On January 18, 2017, the final rule from the Department of Health and Human Services (HHS) and the National Institute of Health (NIH)’s corresponding policy on reporting to ClinicalTrials.gov will take effect. ClinicalTrials.gov, which is run by NIH, is a searchable registry of clinical trials. It is a federal requirement that sponsors of certain clinical studies that either have one American research site or are conducted under an investigational device exemption (IDE) or an investigational new drug (IND) application register and report the summary results on ClinicalTrials.gov. However, currently very few pharmaceutical companies, academic institutions, and government agencies are complying with the requirement. The regulatory changes taking effect will only have a meaningful impact if the incoming Administration chooses to enforce them. Read more
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This week’s Research Ethics Roundup examines what the new 21st Century Cures law means for harmonization efforts, why cancer trials struggle with minority enrollment, a new study on reporting of bias-reducing methodologies in animal research, and the argument for open access publishing.
Cures Law Requires FDA, HHS to Harmonize Regs
Jeannie Baumann reports for Bloomberg BNA about a provision in the new 21st Century Cures law that requires the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) to address any differences between their corresponding [...] Read more
The much-anticipated Notice of Proposed Rulemaking—offering the first changes to the Common Rule since its publication in 1991—has now been released. in the interest of providing PRIM&R’s community with as much exposure to the issues raised within it, and the writing and scholarship around the proposed rules changes, PRIM&R and other organizations are cross-posting their thoughts. This post, from Dr. Celia B. Fisher at Fordham University, focuses on the proposed changes to minimal risk. It originally appeared on Ethics & Society, the Fordham University Center for Ethics Education blog.
On February 28, 2013, PRIM&R hosted a webinar titled Key Decision Points: Is it Research Involving Human Subjects? It is Exempt? Is IRB Review Required? Following the webinar, I had a chance to connect with the presenters, Karen Hale, RPh, MPH, CIP, and Daniel Nelson, MSc, CIP, to discuss some of the questions that came in that they were unable to cover during the allotted time. Below, they share their perspectives on a few of the questions.
Q: Why can't I determine if a study involves "human subjects" before I determine if it is "research"?
A: From a regulatory standpoint, the definition of a “human [...] Read more
Professionals engaged in the protection of human and animal subjects felt the tides of change in 2011: The Department of Health and Human Services proposed an overhaul to the regulations governing human subjects protections. Across the country, people provided feedback and comments on the proposed change; the animal care and use community reacted when the National Institutes [...] Read more