Postapproval monitoring (PAM) ensures that research is being carried out in the manner that was originally approved by the IACUC and many institutions employ PAM as a self-auditing mechanism to check on compliance. A well-run PAM program can also lead to improved animal welfare, science, and collaboration among departments in the animal care and use program. Having a robust framework for conducting PAM promotes education, transparency, and communication between researchers and the institution. Read more
This edition of Research Ethics Roundup covers controversial IRB sanctions of a politically charged research study, direct-to-consumer genetic companies expanding their research capacities, novel human-on-a-chip technology that could reduce the number of animals used in research, and plagiarism in submissions to at a research integrity conference. Read more
Despite the partial government shutdown, it’s business as usual at the Office for Human Research Protections (OHRP), and the revised Common Rule will go into effect, as planned, less than a week from today, on January 21, 2019. Last week, OHRP released a new draft guidance titled, “The Revised Common Rule Compliance Dates and Transition Provision (45 CFR 46.101(l))." Though it’s coming about six months later than would have been ideal, this is the most useful guidance related to the revised Rule released to date. Read more
Integrity and the proper conduct of research are essential for the advancement of science and to maintain continued public trust in the research enterprise. Responsible Conduct of Research (RCR) principles are broad, and provide scientists and scholars from every discipline with a guiding framework of professional responsibilities. Many IRB professionals and members may not realize that “protection of human subjects” is one of the core RCR topics. Gaining knowledge about RCR and research integrity can help IRB and HRPP personnel enhance and promote ethical research.
On October 25, PRIM&R hosted a webinar to provide an overview of RCR and explain its importance and relevance to the human subjects research community. Read more
The US Department of Health and Human Services (HHS) (and other Federal Agencies) plans to implement the revised version of the Federal Policy for the Protection of Human Subjects, or “Common Rule,” on January 19, 2019. I arrived in sunny San Diego early morning Wednesday, November 14, for the 2018 Advancing Ethical Research Conference (AER18) on a mission to learn everything I could about these federal policy changes. Read more
Three researchers at the Texas A&M University School of Public Health—Hye-Chung Kum, PhD; Alva O. Ferdinand, DrPH, JD; and Cason Schmit, JD—invite ethical, legal, and social implications (ELSI) experts to participate in a three-round Delphi study. The purpose of the study is to design an IRB application template for patient-centered comparative effectiveness research that requires record linkage. The researchers are currently seeking feedback on their prototype software, called Minimum Necessary Disclosure for Interactive Record Linkage (MINDFIRL), which is designed to mimimize identity disclosure via controlled information disclosure. Read more