24
Jan2019

Advancing Your Career as a Regulatory Professional

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24 Jan
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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

22
Jan2019

Webinar Follow-Up: Postapproval Monitoring as a Strategy for Animal Care and Use Program Improvement

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22 Jan
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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

18
Jan2019

Research Ethics Roundup: Accusations of Politically Biased IRBs, Plagiarism at a Research Integrity Conference, and more

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18 Jan
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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

15
Jan2019

OHRP releases guidance on transitioning existing studies to the revised Common Rule

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15 Jan
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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 Last week, OHRP released a new draft guidance titled, “The Revised Common Rule Compliance Dates and Transition Provision (45 CFR 46.101(l))."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

27
Dec2018

Webinar Follow-Up: Responsible Conduct of Research

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27 Dec
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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

20
Dec2018

Ready, Set, Go: Implementing the Revised Common Rule

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20 Dec
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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