Hope from tragedy

Thomas Gray lived six days, but his life has lasting impact

Sarah Gray, above, looks over some of the research information about the donated retinas from her late son, Thomas, as her son Callum looks on during a recent visit to the University of Pennsylvania’s Anatomy Chemistry Building in Philadelphia. (David Maialetti/TNS)

There was a compelling story in April 5’s Seattle Times.  The story discusses Sarah Gray who gave birth to twins, knowing that one of those twins, Thomas, was not going to survive.  Thomas died at six days.

To try and pull some goodness out of this tragedy Sarah donated his eyes, his liver along with umbilical-cord blood for medical research purposes.

What made this story compelling is that Sarah followed up with the research institutions to find out what had occurred because of the donations.  She travelled to and met directly with researcher’s that had had access to Thomas’ tissue, was able to see the research reports and other findings directly attributable to that tissue, and was able to also see the growing list of citations for the next level of research projects that in essence were extensions to that original work with Thomas’ tissue.

James Zieske the senior scientist at an Eye Institute at Harvard Medical School told Sarah:

“Your visit helped to remind me that all the eyes we receive are an incredibly generous gift from someone who loved and cared about the person who provided the eyes. I thank you for reminding me of this.”

James also told Sarah that Thomas’ cornea was used in a study that might one day cure corneal blindness.

This article again reminded me of the breadth of work occurring in the biomedical research field, the breakthroughs that are happening every day – and the total reliance of science on both the generosity and support of the public for this work.

We are all beholding, to Thomas and his family for the gift that they made.  As we are also beholding to the millions of individuals who through these most intimate and sacred donations have contributed to the knowledge that we all now totally rely on.

Thank you

Ken Gordon

Executive Director

NWABR

Speak Up for Research-Blog Series (Part 1)

I am an advocate at my core. I am passionate about democracy and civics; culture and philosophy and I care deeply about systemic issues that impact social justice and equality, education, health, and the environment. This passion has always been part me.

I grew up in a family who valued service, giving to the community, and looking after others. My passion, though, became augmented during a research project I undertook during graduate school called the Citizen Divide, Time for a Change of Mind. The research focused on divisions in society that lend to distrust and, in turn, limit progress.

Today, I find myself working for the Northwest Association for Biomedical Research using my passion to promote the public’s trust in biomedical research and its ethical conduct. Out of this intersection between passion and work, civics and science I am coordinating the Annual Life Science Celebration with the aptly named theme Speak Up for Research. This blog series explores the civics issues facing science.

Over the past three years I have been dwelling on the question: Why are we divided? This question has transformed into research on how narratives influence human behavior, social norms and ultimately outcomes for society and public policy. My interest is in learning about the possibilities of influencing behavior to create societal norms that lead to collective understanding and amity in society. My findings center on the need for more collaboration between people with divergent views, cultural and social backgrounds as well as people from various socioeconomic circumstances. Ultimately, I envision a world where human dignity is upheld and where political conversation is not bemoaned. My hope is that civic discourse will entail a process of learning and developing collective understandings that limit discontent and disenfranchisement.

These ideas translate well to the mission of NWABR. When one considers the challenging questions facing the medical research industry, science, and society, one realizes that collectively we have many difficult questions to answer. These are more than questions about scientific data or knowledge; these are questions about our values. For example, what place does stem cell research have in medicine and society, and what conversations should we be having to facilitate its progress?

This question and others remain unanswered in the general public, and, like the safety of vaccines, the use of animals in research these issues persist without deliberative dialogue and often in a contentious manner. Science has witnessed several periods of revolution of thought and faced enormous obstacles, yet it has been the fundamental mechanism for formulating our collective understanding of our world. Is our society at an inflection point now? Is science at the forefront of that inflection? The polarization becomes evident when we analyze the state of public opinion in contrast with scientific understandings.

The Pew Research Center published a report, Public and Scientists’ Views on Science and Society, based on surveys from U.S. adults and a separate survey of scientists who belonged to the American Association for the Advancement of Science (AAAS). The report cites several examples where the body of scientific knowledge contrasts sharply with the views held by the general public. On issues from using animals in research, evolution, climate change, and more, public opinion is divergent from the general scientific consensus. What’s more is that we continually see this translating into our formulation of public policy.

Additionally, we continue to see growing mistrust of institutions of all types, and the messages of animal activists are becoming more succinct and powerful. This is a worrying trend, especially when it leads to barriers and obstacles to positive progress. It seems, then, that we are at a crossroad, and we need to evaluate our course of action and approach to public discourse. The Speak Up for Research Gala is an idea that offers, at the very least, an approach and space to envision a new path forward.

What would that path look like? Look for my next blog to find out more, and Join us for the Speak Up for Research Gala

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.