At Home Ethics During COVID-19

In my work at NWABR I often think about things with an ethics filter. The discipline of bioethics can sometimes seem like a hypothetical exercise, but this pandemic is the real deal and we need to listen to our ethicists. For me, the SARS-Cov-2 novel coronavirus pandemic highlights two key ethical dilemmas:

-How do we allocate scarce medical resources?
-How can everyone enact behaviors and choices that maximize the best outcomes for the most people?

I assert that there is an ethical imperative for each person to do their part to stretch resources and maximize positive outcomes. Many factors affect individual roles, therefore we all have different obligations to the ultimate outcome, and to one another, guided by our capacity. The ethical challenge here is that we have to examine our capacity to contribute honestly and with the sure knowledge that our contributions will not be cost free.

Here is my situation. I still have an income and live in a house with my three young kids. I am well-connected to a community and can work from home while I teach my three kids. I have asthma but otherwise we are healthy. I am hyper-aware that I have extra resources when many don’t have enough. How can I help others to maximize good outcomes?

My children and I are staying home. We aren’t out playing soccer with friends or touching playground equipment. When I get take out, groceries or packages delivered, I meticulously bring these items into my home. Everything seems to take more time during this season. I am doing my best to keep me and mine healthy so we do not have to use scarce resources; I even reduced my daughter’s dislocated kneecap to save mask use by first responders. We are supporting local restaurants and donating to non-profits.

Will it be enough if everyone does everything they can? I hope so.

Leaders and health providers across the globe right now are juggling these ethical issues on a huge scale. Who receives resource-depleting treatments? How much liberty do we need to forego for the common good? How do you balance the competing needs of the linked economic and health crises?

Biomedical ethicists have been dealing with such issues for millennia and have provided a range of ethical frameworks to help think through such constraints. Let us listen more to our ethicists as we continue to work through this pandemic.

Stay tuned for more on this topic!

Celebrating a journey of family, hope, scientists and philanthropy: Triumph

Gala - Alison FraseLast month we left off the story of Joshua Frase, his sister Isabella, and their parents Paul and Alison with their determination to find a treatment for a faulty MTM1 gene, which results in the fatal and physically devastating neuromuscular disease, Myotubular Myopathy (MTM).

Just before Joshua’s first birthday, his parents launched The Joshua Frase Foundation to fund research with the hope of a cure.  There is none more devoted than a child’s parents to raise funds, advocate for research and persistently seek treatment and cures. With the help of Paul’s status as a former NFL defensive lineman (Jets 1988-1994, Jaguars 1995-1996, Packers 1997, Ravens 1998), and the family’s tenacity, the Foundation supports basic and preclinical gene therapy research for MTM.

Alison was inspired when she saw a video of a crippled mouse, soon restored to full mobility following gene therapy.  It was her “aha moment” to find a cure for Joshua.  The research process is often long and complex, but the Frases had a short timeline and high expectations to identify a starting point to move rapidly to a cure.  Myotubular Myopathy is a good candidate for gene therapy where a functional copy of the gene replaces the faulty one and is delivered to each cell in the body using a viral vector.

Through the counsel of researchers, she started searching for a large animal model by calling veterinarians throughout the US and Canada until—miraculously– they identified a female chocolate Labrador retriever who was a carrier of the MTM1 mutation.  This pup, Nibs, became part of the Frase family and the start of a colony of research animal heroes for preclinical research toward a gene therapy cure.  Dr. Martin Childers at the University of Washington leads this research; we honor him at our 2018 Gala.  The dogs bred for this research are born with the MTM1 mutation and untreated would live only about 18 weeks; with gene replacement, they are still alive after 5 years.

Joshua passed away on Christmas Eve at the age of fifteen.  To quote his dad, Joshua’s “story is far from over.”  Thanks to the Frases, their countless supporters, the lab animal heroes, the animal care and research teams, Dr. Martin Childers and his team….the hopeful cure for this disease has entered a phase I/II clinical trial.  The study drug is an AAV8 vector containing a functional copy of the human MTM1 (hMTM1) gene to replace the dysfunctional copy in people with MTM.  Enrollment began August 2017, about 10 years after Joshua’s death and 21 years after the Foundation began, to treat four boys under the age of five with MTM.

For their journey, we are honoring Paul and Alison Frase for their courage, persistence, advocacy and fundraising on behalf of their beautiful son and others affected by Myotubular Myopathy. We are also honoring Dr. Childers for his passionate, compassionate and brilliant research to understand and treat MTM.

 

In his blog as a young teenager, Joshua published intimate thoughts about his personal mission in life.  He wrote, “My ultimate goal is to have a career as a research scientist. I want to specialize in muscle gene therapy so that I will be able to find a cure for Myotubular Myopathy.” He also wrote of his goals to “gain confidence in speaking before a group of people” and to “continue to grow spiritually.”  These are remarkable goals for any person, let alone someone so young and with unusual health challenges.

Help carry on Joshua’s personal mission to cure Myotubuluar Myopathy.  By attending the NWABR Gala you celebrate Joshua, his family, Dr. Childers, and the lab animal heroes who have brought his mission into reach.

 

A Reflection on Brain-computer interfaces: Ethical challenges and opportunities

brain_computer interfaceFacilitated by Kevin Measor, PhD, Gonzaga University, and Jen Wroblewski, MPH, NWABR on April 10, 2018

In a packed room at the back of a popular Spokane pub, we gathered not for a birthday party or alumni gathering. Undergrads, science-enthusiasts, medical students, business owners and professors wedged into a crowded pub to talk about the emerging technology of brain-computer interfaces (BCI). Dr. Kevin Measor, faculty at Gonzaga and founder of the Spokane Center for Public Neuroscience Education, led the discussion.

The ability to record brain activity and use this information to control devices like computers, wheelchairs, and brain stimulators is a goal of brain-computer interface (BCI) research. With this technology comes great promise to improve people’s lives, but will the introduction of BCI devices into medicine and beyond raise ethical concerns? What brain data is private? Will these devices lead to human enhancement? Who will have access to expensive BCI devices? Will this technology raise questions of identity and what makes us human?

We tackled three key scenarios that illustrate currently available technology: (1) Deep Brain Stimulation (used to treat tremor in patients with Parkinson’s Disease) to treat mental/behavioural health issues, (2) Neuroprosthetics capable of interacting with the brain and prosthetic limb and (3) Neurofeedback recordings used to measure states of awareness in long-haul truck drivers.

Scenario #1. Should deep brain stimulation be used to alter undesireable, non-pathologic behavior? What about mandated treatment for pathologic behavior? Most agreed that if the science is solid, DBS should be offered but that no treatments should be forced on people. People did perceive a difference in mandated mental health treatment using medication versus DBS because of concerns that DBS may not be irreversible or that it may have in intended consequences.
Scenario #2. People with neuroprosthetics use their new limbs to restore, as best they can, what they have lost. There is an argument that BCI prosthetics actually enhance, rather than simply restore, the health of a user. In the case of athletes we wondered whether individuals using BCI prosthetics might have an advantage if they could program their ‘robo-limb’to resist fatigue, improve reaction time, etc. Most thought it would be more fair to offer separate competitions for people with BCI prosthetics. We were concerned though that BCI prosthetics will be more costly than traditional prosthetics, which are already 20-40K each. Access to this technology will be tricky, as will repairs to the hardware when it needs refurbishing.
Scenario #3. By far people were most interested in this scenario where long haul truck drivers would be monitored for their state of consciousness/awareness using a hat embedded with EEG sensors. The sensors would send real time data to a control center to judge whether a driver is in a dangerous, sleepy state and would then order the driver to stop driving and rest. Similar technology may be useful for other professions such as soldiers and medical professionals working long shifts. As a group we were split on the legality and usefulness of BCI for this purpose. It raised more questions than answers. For example, who is legally responsible in the event of a truck accident or medical mistake? Isn’t this an invasion of the employee’s privacy? Others felt that BCI could provide useful tools for employees in sleep-deprived professions to self-assess their job safety and provide data to justify changes in company policies. In the end, we arrived at a universal bioethics dilemma: which is more important….individual rights (autonomy) or public safety?

BCI has the power to restore individual agency, reduce suffering and improve human performance. On the other hand it raises concerns about privacy, access and power. Like any good discussion all we could say was…..IT DEPENDS.

 

Celebrating a journey of family, hope, scientists and philanthropy to treat myotubular myopathy in Phase 1 clinical trials, Part 1

Dr. Martin ChildersIf you are a parent you already know the guts, fortitude, desire and village it takes to raise a child from milestone to milestone to adulthood.  Imagine your child is born with a fatal genetic disease affecting the function of all his skeletal muscles.  Meet Alison and Paul Frase, their daughter Isabella, and finally their son Joshua who was born with myotubular myopathy.  If you remember anything about their story, I want you to remember the power of passionate parents working with brilliant, dedicated scientists who tenaciously act and hope for a cure through biomedical research.

The genetic villain in the story is the MTM1 gene, where mutations cause total loss of function in the myotubularin gene.  This gene normally makes an enzyme, myotubularin, which is thought to create and maintain muscle cells.  Kind of important. So when the gene cannot make this enzyme, people (and animals like dogs) experience muscular “floppiness,” breathing issues, feeding issues and scoliosis to name a few.

If you are a scientist, like Dr. Martin Childers, you also know the guts, fortitude, desire and village it takes to conduct research…especially research you hope will treat devastating genetic diseases like the one that affected Joshua.

The Frases, Dr. Childers and other folks have partnered to do something about myotubular myopathy in animals and people.  NWABR is honoring their work at the Speak Up for Research Gala this year.  Want to know more?  Stay tuned for the May newsletter and register for the Gala on May 24th.

What’s in Our Water, Who Decides and Why? A Spokane Community Conversation

This Conversation was facilitated by Ms. Emily Firman, MPH, MSW (ARCORA Foundation) and Jen Wroblewski, MPH (NWABR) on January 16, 2018.

The question of community water fluoridation (CWF) has been long debated in Spokane, WA.  Citizens haveDrinking water voted three times on the matter and all times chosen not to introduce fluoride to the drinking water.  The most recent vote in 2000 failed by 1%.

Given this history, I expected our Conversation last night to include some significant voices of opposition. It turns out that our audience was either neutral or in favor of CWF.  Our attendees were mainly college or medical school students, public health officials and professors.  This demographic has traditionally supported CWF.  What WAS surprising was that many who attended did not know the historical opposition to CWF and did not understand why the benefits of CWF were even in question.  Prior to the Conversation both NWABR and our partners received letters or queries from known opponents to CWF from California and Colorado. I had hoped some would attend the Conversation.

TRUST

Attendees accepted that CWF has great benefit in strengthening tooth enamel and therefore reducing dental decay.  They trust the judgment of most health authorities, who have either conducted their own observational population research or reviewed the research of others, who state that CWF is a safe and effective way to prevent and treat tooth decay.

ECONOMIC FRAME

Based on available data and personal stories, attendees perceived that it is more economical to offer CWF than to pay for the subsequent oral health costs of increased decay. Some studies cite that every dollar spent on CWF saves $38 on future health costs.  The Spokesman Review cited in 2001 that installing CWF would cost about $1million with an additional $300,000 per year (Hansen, 2/12/2001).  One attendee shared that she has 11 crowns, several implants and other dental work.  She wondered, “maybe if I lived in an area with community water fluoridation this [amount of dental work] wouldn’t be the case.” She went on to say, “If I spent the money on my dental work, about $30,000, on fluoridation instead imagine the good I could have done!”

GREATEST GOOD VS. AUTONOMY

It’s a classic clash of two ethical principles in public health: maximizing good vs. autonomy (individual choice, determination). The clash fascinates me because it’s a natural dilemma at which groups of people arrive whether or not they have training in bioethics. “I don’t see why, if just a small percent of people are against it, the rest of the population shouldn’t have a voice when they want fluoridation.” While the attendees tonight strongly valued maximizing good, they also understood the argument for personal choice.

A medical student suggested that autonomy goes both ways.  “People should have a choice on whether to consume water with fluoride, but so should people have the right to smile with comfort and have a pain free mouth.” Poignant.

COMPROMISE POSITION…the THIRD WAY

Someone suggested that the ethics of autonomy and maximizing community good didn’t have to be in conflict.  She thought that perhaps the community water supply could remain nonfluoridated and people could have free access to fluoride drops or tablets.

Numerous comments unfolded about the success of this approach. A mother who moved to Spokane in 2000 just as the “no” vote emerged, said “I wanted fluoride for my kids in their water.  I thought, ‘What sort of backwater place have we moved to?’” She went on to tell the story about administering fluoride drops to her kids.  She thought that if some drops were good, more were better.  Her son is now grown and has cosmetic fluorosis—but no cavities!  When her kids were little the fluoride drops were a prescription and she had to provide a copay.  She acknowledges that the copay system may prevent some people from accessing fluoride drops.

A physician in the group noted that patient compliance is not as good as he’d like and worries that leaving the administration of fluoride up to parents might not be broadly successful. This is even more true when you consider than only 50% of kids in Spokane see a dentist regularly.  In addition, fluoride drops are not currently given to adults who would benefit from cavity reduction through remineralization of early cavities.

BENEFITS OF RESPECTFUL CONVERSATION

I was struck tonight by the impact of the information, stories and shared conversation among folks, even though they largely agreed with one another.  Evaluation comments indicate that people plan to take action on this issue.  Attendees want to build relationships with those who oppose CWF, talk to their city councilpeople, share what they learned with friends and colleagues and invest their time and energy in this issue.  They are eager to influence nuanced thinking about water fluoridation.

By together setting discussion ground rules, by presenting opposition perspectives and by encouraging any and all opinions, tonight’s Conversation had a strong impact. The secret?  Strong science.  Compassionate listening. Personal stories. Moving toward nuanced rather than binary thought.  Seeing one another as people first and opponents second. This Conversation was one of the best yet.

With gratitude,
Jen

The War on Drug Prices

Cost of Drugs_cartoon
Most Americans ask the question, is the price I pay for prescription medications FAIR? In other words, what is the true cost of developing, making and selling a medicine, AND how much profit seems reasonable? This is what we tackled last week during our Community Conversation with experts from the U of Washington’s International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

KEY FACTS THAT INFORMED OUR DISCUSSION
Tufts estimates that it costs $2.6 billion to develop an FDA approved drug, a number that increases 9% per year.  People in the US pay more for drugs than people in other countries for a few reasons: 1) we use more medications because we have better access to new ones, 2) we have a higher burden of chronic disease like diabetes and obesity, and 3)  in the US, the government protects drug manufacturing monopolies and limits price negotiations while other countries have more price regulation.

Another reason people in the US (and in Canada and Europe) pay more for medications is simply because, on the whole, we can afford to. Picture a world map, and picture all the people who live on Earth.  At 326 million, the US population is 4.4% of the world’s 7.5 billion people, but the US accounts for 50% of all medication sales in the world. Mind blown.

We are looking for VALUE in our medications.  We want medications that are novel and offer leaps of improved quality of life.  We are willing to pay more for medications that achieve this high bar, but there is a point for every person where price will exceed our ability to purchase a medication.

Finally, we learned about the trade-off between innovation and access.  Monopoly protection funds innovation. In turn, industry creates more new drugs in the long run that cost more money in the short run and poorer access. “But if new medicines aren’t invented, then no one can access them in the long term.” (ISPOR)  How can the market incentivize innovation if not through the almighty dollar?

DISCUSSION THEMES
Many in the room were for the first time faced with the reality that the US foots HALF the bill of medications in the world.  I don’t think anyone, besides the facilitators, was prepared for this data.  As the discussion dug deeper, we realized that our drug costs fund innovation of new medications and devices.  Despite the relationship between US drug prices and world drug innovation, many participants still did not think it FAIR that people in the US pay more than those in other countries.

Some held high the banner of altruism and seemed happy having the US play this role.  Others felt perhaps that even within the US that medication prices should be on a sliding scale based on what a household could afford.  Some shared personal stories about themselves or people they know who have had to choose between paying for their medications and paying other bills.

Yet others remained firm that prices could drop while maintaining innovation if pharmaceutical companies could lower their profits to reasonable margins.  Some attendees implied that companies could reduce their expenses by accelerating the clinical research process, a point that was strongly opposed by a former industry employee.  Pharmaceutical companies have no interest in accelerating clinical research in this manner because it would cause less confidence in drug safety.

As we were wrapping up our Conversation, we faced the question of whether or not the way we finance medications is sustainable.  Our vocal attendees had faith in the free market to correct anything that was broken.  Others remarked that the balance of medications on and off patent would also help with price competition once medications go off patent.

Our ISPOR facilitators emphasized that drug pricing is a complex ecosystem.  They recommended that consumers, scientists, policy-makers and health care providers and administrators continue to learn and share their perspectives, in venues such as Community Conversations, as much as possible in order to find a stable and sustainable relationship between medication access and innovation.

To read some excellent resources on the topic, visit the Community Conversation archive and scroll until you find the “war on drug prices” topic.

~JenWroblewski

NWABR conference sits at the intersection of technology, ethics, and policy

The “Ethics and Regulation in the Digital Age” conference, co-presented by NWABR and Quorum Review, brought together researchers, regulators, and IRB professionals to discuss the challenges and potential benefits of emerging digital and mobile health (“mHealth”) technologies for biomedical research. Conference presenters represented a range of topics and perspectives, including on-the-ground researchers, federal regulators, and institutional officials. Max Little (MIT) and Joaquin Anguera (UCSF) presented primary research using mobile health technologies as recruitment tools, data collectors, and interventions. Cheryl Grandinetti (FDA) and Misti Anderson (OHRP) gave overviews of what federal agencies are doing to stay up to speed with digital and health technologies, including human subjects protection. Malia Fullerton (UW) provided insight into the ethical dimensions of the Precision Medicine Initiative, including participant consent and return of results. Eric Mah (UCSD) and Jeremy Block (Sloane-Kettering) discussed ways for IRBs and researchers to communicate risks and benefits of research with mHealth technology. Finally, Catherine Hammack and Kathleen Brelsford (Duke) presented ongoing research aimed at better describing risks and protections to participants involved in genomic research.

 

A few weeks has passed since this stimulating day of talks and networking. Many themes have stuck with me. First, we should all keep our sights on ensuring that emerging technologies don’t widen or exacerbate existing inequalities (e.g., health disparities and access to research and care). Dr. Anguera’s targeted expansion of his “Neuroracer” video game intervention to Hispanic/Latino populations is an excellent example. Second, policies need to balance patients’ and participants’ privacy with the collective benefit of leveraging their data for research. Dr. Fullerton’s presentation underscored how challenging this balancing act can be, specifically with the imminent recruitment of a 1M+ US citizens to the Precision Medicine Initiative Cohort. Third, the rapid pace of innovation means we will inevitably put technologies into use — in research, clinical, and everyday contexts — before we fully understand them. Despite the unease of “building the plane as we fly it,” so to speak, the alternative of holding back the technology may be even more problematic. As keynote speaker Dr. Little put it, waiting for the perfect technology may be unethical, akin to “withholding treatment,” and instead we should utilize what we have now despite the imperfections.

In light of these concerns, I have been wondering how much of this is new versus existing controversies and tensions wrapped up in shinier, newer technology? A set of comments by Dr. Block sparked this question in my mind, when he articulated different “tiers” of technology use in research. In some instances we are using mobile or digital technology to do the same research activities as before, just on a different platform (e.g., a web survey versus pen and paper). In such cases, the technology may be distracting us into thinking that the ethical or policy dimensions of these activities have shifted. In many cases perhaps they actually haven’t. The first step when considering any technology use in research is to parse what is new versus old and differentiate between aspects of the platform (e.g., smart phone) versus the research activity (e.g., recording steps taken).

I don’t envy the job of IRBs having to fit cutting-edge research proposals into potentially outdated regulatory frameworks. But at the same time I wonder how much technological novelty may be blinding us to the similarities with what we already know and recognize as ethical and regulatory concerns. Patient privacy, data sharing, informed consent, potential misinformation, etc. Granted the pace and scale of these problems is increasing with our new mobile and digital tech. But as we move forward, let’s make sure we’re taking with us decades of bioethics and policy thought leadership and knowledge.

Sarah Nelson is a PhD candidate in Public Health Genetics at the University of Washington. Follow her blog at myopenreadingframe.com or on Twitter at @blueyedgenes.

Conflict of interest: Ms. Nelson received discounted access to the conference in return for writing a blog post.

Crisis in Antibiotic Resistant Bacteria: Are you Chicken? A Community Conversation Reflection

During the autumn round of Community Conversations in Portland, OR and Seattle and Spokane, How Bacteria Become Resistant to ABXWA, we discussed the concern that ongoing antibiotic use in large-scale commercial chicken farms is producing antibiotic resistant (ABR) bacteria that contribute to more difficult-to-treat human diseases. In a 2014 report on antibiotic (ABX) resistance, the World Health Organization warns of humanity heading for a “post-antibiotic” era in which antibiotics can’t keep up with ABR and the diseases they cause.

Who are the stakeholders in this situation? Large- and small-scale farmers, consumers, researchers looking for new drugs that kill bacteria and medical professionals who want healthy patients. With all these stakeholders, how are we to address this potential public health crisis?

The One Health Initiative holds that human, animal and environmental health are all connected. ABX use practices in food animal agriculture are of particular interest, but not everyone agrees that there is sufficient evidence that the use of ABX in chickens (or other food animals) directly results in ABR infections in people.

Despite expected regional differences, participants in the Conversations were united in several areas. One, we simply need more data. The Food and Drug Administration only recently (2009) began collecting sales data for antimicrobials in food-producing animals. No one is sure what is actually being used. Legislation attempts to limit ABX use and require record-keeping both federally and in some states, including Oregon, have not garnered enough support. Two, consumer education needs are high. We are inundated with messaging and food labeling that is sometimes great marketing (rBST-free!—but there isn’t a significant difference in the milk from cows treated or not with rBST) but low on information (how are egg-laying hens treated if they are cage free?). Many of us still believe that if we have a cold for more than 3 days we are good candidates for antibiotics. Three, the conversation tends to use rhetoric that is sensationalized and prevents authentic discussion. For example, “factory farms are overusing antibiotics and are mostly responsible for this crisis.” Toxic rhetoric.

Participants rallied around some practical action items. People committed to investigating the meaning of food labels. People committed to better hand washing and to touching their faces less often (did you know 30% of people carry MRSA in their nose?). Many also committed to sharing their new knowledge both professionally and personally.

All in all, this round of Community Conversations was high in energy and commitment to better living through smarter consumption of food, data and antibiotics.

Many thanks to our facilitators Kathy Hessler, JD, LL.M and Emma Newton, MS (Portland); Heather Fowler, VMD, MPH and Paul Pottinger, MD (Seattle); and Doug Call, PhD (Spokane). Thank you to our Spokane Series Sponsor, Whitworth University.

 

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.

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.

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