People Not Paperwork: Perspectives from the 2015 Institutional Review Board Conference

On July 23rd in Seattle, WA co-presented by NWABR and Quorum Review IRB, the Revolutionizing Informed Consent Conference brought together scientists, researchers, ethicists and community members to discuss a way to create a better experience for participants in human clinical trials. The “consent document” is a confirmation of the consent process that explains the nature of the research and any risks and benefits to a participant to communication required throughout, but informed consent is an ongoing process. It starts before any forms are signed, and it continues through the completion of the subject’s involvement in the study. A copy of the consent document is reviewed by the IRB before it is presented to prospective participants.

With her daughter, Marie-Térèse Little, PhD, WIRB scholarship recipient.

With her daughter, Marie-Térèse Little, PhD, WIRB scholarship recipient.

Guest blogger and biomed community member Marie-Térèse highlights some of the presentations that were fascinating and thought provoking. We appreciate her contribution, each of the participants attending, our speakers, planning committee, our sponsor partners WIRB, CITI and Fred Hutch, and Boston University for supporting the important work of creating dialog among experts to discuss practical advocacy and compassion for human subjects.

People Not Paperwork

It is clear from the thought-provoking presentations from speakers across North America offered at this year’s conference of Revolutionizing Informed Consent that innovation and technology are indeed starting to revolutionize the informed consent process. These seminars challenged the status quo and how we contemplate this important process in the context of clinical research. Mr. Zachary Hallinan, Director of Patient Communication and Engagement Programs at the Center for Information and Study on Clinical Research Participation, presented Barriers to Change in the Informed Consent Process – a Systematic Review, addressing the barriers to improving consent, general environmental factors affecting patient satisfaction in the informed consent process, instruments for measuring consent and how the current informed consent model impact enrollment in clinical trials.

Mr. Hallinan’s findings concerning the many environmental factors within the consent process affecting patient satisfaction include: limited time to deliberate, feeling overwhelmed by the initial diagnosis, being asked to produce a written consent (for patients with life-threating diagnoses), feeling responsible for their own treatment decision, the physician’s medical language and the structure of the consultation, not enough detail and conversely, and too much detail. It is interesting that some patients simply do not want to be responsible for their decision to enroll in a trial.

Satisfaction appears to result from the actual discussion rather than the document itself. Surprisingly, there is no real evidence to suggest that the informed consent document increases or decreases enrollment; however, there was a positive correlation between the informed consent discussion and enrollment rates. This research is valuable and practical because it reminds us in the research ethics community the value of the entire consent process complete with an open, dynamic discussion, not just a document or a signature. Hallinan’s important presentation was both in-depth and stimulating and culminated with a plea to re-focus on the primary goal of educating and informing participants about the trials so that the decisions they make are truly informed. From his comprehensive research, Hallinan recommends that IRB (and REB) policies and procedures be revised to facilitate collaboration between ethics review communities.

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 ( where complex bio-medical and scientific information is distilled into clear, meaningful and comprehensible communications. Stay tuned for additional speaker sessions featured this month.


Looking for Community that Cares, Creates and Connects?

Yes, NWABR’s goal is to promote the public’s trust in biomedical research and its ethical conduct. But what does that really mean?  How can we achieve this goal?  By building a strong community.

I am passionate about community. I believe that while many of us network and relate to one another through a smartphone, we also crave interactions in face to face settings.  NWABR offers many opportunities for face to face community building: professional conferences, our upcoming Speak Up for Research Gala (Are you in? Student BioExpo, Camp BioMed (sign up your student today), Speakers Bureau engagements and our Community Conversations in Portland, OR and Spokane and Seattle, WA.

In Portland, the Community Conversation Series is receiving rave reviews about our facilitators and topics, but also about the sense of community we are creating.  “Great event.  Will be seeing how I can use this to get others invested in the community.”  Another attendee remarked, “I believe that only by sharing our ideas and thoughts can we grow as individuals and communities.”

Join our growing community by coming to a Community Conversation for the first time or reconnect with us.

Seattle: Tuesday June 9th, “Doctor’s Office Research.  What’s it to you?” Facilitated by Dr. Ben Wilfond, Seattle Childrens. Issues of informed consent and perception of risk in research participation.

Portland: Tuesday Aug 25th (to be confirmed), “Humans and food animals are One Health: Antibiotic resistance development through food animals.” Facilitator TBD

Spokane: Fall 2015 “Humans and food animals are One Health: Antibiotic resistance development through food animals.” Facilitator TBD

Seattle: Fall 2015 “Humans and food animals are One Health: Antibiotic resistance development through food animals.” Facilitator TBD

Chris Rivera, CEO of WBBA Speaks Up for Research: Sites Economic Impact!

Record Year in Washington Life Science Investment Activity Sets the Stage for Life Science Innovation Northwest Conference in June
By Chris Rivera

Since the start of the global economic slide in 2008, the life science industry waited for a sign that the economy has made a turnaround. Last year’s financial activities show without a doubt the recovery is in full swing. In 2014, more than 50 Washington life science financial transactions – IPOs, mergers and acquisitions – amounted to more than $1.6 billion. This financial milestone is more than double the amount generated by 73 transactions in the state’s life science industry in 2013. Of particular note were Juno Therapeutics and Adaptive Biotechnologies, which together raised almost a third of last year’s total financial transaction activity.

In fact, the last two years may be the most active in the history of Washington’s life science industry, a testament to the state’s ability to attract talent and capital in a globally competitive marketplace.
All of this financial activity in Washington bodes well for the upcoming Life Science Innovation Northwest (LSINW) Conference June 30 and July 1 at the Washington State Convention Center in Seattle. The 14th annual LSINW is the largest fully-integrated life science exposition in North America, attracting attention from large strategic partners, venture capitalists and private equity firms to our region’s great innovations in the life sciences.

Despite the early success of Seattle firms such as Juno Therapeutics and Adaptive Biotechnologies and others, it’s often hard for young biotech companies to secure enough venture capital funding and hire more of the nation’s top talent.

LSINW brings together 1,000 life science executives and industry supporters for two days of discussions and relationship-building that helps develop the Northwest into one of the largest globally recognized bio clusters in the world. Currently listed as #7 on the Genetic Engineering & Biotechnology News list of major bio clusters in the world, Washington is considered a rising star by many large investment firms.
With more than 34,000 direct and 90,000 indirect jobs, the life sciences industry is one of Washington’s largest economic sectors, adding more than $7.3 billion to the state’s GDP. Washington is known for the birthplace of commercial jets, the $2 cup of coffee, and software than runs most of the world’s personal computers. Less celebrated are the many scientific breakthroughs that originated here: ultrasound imaging, cardiac defibrillators, and the first bone marrow transplant. The creativity and energy that launched these and many other life-changing products and procedures still exists today, and the future bodes to be even more amazing than the state’s storied past.

I encourage everyone to attend LSINW, June 30 and July 1. Engage in conversations in support of this very important industry for our state. Over the next decade, I truly believe Washington will establish itself as a global leader in life science innovation and health care delivery.

Chris Rivera is President and CEO of Washington Biotechnology & Biomedical Association (WBBA), the life science trade association for Washington State. WBBA has over 650 member organizations in the biotechnology, medical device, health IT, bio-fuel, bio-agriculture and veterinary medicine industries. Further information may be obtained at

Breaking Brain Science News

Good Morning

The Allen Institute for Brain Science has released the initial results of part of their effort to map the human brain.  This initial release includes a database of identified neuronal cells which is being made freely available to the public, researchers and clinicians around the world.  The identified cells are being classified by shape, size, activity and other measures.

The release of this data continues the significant philanthropic contributions from the Allen family.  Often their contributions have been financial however this online database will give life science researchers a tool that will one day be key to the understanding of how our brains work.

Have a great day.

Ken Gordon

Executive Director

Guest Post: Animal models in research are necessary and ethical

Speaking of Research

The following post was originally published in The Daily of the University of Washington on April 26, 2015. It has been reproduced with permission from the newspaper and the original author. Benjamin Cordy is a neurobiology student at UW, he is also the Editor-in-Chief of Grey Matters Journal – an undergraduate neuroscience journal whose mission is to educate the public and develop effective science communicators.

Guest editorial: Animal models in research are necessary and ethical

On Saturday hundreds gathered in Red Square to voice their opposition to scientific research. At its core, this is the true message of the animal rights movement, which believes that research should never rely on animal models. The march on UW was about stopping science altogether. Is this really the best move for society?

Debates about animal models in research are emotional, contentious, and unfortunately, often fraught with demonstrably false “facts.” This is a serious…

View original post 913 more words

Gregoire and Gorton Speak up for Research

Good morning all

There was a great article in Crosscut on April 17 from former Governor Christine Gregoire and former Senator Slade Gorton that highlights the need for the Sate of Washington to support research.  You can click through to the article here.

Gregoire and Gorton note that the lack of dedicated fund to support research means that:

a.  Washington State is losing its place as one of the nations most important medical research hubs, and more importantly,

b.  The chances for the development of life saving technologies, procedures and drugs is being lost.

At NWABR we are excited that these two leaders are Speaking Up For Research.  The NWABR Gala being held on June 19, 2015 has this theme and this will be an opportunity for you to add your voice to this very important message.

Have a great day.

Ken Gordon

Executive Director

Speak Up for Research (part 2)

Speak Up for Research: Part 2
In my introduction to the ‘Speak Up for Research’ blog series I posed the question: Is science facing a civics issue? Of course, after posing the question I have to share that my opinion is that it is, in fact, facing a civics issue. I said it, now let me explain.

No one reading this is surprised by my statement that we are politically and socially divided as a nation. It is also common knowledge that the life science research community faces its own challenges with division and misunderstanding. I pointed this out in my previous blog when I cited a Pew Research study titled Public and Scientists’ Views on Science and Society, which showed a wide gap between the opinions of science and those held by the general public. As evidence of the level of contention, recently, animal rights activists gathered for a week long protest directed against the University of Washington’s new animal facility, which is intended to improve the quality and effectiveness of animal research.

The misinformation and mischaracterization of the work of biomedical research also has impacts on the direction of public policy and the perceived value of the life science research community’s contributions to society, to the economy, and to the health of humans and animals. At the core however, are fundamental breakdowns in the way we approach public discourse and the way we engage in dialogue about our differences, which impacts the health of our democracy.

This situation reflects this current division. Animal rights activists shout, and the research community turns to their research—occasionally looking over their shoulders to disagree. This lack of engagement and productive dialogue is anecdotal, but it is confirmed by the stories I hear, and by the results of NWABR’s own programs. We perform outreach, but struggle to bring contending views to the table to engage in dialogue. The division remains and is highlighted by contending sides and views vying for the public’s attention, and all the while rarely engaging.

The biomedical research community plays its own role in its approach to sharing its story, and time and time again I hear, ‘we have to do better’. Meanwhile, the animal activist community has put forth massive efforts to paint research in an unflattering and misleading light, and others question the profit motives of research, which adds to the growing distrust. This current paradigm leaves us in a cycle of division, character defamation, and misunderstanding—a constant tug of war. The public, caught in the messiness of information, opinion, and emotion, is uncertain as to where to turn. The public does not know who is right, who is wrong, or what to believe.

My research on civics explored normative democratic theory, which is political theory speak for the way things ought to be in the polity. I contrasted these basic theories with our current political and social paradigm, which by all accounts is highly polarized. I don’t portend to have all the answers about the way things ought to be, however I do have insights that can shed light into why I see this as an issue for science.

So why is this a civics issue? Is not democracy the right to protest, the right to voice one’s concerns, freedom of speech? From my view, what I and others see at the very core of the issue is dignity, and a collective failure to uphold it as we engage in these complex phenomena.

In my next blog I will explore civic dignity, and ask readers to share this series with their friends, contribute to the discussion, and to join us to Speak Up for Research.