Several months ago, we learned in the press that an NIH-supported investigator was banned from his university campus pending an ongoing investigation into allegations of sexual misconduct. The institution, which was the recipient of the awards in which this investigator was designated as principal investigator (PI), had not informed us of this situation. Once aware, we contacted senior institutional officials to discuss the need to ensure the effective stewardship of the award under these circumstances. We requested that the institution provide us with alternative plans for conducting the research given that this individual would no longer serve as PI and would have no other involvement in the NIH-funded research, and we reminded them (as we recently reminded the community and as reiterated below) that they are responsible for notifying NIH of any change in status that might affect the ability of an individual identified as key personnel to conduct NIH-supported research. Continue reading
Have to quickly see who can do what in eRA Commons? Check out these handy guides for both at a glance and detailed information on the roles and privileges of eRA Commons users. Continue reading
A new resource, RPPRs: Who Can Do What? provides a quick look at the Annual, Interim, and Final Research Performance Progress Reports (RPPRs), including information such as due dates and how to access RPPR links. It also charts what happens to the Interim RPPR when a Type 2, Competing Renewal application is submitted. Continue reading
For nearly 10 years, more women than men received PhDs in the biomedical sciences, yet women are still underrepresented at every subsequent stage of academic advancement. In 2015, for example, women earned 53% of PhDs, but they comprised only 48% of post-doctoral fellows, 44% of assistant professors, and 35% of professors. To better understand what might be contributing to women’s underrepresentation in later stages of academia, Dr. Lisa Hechtman and her colleagues at the National Institute of General Medical Sciences (NIGMS) analyzed “funding longevity by gender” among funded NIH investigators. Their analysis, recently published in the Proceedings of the National Academy of Sciences, yielded a number of interesting findings which I’d like to share with you.
We recently released a policy notice announcing that as of September 26, 2018, the NIH will no longer be offering the Protecting Human Research Participants (PHRP) course. It is important to note that investigators are still required to comply with all aspects of the NIH policy Required Education in the Protection of Human Research Participants, and can do so through a different training program or course.
On Friday, Sept. 14, General Registration Rates end for this valuable and unique learning opportunity, designed for those new to working with the NIH grants process. If you are interested in attending the Fall NIH Regional Seminar in San Francisco, CA (Oct. 17-19) and have not registered yet, then now is the time! Continue reading
Informed consent is a critical component of clinical research, but there are often challenges to making the process meaningful and effective. Explore these challenges with experts from diverse perspectives and learn innovative ways to address them at the “Meeting New Challenges in Informed Consent” installment of HHS Office for Human Research Protections (OHRP) Exploratory Workshop, a new initiative to provide a forum for the research community to exchange ideas on important issues related to human subjects protections.The workshop will include discussion on how to lay the groundwork for meaningful informed consent, effectively present information for high-quality decision making, and more! Continue reading
For decades, NIH has required valid analysis, also known as stratified analysis, to explore how well interventions work across sex/gender and race/ethnicity for all applicable clinical trials. After revising the policy last year, NIH now requires the findings from these stratified analyses to be reported on ClinicalTrials.gov after an applicable NIH-Defined Phase III clinical trial has completed. Wondering about how this impacts your research? Continue reading
We have written several blogs and articles over the past two years about our efforts to enhance stewardship and transparency in clinical trial research. Indeed, earlier this year Congress applauded our efforts thus far and reaffirmed its commitment to ensuring public access to the results of the NIH-funded clinical trials through timely registration and results information reporting on ClinicalTrials.gov. However, we have heard concern about how the NIH’s Policy on the Dissemination of NIH-Funded Clinical Trial Information applies to fundamental studies involving human participants. Continue reading
Starting January 29, 2019, NIH will begin implementing the Inclusion Across the Lifespan policy, which requires the consideration of age, along with sex/gender and race/ethnicity, in applications that involve human participants. What does this policy mean for you and your study? Continue reading