OHRP Exploratory Workshop: “Meeting New Challenges in Informed Consent in Clinical Research”

August 30, 2018

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! 

New “All About Grants” Podcast on Valid/Stratified Analyses

August 28, 2018

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?

We Want Your Feedback About Results Reporting for Basic Science Studies Involving Human Participants

August 16, 2018

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.

A Look at the Human Subjects System

August 7, 2018

The Human Subjects System (HSS) system was launched in June 2018 and replaced the Inclusion Management System (IMS). Learn about HSS at a glance by viewing the new graphic on the HSS page. The graphic orients users at different stages of the grants process to how and when they can use HSS to update study information on human subjects and clinical trials to NIH.

Trends in Diversity within the NIH-funded Workforce

August 7, 2018

As highlighted in many previous blog posts and the recent National Academies of Sciences, Engineering, and Medicine (NASEM) report, promoting a strong biomedical workforce is a top priority for the NIH.  In 2017, NIH launched the Next Generation Researchers Initiative, which is a multi-pronged approach to increase the number of NIH-funded early stage investigators. An important component of this initiative is the call for increased transparency and availability of data about the make-up of the biomedical research workforce. More complete data will allow NIH leadership to best understand and address the needs of our emerging workforce.