The Northwest Association of Biomedical Research (NWABR) hosted a day of thought-provoking sessions around its theme, “Staying Ahead: Disruption & Ethics Review.” It was NWABR’s annual research ethics conference, and this year speakers addressed the topic of disruption from myriad perspectives.
disturbance or problems that interrupt an event, activity, or process
Representatives from the FDA and OHRP talked about disruption in practical terms with nuts-and-bolts presentations about electronic informed consent policies and the new Common Rule. Thought leaders talked about disruption in philosophical terms with a debate over patient advocacy, therapeutic misconception, and the Right to Try movement. And presenters from a public health nonprofit talked about disruption in inspirational terms, sharing a series of dramatic research successes brought about through technological disruption. The keynote speaker, Dr. Elizabeth Buchanan, laid the groundwork for those topics with a whirlwind tour through the disruptive forces at work in medical research right now.
Dr. Buchanan, the chair in ethics and director of the Center for Applied Ethics at the University of Wisconsin-Stout, shared her view of disruption in research and what’s ahead.
Here are the disruptive trends researchers, regulators, and ethical reviewers need to keep an eye on now and in the near future.
Genome Mapping: For Dr. Buchanan, the sequencing of the human genome in 2000 ranks near the top, if not at the top, of medical research’s most disruptive events. In 2000, the sequencing of the human genome cost $1,000,000,000 and had taken 13 years. Now commercial ventures can do it for $3,000 in two days. The mapping of the human genome has brought us ancestry.com, 23andMe, the Precision Medicine Initiative, and changes to the Common Rule related to biospecimens, secondary use, and genetic testing.
Population: The world’s population went from 2 billion people in 1930 to 6 billion by 2000. Dr. Buchanan said that changes in population have been positive or negative, depending in part on where you live. Europe is seeing a decline in birthrates now, and in other places it is increasing. Dr. Buchanan used the audience as an example of the world’s diversity in age, gender, and background. The challenges of population growth and diversity directly affect our approach to research.
The Internet: “The domain of experts is changing in the face of the internet,” Dr. Buchanan said, observing that the internet, big data, and social media have altered our sense of isolation and of expertise. She compared the experience of researcher George Gey in 1970, who could not convince colleagues to keep a sample of his cancer cells after surgery, to the 2015 social media campaign #savejosh, where thousands of people petitioned online for Josh Harvey to receive an experimental cancer treatment.
Dr. Buchanan also shared what she considered a seminal moment for technology and clinical research: Pfizer’s Remote Study. The Remote Study introduced the possibility of participating in clinical research without visiting a site. The trial was the first randomized, IND-based study that was conducted remotely.
Patient Advocacy: For Dr. Buchanan, the patient advocacy movement truly started with the protests during the the AIDS epidemic. Early in the epidemic, the disease’s victims were largely invisible. Now, Dr. Buchanan said, consider organizations such as PatientsLikeMe, where patients influence care and research. And progress could not happen without research. Advertisements thank clinical trial participants now for the difference they can make. “That’s a real change,” Dr. Buchanan said.
Smartphones: Smartphones have already disrupted society at large, and their impact is just now reaching medical research. The opportunities for data collection and analysis are expanding. Half of web traffic occurs over mobile devices, and as Dr. Buchanan observed, medical researchers are agreeing that smartphones offer the opportunity to increase participation, document consent, and collect research data. These changes could be “more important than we acknowledge,” Buchanan said.
An Amazing Time to Be in Research
Dr. Buchanan closed by recalling how long it had been since the Common Rule changed. “What were you doing in 1991?” she asked. And, she continued, what will people in 26 years conclude about this round of changes? With these and future changes, she said, the Belmont Principles should remain our guide to making decisions about ethics in research. “This is an absolutely amazing time to be involved in research,” she said.