Blogger Brigade

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Immersed in our own uniquely American IACUC culture, it’s easy to become hyper-focused on the numerous (sometimes picky and occasionally onerous) rules and regulations that mandate and constrain our IACUC committees in the United States of America.

Kathryn Bayne’s recent 2015 Regional IACUC Conference talk on “IACUC Oversight Around the World” reminded us that we are not alone in the specialized world of animal ethics committees, and that across the globe, similar committees grapple with the same concerns, but work under somewhat different sets of mandates and constraints.

In many nations, the distinction between support for welfare and rights is not clear-cut.  USA IACUCs are mandated to consider animal pain and distress; in Europe, suffering and lasting harm are added to the mandated considerations.

While we weigh the “3R’s” in our protocol evaluations, EU places them in a hierarchy: 1-Replace, 2-Reduce or 3-Refine. Internationally, there are other “R’s” required such as Rehabilitation (India), and in Europe, Re-use or Rehoming (taking into consideration the lifetime experience of each animal), and Retrospective Review (was the protocol as severe as predicted, was the research goal met, were the 3 R’s complied with?) are added.

As responsible IACUC members, how might a USA IACUC committee’s deliberations change with the requirement that the committee include a representative of an animal welfare/animal rights organization too?  It is certainly food for thought.

Kind thanks to the submissions from professionals of the mystery blogger brigade. These folks are veterinarians, IACUC professionals, community members, regulatory officials and instructional professors who bring insight to the processes of the biomed community. We value your opinions and expertise.

Do you have a thought to share? Become a member of our professional blogger brigade.  Retain your anonymity, speak your mind in a collegial forum.  Contact conferences@nwabr.org for more information.

Just Say No To The Creep

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“When things go astray, don’t find fault, find SOLUTIONS!”

The above quote is my favorite message from the 2015 IACUC keynote of B. Taylor Bennett, Senior Scientist with the National Association for Biomedical Research (NABR).  Bennett shared some progressive strategies for reducing regulatory burden a.k.a. increased paperwork “creep” at a recent NWABR program. He also offered a general assurance that when IACUCs are in doubt, communication and teamwork outside silos is always the best strategy.  That’s great news for quality animal care.

But in practice it’s tougher.

I’m on an IACUC. Picturing our researchers as our customers, remembering that we have the mutual goal of humane care, remembering that as support services we exist because the researchers are doing research, and that regulations are used to promote humane animal care sounds simple, but working as partners takes awareness and practice.  The IACUC is one entity that must assure compliance with regulations - this is still important – but I was reminded that it is also our role to facilitate research and use policies and procedures that optimize humane animal care and use without increasing the paperwork wherever possible.

Paying attention to is key.

You’ll know the familiar feeling.  Regulatory creep feels like the distressing sensation of insects crawling on the flesh.  The main cause of creep is risk aversion – institutions so afraid of non-compliance that they create more policies that don’t accomplish much beyond frustrating researchers. Say NO to the creep! Taylor suggested that we decide on how to implement regulations focusing on involving investigators in the development of new polices and SOPs and protocol forms (that can become so complex that it’s even hard for the investigator to know what is approved)!

Bennett was an engaging speaker, an all-day conference contributor, and throughout wore a wonderfully colorful tie, indicative of his vibrant personality. Although we all know that red tape problems can’t all be solved in one day, we continue to make headway, and can all relate to his dual message of communication and personal accountability at our institutions.

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

Kari Koszdin is a veterinarian and participating member of everyday professionals blogging for NWABR.  We appreciate her insight and contribution, and grateful for her sharing a session from our recent NWABR 2015 Regional IACUC Conference. B. Taylor Bennett is an award-winning author and speaker.

A Learning Adventure! Mock IACUC Protocol Session –Guest Blogger Andrea S.

Attendees of the recent 2015 IACUC Conference participated in practice sessions designed to facilitate some hard choices.  Teams reviewed a “protocol” (a proposal for research).  Not only were participants asked to question whether the behavior of these “mock” proposals complied with the laws governing humane treatment of animals, but they were asked to consider the ethical questions of whether the proposal could pass to actionable as both compassionate and thorough.

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Ok, it’s a mouthful, but this year’s highlight was going over the Veterinarian Verification and Consult (VVC) process of minor vs. major protocol changes. This catchy new acronym was the talk of the conference and explained in detail during the event.  Simply, it’s like this:  If a scientist submits a proposed way of working with animals, and then and has a small change to add, does research that could benefit humans have to delay because of it?  Sometimes yes, sometimes no.  It depends on the scope of change.

An Institutional Care and Use Committee (IACUC) is unique to any organization that works with animals, and consists of at least one veterinarian who has training in laboratory animal science and expertise in the species under review and consideration, at least one practicing research scientist, at least one member whose primary concerns are in a nonscientific area (i.e., ethicist, lawyer, member of the clergy), and at least one person not affiliated with the institution to represent community interests in proper care and use of animals.

On Monday, February 23, 2015 our color-coded badges distinguished each attendee with a committee role. Despite the afternoon break sugar rush from the malted milk balls, MC James Riddle was able to quickly transition participants into forming mock IACUCs at each of the tables. Next, we sought to solve tricky VVC –related protocol scenarios.

It was easily the cherry on top of the sundae, aside from the sunny skies viewable through the large bay windows, but pairing with strangers served as a great networking opportunity for our regulatory community.  Allowing time to exchange expertise across multiple fields and backgrounds was invaluable. We could step Out of the Mouse Cage a bit, to see what perspective someone from a different institution might have.

Mock protocol review sessions during a conference, what a great idea!

Guest blogger Andrea S. attended last week’s Conference Beyond the Mouse Cage: Human Health in Motion at Bell Harbor. She currently supports IACUC work at Western Washington University.

 

Wild About Whale Research, Scatologically Speaking

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Have you heard the story about the rescue dog that is helping scientists understand why killer whales are struggling to reproduce in Puget Sound? If you were at the 2015 NWABR IACUC Conference, then you got to hear conservation biologist Dr. Samuel K. Wasser share an amazing story of hope.

Sam Wasser and his team identify dogs with intense ball-drive. They train the dogs to identify a variety of scat (yes, that’s poo) by scent from endangered animals in the animal’s native environment. For killer whales, this means the dogs like “Tucker” learn to track whale scat for scientists from boats on Puget Sound, braving the environmental challenges of wind, currents, and a 30 minute window to collect the sample before the whale scat breaks apart and sinks.

Collecting and analyzing samples enables Sam Wasser and his team to build robust, individual health profiles about endangered animals without ever seeing them, touching them, or disturbing their environment. Through these profiles, Sam and his team are able to understand the underlying nutritional, reproductive, and environmental factors that are impacting endangered species.

The dogs bring positive attention to research. Tourists on the whale boats ask their guides what the dogs are doing, and the guides help educate the public about how dogs provide scientists a better understanding of the environmental challenges facing the whales.

But the story is bigger than whales, if that’s even possible. The rescue dogs are helping to determine patterns in other threatened animals.  I came away inspired by Dr. Wasser’s creative, insightful, and practical approach to research, and the wonderful potential that exists when sound science and animal welfare intersect.

Institutional Care and Use Committees (IACUCs) like ones at the University of Washington take part in reviewing how these field animals will be used in research, and make recommendations for safety and compliance. Kind thanks to Shannon R., Regulatory Compliance Specialist at the Allen Institute for her thoughts and blog entry, and Sam Wasser for his ongoing important work!

My Favorite 2015 Seattle IACUC Moments

I attended last week’s Conference Beyond the Mouse Cage: Human Health in Motion at Bell Harbor and enjoyed many things about each of the topics, but considered sharing with those who missed the fun a summary of favorite highlights.

In morning basic session, Cindy Pekow was perfection during her introduction to Regulatory Basics. While the content is not all new, it’s still worth getting up at 4am in the morning for this session.  It’s packed with concise information that is perfect for folks new to the industry and for those of us lacking the early morning gene, it’s a great way to ease into the day, calmly reminded of the who’s, when’s and why’s that are the foundation of everything we do in support of our institutional research programs.

After lunch, NWABR hosted a departure from the strict regulatory topics in a panel of researchers who deal daily with non-rodent species in their work.  In the Beyond the Mouse Cage session, each of the speakers had something fantastic to say about how their efforts were benefiting man and animals as a whole.  Key elements were human emotion while caring for animals, the one-on-one correlation of disease (people/animal) and the environmental benefit.  For IACUC committees that don’t normally see issues with field work or hear pitfalls from the researcher’s perspective of the regulatory process, this session was enlightening and helpful.

In addition, there was the end of Conference Levity!  During the Compliance Updates, Taylor Bennett valiantly tried to remain seated but was repeatedly compelled by a greater force to launch from his seat to provide common sense responses to difficult questions. After each reply, he would return to his seat, only to pop right back up again.

Tena Petersen is a Manager of Regulatory Programs at the University of Washington Office of Animal Welfare.  She works closely with Preston Van Hooser, the OAW office co-sponsored Beyond the Gap post-conference activity and zebrafish facility Mock IACUC.​