TAG ARCHIVES FOR informed consent

20
Oct2021

The AER20 keynote address from Wylie Burke, MD, PhD, discussed the implications of the lack of diversity in research. This is a real problem in genetic research: how can a full range of genetic variants be studied if a non-diverse population is assessed? In community research, when obtaining consent, a researcher must make sure the community is fully informed about the extent of the research. Read more

25
Aug2021

As hospitals have become essential treatment centers for COVID-19 patients, clinical trial participants have become increasingly averse to attending check-ups and monitoring visits at these sites. Telemedicine is now being recognized not only as an option for those who do not have convenient access to healthcare, but also as a means by which clinical trials can be accomplished. 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

30
Oct2020

Are investigators at your institution engaging patient and community partners in research? Some of these partners will need training in human research protections—particularly if they will be responsible for recruiting participants, obtaining informed consent, or collecting data. CIRTification Online is a free web-based human research protections training program developed specifically for community research partners. Read more

9
Jul2020

A team comprising Holly Taylor of the NIH Clinical Center’s Department of Bioethics; Susan Kornetsky of Boston Children’s Hospital; and Megan Kasimatis Singleton of the Johns Hopkins University School of Medicine, and myself recently completed a project examining how, in the absence of federal guidance, institutions are interpreting and applying the key information requirement and, specifically, whether and to what extent they are developing policies, guidance, templates, or other tools to help researchers and IRBs apply this provision of the Common Rule. We undertook this project as part of the Consortium to Advance Effective Research Oversight (AEREO)—a group of leaders in human research oversight, research ethics, and empirical methods dedicated to evaluating and improving the effectiveness of IRBs and HRPPs through empirical research. PRIM&R is pleased to share with the human research protections community the materials collected during this project as a public resource. Read more