3
Feb2015

PRIM&R’s Response to NIH’s Draft Policy on the Use of a Single Institutional Review Board for Multi-Site Research

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3 Feb
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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

2
Feb2015

2014 AER Post-Conference To-Do List: Things You Should Do ASAP

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2 Feb
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by Rebecca S. Ohnemus, MAA, CRA, research officer at University of the Incarnate Word

Before the conference you diligently poured over the session and speaker descriptions, planned out your flights for optimal arrival and departure times, and emailed all your conference friends to see if they wanted to meet up for coffee or dinner. You worked hard to make sure everything was in place so you could get the most out of the time you’d spend with your colleagues (and away from the office!).

But what happens when you get back? Your inbox is overflowing with new messages. Your voicemail is at capacity. There is a stack of interdepartmental mail envelopes on [...] Read more

30
Jan2015

Research Ethics Roundup: Priorities for Research Funding, Sharing Clinical Trial Data, and More

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30 Jan
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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

26
Jan2015

New sessions at 2015 IACUC Conference incorporate attendee feedback

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26 Jan
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by Maeve Luthin, Professional Development Manager
The upcoming 2015 Institutional Animal Care and Use Committee (IACUC) Conference will feature some exciting new session topics that originated from suggestions shared in last year’s conference evaluations. We received repeated requests to expand conference offerings for those who work with animals that are beyond the typical laboratory species. The new Not Your Average IACUC track includes sessions on working with nontraditional laboratory animals, including: A8: Managing Non-Traditional [...] Read more

23
Jan2015

The Shift Toward Training and Documentation of Proficiency

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23 Jan
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by Anne Meade, MS, PMP, senior manager for website and social media

The most recent revisions to the Guide for the Care and Use of Laboratory Animals highlighted the importance of training for individuals involved with the care and use of animals. As Chris Newcomer explains in this excerpt on People & Perspectives, this was a welcome addition.

“I’ve seen indiscretions done in animal research…they almost always result not from somebody’s maliciousness; they result from their arrogance of thinking that they know enough to do a procedure the right way.”Read more

22
Jan2015

PRIM&R’s Response to OHRP’s Draft Guidance on Research Evaluating Standards of Care

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22 Jan
Comments: 1

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

Research on the comparative effectiveness of commonly used interventions is becoming increasingly common as clinicians, researchers, and healthcare funders seek to improve the efficiency and effectiveness of health care by developing a strong evidence base about medical interventions. With the growth of such efforts, questions have emerged about how oversight rules and mechanisms for the protection of human subjects should apply to such endeavors. In October, following more than a year of deliberation and public consultation, the Office for Human Research Protections (OHRP) released draft guidance regarding how the [...] Read more