TAG ARCHIVES FOR human subjects research

18
Aug2021

Research Using Secondary Data: New Challenges and Novel Resources for Ethical Governance

Tags:

18 Aug

No comments

The digitization of everyday life has led to an interesting phenomenon for research administrators; the ethical concerns that arise from secondary uses of large and open data now pose a greater challenge for the ethical management of research data than do the conventional challenges of primary data acquisition. As debates over consent forms give way to discussions of differential privacy, it is hard to ignore the new reality that the highest levels of risk and benefit to human participants in research may now arise from secondary data uses. What should research administrators and IRB members do to understand and manage the risks and benefits? Read more

14
Apr2021

Discussion Guides in the Knowledge Center: Spark conversation about research ethics and oversight topics

Tags:

14 Apr

No comments

The new PRIM&R Knowledge Center houses a wide range of resources to keep you inspired and informed for your work in research ethics and oversight! As you familiarize yourself with the Knowledge Center, we want to direct you to some of our top resources. First up in this blog series, our Discussion Guides, which now available individually in the Knowledge Center to help you deepen your understanding of journal articles and other resources by providing a guide for individual review or fostering group discussion. Read more

19
Jan2021

Justice in Research: Reflections on the lessons of 2020

Tags:

19 Jan

Comments: 1

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

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

13
Oct2020

Webinar Follow Up: Complexity in Clinical Trial Design – A Primer on Adaptive and Platform Trials

Tags:

13 Oct

No comments

On June 18, 2020, PRIM&R hosted a webinar, Complexity in Clinical Trial Design: A Primer on Adaptive and Platform Trials. During this webinar, Luke Gelinas and Marianne Kearney Chase defined key terms, explored ethical and regulatory challenges, and provided strategies and examples to bridge the gap between IRBs and researchers in understanding adaptive trial designs. Following the webinar, Luke and Marianne reflected on the session and attendee feedback; we're pleased to share their response with the readers of Ampersand. Read more