The risks associated with social, behavioral, and educational research (SBER) are often subjective, unpredictable, and hard-to-identify. Even the most experienced reviewers struggle with quantifying potential harms associated with SBER. On March 20, 2019, PRIM&R hosted a webinar, Assessing and Mitigating Risk in SBER. Presented by Amy Ben-Arieh, JD, MPH and Lara Sloboda, PhD, this webinar helped attendees understand risk as defined in the regulations and as applied to SBER; implement strategies for mitigating risk in SBER; and appreciate the complex nature of risk assessment and mitigation in SBER. Read more
TAG ARCHIVES FOR privacy
For investigators, IRB members, and IRB staff alike, the revised Common Rule’s new exempt category at 45 CFR 46.104(d)(4)(iii) was a dream come true. The so-called HIPAA Exemption eliminates IRB review for research use of retrospectively or prospectively collected “identifiable health information when that use is regulated by the HIPAA Privacy Rule as health care operations, research, or for public health activities […].” Applying the HIPAA Exemption is not quite as simple as it might seem, though, as I learned at the 2018 Advancing Ethical Research Conference (AER18) session, appropriately titled “Just When You Thought You Understood the Health Insurance Portability and Accountability Act of 1996.” Read more
In April, the EPA published a proposed rule titled, Strengthening Transparency in Regulatory Science. The rule would prohibit the EPA from basing regulatory action on scientific studies for which the underlying raw data and models are not publicly available “in a manner sufficient for validation and analysis.” The due date for comments on this rule is August 16. As a nonpartisan organization dedicated to advancing the highest ethical standards in the conduct of research that advances human health and well-being, PRIM&R decided it was important to comment on this proposed rule, detailing two main concerns. First, we believe that the proposed rule arbitrarily restricts access to and use of rigorous, peer-reviewed science in environmental policymaking, to the detriment of the public’s health and trust in the regulatory process. Second, we argue that the proposed rule fails to respect the contributions of human research participants. We urge EPA to withdraw this misguided rule immediately. Read more
On April 13, 2016, PRIM&R hosted a webinar titled Familiar Faces: Addressing the Challenge of Simultaneous and Sequential Study Enrollment, presented by Stephanie Collins Reed, PhD, CIP and Ilene Wilets, PhD, CIP.
This webinar defined and estimated the prevalence of simultaneous and sequential study enrollment across the research enterprise, discussed best practices for IRBs and investigators, and provided considerations for policy development. (more…)Read more
It’s been four years since PRIM&R’s last Social, Behavioral, and Educational Research (SBER) Conference and, this November, we will host the 2015 SBER Conference in Boston, MA. As we get ready for this year’s event, let’s look back at topics discussed in 2011 to see how they have transformed and evolved over the years.
Issues around data sharing and privacy have been widely discussed in our community, but they’re not new; even back at the 2011 SBER Conference, these issues were important themes:
In his keynote address, Alex (Sandy) Pentland, PhD, Toshiba professor of media [...] Read more