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.

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.

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

 

 

The overhyping of medical research

Dear all

Michael Louella from the University of Washington shared this cautionary article about the overhyping of medical research findings.  The exaggeration that creeps into reporting of medical research falls into three categories:

  1. advice (say, to stop eating eggs or to drink more coffee) that was not indicated by the scientific study,
  2. stronger claims than indicated in the article (for example, saying that stress causes hemorrhoids when a study might show only that stress was associated with hemorrhoids) and
  3. directly relating findings to humans, when in fact the study was performed in rats, mice or cells.

There is a lot of finger pointing associated with these errors.  Some of the fault lies on our research side of the information war.  Researchers and their media helpers summarize their findings in press (media releases) and it is often these releases that are the essential first shot in the information war.  A study published December 9 in the British Medical Journal from Petroc Sumner of Cardiff University in Wales showed that:

  1. 40 % of press releases contained explicit advice not indicated in the journal article.
  2. Another 33% of claims in press releases used stronger language than in the journal article.
  3. Finally, 36% of press releases inferred that a finding was related to human health when the study was not actually performed in humans.

Furthermore the resulting news articles arising from these releases showed that:

  1. When advice was indicated in the press release, 58% of news stories also gave advice.
  2. News stories exaggerated associations 81% of the time if claims were also exaggerated in the press release.
  3. And when press releases improperly extrapolated animal findings to humans, the news extrapolated too — 86% of the time.

At NWABR we try hard to help researchers get the message out about their work.  Sometimes we have advised researchers to reduce nuance to help clarity.  This new research shows that we have to be very careful with this advice as it can lead to inflated claims, misunderstanding and incorrect information – all things that actually will serve to reduce the public’s trust in this most important work.

Heavy thoughts for the season – I hope everyone has a great holiday season and here at NWABR we are excited for the new year.

Regards

Ken Gordon

Executive Director

Is it safe to study deadly viruses?

Good morning

There was a great story on NPR this morning from the wonderfully named Nell Greenfieldboyce.  The story discusses the work of Ralph Baric, who has been studying the MERS virus (Middle East Respiratory Syndrome virus).  A decision from the Whitehouse has stopped all work on MERS, SARS and influenza.  The moratorium was put in place because of a concern that in studying the viruses there was a chance that researchers could actually make the virus more dangerous.

Baric’s work was aimed at doing the exact opposite of making the virus more dangerous.  He was aiming to infect mice with the virus to test the efficacy of different vaccines and other options for stopping the spread and impact of this virus.  MERS is a potential pandemic virus as it is spread by air.  Knowing how to stop its spread is a pretty important thing.

Virologist Ralph Baric in one of his labs at University of North Carolina Chapel Hill.

Ralph Baric

The administration’s moratorium on this research was put in place to ensure that this research is safe, you can’t help but feel that the world is a little more dangerous though when the leading researcher on this virus is no longer allowed to work to find ways to mitigate its impacts.

Have a safe day!

Ken Gordon

Executive Director

 

Emory University Hospital Commitment to Community

Good morning

There was an amazing story on NPR this morning about the preparation and commitment to infection control by the Emory Healthcare.  You can read and listen to the story here.  Their multi-year commitment to preparedness for infectious disease control, training of staff, preparation of facilities and of sharing their own best practices is amazing.

They have developed and keep updating an 84 page Ebola protocol.  For those who are interested this protocol can be downloaded here.

emory_customEbola patient Amber Vinson arrived by ambulance at Emory University Hospital on Oct. 15. Now healthy, Vinson was discharged from the hospital Tuesday (Kevin C. Cox/Getty Images).

Ken Gordon

Executive Director

NIH Funding and Biomedical Research

Good morning all

There is a great story on NPR this morning about the impact on research of reductions in NIH funding.

The story this morning by Richard Harris and Robert Benincasa details the boom and bust environment created by major changes to NIH funding.

Amongst other things the story notes that the NIH funding in the past has driven the development of innovation in biomedical research and the current cuts have meant that labs – and the potential developments associated with those labs – are both closing and all of the hard won knowledge is being lost.

Adding salt to the wounds of lost funding, the article also refers to those scientists who are still working in the field only doing so because of the inordinate amount of time that key researchers are spending on fundraising.

I love fundraising – but I am also not a brilliant scientist. Taking such people away from their core work is such a crying shame for the entire field.

NWABR lost its own NIH funding in 2013 with the commensurate loss of amazing staff and institutional knowledge. The rebuilding process is hard and after over a year we are starting to regain some of the traction that was lost. The NPR story shows that this is an all too familiar story across the United States. The organizational, human, research and community costs of these losses is incalculable.

I am going to enjoy this series of stories as the roll out over the next week.

Update 9/10/14. Part two of the series rolled out today. This part focusses on scientists being lost to the industry and the world of science because of the funding crunch. Here it here.

Take care.

Ken Gordon
Executive Director
Northwest Association of Biomedical Research