Simple Words Make a Difference at NWABR and Quorum Review’s IRB Conference

by Marie-Térèse Little, PhD

Dr. Charlotte Shupert, Product Manager for Compliance Solutions, Evisions Inc. effectively outlined some real-world best practices necessary for a true informed consent process in her session titled How IRBs, Institutions, Sponsors and Subjects Impact What is Required in Consent Forms at this year’s NWABR IRB Conference. Among other practical recommendations, she was emphatic that we need to write good consent forms, conduct a good consent process and find out what the participants understand. Furthermore, she expressed that the e-consent form absolutely needs to be in an active voice, readable, with lay language at a level of literacy that reflects a 5th to 8th school grade level (with brief sentences and words with few syllables), in standard font sizes, headers and margins. Whenever possible, the electronic document should use supplements to the text such as videos, tables, graphs, pictures, drawings and schematics. An absolute necessity is a tool to evaluate the understanding of the participant and the “teach back” method was recommended. Her presentation was both witty and serious, factual and candid, and it was a pleasure to hear her recommendations.

 

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

 

 

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 (www.4Dbrc.com) 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? nwabr.org/annualgala) 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 http://www.washbio.org.

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…

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