Where Should I Address the Inclusion Across the Lifespan Policy in My Application?

Applicants should include a rationale for the age range of study participants and justification for age-based exclusion in the Inclusion of Women, Minorities, and Children section of the PHS Human Subjects and Clinical Trials Information Form (Section 2.4). This section will continue to have the heading “Inclusion of Women, Minorities, and Children” until the next forms update. See the instructions under Inclusion of Children in the application guide for additional information. Continue reading

CMS Seeks Input on Interoperability and Patient Access Proposed Rule and RFIs

Medicare and Medicaid claims data are a uniquely valuable, rich source of health information available to the NIH research community for observational and interventional research. On February 11, 2019, The Center for Medicare and Medicaid Services (CMS) released a proposed rule to advance interoperability and patient access to health information. In addition, CMS released two RFIs to obtain feedback on 1.) interoperability and health IT adoption in post-acute care settings, and 2.) the role of patient matching in interoperability and improved patient care. Continue reading

New “All About Grants” Podcast on Using RePORT Web Tools Throughout the Grants Process

You probably know the NIH RePORT suite of tools as a useful hub of information where you can find reports, data, and analyses of NIH-funded research and answers to the most commonly asked questions on the NIH budget and extramural research programs. But do you know RePORT can be a helpful tool as you are developing your grant application? Continue reading

Uploading Studies to ClinicalTrials.gov Just Got Easier

When conducting clinical trials, NIH funding recipients are required to register their study at ClinicalTrials.gov. To make registration easier, a new feature in the eRA Human Subjects System (HSS) allows applicants and recipients to export study record entries as an XML file, and upload fields that are captured in both systems directly into ClinicalTrials.gov’s Protocol Registration and Results System (PRS). Continue reading

NIH IRL: Join Us at the NIH Regional Seminar

I recently mentioned how much I enjoy starting a conversation through the blog with you, the investigators, grants administrators, research staff, and others in the research community. At the NIH Regional Seminar on Program Funding and Grants Administration, I hold “Open Mike” sessions where I have no slides and no prepared remarks – I let the audience determine the topics we discuss. I love the opportunity for frank conversations about whatever is on your mind. While I meet with people in the grants community at many different events, the NIH Regional Seminar is one of my favorites because of the opportunity to hear in a common setting of the perspectives and challenges of investigators and research administrators. Continue reading

Seeking Input on the Need to Enhance Access to NIH Grants Data

NIH has long been committed to transparency into who and what we fund. We have previously discussed the value of freely-available web tools that allow you to gain insight into NIH funding decisions. Award data available via RePORT and RePORTER, for instance, include non-sensitive information such as awardee institution, principal investigator, funding levels, research abstracts, as well as associated publications, patents, and other project outcomes. The data available through RePORT are quite powerful in their own right. However, compelling arguments exist for why researchers outside NIH should have access to even more information associated with the grants process. Continue reading

Still Have Questions on the NIH Early Stage Investigator (ESI) Policy?

Looking for answers to your questions on our Early Stage Investigator (ESI) policy? Check out the following highlighted frequently asked questions (FAQ) for information on how NIH defines and reviews ESI applications to promote the growth and stability of the biomedical research workforce. Continue reading