Agreement Doesn’t Mean Consent at NWABR and Quorum Review IRB Conference

by Marie-Térèse Little, PhD

The ultimate purpose of the informed consent process in research involving human participants (subjects), is to provide information to the participants about the purpose of the research, its procedures, and the risks, potential benefits, and alternatives so that the individual understands this information and can make voluntary decisions whether to enroll and continue to participate in a given clinical trial. This informed consent process should allow for rational decision making and foster self-determination and an expression of autonomy. It should include information that is reasonably expected; not only a document of consent but an opportunity for a meaningful and intuitive discussion between the researcher and the potential participants with sufficient time allowed for questions and concerns. Participants should ultimately be given the opportunity to obtain, understand, and to act on the information.

At the Revolutionizing Informed Consent conference, there was a general consensus from all the speakers that our current approach to the informed consent process is troubling at best and it is clearly not serving our participants well.

Poignantly acknowledged by every speaker, the audience was reminded that the current models employed to “obtain consent” involve static, long (often over 20 pages), complex documents that are filled with dense, scientific and medical language and confusing regulatory and legalistic jargon. The informed consent document (ICD) is often a defensive deed designed to protect the institutions and the sponsors rather than protecting the participants in a proactive manner. Emphasis is on disclosure rather than learning. The complexity and length of the ICD results in poor readability. Furthermore, the needs of the participants vary greatly and the inflexible templates of the ICD often involve over explanations of the worst-case scenario. This is compounded by the short windows of time allotted to convey the overall message and the difficulty in quantifying what the participant really understands about the study and what they have consented to. Agreement without understanding is not consent. – JLWilbanks.

These difficulties encountered by participants, researchers and the ethics review community in the informed consent process were unambiguously acknowledged and openly demonstrated in the Keynote address titled “Informing the Research Participant: Emerging Models, Trends, and Regulatory Requirements” delivered by Mr. Kevin Hudziak, Emergent Strategy Consultant and leader of the Informed Consent Transformation project at Eli Lily and Company. Mr. Hudziak also questioned the current approaches and suggested that we, as Institutional Review Board (IRB) or Research Ethics Board (REB) members and staff, researchers and investigators, regulatory personnel and sponsors, need to uncouple Informed/Consent and treat it not as a single incident but an ongoing process that informs first and consents second. The Keynote address also served to introduce the trends in informed consent including e-consent and tiered, progressive, remote, and dynamic consent and the concept that innovation and technology can be leveraged to revolutionize the 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. This is her last entry for this conference. We thank her for her time and talent in serving her regional biomedical community, and the Western IRB for providing supplementary funding for her and other participants in 2015.

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.

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.

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.