User Centric Makes All the Difference at NWABR and Quorum Review IRB Conference

by Marie-Térèse Little, PhD

The 2015 Revolutionizing Informed Consent Conference session topic Emerging Trends in Research given by Mr. John Wilbanks was especially riveting. Mr. Wilbanks is Chief Commons Officer at Sage Bionetworks and he has focused his career on advancing open content, open data and open innovation systems. With a bridge grant from the Robert Wood Johnson Foundation, Sage Bionetworks developed and maintains the Participant-Centered Consent (PCC) toolkit . The toolkit was built for architects of clinical studies who are interested in leveraging technology and employing electronic consents in a mobile context with the goal to make their informed consent user-centered, rather than document-centered. Wilbanks demonstrated that the publicly available PCC toolkit contains the building blocks of a visual, interactive approach to informed consent that creates visual summaries of consent forms mapped to key underlying text, for use in software or print. Visual summaries can assist with clarifying key research concepts so the participant is engaged, well-versed and cognizant of the risks, benefits and alternatives of a clinical study. A mixture of icons and text labels are designed to convey the essential concepts of a study in a more intuitive manner facilitating a meaningful and fulsome conversation about informed choices. The toolkit is used to develop mobile-centric informed consent processes for the collaborative clinical studies involving Sage Bionetworks. The tools are used to assist the learning in the consent process and include: tiered information accessed by the participant, pictorial dominant first tier information (with icons, text slugs and labels), a text dominant second information tier and a short learning assessment. The PCC toolkit was developed with the Electronic Data Methods (EDM) Forum, a project funded by the US Agency for Healthcare Research and Quality as a part of the Collaborative Methods Project. With this framework, one can only imagine our participants eagerly participating with fascination and engrossed in this engaging e-consent informed consent process.

 

Marie-Térèse Little, PhD is a volunteer member of Island Health clinical research ethics board on Vancouver Island, B.C. She worked at the Fred Hutch developing novel strategies for reduced intensity bone marrow transplants and she now lives in Victoria, BC with her family. Marie-Térèse is the founder and chief consultant at 4th Dimension Biomedical Research Communications (www.4Dbrc.com) where complex bio-medical and scientific information is distilled into clear, meaningful and comprehensible communications. Stay tuned for additional featured speaker sessions.

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Speak Up For Research Education Fund

How did science hook you?

Strawberry DNA extraction

Strawberry DNA extraction

Did you have a teacher whose lab was your favorite place to hang out in high school? Were you a biology graduate student who fought for better treatment of animals and found a calling in animal care or health ethics? Did you travel and see suffering that would be diminished with the right vaccination?

I got hooked as a member of the St John Ambulance Brigade in New Zealand where as a teenager I was able to volunteer in ambulances, hospitals and rest homes and saw evolving treatments driven by research.

I’m both excited about science and concerned about its future. I see a growing distrust in biomedical research, waning science literacy and an almost perverse celebration of anti-science sentiments; this all of course at a time when new biomedical research breakthroughs are occurring on a daily basis. Here at NWABR, we see the possibilities of science and are excited by the opportunities for young people to get hooked into fascinating and important science fields—but we also see a gap in the science education for the general public that results in twisted logic, misinformation, hijacked conversations and bad policy decisions.

NWABR bridges that gap, combats that misinformation, and leads spirited and informative conversations about complex issues related to biomedical research.  And we need your help.

Today, I’m asking readers you to join our newest fundraising initiative: the Speak Up For Research Education Fund.  Over the last two years more that 1,400 people have joined NWABR at a series of events:

  • Perhaps they volunteered for our popular Bio Expo that engaged close to 700 high school students;
  • Or they attended a Community Conversation on the ethics of end of life care, or vaccinations, or direct to consumer genetic testing.
  • Perhaps they are a professional dedicated to ethical protections for humans and animals in research and you attended one of our research conferences;
  • Or they attended our Security Conference and joined colleagues from across the country who are committed to keeping scientists, their facilities and their work safe.

This campaign to create a Speak Up For Research Education Fund is about protecting the belief and trust in biomedical research and ensuring that this work can continue robustly into the future.

Join the Speak Up For Research Education Fund and make a donation today by visiting:  https://donatenow.networkforgood.org/nwabr?code=Speak%20Up%20For%20Research

Alternatively you can send a contribution to the Northwest Association for Biomedical Research, 2633 Eastlake Ave E., Suite 302, Seattle WA 98102.

All supporters will be thanked by name in our public materials, unless of course they request to make an anonymous contribution.  All contributions will also be acknowledged with a tax deduction receipt.

This is a vital time for science – with the support of the Speak Up For Research Education Fund we can continue and expand the work of engaging students, families and communities with science.  With the support of this fund then one student at a time, one family at a time, one community at a time we will build support for, and trust in, biomedical research.

Thank you for Speaking Up For Research.

Kind Regards

 

Ken Gordon – Executive Director

Northwest Association for Biomedical Research

(P) 206-957-3337 (C) 206-595-2450

 

 

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

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.

 

Better Them Than Me? –Guest Blogger Saradha S.

NWABR features of series of volunteer guest bloggers over the next months who will be documenting programs, speakers and events. We thank each contributor for their time, talent and opinions.

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As a compassionate member of the public, my first professional foray into the much talked about field of bioethics happens next week.  I’m looking forward to a transition from coffee shop talk to finding out what really happens behind the scenes in biomedical research.

I come, as we all do, with questions. Is the scientific community really as unconcerned about bioethics as we make them out to be, or is there something that the public is missing here? While news pieces like this recent one get me thinking about the downside of using animals for research, it also makes me question all the big and small advantages I’ve (or anyone I care about) had from such research on animals, and it leads me to consider a conflict among the research fraternity about the best way to conduct animal research. How does such conflict get resolved? I want the real story.

It’s these and many such musings that drew me to NWABR and the 2015 IACUC conference organized in Seattle this February. I realized there was a lot more I needed to know about ethical research. I’m hoping that the IACUC conference will provide me an opportunity to learn more about how and why we consider our fellow living beings (animals) and how we are responsible to save, protect and treat them and beyond them, how we protect ourselves from disease and suffering. With luck this valuable forum enables our scientific community to interact among themselves and share their best practices to make sure animals are used in the most humane, painless and responsible manner. 

So I’m looking forward to catch a glimpse of the deliberation and debate around research animals and the role of the Institutional Animal Care and Use Committees gathered here!

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 development and several biotech industry internships to bear as a volunteer in the life sciences

Bridging the Gap at UW: A Post-Conference Networking Event and Zebrafish Facility Tour

zebra fish

Zebra Fish

It’s a fun, limited space event for members and attendees. 

It’s all happening on Tuesday February 24th following the 2015 IACUC Conference.  NWABR in partnership with the University of Washington Office of Animal Welfare sponsors the 1st Annual behind-the-scenes look at various components of UW animal care and use program and a guided tour/mock IACUC inspection of one of their state-of-the-art zebrafish facilities. 

You wanted low-key and casual – and here it is, a networking event bringing together IACUC administrators/staff, researchers, educators, leaders, government officials and others who play a role in conducting outstanding service to the research community. It’s a bit of training and touring, a bit of lunch, and an interactive mock-iacuc review.

We’ll exchange ideas that are instrumental in creating a culture of compliance. Our goal is to strengthen IACUC administrative relationships throughout the region, and learn from each other.

If you have an interest in attending, email to Janine at conferences@nwabr.org.

Bring ideas and a notebook. We are stronger when we share ideas, best practices and passion.  We’ll see you there. 

Janine Kennedy

Conference Lead

Northwest Association for Biomedical Research

Brown Fat to the Rescue

Insulin_leptin convert white to brown fatAs many of you might remember from your animal development lessons, mammals are born with brown fat, a type of fat that stores energy and releases that energy as heat–which is very handy in creating body heat for critters that cannot generate heat by shivering.  So cool (or hot, as the case may be)!  As mammals get older, brown fat is greatly reduced unless they are hibernating mammals. Mammals are then sidled with white fat, which many of us have come to know as love handles and muffin tops and in most cases just adds to our growing overweight and obesity epidemic.

Published today in The Scientist and in Cell, researchers Dodd et.al. in Australia have demonstrated a strong, if not causative relationship, between the conversion of white fat to brown fat through the hormones leptin and insulin.  These hormones have long been associated with metabolism, hunger and satiety and weight, but until now were not understood in this mechanism. Here is how it works: appetite suppressing neurons in the hypothalamus receive information from blood-borne leptin and insulin, telling the rest of the body, including fat tissue, that “we’re satisfied.”  In the lab, mouse models were designed such that genes were disabled for two phosphatase enzymes that dim the responsiveness of these hypothalamic neurons to leptin and insulin.  These mice converted white to brown fat and did not gain weight when fed a high-fat diet, unlike mice without the double gene knockout.

It will be interesting to study this mechanism in people, though we can’t use the same study design–genetic engineering isn’t possible in this way with humans.  That being said, I just might sign up for a Phase II trial on this work.  I’d be very enthusiastic about having more brown fat and less white fat!

Best regards and happy browning,

Jen Wroblewski