NIH Population Tracking Requirements for ARRA Awards

Notice Number: NOT-OD-10-003

Key Dates
Release Date: October 16, 2009

Issued by
National Institutes of Health (NIH), (http://www.nih.gov)

Purpose

The purpose of this Notice is to describe the NIH expectations for implementing Population Tracking requirements for clinical research protocols supported or conducted with ”American Recovery and Reinvestment Act of 2009”  (ARRA) funds.

Applicability

This Notice applies to all NIH- supported or -conducted clinical research studies that use ARRA funds.

Background

In August, 2001 NIH published the “NIH Policy on Reporting Race and Ethnicity data: Subjects in Clinical Research.” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html ). The Policy specifies that applicants for NIH funds must provide Targeted/Planned enrollment data for each clinical research protocol and Cumulative Inclusion enrollment data for each ongoing protocol. Instructions for providing these data are located in the application instructions (http://grants.nih.gov/grants/forms.htm).

The American Recovery and Reinvestment Act of 2009 was enacted to stimulate the economy; preserve and create jobs; and advance biomedical research. NIH received $8.2 billion in extramural funds to help stimulate the US economy through the support and advancement of scientific research. Awards made with ARRA funds have reporting requirements in addition to those required by NIH.  Data related to Recovery Act spending are located at: http://www.recovery.gov/Pages/home.aspx .

All Recovery Act funds are awarded separately from the normal appropriation funds. The awards must comply with both existing NIH reporting requirements and the Recovery Act reporting requirements (http://www.hhs.gov/recovery/reports/plans/scientific_research.pdf )

Definitions

The NIH definition of clinical research is:

• Patient-oriented research: This type of research involves a particular person or group of people or uses materials from humans. This research can include:

Studies of mechanisms of human disease
Studies of therapies or interventions for disease
Clinical trials 
Studies to develop new technology related to disease

• Epidemiological and behavioral studies: These types of studies examine the distribution of disease, the factors that affect health, and how people make health-related decisions.
•  
• Outcomes and health services research: These studies seek to identify the most effective and most efficient interventions, treatments, and services

Policy

NIH requires that awardees provide a separate Targeted/Planned Enrollment and Inclusion Enrollment table for each clinical research protocol funded with ARRA funds and NIH Appropriations funds. Population Tracking Tables should be labeled with respect to funding source. This reporting requirement takes effect upon publication.

NOTE:  Current awards need not be revised to meet the policy requirement.

Compliance

NIH awardees must comply with all HHS and NIH reporting requirements.

Resources
http://www.nih.gov/recovery/
http://www.grants.gov/applicants/recovery.jsp
http://www.hhs.gov/recovery/programs/index.html
http://www.recovery.gov/Pages/home.aspx

Inquiries

Questions concerning this Notice should be directed to: OEPMailbox@mail.nih.gov