NIH providing new capability for contract vendors to submit inclusion data

The NIH announces implementation of new eRA system capabilities to allow for NIH R&D contract vendors to submit and update data associated with NIH policies on participant inclusion in clinical research directly into the Human Subjects System (HSS) if requested by NIH staff. 

Background

The NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research requires women and members of racial and ethnic minority groups be included in all NIH funded clinical research unless there is a compelling rationale for their exclusion.

The NIH Policy and Guidelines on the Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects requires that individuals of all ages, including children and older adults, must be included in all human subjects research, conducted, or supported by the NIH, unless there are scientific or ethical reasons not to include them.

The existing process for contract vendors to submit participant inclusion data to NIH is email based. NIH sends a request for inclusion data to vendors and the vendors send the data in a PDF form via email, which is then manually entered into HSS by NIH staff.

NIH is now providing the ability for contract vendors to submit inclusion data directly into HSS, accessible via the eRA Commons, if requested by an NIH staff member.

Direct submission of inclusion data will streamline the process; ensure secure data transfer in HSS; and harmonize with the process currently utilized under grants.

Implementation

Affected contract vendors will be notified of any changes to contract requirements by their NIH Contracting Officer.

In order to access HSS, the vendor organization must be registered in eRA Commons (the vendor’s signing official (SO) creates their account at that time). The SO can create Commons accounts for any principal investigators associated with the vendor organization who will be entering information in HSS. DSP staff serve as the SO for The University of Iowa.  To request a Commons ID please email dsp-nih@uiowa.edu.

Note that HSS also interacts with ClinicalTrials.gov. Data entered into HSS can also be exported to ClinicalTrials.gov and HSS allows import of some Clinicaltrials.gov fields directly into HSS.

Full Notice

NOT-OD-24-128
June 6, 2024

Research Administration Dispatch (RAD) Distribution List

The Division of Sponsored Programs (DSP) periodically e-mails Research Administration Dispatches (RAD) to the University of Iowa research community with news about sponsors, compliance issues, upcoming training, and other essential information for researchers. 

The RAD distribution list includes:

• Individuals in the institutional role of Pre-Award Research Administrator (PARA) at the collegiate/org levels;
• Individuals listed as UI contacts (investigator, key personnel, initiator, submitter, budget contact, alternative contact) on the proposal routing form in the past two years; and
• DSP, Grant Accounting Office, and central research compliance contacts.

DSP also maintains an archive of RAD announcements.