COVID-19 presents enormous challenges to research ethics oversight. Here, we’ve begun a collection of oversight-related resources in order to best prepare our community for the operational and review concerns brought on by the viral outbreak. Read more
This edition of Research Ethics Roundup covers ClinicalTrials.gov reporting, the ethics of gene drive technology, varied responses to germline editing, and the insufficiency of deidentification in the protection of subjects in environmental research. Read more
Sharing participant research data is critical to supporting reproducibility and collaboration in the scientific community, and leads to more reliable, effective results for research and eventual clinical application. But honesty and transparency are also critical when communicating to participants about these activities. Read more
Conducting an Institutional Review Board (IRB) self-assessment may help administrators refine standard operating procedures and streamline communication. It’s an essential part of performance evaluation and provides an opportunity to celebrate achievements, conduct appraisals, and reflect upon past decisions. It also provides a thoughtful written review of established goals, competencies, and overall office performance. Read more
On November 8, 2019, the National Institutes of Health (NIH) released its Draft NIH Policy for Data Management and Sharing and Supplement Draft Guidance as part of its continuing efforts to ensure public access to research the government conducts and pays for. Today, PRIM&R submitted comments applauding the NIH for taking steps to accelerate data sharing efforts while also offering a few constructive suggestions primarily centered around privacy and funding issues. The comment period closes today, and we encourage interested parties to consider submitting their own comments. Read more
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
IRB Administrators face evolving challenges in their day-to-day work, especially around setting clear expectations for human research protection policies, to clearly communicating those policies to researchers with diverse skill sets. In September 2019, I attended PRIM&R's IRB Administrator Boot Camp in Orlando, Florida to strengthen my skills and learn strategies for successfully carrying out daily responsibilities related to IRB oversight and the protection of participants in constrained contexts. I also benefited from talking with other IRB administrators, sharing ideas and experiences. Read more
