Today is the 40th anniversary of the Belmont Report, the foundational document on which our federal oversight system for human subjects research is based. This milestone warrants a pause in our busy day to reflect on its impact and its legacy. Read more
You are the chairperson of a central IRB. You have learned that one of the sites in a study you oversee is achieving subject recruiting and retention rates far superior to that of other sites. An investigation has found nothing unethical or unusual about the site’s activities — the subjects just find the investigator’s personality irresistible. Read more
In the regulatory world, time is a precious commodity. Though we are frequently tasked with high volumes of work, taking time to work on professional growth and advancement is critical. The "Advancing Yourself as a Regulatory Professional" session at the 2018 Advancing Ethical Research Conference (AER18) provided practical tips on how to advance professionally. Read more
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 Last week, OHRP released a new draft guidance titled, “The Revised Common Rule Compliance Dates and Transition Provision (45 CFR 46.101(l))."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
