April 17, 2023
NOT-AG-21-029 - NIA Announces New Policy and Procedures for the Reporting of Human Subjects Enrollment Data for NIA Clinical Research Trials/Studies
National Institute on Aging (NIA)
The purpose of this Notice is to inform and provide additional clarification to the research community regarding the National Institute on Aging’s (NIA's) policy and procedures for reporting enrollment data for clinical research trials/studies funded through an NIA funding mechanism (including grants, contracts, and cooperative agreements). This Notice details the requirements and expectations of NIA-funded investigators and NIA’s Clinical Research Operations & Management System (CROMS).
Policy Requirements
The policy applies to all NIA grants, contracts, and cooperative agreements that are active as of July 1, 2021 and support human subjects research as defined by the DHS HHS OHRP regulations at 45 CFR 46. In addition to NIH reporting requirements for study enrollment, NIA investigators are required, on a monthly basis, to electronically submit participant enrollment data into the secure NIA Clinical Research Operations & Management System (CROMS) for all human subjects enrolled in their trials/studies. All new Notices of Funding Opportunities (NOFOs), Notices of Awards (NoAs), and Terms of Agreements (ToAs) will include the following language:
The National Institute on Aging (NIA) utilizes a central resource to NIA staff and extramural investigators to facilitate/support the conduct and management of clinical research. NIA Clinical Research Operations & Management System (CROMS) is a comprehensive data management system to support the business functions, management, and oversight responsibilities of NIA grants that support the conduct of clinical research with human subjects. NIA investigators of grants, contracts, and cooperative agreements that are active as of July 1, 2021 and support human subjects research as defined by the DHS HHS OHRP regulations at 45 CFR 46 will be required to interact with and use existing and future components of CROMS as required by NIA throughout the lifecycle of the grant and as described in this notice. Data to be submitted to NIA CROMS includes those elements reported in the standard NIH requirement annual progress report (GPS 4.1.15.7). Details regarding the standard operating procedures for CROMS can be found on the NIA CROMS website.
When applicable, all NIA grantees must ensure:
1. The study’s Informed Consent Document (ICD) lists “The National Institutes of Health (NIH) and its authorized representatives” as one of the organizations that may look at or receive copies of information in participants’ study records. According to DHS HHS OHRP 45 CFR 46 46.116, all ICDs must contain “A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained.” If using the NIA informed consent template please see Section 6: Statement of Confidentiality.
2. An assigned NIH ClinicalTrials.gov identifier (NCT number) is reported in its respective CROMS study record within three months after assignment, and the reporting of final enrollment data to CROMS is consistent with final enrollment data reported in ClinicalTrials.gov.
Resources describing the policy and procedures to use CROMS can be found on the NIA CROMS website. The NIA CROMS website also provides additional information regarding which studies are expected to use CROMS, the standard operating procedures (SOPs) for the use of CROMS, the timelines required for satisfactory participation, and reasons why a study with a CROMS record would be considered non-compliant. NIA CROMS provides a support help desk to assist CROMS users within 48 business hours that can be reached at: NIAcromsSupport@niacroms.org.
CROMS Compliance:
NIA may take actions for those NIA-funded grants that are non-compliant with this policy. As stated in the Grants Policy Statement, “If a recipient has failed to comply with the terms and conditions of award, NIH may take one or more enforcement actions which include disallowing costs, withholding of further awards, or wholly or partly suspending the grant, pending corrective action. NIH may also terminate the grant in whole or in part as outlined in 2 CFR Part 200.340 and 45 CFR Part 75.372.”
Examples of non-compliance and how to remediate each can be found on the CROMS resource page.
Policy Motivation/Impetus
NIA, one of the 27 Institutes and Centers (ICs) of NIH, leads the federal government in conducting and supporting research on aging and the health and well-being of older people. Through NIA’s extramural research program, the Institute oversees a robust clinical research portfolio and generates a vast collection of unique data.
One of the biggest hurdles in advancing aging research is participant recruitment and retention into NIA-funded clinical trials/studies, particularly among diverse and traditionally underrepresented populations. Tracking near real-time (monthly) participant enrollment in NIA-funded trials/studies through CROMS will allow NIA to identify enrollment challenges and to ensure that NIA-funded trials/studies meet the requirements of NIH inclusion policies. CROMS will provide NIA a more efficient and seamless ability to manage the enrollment performance of its clinical research portfolio, allowing the ability to track, report, and manage extramural clinical research enrollment data, study documents, activities, and portfolios in real time. Data provided in CROMS also allows the Institute to ensure accountability and transparency in the responsible use of government funds.
NIH policy requires certain information regarding research that involves human subjects. The terms outlined here are in addition to and not in lieu of other NIH policies, including the PHS Human Subjects and Clinical Trials Information Form instructions regarding the Protection of Human Subjects attachment (Section 3.1) in the SF424 Application Guide and the Research Performance Progress Report (RPPR). CROMS has the capabilities to allow investigators to generate reports to meet requirements for annual NIH/NIA reporting. For more information on CROMS, please see NIA’s announcement.
Holly Massett, Ph.D.
Director, Office of Clinical Research
Division of Extramural Activities
National Institute on Aging (NIA)
Email: NIAclinicalresearch@nia.nih.gov
and Human Services (HHS)
