19
Jan2021

Last year, Heather H. Pierce, JD, MPH and I shared some thoughts about the Belmont Report at 40, and about the evolution and flexibility of the Belmont principles of respect for persons, beneficence, and justice in the face of changing circumstances. As we leave behind the extraordinary year of 2020, I have been thinking about how the pandemic, together with the Black Lives Matter social justice movement, has shone new, and I would say welcome, light on the principle of justice in research. Read more

14
Jan2021

There are few constants in life—one though, is change. Being able to effectively shepherd and champion a change, especially one (or many) that can have impacts over a large group of people is a critical skill that IACUC administrators should work to hone. To start honing this skill, knowing the components of how to effectively be a part of the change is crucial. Read more

7
Jan2021

On November 4, 2020 HHS published a proposed rule titled Securing Updated and Necessary Statutory Evaluations Timely that implements an automatic expiration date for all new HHS regulations of ten years after their initial promulgation. Before that ten-year period is up, HHS regulators may choose to initiate a process to evaluate the rule to assess its continued effectiveness and relevance; if they do not, the rule simply expires. PRIM&R submitted a comment to HHS offering our perspective on the rule’s potential impact, with specific regard to the research ethics and oversight communities. Despite the clear benefits of regular, retrospective review of regulations, the rule’s attempt to enact it is hasty, blunt, and overly rigid and we urge HHS to carefully reconsider it before it is finalized. Read more

15
Dec2020

On October 29, the Final NIH Policy for Data Management and Sharing was published. It will require “researchers to prospectively plan for how scientific data will be preserved and shared through submission of a Data Management and Sharing (DMS) Plan” and will apply to any NIH-funded or -conducted research that generates scientific data. It will be effective as of January 25, 2023. The final rule isn’t perfect: there is no mandate to share data, and grantees will need guidance on crucial questions of communicating these complex issues to participants. Nevertheless, the rule represents a positive step toward expanded, responsible sharing of data, which is critical to both good science and just treatment of research subjects.  Read more

4
Dec2020

On September 17, 2020, PRIM&R hosted a webinar, IACUC Operations: Pandemic & Beyond. During this webinar, Dr. Stacy Pritt and Kathryn Cavanaugh, CPIA, shared various methods for conducting IACUC business electronically and virtually and explored employee engagement strategies for keeping IACUC staff connected during a remote work setting. Following the webinar, Stacy and Kathryn reflected on the session and attendee feedback; we're pleased to share their response with the readers of Ampersand. Read more