# Presentation: 130957

## NCRR Report on Population Tracking

**Dr. Shelia McClure**
**Program Officer**
**Division of Research Infrastructure **

## NIH Policy on Inclusion of Women and Minorities in Clinical Research 

**it is the policy of NIH that women and members of minority groups* and their subpopulations must be included in all NIH-funded clinical research**
**exclusion may be made by the Director, NIH, upon the recommendation of an Institute/Center Director based on a compelling rationale and justification.**
***A minority group is a readily identifiable subset of the U.S. population that is distinguished by racial, ethnic, and/or cultural heritage. **
**Additional information concerning the NIH Policy on Inclusion of Women and Minorities as Subjects in Clinical Research is available at **_**[http://](http://grants.nih.gov/grants/funding/women_min/women_min.htm)**__**[grants.nih.gov/grants/funding/women_min/women_min.htm](http://grants.nih.gov/grants/funding/women_min/women_min.htm)**_**. **

## Why does NIH have this policy?

**The NIH Revitalization Act of 1993, PL 103-43, signed into law on June 10, 1993, directed the NIH to establish guidelines for inclusion of women and minorities in clinical research **
**the statute states that: In conducting or supporting clinical research for the purposes of this title, the Director of NIH shall ... ensure that (a) women are included as subjects in each project of such research; and (b) members of minority groups are included in such research 492B(a)(1) **
**NIH monitors the inclusion of women and minorities in clinical research through the population tracking reports submitted by the individual Institutes/Centers (IC)**

## Monitoring of Compliance by NIH

**NCRR representatives to the trans-NIH Population Tracking Committee include:  Dr. Louise Ramm, Deputy Director; Dr. Shelia McClure; Ms. Delores Lee, Director of ITO; and Ms. Patricia Newman, Program Analyst in OSPPL**
**all NCRR Program Staff with grants that require tracking review and approve data for annual tracking reports**
**GCRCs (M01) are exempt from the tracking requirement**

## Monitoring of Compliance by NIH

**NIH Advisory Councils**
**in addition to other responsibilities for review of projects, the Advisory Council of each NIH IC prepares biennial reports describing the manner in which the IC has complied with the provisions of the statute**
**individual IC reports are included in the overall NIH Director's biennial report **

## NCRR Population Tracking Biennial Report

| Table 1. Summary of  NCRR Clinical Research Reported In FY 2005  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- |
|  |  |  |  |  |  |  |
|   |   |   |   |   |   |  |
| 1A. PROTOCOLS REPORTED | Total All Clinical Studies | Domestic | % | Foreign | % |  |
| Protocols with Enrollment  | 197 | 197 | 100.0% | 0 | 0.0% |  |
| % | 83.8% | 83.8% |   | 0.0% |   |  |
| Protocols with zero enrollment. Enrollment data has not yet been submitted | 38 | 38 | 100.0% | 0 | 0.0% |  |
|   | 16.2% | 16.2% |   | 0.0% |   |  |
| Total Number of Protocols | 235 | 235 | 100.0% | 0 | 0.0% |  |
| % | 100.0% | 100.0% |   | 0.0% |   |  |

**Notes:**
% Protocols with enrollment at NIH overall is 69.2%.  14,798 protocols

## NCRR Population Tracking Report FY 2005

| Enrollment of Women in Protocols reported in FY 2005 |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- |
| 1B. ENROLLMENT REPORTED | Total All Clinical Studies | Domestic | % | Foreign | % |
| Females Enrolled | 14,082 | 14,082 | 100.0% | 0 | 0.0% |
| % | 56.7% | 56.7% |   | 0.0% |   |
| Males Enrolled | 9,934 | 9,934 | 100.0% | 0 | 0.0% |
| % | 40.0% | 40.0% |   | 0.0% |   |
| Sex of Subjects is Unknown  | 808 | 808 | 100.0% | 0 | 0.0% |
| % | 3.3% | 3.3% |   | 0.0% |   |
| Total Subjects Enrolled | 24,824 | 24,824 | 100.0% | 0 | 0.0% |
| % | 100.0% | 100.0% |   | 0.0% |   |

**Notes:**
NIH Domestic studies 62.3% Females; 35.6% males; 2.1% unknown

## NCRR Report on Minority Enrollment in FY 2005

| 1C. MINORITY ENROLLMENT REPORTED | Total All Clinical Studies | Domestic | % | Foreign | % |
| --- | --- | --- | --- | --- | --- |
| Minority Total | 20,858 | 20,858 | 100.0% | 0 | 0.0% |
|   | 84.0% | 84.0% |   | 0.0% |   |

**Notes:**
 NIH Domestic; 3,468,864- 27.4% 

## NCRR Report on Enrollment by Racial Categories

|  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| FY Reported | FY Funded | Amer. Indian/ Alaska Native | Asian | Black | Hawaiian /Pacific Islander | White | >1 Race | UN |
| 2002 | 2001 | 73 | 825 | 10,796 | 406 | 6,371 | 657 | 212 |
|   | % | 0.4% | 4.3% | 55.8% | 2.1% | 32.9% | 3.4% | 1.1% |
| 2003 | 2002 | 127 | 1,415 | 2,410 | 814 | 4,594 | 7,778 | 3,295 |
|   | % | 0.6% | 6.9% | 11.8% | 4.0% | 22.5% | 38.1% | 16.1% |
| 2004 | 2003 | 1,133 | 1,922 | 2,630 | 1,454 | 7,010 | 11,192 | 1,314 |
|   | % | 4.3% | 7.2% | 9.9% | 5.5% | 26.3% | 42.0% | 4.9% |
| 2005 | 2004 | 2,080 | 186 | 5,613 | 54 | 4,646 | 10,857 | 1,388 |
|   | % | 8.4% | 0.7% | 22.6% | 0.2% | 18.7% | 43.7% | 5.6% |

## NCRR Report on Enrollment by Ethnic Category      		(Hispanic or Latino)

| FY Reported | FY Funded | American Indian/Alaska Native | Asian | Black | Hawaiian /Pacific Islander | White | >1 | UN |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2002 | 2001 | 0 | 4 | 8,383 | 0 | 3,217 | 4 | 7 |
|   | % | 0.0% | 0.0% | 72.2% | 0.0% | 27.7% | 0.0% | 0.1% |
| 2003 | 2002 | 3 | 0 | 83 | 0 | 1,098 | 6,695 | 1,913 |
|   | % | 0.0% | 0.0% | 0.8% | 0.0% | 11.2% | 68.4% | 19.5% |
| 2004 | 2003 | 5 | 14 | 1,970 | 7 | 2,556 | 7,913 | 778 |
|   | % | 0.0% | 0.1% | 14.9% | 0.1% | 19.3% | 59.8% | 5.9% |
| 2005 | 2004 | 68 | 0 | 241 | 0 | 808 | 10,593 | 1,260 |
|   | % | 0.5% | 0.0% | 1.9% | 0.0% | 6.2% | 81.7% | 9.7% |