Life Sciences Law & Industry Report connects the dots among the many disciplines that make up the burgeoning life sciences industry, with biweekly updates on current regulatory, legislative,...
By Jeannie Baumann
Nov. 30 — A tool to weigh the ethical considerations for research involving mobile health platforms is under development by a team at the University of California, San Diego, the university announced Nov. 25.
“What is challenging now is that technology is outpacing the development of ethical standards to guide the evaluation of study risks and benefits,” Camille Nebeker, the principal investigator on the project, said in a Nov. 25 statement.
The Connected and Open Research Ethics (CORE) project coincides with the first-ever effort to modernize the federal regulations for human research protections (45 C.F.R. Part 46), UCSD said (9 LSLR 1031, 9/18/15). The project also is underway as the National Institutes of Health is in the early phases of developing its million-person national research cohort under the White House's Precision Medicine Initiative, which is expected to rely heavily on mobile health technologies.
The project is designed to help both the researchers who design and conduct studies using mobile health platforms as well as the institutional review boards that must approve them before they can go forward.
Nebeker, who also is an assistant professor in the UCSD School of Medicine's Department of Family Medicine and Public Health, said IRBs frequently lack the expertise or resources necessary for making informed decisions about studies involving methods that use mobile imaging, pervasive sensing, social-media and location tracking, or what she called “MISST technologies.”
“There are an estimated 6,000 IRBs out there, and they all will need to think about how the existing regulations apply to 21st century research tools and methods,” Nebeker said in a Nov. 25 statement. Because many IRBs don't have the necessary expertise to weigh the ethical questions, she said, researchers are engaging independently with the IRBs themselves, “which means they're often duplicating efforts.”
The CORE is designed to provide consistency, accuracy and convenience for researchers, as well as an opportunity for IRBs and researchers to share experiences, she said. If the CORE resources prove to be successful, there's potential to adapt them to other data-driven research, such as genomics, she said.
“It has the potential to augment the IRB process by bringing all the right experts to the table,” Nebeker said.
The CORE project received funding both from UCSD and the Robert Wood Johnson Foundation. Deborah Bae, senior program officer at the foundation, said instruments like the CORE will be a “game changer” for research ethics. “These tools will encourage broad participation and allow researchers to discover new insights and solutions to today's pressing health problems,” Bae said.
To contact the reporter on this story: Jeannie Baumann in Washington at firstname.lastname@example.org
To contact the editor responsible for this story: Randy Kubetin at email@example.com
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to firstname.lastname@example.org.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to email@example.com.
Put me on standing order
Notify me when new releases are available (no standing order will be created)