It has been eleven years since the NIH last updated their federal regulations on financial conflict of interest. But, during that time, and especially over the past four years, a lot has been discussed about conflict of interest. What started out as concerns over the loss of intellectual property has now morphed into overall requirements for research security, with conflict of interest as the lynchpin. Read more
We are part of a research group at Columbia University Irving Medical Center that is participating in the NIH-sponsored Electronic Medical Records and Genomics (eMERGE) Network study. As part of our site’s exploration of the ethical, legal, and social issues involved in research using polygenic risk scores (PRS), we are conducting a series of focus groups with stakeholders to explore views on these issues. We are interested in IRB members’ perspectives on the ethical and regulatory challenges that can arise from a study like this. 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
Researchers in the Department of Bioethics at the National Institutes of Health invite IRB members to participate in a short study related to pediatric research ethics. The purpose of the study is to explore and compare the views of members of the general public and the views of members of IRBs on various types of medical research with children. The information collected is intended to inform how IRBs evaluate the ethical acceptability of proposed medical research in the future. Read more
Is your IRB reviewing research or expanded access requests related to COVID-19? If so, our team of NIH-funded researchers at Washington University in St. Louis wants to learn about your IRB experiences reviewing and overseeing COVID-19 research and expanded access requests. Read more
