TAG ARCHIVES FOR regulatory

29
May2015

By Anne Meade, senior manager for website and social media

The process of developing federal regulations may be unfamiliar to those whose jobs require adherence. In this excerpt from People and Perspectives, Richard Klein, director of the Food and Drug Administration’s Patient Liaison Program in the Office of Health and Constituent Affairs, talks about being involved in the process of writing the Common Rule. As this was his first foray into writing regulations, at the beginning, Mr. Klein did not anticipate too much difficulty. He quickly realized that assembling [...] Read more

3
Feb2015

by Elisa A. Hurley, PhD, Executive Director, and Avery Avrakotos, Education and Policy Manager The biomedical research landscape has evolved dramatically since the publication of the federal regulations for the protection of human subjects in 1974. In particular, research with human subjects has become an increasingly complex endeavor in which multi-center rather than institution-based research is increasingly the norm. In light of this shift, it is sensible to consider whether an alternative structure for research review better safeguards the rights and welfare of research participants and lessens unnecessary administrative burdens. In December, the National Institutes of Health (NIH) took a step in this direction with the release of a draft policy aimed at reducing inefficiencies associated with [...] Read more

30
Jan2015

It has been a busy few weeks in the research oversight field with the release of a much anticipated Institute of Medicine report on data sharing and a new bill that seeks to overhaul drug and device development. Explore these and other stories below. HHS, Research Community Debate Informed Consent Policy: This piece from Kaiser Health News explores some of the various viewpoints surrounding the changes proposed by the Office for Human Research Protections in their “Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care." Read more

13
Jan2015

by Elisa A. Hurley, PhD, Executive Director, and Avery Avrakotos, Education and Policy Manager

On December 3, the National Institutes of Health (NIH) issued a request for comments on its "Draft NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research," which "proposes that all NIH-funded multi-site studies carried out in the [United States], whether supported through grants, contracts, or the NIH intramural program, should use a single IRB."

Citing a changed research landscape, the background section of the policy suggests [...] Read more

10
Dec2014

 

by Rebecca S. Ohnemus, MAA, CRA, Research Officer at University of the Incarnate Word

PRIM&R is pleased to introduce Rebecca Ohnemus, MAA, CRA, a member of the PRIM&R Blog Squad for the 2014 Advancing Ethical Research (AER) Conference. The PRIM&R Blog Squad is composed of PRIM&R members who will blog here, on Ampersand, about the conference to give our readers an inside peek of what happened December 4-7 in Baltimore, MD.

I love listening in on [...] Read more

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