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

March 25, 2019

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.

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

March 25, 2019

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.

Uploading Studies to ClinicalTrials.gov Just Got Easier

March 7, 2019

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).

NIH IRL: Join Us at the NIH Regional Seminar

March 5, 2019

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.

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

March 4, 2019

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.