Now, entire research studies are being run through a handful of apps, released in mid-March, through the iTunes App Store. These apps consent study participants, determine eligibility of participants, and run study tasks — all without the need for participants to travel to study sites.
Federal regulatory agencies acknowledged in recent draft guidance that research informed consent is moving in directions not quite imagined several decades ago. The Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) published draft guidance for industry, clinical investigators, and IRBs in the “Use of an Electronic Informed Consent in Clinical Investigations” in the March 9, 2015, Federal Register.
Human research protection program (HRPP) training at the institutional level often lacks uniformity and evidence-based strategies, some experts say. Some organizations and research programs require new investigators and IRB staff to have extensive online coursework or on-campus classes, and others provide only general guidelines and requirements.
A research institution’s centralized research training program began as a way to help new investigators and research teams learn more about the IRB process and human research protection. But the program, called Navigating Clinical Research, has expanded into a comprehensive training course that uses a variety of adult learning strategies.
The IRB at the University of Illinois at Urbana-Champaign had a number of issues to consider when researchers submitted a study involving a social network analysis on sensitive issues. In this case, the sensitive issue was sexual assault on a college campus.
IRBs typically give guidance to researchers only during the pre-study regulatory review process, but investigators also struggle with ethical questions that arise during research. “For years, this has been done informally,” says Benjamin Wilfond, MD, director of the Treuman Katz Center for Pediatric Bioethics at Seattle Children’s Research Institute.