Technology takes center stage in this week’s Research Ethics Roundup. On Monday, Apple introduced a new open-source framework that could have significant implications for the research enterprise, while, on the same day, the Food and Drug Administration (FDA) released draft guidance aimed at clarifying the use of electronic processes to obtain informed consent.
Apple’s ResearchKit Is a New Way to Do Medical Research: On Monday, Apple announced ResearchKit, an “open-source framework that lets medical researchers create diagnostic apps that tap into the screens and accelerometers on the iPhone.” This article from Wired discusses the announcement and how the use of the framework could revolutionize research.
Ethics Rounds Examines Need for National System Protecting Research Subjects: In this article from the NIH Record, author Rich McManus summarizes a recent panel discussion at the National Institutes of Health (NIH) Clinical Center on the creation of a system for compensation for research-related injuries. Kenneth Feinberg, who has administered a number of high-profile victim compensation programs, participated in the lively discussion.
NIH Moving Ahead with Review of Risky Virology Studies: In October 2014, the United States government announced a moratorium on funding for gain-of-function research. In this article for Science, reporter Jocelyn Kaiser highlights the National Institutes of Health’s efforts to secure an external risk assessment firm to review such research.
Patients Want Docs to Disclose Ties to Pharma Before They Enroll in Trials: In this article for the Wall Street Journal’s Pharmalot, Ed Silverman reports on a new study that suggests that patients would prefer to be made aware of any potential conflicts of interest that their physician may have before making a research participation decision.
FDA Says it’s OK with Modernizing the Clinical Trial Informed Consent Process: On Monday, the FDA released draft guidance on the use of electronic informed consent in clinical investigations. This article from Regulatory Focus summarizes the draft guidance and discusses its potential benefits.