12
Aug2019

PRIM&R’s Advancing Ethical Research: Conference Summary (2018) & Looking Ahead

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12 Aug
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Attending the 2018 Advancing Ethical Research (AER) Conference was a fantastic opportunity to connect with colleagues, hear renowned speakers address regulatory hot topics, and share ideas and best practices. Science and technology are expanding exponentially; as a result, our research community is becoming increasingly diverse and multi-center research is booming. While historically the regulations have remained relatively unchanged, in recent years the regulatory community has worked together to provide feedback on suggested major updates and new guidance which are greatly shifting the regulatory world. This year's AER Conference takes place November 18-20, 2019 in Boston, MA Read more

5
Aug2019

Webinar Follow-Up: Data Sharing in SBER: Balancing Transparency and Human Research Protections

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5 Aug
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Enthusiasm for data sharing and research transparency has grown across the social sciences. This newer scholarly imperative has begun to overlap with the long-standing mandate to minimize risks for human subjects in research. IRBs play a crucial role in this realm, as the IRB’s recommendations on a social science research protocol will often determine whether or not the data obtained through the study may be shared in the future. IRBs are tasked with assisting and educating social scientists to include the appropriate elements, language, and procedures in their protocol materials in order for researchers to approach data sharing in an ethical and responsible manner. Read more

30
Jul2019

PRIM&R’s Response to FDA’s Draft Guidance on Enhancing the Diversity of Clinical Trial Populations

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30 Jul
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In June, the FDA issued a draft guidance, "Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs." The issuance of this guidance satisfies a mandate of the FDA Reauthorization Act of 2017 (FDARA), and builds on other recent efforts by the FDA to broaden eligibility criteria for clinical trials and avoid unnecessary exclusions. PRIM&R submitted comments on the guidance this week, and we wanted to share them with you and encourage you to consider submitting your own comments on this important topic—the FDA is accepting comments until August 6. Read more

23
Jul2019

Webinar Follow-Up: IRBs and Research Ethics Consultation Services: An Emerging Resource and Opportunity for Collaboration

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23 Jul
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For a variety of reasons, increasing numbers of institutions are developing research ethics consultation services to provide guidance to investigators, study teams, research subjects, and IRBs about ethical issues arising in particular research studies. The principal source of ethical review for human subjects research has traditionally been the IRB, and so the presence of an consultation service can raise questions about each entity’s role in the research review process. Read more

16
Jul2019

A User’s Guide to Critical Thinking

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16 Jul
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Why are people taken in by pseudoscience and the accompanying “scientific” jargon that gives a false impression claims are backed by laboratory research and facts? Why have scientists like me gone from being viewed as god-like, having put mankind on the moon, to nimrods who’re in the pocket of big pharma? And most of all, how is it that I had not heard of Timothy Caulfield before the 2018 Advancing Ethical Research Conference (AER18)? Read more

11
Jul2019

Webinar Follow-Up: Every Day with Every Interaction: Deepening the IACUC’s Understanding of Positive Reinforcement Training

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11 Jul
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Every day and with every interaction, animals learn how to respond to the people in their research environment. Positive reinforcement training (PRT) techniques can improve animals’ level of compliance with research tasks, as well as their physiological response to their environment. It’s critical that IACUC members have a working knowledge of classical and operant conditioning in order to critically assess whether research proposals include appropriate PRT. On April 17, PRIM&R hosted a webinar to instruct IACUC professionals and members about PRT. Kelly Morrisroe, a research scientist and primate trainer at the Washington National Primate Research Center (WaNPRC) at the University of Washington, served as the speaker. After the webinar, the presenter responded to some of the attendee questions that time didn’t permit us to address live. We’re pleased to share those responses with the readers of Ampersand. Read more