Search Results for: "clinical trials"

Proposed Changes to Human Subjects Regulations Are Open for Comment

As many in the research community know, the “Common Rule” refers to current regulations to protect individuals who participate in research as human subjects. The regulations, which have been in place since 1991, are followed by 18 federal agencies that support research – hence the name. Today I’d like to give you some background on how these regulations – and the conversation around these regulations – have evolved since 1991, and let you know about an opportunity to provide feedback on the modernization of these important rules. ….

Welcoming the Inaugural Director of the NIH Division of Biomedical Research Workforce Programs

I am pleased and excited to announce that in August, Dr. Kay Lund will join NIH as the inaugural director of the NIH Division of Biomedical Research Workforce Programs. As you might recall, the NIH Advisory Committee to the Director‘s Biomedical Workforce Working Group recommended that NIH recruit a leader and establish a dedicated office to guide NIH’s training and development of a well-prepared biomedical workforce….

Tune in to the ACD Meeting Today and Friday

I’m at the December Advisory Council to the Director (ACD) meeting today and tomorrow. Several updates and reports from ACD working groups are on the agenda.

Today, we’ll discuss the whirlwind of activities that NIH and HHS have been involved in related to the 2014 Ebola crisis, and we’ll hear updates on peer review evaluation and workforce diversity efforts. I’ll also be co-presenting with Dr. Sherry Mills, director of the Office of Extramural Programs within OER, and co-chair of the ACD’s Physician-Scientist Workforce working group. ….

Updates to Our World Research Reporting Tool – World RePORT

An article published in Science last week discusses the value of creating a global map of health R&D activity to improve coordination of research and create a “global observatory” for health research. I encourage you to check it out, and I also thought it was a timely reminder for discussing updates to the world research reporting tool I blogged about in March last year. The World Research Portfolio Online Reporting Tool (World RePORT) located at http://WorldRePORT.NIH.gov is an online database and map of research funded by NIH and other members of the Heads of International Research Organizations (HIROs). ….

Considering Sex as a Biological Variable in Research – Your Input is Requested

We as a scientific community have made major progress toward balancing the number of men and women who volunteer as participants in biomedical research studies; in fact, women now account for roughly half of the participants in NIH-funded clinical trials. However, we haven’t seen a similar pattern in the pre-clinical research involving animals and cells. …. Thus, as announced in May, NIH intends to develop and implement policies requiring NIH applicants to consider sex as a variable in biomedical research involving animals and cells. …. today we announced a formal request for information (RFI) to get input from the research community, and others. As described in the RFI, we want to hear your thoughts on several topics – for example, whether consideration of sex as a biological variable is an issue affecting the reproducibility of research findings ….

One Nation in Support of Biomedical Research?

“It was the best of times, it was the worst of times.” Until recently, we’d never have dreamed of mentioning the famous opening line of Charles Dickens’ Tale of Two Cities in the context of U.S. biomedical research. But now those words ring all too true. ….

Reporting to NIH on Race and Ethnicity of Clinical Research Participants

The inclusion of women, different racial and ethnic groups, and children is extremely important in clinical research to understand who is affected by a given disease or condition and to develop the appropriate treatments. …. I’m bringing this topic to your attention because there has been some confusion about the distinction between race and ethnicity and how to report this information to the NIH. ….

Fostering Workforce Diversity

Beginning this month, we will be accepting applications for the NIH Director’s ARRA Pathfinder Award to Promote Diversity in the Scientific Workforce. This program challenges the research community to develop new approaches to biomedical workforce diversity. We hope that creative scientists will accept this challenge. We anticipate making five, 3-year awards, for $2 million each, to stimulate the development of new ideas to address this very difficult problem.