Department of Health and Human Services 

National Institutes of Health 

MONITORING ADHERENCE TO THE 

NIH POLICY ON THE INCLUSION 

OF WOMEN AND MINORITIES 

AS SUBJECTS IN CLINICAL RESEARCH 

 

Comprehensive Report: Tracking of Human Subjects Research 

As Reported in Fiscal Year 2009 and Fiscal Year 2010 

 

 2011 Report 

Table of Contents

 Page

Historical Summary and Current Activities 

Monitoring Adherence to the NIH Policy on the Inclusion of Women and Minorities as Subjects 

in Clinical Research .................................................................................................................................. 1-8 

FY2009 and FY2010 Data Analyses 

Data Analyses Report, Executive Summary Data Tables and Fifteen-Year Trend Tables ..................... 1-66 

NIH Wide Clinical Research Performed in FY2008-2009 and Reported in FY2009-2010

Table 1 Summary of NIH Clinical Research Reported in FY2009: Total Number of 

Protocols and Enrollment by Sex and Domestic versus Foreign Protocols ...................... 19 

Table 2 Summary of NIH Clinical Research Reported in FY2010: Total Number of 

Protocols and Enrollment by Sex and Domestic versus Foreign Protocols ...................... 20 

Table 3 Summary of NIH Phase III Clinical Research Reported in FY2009: Total Number 

of Protocols and Enrollment by Sex, and Domestic versus Foreign Protocols ................. 21 

Table 4 Aggregate Enrollment Data for Extramural and Intramural Phase III Research 

Funded in FY2008 and Reported in FY2009: Percent Analysis ....................................... 22 

Table 5 Summary of NIH Phase III Clinical Research Reported in FY2010: Total Number 

of Protocols and Enrollment by Sex, and Domestic versus Foreign Protocols ................ 24 

Table 6 Aggregate Enrollment Data for Extramural and Intramural Phase III Research 

Funded in FY2009 and Reported in FY2010: Percent Analysis ...................................... 25 

Table 7 Sixteen-Year Trend Summary of NIH Extramural and Intramural Phase III Clinical 

Research Reported in FY1995-2010 ................................................................................ 27 

Table 8 Overview of NIH Extramural and Intramural Clinical Research Reported in 

FY2009: Number of Sex-Specific Protocols, and Domestic versus Foreign Protocols .... 34 

Table 9 Aggregate Enrollment Data for Extramural Research Protocols Funded in FY2008 

and Reported in FY2009: Percent Analysis ..................................................................... 36 

Table 10 Overview of NIH Extramural and Intramural Clinical Research Reported in 

FY2010: Number of Sex-Specific Protocols, and Domestic versus Foreign Protocols .... 38 

Table 11 Aggregate Enrollment Data for Extramural Research Protocols Funded in FY2009 

and Reported in FY2010: Percent Analysis ..................................................................... 40 

Table 12 Aggregate Enrollment Data for Extramural Research Protocols Excluding 

Male-Only and Female-Only Protocols Funded in FY2008 and Reported in FY2009: 

 Percent Analysis .............................................................................................................. 42 

Table 13 Aggregate Enrollment Data for Extramural Research Protocols Excluding 

Male-Only and Female-Only Protocols Funded in FY2009 and Reported in FY2010: 

 Percent Analysis ............................................................................................................... 44 
Table 14 Overview of NIH Phase III Extramural and Intramural Clinical Research Reported 

in FY2009: Number of Sex-Specific Protocols and Enrollment, and Domestic 

versus Foreign Protocols .................................................................................................. 46 

Table 15 Aggregate Enrollment Data for Extramural Phase III Research Funded in FY2008 

and Reported in FY2009: Percent Analysis ...................................................................... 48 

Table 16 Overview of NIH Phase III Extramural and Intramural Clinical Research Reported 

in FY2010: Number of Sex-Specific Protocols and Enrollment, and Domestic versus 

Foreign Protocols ............................................................................................................. 50 

Table 17 Aggregate Enrollment Data for Extramural Phase III Research Protocols Funded in 

FY2009 and Reported in FY2010: Percent Analysis ....................................................... 52 

Table 18 Aggregate Enrollment Data for Intramural Research Protocols Funded in FY2008 

and Reported in FY2009: Percent Analysis ...................................................................... 54 

Table 19 Aggregate Enrollment Data for Intramural Research Protocols Funded in FY2009 

and Reported in FY2010: Percent Analysis ...................................................................... 56 

Table 20 Aggregate Enrollment Data for Intramural Phase III Research Protocols Funded in 

FY2008 and Reported in FY2009: Percent Analysis ........................................................ 58 

Table 21 Aggregate Enrollment Data for Intramural Phase III Research Protocols Funded in 

FY2009 and Reported in FY2010: Percent Analysis ...................................................... 60 

 

Table 22 NIH Sixteen-Year Trends for Protocol and Enrollment Data: 1995-2010* ..................... 62 

Table 23 NIH Sixteen-Year Minority Trend Summary of NIH Extramural and Intramural 

 Clinical Research Reported in FY 1995-2010 .................................................................. 64 

Appendices

Appendix A Historical Narrative on the Implementation of the NIH Inclusion Policy 

Appendix B Explanation of Gender and Minority Codes 

 

Appendix C Internet Homepage: Inclusion of Women and Minorities Policy Implementation 

Appendix D NIH Policy and Guidelines on the Inclusion of Women and Minorities as 

Subjects in Clinical Research - Amended, October, 2001 

Appendix E NIH Policy on Reporting Race and Ethnicity Data: Subjects in Clinical 

Research 

Appendix F NIH Inclusion Tables for Target and Enrollment Data 

Appendix G FY2010 Aggregate Extramural and Intramural Data Tables 

Monitoring Adherence to the NIH Policy on the Inclusion 

of Women and Minorities as Subjects in Clinical Research

Historical Perspective 

The establishment and implementation of policies for the inclusion of women and minorities in clinical 

research funded by the National Institutes of Health (NIH) has its origins in the women’s health 

movement. Following the issuance of the report of the Public Health Service Task Force on Women’s 

Health in 19851

, the NIH established a policy in 1986 for the inclusion of women in clinical research. 

This policy, which urged the inclusion of women, was first published in the NIH Guide to Grants and 

Contracts in 19872

. Later that year, minority and other scientists at the NIH recognized the need to 

address the inclusion of minority populations. Therefore, in a later 1987 version of the NIH guide, a 

policy encouraging the inclusion of minorities in clinical studies was first published. 

In order to ensure that the policies for inclusion were firmly implemented by NIH, the Congress made 

what had previously been policy into Public Law, through a section in the NIH Revitalization Act of 1993 

(PL 103-43)3

 entitled Women and Minorities as Subjects in Clinical Research. In 1994, NIH revised its 

inclusion policy to be in compliance with the statutory language. The Revitalization Act essentially 

reinforced the existing NIH policies, but with four major differences: 

• that NIH ensure that women and minorities and their subpopulations be included in all clinical 

research; 

• that women and minorities and their subpopulations be included in Phase III clinical trials in numbers 

adequate to allow for valid analyses of differences in intervention effect; 

• that cost is not allowed as an acceptable reason for excluding these groups; and, 

• that NIH initiate programs and support for outreach efforts to recruit and retain women and minorities 

and their subpopulations as participants in clinical studies. 

Revised inclusion guidelines developed in response to this law were published in the Federal Register4

 in 

March 1994, and they became effective in September 1994. The result was that NIH could not and would 

not fund any grant, cooperative agreement or contract or support any intramural project to be conducted 

or funded in Fiscal Year 1995 and thereafter which did not comply with this policy. 

Strategies to ensure uniform implementation and adherence to the revised guidelines across the NIH 

included NIH –wide training of staff and Institutonal Review Board chairs in 1994. An NIH Tracking 

and Inclusion Committee was established made up of representatives of the directors of each of the 

Institutes and Centers (ICs). This trans-NIH committee, convened by the Office of Research on Women’s 

Health (ORWH) and co-chaired with a senior IC official, met on a regular basis, focusing on consistent 

and widespread adherence to the NIH guidelines by all the ICs. Working in collaboration with the Office 

of Extramural Research (OER), the Office of Intramural Research (OIR), and other components of NIH, 

ORWH coordinated the development of data collection and reporting methodologies to ensure uniform 

standards and definitions in the reporting of data on women and minority participants in NIH-funded 

clinical research. 

In addition, a variety of outreach activities were initiated to explain the revised policy to the scientific 

research community and to clear up common misunderstandings about the new requirements. Training 

was especially important in light of 1990 General Accounting Office (GAO) findings that NIH’s initial 

1 
policy on inclusion was inconsistently applied and had not been well communicated or understood within 

NIH or in the research community. 

GAO Report, May 2000: Recommendations and Actions Taken

Following a Congressional request for an assessment of NIH progress in implementing the1994 

guidelines on including women in clinical research, the GAO issued another report in May, 2000, entitled 

Women’s Health - NIH Has Increased Its Efforts to Include Women in Research.5

 It concluded that in the 

past decade, NIH had made significant progress in implementing a strengthened policy on including 

women in clinical research. 

The GAO report also included two specific recommendations to the Director of NIH: 

• that the requirement be implemented that Phase III clinical trials be designed and carried out to allow 

for the valid analysis of differences between women and men and communicate this requirement to 

applicants as well as requiring peer review groups to determine whether each proposed Phase III 

clinical trial is required to have such a study design, and that summary statements document the 

decision of the initial reviewers; and 

• that NIH staff members who transmit data to the inclusion tracking data system receive ongoing 

training on the requirements and purpose of the system. 

Immediately following the release of this report, a NIH Subcommittee Reviewing Inclusion Issues was 

formed, consisting of representatives from several ICs, ORWH, OER, and OIR, to reexamine NIH’s 

system for tracking data on the inclusion of women and minorities in clinical research, recommend any 

necessary changes to improve its accuracy and performance, and reiterate the NIH policy. Several actions 

resulted to clarify the requirement for inclusion of women and minority groups, where scientifically 

appropriate, in NIH-funded clinical research. In addition, NIH-defined Phase III clinical trials are 

required to include plans for analysis of sex/gender and/or racial/ethnic differences. Significant actions in 

2001 included: 

• Updating the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects 

in Clinical Research6

 and posting it on the ORWH home page http://orwh.od.nih.gov/inclusion.html

and NIH web page, Inclusion of Women and Minorities Policy Implementation at: 

http://grants.nih.gov/grants/funding/women_min/women_min.htm 

• Developing a new term and condition of award statement for awards made after October 1, 2000 

that have NIH-defined Phase III clinical trials. 

• Incorporating language in NIH solicitations for grant applications and contract proposals to 

clarify the submission requirement for NIH-defined Phase III clinical trials, a description of 

plans for sex/gender and/or race/ethnicity analysis including subgroups, if applicable, and reporting 

enrollment annually and results of analyses, as appropriate. 

• Guidelines and instructions for reviewers and Scientific Review Officers (SROs) were 

developed to emphasize and clarify the need to review research proposals that are classified as NIHdefined Phase III clinical trials for both inclusion requirements and issues related to analyses by 

sex/gender and/or race/ethnicity. Instructions were developed for the proper documentation to 

include in summary statements to address adherence to these policies. 

2 
Training to ensure compliance with this policy was provided to NIH program and review officials, grants 

and contracts management staff, and current and prospective research investigators. Several initiatives 

were implemented for review, grants management and program staff since 2000, including specific topics 

addressing revisions to the NIH Inclusion policy, a grants policy update and Scientific Review Officer 

(SRO) orientation on specific issues related to review meetings and proceedings. 

Format Changes for Reporting Race and Ethnicity Data as of FY2002

Beginning in FY2002, NIH changed how data are reported based on the 1997 Office of Management and 

Budget (OMB) revisions to the 1977 Directive 15 “Race and Ethnic Standards for Federal Statistics and 

Administrative Reporting,” which provided minimum standards for maintaining, collecting and reporting 

data on race and ethnicity. In October 1997, OMB published “Revisions to the Standards for the 

Classification of Federal Data on Race and Ethnicity; and their implementation involved a number of 

changes, including collecting and reporting information on race and ethnicity separately, whereas the 

1977 OMB standards used a combined race and ethnicity format. NIH aggregate population data tables 

describe data using both the 1997 and 1977 OMB standards for reporting data on race and ethnicity. Since 

2002, the number of studies reporting data using the 1997 format (NEW FORM) has steadily increased, 

whereas the number of studies using the 1977 format (OLD FORM) has steadily decreased as the studies 

funded prior to FY2002 are completed. 

The 1997 OMB reporting format (NEW FORM) and standards do not easily allow direct comparison of 

ethnic and racial data with similar data collected under the 1977 OMB reporting format (OLD FORM) 

and standards because the categories and methods for collecting the data are fundamentally different. 

Changes in the standardization of definitions and business rules across NIH for improving the data 

entered in the population tracking system are reflected in data reported beginning in FY2002. While 

implementation of these changes will improve the consistency and comparability for future reporting, 

comparisons with data originating prior to FY 2002 data are difficult although trends can be 

approximated. 

As demonstrated below, the primary differences are: (1) the Hispanic population is considered an ethnic 

category and reported separately from racial data; (2) there are separate racial categories for Asian 

population data as distinct from Hawaiian and Pacific Islander population data; and 3) respondents are 

given the option of selecting more than one race. 

Race and ethnicity data from the OLD and NEW Forms are combined differently as described below for 

purposes of reporting on the minority population enrolled in NIH clinical research: 

• The OLD FORM uses the 1977 OMB combined Race and Ethnicity Format, which has mutually 

exclusive categories, and allows Hispanics to be reported as either "Hispanic, Not White" or "White". 

• The NEW FORM uses the 1997 OMB Race and Ethnicity Categories, with separate reporting for 

Ethnicity (Hispanic or Latino; Not Hispanic or Latino) and Race (Part A); in this format, an 

individual is classified both by Ethnic Category and by Race Category. Part B of the NEW FORM 

therefore provides a distribution of only "Hispanics or Latinos" by the five main Race categories. 

Since minority categories are defined to include both "Hispanic or Latino ethnicity" and non-white 

racial categories when providing summary totals of minorities, it is necessary to add White 

Hispanics" and "Unknown/Other Hispanics" based on their ethnicity to the non-white racial 

categories. 

• Hispanics are defined by country of origin, and may be identified as belonging to any one race, or 

more than one racial category. 

3 
Targeted/Planned Enrollment: Comparison of Old (1977) and New (1997) Forms 

I. Old Form (1977 OMB Race/Ethnicity Categories) 

Race/Ethnicity Category

Inclusion in 

Minority Total 

American Indian/Alaska Native X 

Asian/Pacific Islander X 

Black or African American X 

Hispanic, Not White X 

White 

Unknown/Other 

II. New Form (1997 OMB Race./Ethnicity Categories) 

Part A. Total Enrollment Report 

Racial / Ethnic Categories 

Racial or Ethnic 

Category 

 Inclusion in 

Minority Total 

American Indian/Alaska Native Racial X 

Asian Racial X 

Black or African American Racial X 

Hawaiian/Pacific Islander Racial X 

White Racial 

More Than One Race Racial X 

Unknown/Other Racial 

Racial Categories: Total of all Subjects Racial Total* 

Hispanic or Latino Ethnic** 

Not Hispanic or Latino Ethnic 

Unknown (ethnicity not reported) Ethnic 

Ethnic Categories: Total of All Subjects Ethnic Total* 

Part B: Hispanic Enrollment Report

Racial / Ethnic Categories 

Racial or Ethnic 

Category 

 Inclusion in 

Minority Total 

American Indian/Alaska Native Ethnic 

Asian Ethnic 

Black or African American Ethnic 

Hawaiian/Pacific Islander Ethnic 

White (Hispanic) Ethnic X 

More Than One Race Ethnic 

Unknown/Other (Hispanic) Ethnic X 

Racial Categories: Total of Hispanics or Latinos Ethnic Total** 

* The "Ethnic Categories: Total of All Subjects" must be equal to the "Racial Categories: Total of All Subjects" 

** The "Hispanic or Latino"(Part A) must be equal to "Racial Categories: Total of Hispanics or Latinos"(Part B).

4 
Continuing Implementation and Monitoring Activities 

The PHS 398 grant application was significantly revised to provide additional instructions concerning the 

Women and Minorities Inclusion Policy and the new enrollment form became mandatory as of May 10, 

2005. These PHS 398 instructions are also included in the federal application form SF-424 (R&R) for 

NIH grants using the federal Grants.gov system (http://era.nih.gov/ElectronicReceipt/) including two 

significant changes in definitions. First, NIH requires use of a revised definition of clinical research that 

was reported in the 1997 Report of the NIH Director’s Panel on Clinical Research and adopted by NIH. 

Second, NIH adopted the 1997 revisions to OMB Directive 15, “Race and Ethnic Standards for Federal 

Statistics and Administrative Reporting”, and required the revised categories to be used when reporting 

race and ethnic data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html). In addition, 

NIH policy reemphasized that that NIH-defined Phase III clinical trials must be designed and conducted 

in a manner to allow for a valid analysis of whether the interventions being studied affect women or 

members of minority groups differently than other subjects. 

In FY 2007, two training sessions were developed for NIH staff involved in the management or review of 

clinical research studies. Approximately 300 NIH staff members attended each session in person, and 

additional staff participated in the training via webcast. 

Communication and Outreach Efforts to the Scientific Community 

NIH staff members provide outreach to the scientific community to help increase understanding of any 

revised inclusion policies. These training and outreach efforts improve understanding of the sex/gender 

and minority inclusion policy and assist investigators and NIH intramural research staff to appropriately 

address these issues throughout the research grant and contract process. Investigators are instructed to 

address women and minority inclusion issues in the development of their applications and proposals for 

clinical research. 

Reference documents such as the Outreach Notebook for the NIH Guidelines on Inclusion of 

Women and Minorities as Subjects in Clinical Research

(http://orwh.od.nih.gov/inclusion/outreach.pdf) and the Frequently Asked Questions (FAQs) for the 

Inclusion , Recruitment and Retention of Women and Minority Subjects in Clinical Research

(http://orwh.od.nih.gov/inclusion/outreachFAQ.pdf) have been published and distributed for 

investigators and NIH staff. These publications discuss the elements of recruitment and retention, 

the NIH inclusion policy, current OMB requirements for reporting race and ethnicity data, and 

information for application submission, peer review, and funding. Both the Outreach Notebook 

and the FAQs are posted on the ORWH website http://orwh.od.nih.gov as well as on the NIH 

website for the inclusion of women and minorities policy implementation at: 

http://grants1.nih.gov/grants/funding/women_min/women_min.htm. The revised Outreach Notebook 

and FAQs continue to be available to the research community to further explore the inclusion 

policy and its intent. Additionally, a slide show is available electronically and in hard copy, 

entitled “Sex/Gender and Minority Inclusion in NIH Clinical Research: What Investigators Need 

to Know!” The slide show was developed for NIH staff to assist them in working with the 

extramural community.

5 
Monitoring Compliance: Extramural and Intramural Population Data Analysis 

 Inclusion enrollment data from each NIH Institute and Center are presented in this report in aggregate 

data tables, providing documentation of the monitoring of inclusion with some degree of analysis of data. 

Caution should be used in interpreting these figures. Conclusions that can be reasonably drawn from the 

data are provided. 

When assessing inclusion data, enrollment figures should not be directly compared to the national 

census figures. The goal of the NIH policy is to conduct biomedical and behavioral research in such a 

manner that the scientific knowledge acquired will be generalizable to the entire population of the United 

States, and not to satisfy any proportional target based upon census data. The number of women, men 

and/or representatives of racial/ethnic subpopulations included in a particular study depends upon the 

scientific question addressed in the study and the prevalence among women, men and/or racial/ethnic 

subpopulations of the disease, disorder, or condition under investigation. 

Scientific Review Groups are instructed to focus on scientific considerations when assessing the planned 

enrollment described in a NIH grant application for a proposed study. The Scientific Review Group 

(SRG) evaluates the inclusion plan and finds it unacceptable if it: 1) fails to provide sufficient information 

about target enrollment; 2) does not adequately justify limited or lack of inclusion of women or 

minorities; or 3) does not realistically address recruitment and retention. For NIH-defined Phase III 

clinical trials, the SRG also evaluates the description of plans to conduct analyses, as appropriate, to 

address differences in the intervention effect by sex/gender and/or racial/ethnic groups. Applications with 

unacceptable inclusion plans cannot be funded until NIH staff members are assured that revised inclusion 

plans meet the inclusion policy requirements. Research awards covered by this policy require the grantee 

to report annually on enrollment of women and men, and on the race and ethnicity of research participants 

so that enrollment can be monitored. 

NIH has monitored aggregate inclusion data for study populations through the evolving NIH automated 

tracking system since FY1994 and monitoring compliance with the NIH Inclusion policy is well 

established in all IC’s. In May 2002, the NIH successfully deployed a population tracking system for 

monitoring inclusion data that was designed to provide easier entry of investigator-reported enrollment 

data and project monitoring for NIH staff. An eRA Population Tracking User Group consisting of 

representatives from several ICs provides continuous feedback related to procedures to monitor 

compliance. 

DEFINITIONS: 

Clinical Research as defined by the 1997 Report of the NIH Director’s Panel on Clinical Research, 

(1) Patient-oriented research. Research conducted with human subjects (or on material of human origin 

such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly 

interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues 

that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human 

disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies; 

(2) Epidemiologic and behavioral studies; and (3) Outcomes research and health services research. 

NIH-Defined Phase III Clinical Study 

For the purpose of these guidelines, an NIH-defined "clinical trial" is a broadly based prospective Phase 

III clinical investigation, usually involving several hundred or more human subjects, for the purpose of 

evaluating an experimental intervention in comparison with a standard or control intervention or 

comparing two or more existing treatments. Often the aim of such investigation is to provide evidence 

6 
leading to a scientific basis for consideration of a change in health policy or standard of care. The 

definition includes pharmacologic, non-pharmacologic, and behavioral interventions given for disease 

prevention, prophylaxis, diagnosis, or therapy. Community trials and other population-based intervention 

trials are also included. 

Valid Analysis 

The term "valid analysis" means an unbiased assessment. Such an assessment will, on average, yield the 

correct estimate of the difference in outcomes between two groups of subjects. Valid analysis can and 

should be conducted for both small and large studies. A valid analysis does not need to have a high 

statistical power for detecting a stated effect. The principal requirements for ensuring a valid analysis of 

the question of interest are: 

• allocation of study participants of both sexes/genders (males and females) and different racial/ethnic 

groups to the intervention and control groups by an unbiased process such as randomization, 

• unbiased evaluation of the outcome(s) of study participants, and 

• use of unbiased statistical analyses and proper methods of inference to estimate and compare the 

intervention effects among the sex/gender and racial/ethnic groups. 

Significant Difference

For purposes of this policy, a "significant difference" is a difference that is of clinical or public health 

importance, based on substantial scientific data. This definition differs from the commonly used 

"statistically significant difference," which refers to the event that, for a given set of data, the statistical 

test for a difference between the effects in two groups achieves statistical significance. Statistical 

significance depends upon the amount of information in the data set. With a very large amount of 

information, one could find a statistically significant, but clinically small difference that is of very little 

clinical importance. Conversely, with less information one could find a large difference of potential 

importance that is not statistically significant. 

Domestic organization 

A public (including a State or other governmental agency) or private non-profit or for-profit organization 

that is located in the United States or its territories, is subject to U.S. laws, and assumes legal and 

financial accountability for awarded funds and for the performance of the grant-supported activities 

Foreign institution 

An organization located in a country other than the United States and its territories that is subject to the 

laws of that country, regardless of the citizenship of the proposed PI. 

CONCLUSION AND CURRENT STATUS 

NIH staff continue to monitor, document, and work with grantees and contractors to ensure compliance 

with the inclusion policy. Program officers/staff provide technical assistance to investigators as they 

develop their applications and proposals throughout the application process. Review officers introduce 

and discuss with reviewers the Guidelines/Instructions for reviewing the Inclusion of Women and 

Minorities in Clinical Research as well as the instructions and requirements for designing Phase III 

Clinical Trials in order that valid analyses can be conducted for sex/gender and ethnic/racial differences. 

At the time of award and submission of progress reports, program officials monitor and verify that 

inclusion policy requirements are met. When new and competing continuation applications that are 

selected for payment are deficient in meeting policy requirements, grants management staff and program 

officials are required to withhold funding until the principal investigator has satisfactorily addressed the 

policy requirements. 

7 
References

1. Report of the Public Health Task Force on Women’s Health: US Public Health Service, 1985. JanFeb; 100(1):73-106. 

2. NIH Guide to Grants and Contracts, Vol. 16, No. 3, Pg 2, January 23, 1987. 

3. Public Law 103-43. National Institutes of Health Revitalization Act of 1993. 42 USC 289 (a)(1). 

4. NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, 59 Fed. 

Reg. 14508-14513 (1994). 

5. Women’s Health: NIH Has Increased Its Efforts to Include Women in Research (GAO/HEHS-00-96, 

May, 2000). 

6. NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical 

Research, NIH Guide for Grants and Contracts, Amended 2001. 

For additional information on the implementation of the inclusion policy, please visit: 

NIH Office of Extramural Research Inclusion of Women and Minorities Policy Implementation Website: 

HYPERLINK "http://grants.nih.gov/grants/funding/women_min/women_min.htm" 

http://grants.nih.gov/grants/funding/women_min/women_min.htm 

Revitalization Act of 1993, 42 USC 289 (a)(1): HYPERLINK "http://grants.nih.gov/grants/guide/notice-files/not94-

100.html" http://grants.nih.gov/grants/guide/notice-files/not94-100.html 

NIH Policy on Reporting Racial and Ethnicity Data: Subjects in Clinical Research, NIH Guide for Grants and 

Contracts Web page: HYPERLINK "http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html" 

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html 

Office of Research on Women’s Health Website: HYPERLINK "http://orwh.od.nih.gov/inclusion.html" 

http://orwh.od.nih.gov/inclusion.html 

8 
Monitoring Adherence to the NIH Policy on the Inclusion 

of Women and Minorities as Subjects in Clinical Research 

Summary Report of NIH Inclusion Data

NIH AGGREGATE POPULATION DATA REPORTED IN FY2009 and FY2010 

Because new clinical research studies begin each year while other studies may be ending, the inclusion 

data will vary from year to year due to the scientific topics under study and the prevalence of those 

conditions within each individual study. These data help to establish trends on the inclusion of women 

and minorities as subjects in clinical research. Data on inclusion are tabulated from human subject 

populations in NIH-defined Phase III clinical trials and other human subject research studies and are 

based on self identification by the participants. NIH clinical research studies are determined in accordance 

with the NIH definition of clinical research to include, for example, non-intervention clinical research, 

non Phase III clinical trials, epidemiological studies, behavioral studies, and database studies. 

Analysis of aggregate NIH data on inclusion for FY2009 and FY2010 documents that substantial 

numbers of women and men, including minorities have been included as research subjects in NIH clinical 

trials, as well as other human subject research studies during these fiscal years. However, caution should 

be utilized to avoid over-interpreting the figures that are provided. 

Previous inclusion reports and aggregate enrollment figures for women, men and minority groups for 

FY1994 to the present can be found on the ORWH website at http://orwh.od.nih.gov/inclusion.html. 

NIH CLINICAL RESEARCH: Fiscal Years 2009 and 2010 

In FY2009 there were 16,689 extramural and intramural clinical research protocols, including Phase III 

and other clinical studies, of which 11,171 protocols reported human subject participation as noted in this 

report’s trend summary tables (table 1A). Of these, 91.9% were domestic protocols and 8.1% were 

foreign protocols (table 1A). Approximately 19.1 million participants were enrolled in extramural and 

intramural research protocols of which 93.3% were domestic participants and 6.7% were foreign 

participants (table 1B). Of the 19.1 million participants, 59.8% were women, 39.6% were men and 0.7% 

did not provide sex identification (table 1B). Further 30.2% of the total participants, and 27.4% of the 

domestic-only participants, were reported as minorities following the OMB categories for race and 

ethnicity (table 1C). 

Correspondingly, in FY2010 there were 17,251 extramural and intramural clinical research protocols, 

including Phase III and other clinical studies, of which 12,079 protocols reported human subject 

participation (table 2A). Of these, were 93.0% domestic protocols and 7.0% were foreign protocols (table 

2A). Approximately 23.4 million participants were enrolled in extramural and intramural research 

protocols of which 92.1% were domestic participants and 7.9% were foreign participants (table 2B). Of 

the 23.3 million participants, 56.1% were women, 43.0% were men and 0.9% did not provide sex 

identification (table 2B). Further 32.1% of the total participants, and 28.1% of the domestic-only 

participants, were reported as minorities following the OMB categories for race and ethnicity (table 2C). 

Although the number of participants in all extramural and intramural clinical research increased (19.1M 

in FY2009 and 23.4M in FY2010), the proportion of women and men shifted slightly (59.8% F and 

39.6% M in FY2009; and 56.1% F and 43.0% M in FY2010). 

9 
NIH Defined Phase III Clinical Research: FY2009 and FY2010

In FY2009 there were 662 extramural and intramural Phase III clinical research protocols, of which 630 

protocols reported human subject participation (table 3A). Of these, 71.6% were domestic protocols and 

28.4% were foreign protocols (table 3A). Clinical trials not included in this analysis are those studies that 

have just begun and have not reported enrollment data or have not begun recruiting patients. A total of 

652,300 participants were enrolled in extramural and intramural Phase III research protocols of which 

66.5% were domestic participants and 33.5% were foreign participants (table 3B). Of the 652,300 

participants, 53.0% were women, 42.3% were men and 4.7% did not provide sex identification (table 3B). 

Further 44.8% of the total participants and 22.4% of domestic-protocol participants, in Phase III clinical 

research were reported as minorities following the OMB categories for race and ethnicity (table 3C). 

Moreover, in FY2009, there were 434 extramural and intramural Phase III research protocols reporting 

data following the current OMB standards for reporting by both race and ethnicity (table 4B). 

Accordingly, minority representation by race was highest for Blacks at 23.9% and lowest for 

Hawaiian/Pacific Islanders 0.2%. American Indian/Alaska Natives represented 3.6%, Asians 19.1%, and 

Whites 39.0% of participants (table 4B). Participants identifying as More Than One Race were 1.0% of 

the total number of participants (table 4B). In addition, 13.3% did not identify a race category (table 4B). 

Of the 486,563 participants enrolled in extramural and intramural Phase III research protocols in FY2009 

and reported following the current OMB standards, 80.6 % of total participants identified as “Not 

Hispanic”, 10.7% identified as “Hispanic or Latino”, and 8.7% of the total participants did not identify an 

ethnicity category (table 4B). The racial distribution of the “Hispanic or Latino” participants is also 

provided separately (table 4B; New Form (Part B)). 

In FY2009, 196 extramural and intramural Phase III research protocols reported data following the former 

OMB standards; minority representation was highest for Blacks (not Hispanic) at 9.0% and lowest for 

American Indian/Alaska Natives at 0.4% (table 4B). Asian/Pacific Islanders represented 2.0%, Hispanics 

were approximately 3.9%, and Whites (not Hispanic) 82.1% of the participants (table 4C). The categories 

Hawaiian/Pacific Islander and More Than One Race were not designations with the former OMB 

standards. 

Correspondingly, in FY2010 there were 743 extramural and intramural Phase III clinical research 

protocols, of which 696 protocols reported human subject participation (table 5A). Of these, 77.6% were 

domestic protocols and 22.4% were foreign protocols (table 5A). Clinical trials not included in this 

analysis are those studies that have just begun and have not reported enrollment data or have not begun 

recruiting patients. A total of 769,885 participants were enrolled in extramural and intramural Phase III 

research protocols of which 51.0% were domestic participants and 49.0% were foreign participants (table 

5B). Of the 769,885 participants, 53.0% were women, 43.0% were men and 4.0% did not provide sex 

identification (table 5B). Further, 58.1% of the total participants, and 23.5% of Domestic-only 

participants, in Phase III clinical research were reported as minorities following the OMB categories for 

race and ethnicity (table 5C). 

Moreover, in FY2010, there were 634 extramural and intramural Phase III research protocols reporting 

data following the current OMB standards for reporting by both race and ethnicity (table 6B).

Accordingly, minority representation by race was highest for Blacks at 36.8% and lowest for 

Hawaiian/Pacific Islanders at 0.1% (table 6B). American Indian/Alaska Natives represented 2.3%, Asians 

16.4%, and Whites 33.2% of participants (table 6B). Participants identifying as More Than One Race 

were 1.2% of the total number of participants (table 6B). In addition, 10.0% did not identify a race 

category (table 6B). Of the 691,450 participants enrolled in extramural and intramural Phase III research 

protocols in FY2010 and reported following the current OMB standards, 84.2% of total participants 

identified as “Not Hispanic”, 8.8% identified as “Hispanic or Latino”, and 7.0% of the total participants 

10 
did not identify an ethnicity category (table 6B). The racial distribution of the “Hispanic or Latino” 

participants is also provided separately (table 6B; New Form (Part B)). 

Sixty-two extramural and intramural Phase III research protocols reported in FY2009 following the 

former OMB standards; minority representation was highest for Blacks (not Hispanic) at 8.8% and lowest 

for American Indian/Alaska Natives at 0.4%. Asian/Pacific Islanders represented approximately 1.5%, 

Hispanics were 4.1%, and Whites (not Hispanic) 84.2% of the participants (table 6C). The categories 

Hawaiian/Pacific Islander and More Than One Race were not designations with the former OMB 

standards. 

The number of participants in Phase III extramural and intramural clinical research in FY2010, 769,885, 

remained within the ranges reported since FY1995. Similarly, the proportion of males and females, 

53.0%F and 43.0%M in FY2010, is similar to previous years (table 7A).

The following sections provide data on extramural research and intramural research separately. 

EXTRAMURAL CLINICAL RESEARCH: Fiscal Years 2009 and 2010 

In FY2009, there were 14,725 extramural clinical research protocols, including Phase III and other 

clinical studies, of which 9,444 protocols reported human subject participation (table 8A). Of these, 

91.4% were domestic protocols and 8.6% were foreign protocols (table 8A). Approximately 16.2 million 

participants were enrolled in extramural research protocols of which 95.3% of the total enrollment is 

domestic participants and 4.7% of the total enrollment is foreign participants (table 8B). Of the 16.2 

million participants, 62.9% were women, 36.5% were men and 0.52% did not provide sex identification 

(table 9A). Further, 30.4% of the total participants were reported as minorities (table 9A). 

Correspondingly, in FY2010, there were 15,201 extramural clinical research protocols, including Phase 

III and other clinical studies, of which 10,309 protocols reported human subject participation (table 10A). 

Of these, 92.4% were domestic protocols and 7.6% were foreign protocols (table 10A). Approximately 

20.3 million participants were enrolled in extramural research protocols of which 93.7% of the total 

enrollment is domestic participants and 6.3% of the total enrollment is foreign participants (table 10B). 

Of the 20.3 million participants, 58.1% were women, 41.2% were men and 0.74% did not provide sex 

identification (table 11A). Further, 32.5% of the total extramural participants were reported as minorities 

(table 11A). 

While the number of participants in extramural clinical research protocols increased (16.2 million in 

FY2009 and 20.3 million in FY2010), the proportions of women and men shifted slightly (62.9%F and 

36.5%M in FY2009 and 58.1%F and 41.2%M in FY2010). When sex-specific studies were excluded, 

the proportions of women and men in extramural clinical research reported in FY2009 were 50.2% for 

females and 49.0% for males (table 12A), and in FY2010 51.7% for females and 47.3% for males (table 

13A). 

NIH Defined Phase III Extramural Clinical Research: FY2009 and FY2010

In FY2009 there were 619 extramural Phase III clinical research protocols, of which 592 protocols 

reported human subject participation (table 14A). A total of 635,825 participants were enrolled in 

extramural Phase III research protocols of which 52.6% were women, 42.6% were men and 4.8% did not 

provide sex identification (table 15A). 

In FY2009 there were 407 extramural Phase III research protocols reporting data following the current 

OMB standards for reporting race and ethnicity (table 15B). Minority representation by race was highest 

11 
for Blacks at 24.4% and lowest for Hawaiian/Pacific Islanders 0.18% (table 13B). American 

Indian/Alaska Natives represented 3.7%, Asians 19.6%, and Whites 39.9% of participants (table 15B). 

Participants identifying as More Than One Race were 0.99% of the total number of participants (table 

15B). In addition, 11.3 % did not identify a race category (table 15B). Of the 473,128 participants 

enrolled in extramural and intramural Phase III research protocols in FY2009 and reported following the 

new OMB standards, 82.3 % of total participants identified as “Not Hispanic”, 9.4% of the total 

participants identified as “Hispanic or Latino”, and 8.3 % of the total participants did not identify an 

ethnicity category (table 15B). The racial distribution of the “Hispanic or Latino” participants is also 

provided separately (table 15B, New Form (Part B)). 

In FY2010 there were 696 extramural Phase III clinical research protocols, of which 650 protocols 

reported human subject participation (table 16A). A total of 749,518 participants were enrolled in 

extramural Phase III research protocols of which 52.3% were women, 43.6% were men and 4.1% did not 

provide sex identification (table 17A). 

Correspondingly in FY2010, there were 599 extramural Phase III research protocols reporting data 

following the current OMB standards for reporting race and ethnicity (table 17B). Minority representation 

by race was highest for Blacks at 37.4% and lowest for Hawaiian/Pacific Islanders 0.14%. American 

Indian/Alaska Natives represented 2.3%, Asians 16.7%, and Whites 33.5% of participants (table 17B). 

Participants identifying as More Than One Race were 1.2% of the total number of participants (table 

17B). In addition, 8.7% did not identify a race category (table 17B). Of the 674,142 participants enrolled 

in extramural Phase III research protocols in FY2009 and reported following the new OMB standards, 

85.4% of total participants identified as “Not Hispanic”, 7.8% of the total participants identified as 

“Hispanic or Latino”, and 6.8% of the total participants did not identify an ethnicity category (table 17B). 

The racial distribution of the “Hispanic or Latino” participants is also provided separately (table 17B, 

New Form (Part B)). 

The number of extramural Phase III clinical research protocols and participants increased (619 protocol 

and 635,825 participants in FY2009 and 696 protocols and 749,815 participants in FY2010), but the 

proportion of women remained relatively stable (52.6%F and 42.6%M in FY2009 and 52.3%F and 

43.6%M in FY2010) as did the proportion not providing sex identification (4.8% in FY2009 and 4.1% in 

FY2010). There was a sharp increase in the reported enrollment of Blacks or African Americans 

reported in FY2010 (254,738 participants) in comparison to FY2009 (116,233) resulting primarily from 

expanded enrollment in the NICHD Global Network for Women's and Children's Health Research, a 

large, foreign, Phase 3 Clinical Trial (U01HD040636). 

INTRAMURAL CLINICAL RESEARCH: Fiscal Years 2009 and 2010 

In FY2009 there were 1,964 intramural clinical research protocols, including Phase III and other clinical 

studies, of which 1,727 protocols reported human subject participation (table 8A). Approximately 3.0 

million participants were enrolled in intramural research protocols of which 42.4% were women, 56.1% 

were men and 1.5% did not provide sex identification (table 18A). 

For the 1,335 intramural clinical research studies that reported data following the current OMB standards 

in FY2009, the largest racial minority group was Asians at 10.0 % and the smallest racial minority group 

was Hawaiian/Pacific Islanders at 0.05% (table 18B). American Indian/Alaska Natives represented 

0.75%, Blacks 9.8%, and Whites 63.5% of participants in all intramural clinical research (table 18B).

Approximately 5.5% of participants reported More Than One Race as their racial category. In addition, 

10.5 % did not identify a race category (table 18B). Of the 2,790,196 participants enrolled in intramural 

clinical research protocols in FY2009 and reported following the current OMB standards, 81.2% of total 

participants identified as “Not Hispanic”, 4.0% of the total participants identified as “Hispanic or Latino”, 

12 
and 14.8% of the total participants did not identify an ethnicity category (table 18B). The racial 

distribution of the “Hispanic or Latino” participants is also provided separately (table 18B). 

Among the 392 intramural research protocols that report data following the former OMB standards, 

minority representation was highest for Blacks (not Hispanic) at 13.6% and lowest for American 

Indian/Alaska Natives at 0.17% (table 18C). Asian/Pacific Islanders represented 4.2%, Hispanics 5.6%, 

and Whites (not Hispanic) 74.9% of the intramural research study population (table 18C). The categories 

Hawaiian/Pacific Islander and More Than One Race were not designations with the former OMB 

standards. 

Correspondingly, in FY2010 there were 2,050 intramural clinical research protocols, including Phase III 

and other clinical studies, of which 1,770 protocols reported human subject participation (table 10A). 

Approximately 3.1 million participants were enrolled in intramural research protocols of which 43.2% 

were women, 54.7% were men and 2.2% did not provide sex identification (table 19A). 

For the 1,408 intramural clinical research studies that reported data following the current OMB standards 

in FY2010, the largest racial minority group was Black or African American, at 10.3%, and the smallest 

racial minority group was Hawaiian/Pacific Islanders at 0.13% (table 19B). American Indian/Alaska 

Natives represented 0.79%, Asians 9.8%, and Whites 62.0% of participants in all intramural clinical 

research (table 19B). Approximately 5.4% of participants reported More Than One Race as their racial 

category (table 17). In addition, 11.6% did not identify a race category (table 19B). Of the 2,947,158 

participants enrolled in intramural clinical research protocols in FY2010 and reported following the 

current OMB standards, 80.0% of total participants identified as “Not Hispanic”, 4.2% of the total 

participants identified as “Hispanic or Latino”, and 15.9% of the total participants did not identify an 

ethnicity category (table 19B). The racial distribution of the “Hispanic or Latino” participants is also 

provided separately (table 19B, New Form (Part B)). 

Among the 362 intramural research protocols that report data following the former OMB standards, 

minority representation was highest for Blacks (not Hispanic) at 13.7% and lowest for American 

Indian/Alaska Natives at 0.19% (table 19C). Asian/Pacific Islanders represented 4.3%, Hispanics 5.3%, 

and Whites (not Hispanic) 74.9% of the intramural research study population (table 19C). The categories 

Hawaiian/Pacific Islander and More Than One Race were not designations with the former OMB 

standards. 

While the number of participants in intramural clinical research protocols increased slightly (3.0M in 

FY2009 and 3.1M in FY2010), there was no substantive change in the proportions of women and men 

(42.4%F and 56.1%M in FY2009 and 43.2%F and 54.7%M in FY2010). 

NIH Defined Phase III Intramural Clinical Research: FY2009 and FY2010

In FY2009 there were 43 intramural Phase III clinical research protocols, of which 38 protocols reported 

human subject participation (table 14A). Of these, 89.5% of the total number of protocols are domestic 

and 10.5% of the total number of protocols is foreign (table 14A). A total of 16,475 participants were 

enrolled in intramural Phase III research protocols of which 36.4% are domestic participants and 63.6% 

are foreign participants (table 14B). Of the 16,475 participants, 68.7% were women, 31.2% were men 

and 0.08% did not provide sex identification (table 18A). Further, 56.1% of total participants in Phase III 

intramural clinical research protocols were reported as minorities (table 18A). 

Correspondingly, in FY2010 there were 47 intramural Phase III clinical research protocols, of which 46 

protocols reported human subject participation (table 16A). Of these, 91.3% of the total number of 

protocols is domestic and 8.7% of the total number of protocols is foreign (table 16A). A total of 20,367 

13 
participants were enrolled in intramural Phase III research protocols of which 48.4% of the total 

enrollment is domestic participants and 51.6% are foreign participants (table 16B). Of the 20,367 

participants, 79.2% were women, 20.8% were men and 0.06% did not provide sex identification (table 

21). Further, 55.0% of total participants in intramural Phase III clinical research protocols were reported 

as minorities following the OMB categories for race and ethnicity (table 21).

The number of participants enrolled in Phase III intramural clinical research protocols increased (16,475 

in FY2009 and 20,367 in FY2010), as did the proportions of women (68.7%F and 31.2%M in FY2009 

and 79.2%F and 20.8%M in FY2010).

14 
TREND REPORT ON NIH AGGREGATE POPULATION DATA: FY1995 – FY2010 

Trend data vary over time because the data for each year represent the net total of data resulting from: (1) 

studies continuing from the prior year; (2) the addition of new studies reported; and (3) the subtraction of 

studies that are no longer reported. 

Table 22B is a sixteen-year summary report showing a steady increase in the number of protocols and 

enrollment. Overall, the number of protocols with enrollment increased from 3,188 in FY1995 to 12,079 

in FY2010 – a 3.8 fold increase (table 22A. Part I). Reported enrollment increased from approximately 

1.0 million (FY1995) to 23.3 million (FY2010) – a 22.9 fold increase; minority enrollment increased 

from approximately 0.4 million (FY1995) to 7.5 million (FY2010) – a 20.1 fold increase in the number of 

minority participants in NIH clinical research (table 22A, Part I). The total number of protocols reported 

with enrollment data has increased such that, since FY2003 the number is in excess of 10,000 protocols 

per year. 

With the deployment of an updated population tracking system in 2002 and the OMB requirement to 

report data using the current format, NIH was able to report domestic and foreign data in a better way. 

Thus, trend data are available for domestic and foreign protocols and participation beginning in FY2002. 

Domestic enrollment increased from 10.2 million (FY2002) to 21.5 million (FY2010) – a 2.1 fold 

increase (table 22A, Part II). Foreign enrollment increased from 0.9 million (FY2002) to 1.8 million 

(FY2010) – a 1.9 fold increase (table 22A, Part II). Overall, the total enrollment has increased with 

domestic participation ranging between 75.9 to 93.3% and foreign participation ranging between 6.1 to 

24.1%. In FY2010, domestic and foreign enrollment was 92.1% and 7.9% respectively (table 22C).

Table 23 is a summary report of all extramural and intramural clinical research by sex/gender and 

minority representation following the old and new data formats for domestic and foreign studies. The 

report demonstrates that female participation in all extramural and intramural research generally ranged 

between 51.7% and 64.2%, male participation in all extramural and intramural research ranged between 

34.0% and 45.0% (table 23A). Overall minority participation in all extramural and intramural clinical 

research ranged between 28.6% and 43.1% (table 23A). 

Table 23E provides a comparison of domestic and foreign participation between FY2002 and FY2010. 

The vast majority of the total clinical research protocols are domestic (91.9% to 96.4%, table 21E). 

Although the number of foreign protocols has increased, they comprise only about 3.6% to 8.1% of the 

total clinical research protocols with enrollment. Table 23F shows domestic and foreign minority 

enrollment for the nine-year period (FY2002-FY2010). Minority enrollment varied between 24.1% and 

28.9% of total domestic participation, while minority enrollment varied between 67.7% and 90.9% of 

total foreign participation (table 23F). 

Table 7 is a summary of NIH-funded Phase III extramural and intramural clinical research by sex/gender 

and minority enrollment following the old and new data reporting formats for domestic and foreign 

studies. This table demonstrates that female participation in NIH funded Phase III extramural and 

intramural clinical research generally ranged between 53.0% and 74.8% and male participation in NIHfunded Phase III extramural and intramural clinical research ranged between 24.3% and 44.6% (table 

4A). Overall minority participation in NIH-funded Phase III extramural and intramural clinical research 

ranged from 22.5% to 41.4% (table 7A). Table 7E provides a comparison of domestic and foreign 

participation between FY2002 and FY2010. The majority of protocols are domestic, ranging from 72.5% 

and 95.8% of the total Phase III clinical research protocols. The number of foreign protocols has ranged 

from 4.2% to 27.5% during this time. Table 7F shows domestic and foreign enrollment for the same 

nine-year period. Minority enrollment varied between 20.2% and 25.4% of total domestic participation, 

15 
while minority enrollment in NIH-funded Phase III clinical research varied between 48.4% and 96.2% of 

total foreign participation. 

16 
Aggregate Enrollment Data Tables 

For Extramural and Intramural 

Research Protocols 

Fiscal Year 2010 Summary Reports 

Fourteen-year Trend Summary Reports 

17 
18 
Table 1. Summary of NIH Clinical Research Reported In FY2009: Total Number of Protocols and 

Enrollment by Sex and Domestic versus Foreign Protocols 

Table 1A. PROTOCOLS REPORTED 

Total All Clinical 

Studies* 

Domestic 

Protocols 

% Domestic 

Protocols 

Foreign 

Protocols 

% Foreign

Protocols 

Protocols with Enrollment 11,171 10,263 91.9% 908 8.1%

% Protocols with Enrollment 66.9% 65.9% Empty Cell 81.3% Empty Cell 

Protocols with zero enrollment 

(Enrollment data have not yet been 

submitted) 5,518 5,309 96.2% 209 3.8%

 % Protocols with zero enrollment 33.1% 34.1% Empty Cell 18.7% Empty Cell 

Total Number of Protocols 16,689 15,572 93.3% 1,117 6.7%

Total % 100.0% 100.0% Empty Cell 100.0% Empty Cell 

Table 1B. ENROLLMENT REPORTED 

Total All Clinical 

Studies* 

Domestic 

Protocols 

% Domestic 

Protocols 

Foreign 

Protocols 

% Foreign 

Protocols 

Females Enrolled 11,439,143 10,694,225 93.5% 744,918 6.5%

% Females Enrolled 59.8% 59.9% Empty Cell 57.7% Empty Cell 

Males Enrolled 7,570,646 7,033,607 92.9% 537,039 7.1%

% Males Enrolled 39.6% 39.4% Empty Cell 41.6% Empty Cell 

Sex of Subjects is Unknown 128,949 120,242 93.2% 8,707 6.8%

% Unknown Sex 0.7% 0.7% Empty Cell 0.7% Empty Cell 

Total Subjects Enrolled 19,138,738 17,848,074 93.3% 1,290,664 6.7%

Total % 100.0% 100.0% Empty Cell 100.0% Empty Cell 

Table 1C. MINORITY ENROLLMENT 

REPORTED 

Total All Clinical 

Studies* 

Domestic 

Protocols 

% Domestic 

Protocols 

Foreign 

Protocols 

% Foreign 

Protocols 

Minority Total** 5,783,543 4,883,794 84.4% 899,749 15.6%

% Minority Enrollment 30.2% 27.4% Empty Cell 69.7% Empty Cell 

* Clinical research studies include non-intervention clinical research, clinical trials, epidemiologic studies, behavioral 

studies, database studies, etc., based on the NIH definition of clinical research. "Total All Clinical Studies" includes NIH 

Defined Phase III Clinical Trials. 

** See Page 4 for the Race and Ethnicity categories included in Minority Enrollment Data from the 1977 and 1997 U.S. 

OMB race/ethnicity categories. Foreign enrollment was reported using the U.S. race and ethnicity categories. 

NOTE: Percentages are reported with one decimal point; due to rounding, adding percentages may not equal 100%.

19
Table 2. Summary of NIH Clinical Research Reported In FY2010: Total Number of Protocols and 

Enrollment By Sex and Domestic versus Foreign Protocols 

Table 2A. PROTOCOLS REPORTED 

Total All Clinical 

Studies* 

Domestic 

Protocols 

% Domestic 

Protocols 

Foreign 

Protocols 

% Foreign 

Protocols 

Protocols with Enrollment 12,079 11,189 92.6% 890 7.4%

% Protocols with Enrollment 70.0% 69.7% Empty Cell 74.2% Empty Cell 

Protocols with zero enrollment. 

(Enrollment data have not yet been 

submitted) 5,172 4,862 94.0% 310 6.0%

 % Protocols with zero Enrollment 30.0% 30.3% Empty Cell 25.8% Empty Cell 

Total Number of Protocols 17,251 16,051 93.0% 1,200 7.0%

Total % 100.0% 100.0% Empty Cell 100.0% Empty Cell 

Table 2B. ENROLLMENT REPORTED 

Total All Clinical 

Studies* 

Domestic 

Protocols 

% Domestic 

Protocols 

Foreign 

Protocols 

% Foreign 

Protocols 

Females Enrolled 13,102,832 12,018,942 91.7% 1,083,890 8.3%

% Females Enrolled 56.1% 55.8% Empty Cell 58.9% Empty Cell 

Males Enrolled 10,044,444 9,301,128 92.6% 743,316 7.4%

% Males Enrolled 43.0% 43.2% Empty Cell 40.4% Empty Cell 

Sex of Subjects is Unknown 216,359 203,006 93.8% 13,353 6.2%

% Unknown Sex 0.9% 0.9% Empty Cell 0.7% Empty Cell 

Total Subjects Enrolled 23,363,635 21,523,076 92.1% 1,840,559 7.9%

Total % 100.0% 100.0% Empty Cell 100.0% Empty Cell 

Table 2C. MINORITY ENROLLMENT 

REPORTED 

Total All Clinical 

Studies* 

Domestic 

Protocols 

% Domestic 

Protocols 

Foreign 

Protocols 

% Foreign 

Protocols 

Minority Total** 7,510,763 6,041,531 80.4% 1,469,232 19.6%

% Minority Enrollment 32.1% 28.1% Empty Cell 79.8% Empty Cell 

* Clinical research studies include non-intervention clinical research, clinical trials, epidemiologic studies, behavioral 

studies, database studies, etc., based on the NIH definition of clinical research. "Total All Clinical Studies" includes NIH 

Defined Phase III Clinical Trials. 

** See Page 4 for the Race and Ethnicity categories included in Minority Enrollment Data from the 1977 and 1997U.S. 

OMB race/ethnicity categories. Foreign enrollment was reported using the U.S. race and ethnicity categories. 

 

NOTE: Percentages are reported with one decimal point; due to rounding, adding percentages may not equal 100%. 

 

20
Table 3. Summary of NIH Phase III Clinical Research Reported In FY2009: Total Number of Protocols 

and Enrollment by Sex, and Domestic versus Foreign Protocols 

Table 3A. PROTOCOLS REPORTED 

Total of Phase 

III Clinical 

Trials* 

Domestic 

Protocols 

% Domestic 

Protocols 

Foreign 

Protocols 

% Foreign 

Protocols 

Protocols with Enrollment 630 451 71.6% 179 28.4%

% Protocols with Enrollment 95.2% 94.2% Empty Cell 97.8% Empty Cell 

Protocols with zero enrollment 

(Enrollment data have not yet been 

submitted) 32 28 87.5% 4 12.5%

 % Protocols with zero enrollment 4.8% 5.8% Empty Cell 2.2% Empty Cell 

Total Number of Protocols 662 479 72.4% 183 27.6%

Total % 100.0% 100.0% Empty Cell 100.0% Empty Cell 

Table 3B. ENROLLMENT REPORTED 

Total of Phase 

III Clinical 

Trials* 

Domestic 

Protocols 

% Domestic 

Protocols 

Foreign 

Protocols 

% Foreign 

Protocols 

Females Enrolled 345,748 232,936 67.4% 112,812 32.6%

% Females Enrolled 53.0% 53.7% Empty Cell 51.7% Empty Cell 

Males Enrolled 276,159 171,078 61.9% 105,081 38.1%

% Males Enrolled 42.3% 39.4% Empty Cell 48.1% Empty Cell 

Sex of Subjects is Unknown 30,393 29,881 98.3% 512 0.0%

% Unknown Sex 4.7% 6.9% Empty Cell 0.2% Empty Cell 

Total Subjects Enrolled 652,300 433,895 66.5% 218,405 33.5%

Total % 100.0% 100.0% Empty Cell 100.0% Empty Cell 

Table 3C. MINORITY ENROLLMENT 

REPORTED** 

Total of Phase 

III Clinical 

Trials* 

Domestic 

Protocols 

% Domestic 

Protocols 

Foreign 

Protocols 

% Foreign 

Protocols 

Minority Total for all Phase III studies 291,949 97,079 33.3% 194,870 66.7%

 % Minority Enrollment 44.8% 22.4% Empty Cell 89.2% Empty Cell 

* An NIH-defined Phase III clinical trial is a broadly based prospective Phase III clinical investigation, usually involving 

several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a 

standard or controlled intervention or comparing two or more existing treatments. Often the aim of such investigation is to 

provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care. 

** See Page 4 for the Race and Ethnicity categories included in Minority Enrollment Data from the 1977 and 1997 U.S. 

OMB race/ethnicity categories. Foreign enrollment was reported using the U.S. race and ethnicity categories. 

NOTE: Percentages are reported with one decimal point; due to rounding, adding percentages may not equal 100%.

 

21
Table 4. Aggregate Enrollment Data for Extramural and Intramural Phase III Research 

Funded in FY2008 and Reported in FY2009: Percent Analysis 

Table 4A. SUMMARY TOTALS: Old Form + New Form 

Total # Protocols 

with Enrollment 

Data: 630

Sex /Gender Total 

Enrollment 

Minority 

Enrollment 

% Minority 

Enrollment 

Females (#) 345,748 157,952 45.68% 

Females (% of total) 53.00% 54.10% Empty Cell 

Males (#) 276,159 133,282 48.26% 

Males (% of total) 42.34% 45.65% Empty Cell 

Unknown (#) 30,393 715 2.35% 

Unknown (% of total) 4.66% 0.24% Empty Cell 

TOTAL (#) 652,300 291,949 44.76% 

Total (%) 100% 100.00% Empty Cell 

Table 4B. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 

I. Total of All Subjects by Race 

Sex/ 

Gender 

American 

Indian/ 

Alaska Native 

Asian 

Black/ 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total 

Females (number) 9,875 47,848 61,823 438 107,105 2,283 23,530 252,902

% of total 2.03% 9.83% 12.71% 0.09% 22.01% 0.47% 4.84% 51.98%

% females in each race 3.90% 18.92% 24.45% 0.17% 42.35% 0.90% 9.30% 100.00%

% of each race females 56.40% 51.52% 53.19% 50.99% 56.51% 48.82% 36.26% 51.98%

Males (number) 7,575 44,912 54,229 417 81,253 2,334 12,585 203,305

% of total 1.56% 9.23% 11.15% 0.09% 16.70% 0.48% 2.59% 41.78%

% males in each race 3.73% 22.09% 26.67% 0.21% 39.97% 1.15% 6.19% 100.00%

% of each race males 43.26% 48.36% 46.66% 48.54% 42.87% 49.91% 19.39% 41.78%

Unknown (number) 59 108 181 4 1,169 59 28,776 30,356

% of total 0.01% 0.02% 0.04% 0.00% 0.24% 0.01% 5.91% 6.24%

% unknown in each race 0.19% 0.36% 0.60% 0.01% 3.85% 0.19% 94.80% 100.00%

% of each race unknown 0.34% 0.12% 0.16% 0.47% 0.62% 1.26% 44.35% 6.24%

Total (number) 17,509 92,868 116,233 859 189,527 4,676 64,891 486,563

% of each race in total 3.60% 19.09% 23.89% 0.18% 38.95% 0.96% 13.34% 100.00%

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

II. Total of All Subjects by Ethnicity 

Sex/ 

Gender Not Hispanic Hispanic or Latino 

Unknown / 

Not Reported 

Total 

Females (number) 210,945 34,357 7,600 252,902 

% of total 43.35% 7.06% 1.56% 51.98% 

% females in each ethnicity 83.41% 13.59% 3.01% 100.00% 

% of each ethnicity females 53.81% 65.79% 17.95% 51.98% 

Males (number) 179,583 17,487 6,235 203,305 

% of total 36.91% 3.59% 1.28% 41.78% 

% males in each ethnicity 88.33% 8.60% 3.07% 100.00% 

% of each ethnicity males 45.81% 33.49% 14.72% 41.78% 

Unknown (number) 1,462 379 28,515 30,356 

% of total 0.30% 0.08% 5.86% 6.24% 

% unknown in each ethnicity 4.82% 1.25% 93.94% 100.00% 

% of each ethnicity unknown 0.37% 0.73% 67.33% 6.24% 

Total (number) 391,990 52,223 42,350 486,563 

% of each ethnicity in total 80.56% 10.73% 8.70% 100.00% 

Total (%) 100.00% 100.00% 100.00% 100.00% 

Number of 

Protocols with 

Enrollment Data 

Reported on New 

Form: 434

22
III. New Form (Part B): Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Total of All Hispanic or Latino Subjects by Race 

Sex/ 

Gender 

American 

Indian/ 

Alaska Native 

Asian 

Black or 

African 

American

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race

Unknown/ 

Other Total 

 Females (number) 8,729 138 488 99 7,265 431 17,207 34,357

% of total 16.71% 0.26% 0.93% 0.19% 13.91% 0.83% 32.95% 65.79%

% females in each race 25.41% 0.40% 1.42% 0.29% 21.15% 1.25% 50.08% 100.00%

% of each race females 57.00% 39.32% 52.08% 50.00% 63.25% 44.71% 74.90% 65.79%

Males (number) 6,543 203 439 95 4,160 521 5,526 17,487

% of total 12.53% 0.39% 0.84% 0.18% 7.97% 1.00% 10.58% 33.49%

% males in each race 37.42% 1.16% 2.51% 0.54% 23.79% 2.98% 31.60% 100.00%

% of each race males 42.73% 57.83% 46.85% 47.98% 36.21% 54.05% 24.05% 33.49%

Unknown (number) 41 10 10 4 62 12 240 379

% of total 0.08% 0.02% 0.02% 0.01% 0.12% 0.02% 0.46% 0.73%

% unknown in each race 10.82% 2.64% 2.64% 1.06% 16.36% 3.17% 63.32% 100.00%

% of each race unknown 0.27% 2.85% 1.07% 2.02% 0.54% 1.24% 1.04% 0.73%

Total (number) 15,313 351 937 198 11,487 964 22,973 52,223

% of each race in total 29.32% 0.67% 1.79% 0.38% 22.00% 1.85% 43.99% 100.00%

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Sex/

Gend

er 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B 

Fema

les 

(num

ber) 146,739 

% of 

total 30.16% % 

femal

es in 

each 

race 58.02% % of 

each 

race 

femal

es 55.04% Male

s 

(num

ber) 119,153 

% of 

total 24.49% % 

males 

in 

each 

race 58.61% % of 

each 

race 

males 44.69% Unkn

own 

(num

ber) 713 

% of 

total 0.15% % 

unkn

own 

in 

each 

race 2.35% % of 

each 

race 

unkn

own 0.27% Total 

(num

ber) 266,605 % of 

each 

race 

in 

total 54.79% Total 

(%) 

100.00% 

Number of 

Protocols with 

Enrollment 

Data Reported 

on Old form: 

196

Table 4C. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards 

Sex/ 

Gender 

American 

Indian/ 

Alaska 

Native 

Asian/ 

Pacific 

Islander 

Black or 

African 

American

Hispanic White Unknown/ 

Other Total 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

Females (number) 352 2,114 6,122 2,625 79,752 1,881 92,846 11,213

% of total 0.21% 1.28% 3.69% 1.58% 48.12% 1.13% 56.02% 6.77%

% females in each race 0.38% 2.28% 6.59% 2.83% 85.90% 2.03% 100.00% 12.08%

% of each race females 57.42% 64.24% 40.93% 40.48% 58.61% 43.63% 56.02% 44.24%

Males (number) 261 1,176 8,833 3,859 56,319 2,406 72,854 14,129

% of total 0.16% 0.71% 5.33% 2.33% 33.98% 1.45% 43.96% 8.52%

% males in each race 0.36% 1.61% 12.12% 5.30% 77.30% 3.30% 100.00% 19.39%

% of each race males 42.58% 35.73% 59.06% 59.52% 41.39% 55.81% 43.96% 55.75%

Unknown (number) 0 1 1 0 11 24 37 2

% of total 0.00% 0.00% 0.00% 0.00% 0.01% 0.01% 0.02% 0.00%

% unknown in each race 0.00% 2.70% 2.70% 0.00% 29.73% 64.86% 100.00% 5.41%

% of each race unknown 0.00% 0.03% 0.01% 0.00% 0.01% 0.56% 0.02% 0.01%

Total (number) 613 3,291 14,956 6,484 136,082 4,311 165,737 25,344

% of each race in total 0.37% 1.99% 9.02% 3.91% 82.11% 2.60% 100.00% 15.29%

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Legend

Bold: Percentage of Total No. of Participants in Research Protocols (Old or New Form) 

Italics: Percentage of Total No. of Participants Sorted by Sex/Gender (Row Total) 

Plain Typeface: Percentage of Total No. of Participants sorted by Race/Ethnicity (Column Total) 

Columns denoted with shading (American Indian/ Alaska Native, Asian, Black/ African American, Hawaiian/ 

Pacific Islander, Asian/ Pacific Islander, Hispanic and Unknown, More than one race and Unknown/Other) are 

summed to calculate Minority enrollment in Table 4A. 

23
Table 5. Summary of NIH Phase III Clinical Research Reported In FY2010: Total Number of Protocols 

and Enrollment by Sex, and Domestic versus Foreign Protocols 

Table 5A. PROTOCOLS REPORTED 

Total of Phase 

III Clinical 

Trials* 

Domestic 

Protocols 

% Domestic 

Protocols 

Foreign 

Protocols 

% Foreign 

Protocols 

Protocols with Enrollment 696 540 77.6% 156 22.4%

% Protocols with Enrollment 93.7% 93.1% Empty Cell 95.7% Empty Cell 

Protocols with zero enrollment 

(Enrollment data have not yet been 

submitted) 47 40 85.1% 7 14.9%

 % Protocols with zero enrollment 6.3% 6.9% Empty Cell 4.3% Empty Cell 

Total Number of Protocols 743 580 78.1% 163 21.9%

Total % 100.0% 100.0% Empty Cell 100.0% Empty Cell 

Table 5B. ENROLLMENT REPORTED 

Total of Phase 

III Clinical 

Trials* 

Domestic 

Protocols 

% Domestic 

Protocols 

Foreign 

Protocols 

% Foreign 

Protocols 

Females Enrolled 408,181 197,608 48.4% 210,573 51.6%

% Females Enrolled 53.0% 50.3% Empty Cell 55.9% Empty Cell 

Males Enrolled 330,808 165,205 49.9% 165,603 50.1%

% Males Enrolled 43.0% 42.1% Empty Cell 43.9% Empty Cell 

Sex of Subjects is Unknown 30,896 30,054 97.3% 842 0.0%

% Unknown Sex 4.0% 7.6% Empty Cell 0.2% Empty Cell 

Total Subjects Enrolled 769,885 392,867 51.0% 377,018 49.0%

Total % 100.0% 100.0% Empty Cell 100.0% Empty Cell 

Table 5C. MINORITY ENROLLMENT 

REPORTED** 

Total of Phase 

III Clinical 

Trials* 

Domestic 

Protocols 

% Domestic 

Protocols 

Foreign 

Protocols 

% Foreign 

Protocols 

Minority Total for all Phase III studies 447,187 92,509 20.7% 354,678 79.3%

% Minority Enrollment 58.1% 23.5% Empty Cell 94.1% Empty Cell 

* An NIH-defined Phase III clinical trial is a broadly based prospective Phase III clinical investigation, usually involving 

several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a 

standard or controlled intervention or comparing two or more existing treatments. Often the aim of such investigation is to 

provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care. 

** See Page 4 for the Race and Ethnicity categories included in Minority Enrollment Data from the 1977 and 1997 U.S. 

OMB race/ethnicity categories. Foreign enrollment was reported using the U.S. race and ethnicity categories. 

NOTE: Percentages are reported with one decimal point; due to rounding, adding percentages may not equal 100%.

 

24
Table 6. Aggregate Enrollment Data for Extramural and Intramural Phase III Research Funded in 

FY2009 and Reported in FY2010: Percent Analysis 

Table 6A. SUMMARY TOTALS: Old Form + New Form 

Sex /Gender Total 

Enrollment 

Minority 

Enrollment 

% Minority 

Enrollment 

Females (#) 408,181 250,716 61.42% 

Females (% of total) 53.02% 56.07% Empty Cell 

Males (#) 330,808 195,249 59.02% 

Males (% of total) 42.97% 43.66% Empty Cell 

Unknown (#) 30,896 1,222 3.96% 

Unknown (% of total) 4.01% 0.27% Empty Cell 

TOTAL (#) 769,885 447,187 58.08% 

Total (%) 100% 100.00% Empty Cell 

Total # Protocols 

with Enrollment 

Data: 696

Table 6B. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 

I. Total of All Subjects by Race 

Sex/Gender 

American 

Indian/ 

Alaska Native 

Asian 

Black/ 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total 

Females (number) 7,972 62,284 143,931 482 129,143 3,125 27,173 374,110 

 % of total 1.15% 9.01% 20.82% 0.07% 18.68% 0.45% 3.93% 54.11% 

% females in each race 2.13% 16.65% 38.47% 0.13% 34.52% 0.84% 7.26% 100.00% 

% of each race females 50.31% 55.10% 56.50% 51.50% 56.29% 37.84% 39.26% 54.11% 

Males (number) 7,817 50,663 110,032 450 99,645 5,073 12,768 286,448 

% of total 1.13% 7.33% 15.91% 0.07% 14.41% 0.73% 1.85% 41.43% 

% males in each race 2.73% 17.69% 38.41% 0.16% 34.79% 1.77% 4.46% 100.00% 

% of each race males 49.33% 44.82% 43.19% 48.08% 43.44% 61.43% 18.45% 41.43% 

Unknown (number) 57 95 775 4 622 60 29,279 30,892 

% of total 0.01% 0.01% 0.11% 0.00% 0.09% 0.01% 4.23% 4.47% 

% unknown in each race 0.18% 0.31% 2.51% 0.01% 2.01% 0.19% 94.78% 100.00% 

% of each race unknown 0.36% 0.08% 0.30% 0.43% 0.27% 0.73% 42.30% 4.47% 

Total (number) 15,846 113,042 254,738 936 229,410 8,258 69,220 691,450 

% of each race in total 2.29% 16.35% 36.84% 0.14% 33.18% 1.19% 10.01% 100.00% 

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 

II. Total of All Subjects by Ethnicity 

Number of 

Protocols with 

Enrollment Data 

Reported on New 

Form: 634

Sex/Gender Not Hispanic Hispanic or 

Latino 

Unknown /Not 

Reported Total 

Females (number) 325,083 38,153 10,874 374,110 

% of total 47.01% 5.52% 1.57% 54.11% 

% females in each ethnicity 86.90% 10.20% 2.91% 100.00% 

% of each ethnicity females 55.83% 62.94% 22.39% 54.11% 

Males (number) 255,655 22,154 8,639 286,448 

% of total 36.97% 3.20% 1.25% 41.43% 

% males in each ethnicity 89.25% 7.73% 3.02% 100.00% 

% of each ethnicity males 43.91% 36.55% 17.79% 41.43% 

Unknown (number) 1,529 311 29,052 30,892 

% of total 0.22% 0.04% 4.20% 4.47% 

% unknown in each ethnicity 4.95% 1.01% 94.04% 100.00% 

% of each ethnicity unknown 0.26% 0.51% 59.82% 4.47% 

Total (number) 582,267 60,618 48,565 691,450 

% of each ethnicity in total 84.21% 8.77% 7.02% 100.00% 

Total (%) 100.00% 100.00% 100.00% 100.00% 

25
III. New Form (Part B): Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Total of All Hispanic or Latino Subjects by Race 

Sex/ 

Gender 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White 

More 

Than One 

Race 

Unknown/

Other Total 

 Females (number) 6,517 144 565 104 9,687 642 20,494 38,153

% of total 10.75% 0.24% 0.93% 0.17% 15.98% 1.06% 33.81% 62.94%

% females in each race 17.08% 0.38% 1.48% 0.27% 25.39% 1.68% 53.72% 100.00%

% of each race females 49.71% 40.00% 52.51% 50.98% 62.99% 20.70% 74.83% 62.94%

Males (number) 6,553 206 501 96 5,645 2,444 6,709 22,154

% of total 10.81% 0.34% 0.83% 0.16% 9.31% 4.03% 11.07% 36.55%

% males in each race 29.58% 0.93% 2.26% 0.43% 25.48% 11.03% 30.28% 100.00%

% of each race males 49.98% 57.22% 46.56% 47.06% 36.71% 78.81% 24.50% 36.55%

Unknown (number) 41 10 10 4 46 15 185 311

% of total 0.07% 0.02% 0.02% 0.01% 0.08% 0.02% 0.31% 0.51%

% unknown in each race 13.18% 3.22% 3.22% 1.29% 14.79% 4.82% 59.49% 100.00%

% of each race unknown 0.31% 2.78% 0.93% 1.96% 0.30% 0.48% 0.68% 0.51%

Total (number) 13,111 360 1,076 204 15,378 3,101 27,388 60,618

% of each race in total 21.63% 0.59% 1.78% 0.34% 25.37% 5.12% 45.18% 100.00%

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Sex/

Gend

er 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B 

Fema

les 

(num

ber) 247,975 

% of 

total 35.86% % 

femal

es in 

each 

race 66.28% % of 

each 

race 

femal

es 56.93% Male

s 

(num

ber) 186,389 

% of 

total 26.96% % 

males 

in 

each 

race 65.07% % of 

each 

race 

males 42.79% Unkn

own 

(num

ber) 1,222 

% of 

total 0.18% % 

unkn

own 

in 

each 

race 3.96% % of 

each 

race 

unkn

own 0.28% Total 

(num

ber) 435,586 % of 

each 

race 

in 

total 63.00% Total 

(%) 

100.00% 

Number of 

Protocols with 

Enrollment 

Data Reported 

on Old form: 

62

Table 6C. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards 

Sex/ 

Gender 

American 

Indian/ 

Alaska 

Native 

Asian/ 

Pacific 

Islander 

Black or 

African 

American

Hispanic White Unknown/

Other Total 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD 

FORM 

Females (number) 142 565 1,304 730 30,962 368 34,071 2,741

% of total 0.18% 0.72% 1.66% 0.93% 39.47% 0.47% 43.44% 3.49%

% females in each race 0.42% 1.66% 3.83% 2.14% 90.87% 1.08% 100.00% 8.04%

% of each race females 47.97% 47.40% 18.93% 22.64% 46.85% 49.13% 43.44% 23.63%

Males (number) 154 627 5,584 2,495 35,120 380 44,360 8,860

% of total 0.20% 0.80% 7.12% 3.18% 44.78% 0.48% 56.56% 11.30%

% males in each race 0.35% 1.41% 12.59% 5.62% 79.17% 0.86% 100.00% 19.97%

% of each race males 52.03% 52.60% 81.07% 77.36% 53.14% 50.73% 56.56% 76.37%

Unknown (number) 0 0 0 0 3 1 4 0

% of total 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.01% 0.00%

% unknown in each race 0.00% 0.00% 0.00% 0.00% 75.00% 25.00% 100.00% 0.00%

% of each race unknown 0.00% 0.00% 0.00% 0.00% 0.00% 0.13% 0.01% 0.00%

Total (number) 296 1,192 6,888 3,225 66,085 749 78,435 11,601

% of each race in total 0.38% 1.52% 8.78% 4.11% 84.25% 0.95% 100.00% 14.79%

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Legend

Bold: Percentage of Total No. of Participants in Research Protocols (Old or New Form) 

Italics: Percentage of Total No. of Participants Sorted by Sex/Gender (Row Total) 

Plain Typeface: Percentage of Total No. of Participants sorted by Race/Ethnicity (Column Total) 

Columns denoted with shading (American Indian/ Alaska Native, Asian, Black/ African American, Hawaiian/ Pacific 

Islander, Asian/ Pacific Islander, Hispanic and Unknown, More than one race and Unknown/Other) are summed to 

calculate Minority enrollment in Table 6a. 

26
Table 7. Sixteen-Year Trend Summary of NIH Extramural and Intramural Phase III Clinical Research Reported in FY1995-2010 

Table 7A. Phase III SIXTEEN YEAR SUMMARY TOTALS: ENROLLMENT BY SEX/GENDER AND MINORITIES IN ALL PHASE 3 PROTOCOLS (Old + New 

Forms) 

FY Reported/ 

Funded Form Females Males Unknown Total All Subjects (Old + New Forms) Subtotal: All Subjects Enrolled by US Minority Categories Number of Protocols with Enrollment data (Old + New Forms) 

1995/1994 Old 171,181 108,324 19,818 299,323 80,562 560 

% Reported in 1995 Empty cell 57.2% 36.2% 6.6% 100.0% 26.9% Empty Cell 

1996/1995 Old 264,755 203,698 21,210 489,663 110,669 608 

% Reported in 1996 Empty cell 54.1% 41.6% 4.3% 100.0% 22.6% Empty Cell

1997/1996 Old 264,755 203,698 21,210 489,663 110,000 608 

% Reported in 1997 Empty cell 54.1% 41.6% 4.3% 100.0% 22.5% Empty Cell

1998/1997 Old 228,417 74,389 2,705 305,511 69,599 320 

% Reported in 1998 Empty cell 74.8% 24.3% 0.9% 100.0% 22.8% Empty Cell

1999/1998 Old 339,533 163,950 1,446 504,929 141,449 578 

% Reported in 1999 Empty cell 67.2% 32.5% 0.3% 100.0% 28.0% Empty Cell

2000/1999 Old 313,952 180,705 1,086 495,743 120,339 589 

% Reported in 2000 Empty cell 63.3% 36.5% 0.2% 100.0% 24.3% Empty Cell

2001/2000 Old 412,379 168,085 1,273 581,737 117,873 645 

% Reported in 2001 Empty cell 70.9% 28.9% 0.2% 100.0% 20.3% Empty Cell

2002/2001 Old + New 278,876 195,090 781 474,747 111,269 754 

% Reported in 2002 Empty cell 58.7% 41.1% 0.2% 100.0% 23.4% Empty Cell

2003/2002 Old + New 294,950 239,403 1,914 536,267 132,302 852 

% Reported in 2003 Empty cell 55.0% 44.6% 0.4% 100.0% 24.7% Empty Cell

2004/2003 Old + New 301,353 242,913 1,101 545,367 150,456 573 

% Reported in 2004 Empty cell 55.3% 44.5% 0.2% 100.0% 27.6% Empty Cell

2005/2004 Old + New 290,977 197,300 4,723 493,000 154,191 547 

% Reported in 2005 Empty cell 59.0% 40.0% 1.0% 100.0% 31.3% Empty Cell

2006/2005 Old + New 314,066 179,975 5,389 499,430 167,446 624 

% Reported in 2006 Empty cell 62.9% 36.0% 1.1% 100.0% 33.5% Empty Cell

2007/2006 Old + New 324,694 249,633 16,832 591,159 244,932 621 

% Reported in 2007 Empty cell 54.9% 42.2% 2.8% 100.0% 41.4% Empty Cell

2008/2007 Old + New 455,612 319,732 17,234 792,578 270,899 639 

% Reported in 2008 Empty cell 57.5% 40.3% 2.2% 100.0% 34.2% Empty Cell

2009/2008 Old + New 345,748 276,159 30,393 652,300 291,949 630 

% Reported in 2009 Empty cell 53.0% 42.3% 4.7% 100.0% 41.4% Empty Cell

2010/2009 Old + New 408,181 330,808 30,896 769,885 447,187 696 

% Reported in 2010 Empty cell 53.0% 43.0% 4.0% 100.0% 37.9% Empty Cell

Table 7A Comments: 1. Table 7A summarizes enrollment by sex/gender and minority race/ethnicity categories for the sixteen year reporting period (1995-2010). The data are compiled from Tables 7B, 7C and 7D below, which provide the detailed distributions by sex/gender and race/ethnicity using the OLD Enrollment Form (Table 7B) and the NEW Enrollment Form (Tables 7C and 7D). 2. The Race and Ethnicity data in the OLD FORM and the NEW FORM cannot be combined by individual race and ethnicity categories because the categories reflect the different OMB Formats used based on the 1977 OMB standards (OLD FORM) and the 1997 OMB Standards (NEW FORM). 

27
Figure 7a. Sixteen-Year Trend Summary of Enrollment in NIH Extramural and Intramural 

Phase III Clinical Research 

Note: Trend data vary over time because the data for each year represent the net total resulting from (1) studies 

continuing from the prior year; (2) the addition of new studies reported; and (3) subtraction of studies that are not longer 

reported. 

28
Table 7 (cont’d): Sixteen-Year Trend Summary of NIH Extramural and Intramural Phase III Clinical Research Reported in FY1995-2010 

Notes: Tables 7B-D NOTE 1: The shaded portions of the Tables 7B, 7C and 7D below show the race/ethnicity categories that are identified as minority categories. The Data Reported in FY 2002 and later are from the new Population Tracking System that was deployed with data reported in FY 2002 and later, and allows separate reporting using the Old Form and the New Form, 

and separate reporting for Foreign and Domestic Data. NOTE 2: Data from Tables 7B, 7C and 7D are combined to provide the summary data in Table 7A.

Table 7B. Phase III OLD FORM: Total of All Subjects Reported Using the 1977 OMB Standards in a Combined Race/Ethnicity Format 

FY Reported/ 

Funded 

American 

Indian/ Alaska 

Native 

Asian/ 

Pacific 

Islander 

Black or 

African 

American 

Hispanic, 

Not White White Unknown/ Other Total 

Subtotal Using 

US Minority 

Categories (shaded): 

OLD FORM 

Number 

Protocols with 

Enrollment data 

(Old Form): 

1995/1994 5,358 2,740 52,433 20,031 172,773 45,988 299,323 80,562 560 

% Reported in 1995 1.8% 0.9% 17.5% 6.7% 57.7% 15.4% 100.0% 26.9% Empty Cell

1996/1995 4,235 40,126 46,838 19,470 321,445 57,549 489,663 110,669 608 

% Reported in 1996 0.9% 8.2% 9.6% 4.0% 65.6% 11.8% 100.0% 22.6% Empty Cell

1997/1996 4,235 40,126 46,838 19,470 321,445 57,549 489,663 110,669 608 

% Reported in 1997 0.9% 8.2% 9.6% 4.0% 65.6% 11.8% 100.0% 22.6% Empty Cell

1998/1997 5,030 5,324 42,805 16,440 229,534 6,378 305,511 69,599 320 

% Reported in 1998 1.6% 1.7% 14.0% 5.4% 75.1% 2.1% 100.0% 22.8% Empty Cell

1999/1998 3,685 20,276 76,921 40,567 336,703 26,777 504,929 141,449 578 

% Reported in 1999 0.7% 4.0% 15.2% 8.0% 66.7% 5.3% 100.0% 28.0% Empty Cell

2000/1999 3,726 24,017 62,512 30,084 335,824 39,580 495,743 120,339 589 

% Reported in 2000 0.8% 4.8% 12.6% 6.1% 67.7% 8.0% 100.0% 24.3% Empty Cell

2001/2000 4,079 11,132 70,110 32,552 422,802 41,062 581,737 117,873 645 

% Reported in 2001 0.7% 1.9% 12.1% 5.6% 72.7% 7.1% 100.0% 20.3% Empty Cell

2002/2001 1,645 20,560 51,991 29,636 315,543 12,228 431,603 103,832 660 

% Reported in 2002 0.38% 4.8% 12.0% 6.9% 73.1% 2.8% 100.00% 24.1% Empty Cell

2003/2002 1,689 20,038 49,255 29,066 337,654 16,615 454,317 100,048 656 

% Reported in 2003 0.4% 4.4% 10.8% 6.4% 74.3% 3.7% 100.0% 22.0% Empty Cell

2004/2003 1,505 18,807 45,285 32,974 265,764 14,050 378,385 98,571 296 

% Reported in 2004 0.4% 5.0% 12.0% 8.7% 70.2% 3.7% 100.0% 26.1% Empty Cell

2005/2004 1,319 17,740 39,402 21,829 231,492 4,507 316,289 80,290 210 

% Reported in 2005 0.4% 5.6% 12.5% 6.9% 73.2% 1.4% 100.0% 25.4% Empty Cell

2006/2005 1,012 16,800 20,355 9,524 175,724 6,348 229,763 47,691 215 

% Reported in 2006 0.4% 7.3% 8.9% 4.1% 76.5% 2.8% 100.0% 20.8% Empty Cell

2007/2006 751 3,943 21,582 9,333 169,789 4,259 209,657 35,609 197 

% Reported in 2007 0.4% 1.9% 10.3% 4.5% 81.0% 2.0% 100.0% 17.0% Empty Cell

2008/2007 900 4,542 22,445 9,642 190,753 4,262 232,544 37,529 164 

% Reported in 2008 0.4% 2.0% 9.7% 4.1% 82.0% 1.8% 100.0% 16.1% Empty Cell

2009/2008 613 3,291 14,956 6,484 136,082 4,311 165,737 25,344 196 

% Reported in 2009 0.4% 2.0% 9.0% 3.9% 82.1% 2.6% 100.0% 15.3% Empty Cell

2010/2009 296 1,192 6,888 3,225 66,085 749 78,435 11,601 62 

% Reported in 2010 0.4% 1.5% 8.8% 4.1% 84.3% 1.0% 100.0% 14.8% Empty Cell

29
Table 7 (cont’d): Nine-Year Minority Trend Summary of NIH Extramural and Intramural 

Phase III Clinical Research Reported in FY1995-2010: Enrollment by Race and Ethnicity 

1. The New Form consists of Parts A and B (Tables 7C and 7D) for reporting years 2002-2009. This Form is provided as part of the 

annual progress report. 

2. Table 7C displays the New Form Part A for reporting separate race and ethnicity data. 

3. Table 7D displays the New Form Part B, which is the Distribution of Hispanics reported by race, using the totals from the "Hispanic or 

Latino" column in Part A.

Table 7C. Phase III New Form: Total of All Subjects Reported Using the 1997 OMB Standards for Separate Race 

and Ethnicity 

I. Total of All Subjects by Race 

FY Reported/Funded 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White 

More 

Than 

One 

Race 

Unknown/ 

Other Total* 

2002/2001 159 799 4,647 52 34,654 560 2,273 43,144

% Reported in 2002 0.37% 1.85% 10.77% 0.12% 80.32% 1.30% 5.27% 100.00% 

2003/2002 484 2,609 21,641 220 47,869 989 8,138 81,950

% Reported in 2003 0.6% 3.2% 26.4% 0.3% 58.4% 1.2% 9.9% 100.0% 

2004/2003 1,396 4,385 43,721 611 106,793 4,419 5,657 166,982

% Reported in 2004 0.8% 2.6% 26.2% 0.4% 64.0% 2.6% 3.4% 100.0% 

2005/2004 2,164 9,192 50,338 462 101,238 3,063 10,254 176,711

% Reported in 2005 1.2% 5.2% 28.5% 0.3% 57.3% 1.7% 5.8% 100.0% 

2006/2005 4,630 32,360 50,780 535 126,670 4,246 50,446 269,667

% Reported in 2006 1.7% 12.0% 18.8% 0.2% 47.0% 1.6% 18.7% 100.0% 

2007/2006 9,351 47,364 84,468 555 133,002 4,145 102,617 381,502

% Reported in 2007 2.5% 12.4% 22.1% 0.1% 34.9% 1.1% 26.9% 100.0% 

2008/2007 15,006 95,296 103,166 716 281,344 12,136 52,370 560,034

% Reported in 2008 2.7% 17.0% 18.4% 0.1% 50.2% 2.2% 9.4% 100.0% 

2009/2008 17,509 92,868 116,233 859 189,527 4,676 64,891 486,563

% Reported in 2009 3.6% 19.1% 23.9% 0.2% 39.0% 1.0% 13.3% 100.0% 

2010/2009 15,846 113,042 254,738 936 229,410 8,258 69,220 691,450

% Reported in 2010 2.3% 16.3% 36.8% 0.1% 33.2% 1.2% 10.0% 100.0% 

II. Total of All Subjects by Ethnicity 

FY Reported/Funded 

Not Hispanic Hispanic or 

Latino** 

Unknown/ 

Not Reported Total* 

2002/2001 36,224 1,630 5,290 43,144 

% Reported in 2002 83.96% 3.78% 12.26% 100.00% 

2003/2002 64,295 7,831 9,824 81,950 

% Reported in 2003 78.5% 9.6% 12.0% 100.0% 

2004/2003 145,742 13,435 7,805 166,982 

% Reported in 2004 87.3% 8.0% 4.7% 100.0% 

2005/2004 156,650 10,397 9,664 176,711 

% Reported in 2005 88.6% 5.9% 5.5% 100.0% 

2006/2005 202,358 31,034 36,275 269,667 

% Reported in 2006 75.0% 11.5% 13.5% 100.0% 

2007/2006 254,692 71,622 55,188 381,502 

% Reported in 2007 66.8% 18.8% 14.5% 100.0% 

2008/2007 460,862 64,351 34,821 560,034 

% Reported in 2008 82.3% 11.5% 6.2% 100.0% 

2009/2008 391,990 52,223 42,350 486,563 

% Reported in 2009 80.6% 10.7% 8.7% 100.0% 

2010/2009 582,267 60,618 48,565 691,450 

% Reported in 2010 84.2% 8.8% 7.0% 100.0% 

* These totals must agree 

** The Hispanic enrollment totals must agree with totals in Table 7D. 

Table 7C Comment: In FY2009, the NICHD Global Network for Women's and Children's Health Research, a large, foreign, 

Phase 3 Clinical Trial (U01HD040636) expanded enrollment, causing a sharp increase in the reported enrollment of Blacks or 

African Americans reported in FY2010. 

30
Table 7 (cont’d): Nine-Year Minority Trend Summary of NIH Extramural and Intramural 

Phase III Clinical Research Reported in FY1995-2010: Enrollment by Race and Ethnicity 

Table 7D. Phase III Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date (Cumulative)

FY 

Reported/Funded 

American 

Indian/ Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White 

More Than 

One Race 

Unknown/ 

Other Total** 

Subtotal Using US Minority Categories (shaded): NEW FORM Parts A+B 

Number of Protocols with Enrollment data (New Form): 

2002/2001 49 22 31 4 660 304 560 1,630 7,437 94 

% Reported in 2002 3.0% 1.3% 1.9% 0.2% 40.5% 18.7% 34.4% 100.0% 17.2% Empty Cell

2003/2002 37 70 186 23 2,115 203 5,197 7,831 32,254 196 

% Reported in 2003 0.5% 0.9% 2.4% 0.3% 27.0% 2.6% 66.4% 100.0% 39.4% Empty Cell

2004/2003 269 59 193 26 7,264 3,052 2,572 13,435 54,405 277 

% Reported in 2004 2.0% 0.4% 1.4% 0.2% 54.1% 22.7% 19.1% 100.0% 32.6% Empty Cell

2005/2004 759 42 446 45 3,667 423 5,015 10,397 73,901 337 

% Reported in 2005 7.3% 0.4% 4.3% 0.4% 35.3% 4.1% 48.2% 100.0% 41.8% Empty Cell

2006/2005 2,307 50 720 40 6,872 713 20,332 31,034 119,755 409 

% Reported in 2006 7.4% 0.2% 2.3% 0.1% 22.1% 2.3% 65.5% 100.0% 44.4% Empty Cell

2007/2006 7,333 45 458 24 7,430 322 56,010 71,622 209,323 424 

% Reported in 2007 10.2% 0.1% 0.6% 0.0% 10.4% 0.4% 78.2% 100.0% 54.9% Empty Cell

2008/2007 13,060 229 717 122 22,293 5,654 22,276 64,351 270,889 475 

% Reported in 2008 7.3% 0.4% 4.3% 0.4% 35.3% 4.1% 48.2% 100.0% 48.4% Empty Cell

2009/2008 15,313 351 937 198 11,487 964 22,973 52,223 266,605 434 

% Reported in 2009 29.3% 0.7% 1.8% 0.4% 22.0% 1.8% 44.0% 100.0% 54.8% Empty Cell

2010/2009 13,111 360 1,076 204 15,378 3,101 27,388 60,618 435,586 634 

% Reported in 2010 21.6% 0.6% 1.8% 0.3% 25.4% 5.1% 45.2% 100.0% 0.0% Empty Cell

** These totals must agree with the Hispanic enrollment in Table 7C.II 

31
Table 7 (cont’d): Nine-Year Minority Trend Summary of NIH Extramural and Intramural 

Phase III Clinical Research Reported in FY1995-2010: Enrollment by Race and Ethnicity 

Table 7E. Comparison of Domestic and Foreign Phase III Enrollment and Protocols with Enrollment for the period FY2002-2010

FY 

Reported/ 

Funded 

Total Enrollment 

data 

(Old + New Forms): 

Total 

DOMESTIC 

Enrollment 

Percent 

DOMESTIC 

Enrollment 

Total 

FOREIGN 

Enrollment 

Percent 

FOREIGN 

Enrollment 

Number of Protocols 

with Enrollment data 

(Old + New Forms): 

Number of 

DOMESTIC 

Protocols 

Percent 

Domestic 

Protocols 

Number of 

FOREIGN 

Protocols 

Percent 

Foreign 

Protocols 

2002/2001 474,747 444,436 93.6% 30,311 6.4% 754 582 77.2% 172 22.8% 2003/2002 536,267 486,857 90.8% 49,410 9.2% 852 643 75.5% 209 24.5% 2004/2003 545,367 496,241 91.0% 49,126 9.0% 573 549 95.8% 24 4.2% 2005/2004 493,000 437,902 88.8% 55,098 11.2% 547 517 94.5% 30 5.5% 2006/2005 499,430 400,297 80.2% 99,133 19.8% 624 564 90.4% 60 9.6% 2007/2006 591,159 428,440 72.5% 162,719 27.5% 653 609 93.3% 44 6.7% 2008/2007 792,578 591,105 74.6% 201,473 25.4% 639 585 91.5% 54 8.5% 2009/2008 652,300 433,895 66.5% 218,405 33.5% 630 451 71.6% 179 28.4% 2010/2009 769,885 392,867 51.0% 377,018 49.0% 696 540 77.6% 156 22.4% 

Table 7E comments: 1. The Total Enrollment, Total Domestic and Total Foreign Enrollment increased overall from FY 2002 – 2010. 2. The Percent Domestic enrollment decreased from over 90% reported in FY2002 to less than 80% reported in FY2010. Percent Foreign enrollment has 

correspondingly increased during the same period. 

Figure 7b. Nine-Year Trend Summary of Domestic and Foreign Enrollment in NIH Extramural and Intramural Phase III Clinical Research 

32
Table 7 (cont’d): Nine-Year Minority Trend Summary of NIH Extramural and Intramural 

Phase III Clinical Research Reported in FY1995-2010: Enrollment by Race and Ethnicity 

 Table 7F. Phase III Foreign and Domestic Minority Comparison for FY 2002-2010 

FY Reported/Funded 

FOREIGN 

Phase III Minority 

FOREIGN 

Phase III Total 

DOMESTIC 

Phase III Minority 

DOMESTIC 

Phase III Total 

2002/2001 18,308 30,311 92,961 444,436 

% Reported in 2002 60.4% 100.0% 20.9% 100.0% 

2003/2002 23,927 49,410 109,376 486,857 

% Reported in 2003 48.4% 100.0% 22.5% 100.0% 

2004/2003 37,126 49,126 125,813 496,241 

% Reported in 2004 75.6% 100.0% 25.4% 100.0% 

2005/2004 44,281 55,098 109,910 437,902 

% Reported in 2005 80.4% 100.0% 25.1% 100.0% 

2006/2005 84,412 99,133 83,034 400,297 

% Reported in 2006 85.2% 100.0% 20.7% 100.0% 

2007/2006 156,533 162,713 79,769 383,050 

% Reported in 2007 96.2% 100.0% 20.8% 100.0% 

2008/2007 188,851 201,473 119,582 591,105 

% Reported in 2008 93.7% 100.0% 20.2% 100.0% 

2009/2008 194,870 218,405 97,079 433,895 

% Reported in 2009 89.2% 100.0% 22.4% 100.0% 

2010/2009 354,678 377,018 92,509 392,867 

% Reported in 2010 94.1% 100.0% 23.5% 100.0% 

Table 7F Comment: 

In FY2009, the NICHD Global Network for Women's and Children's Health Research, a large, foreign, Phase 3 Clinical Trial 

(U01HD040636) expanded enrollment, causing a sharp increase in the aggregate foreign minority enrollment reported in 

FY2010. 

 Figure 7c. Phase III Foreign and Domestic Minority Comparison for FY 2002-2010 

33
Table 8: Overview of NIH Extramural and Intramural Clinical Research Reported in FY2009: Number of Sex-Specific Protocols, and 

Domestic versus Foreign Protocols 

Table 8A. PROTOCOLS REPORTED 

Total All 

Clinical 

Studies* 

Domestic 

Extramural 

Protocols 

% Domestic 

Extramural 

Protocols 

Domestic 

Intramural 

Protocols 

% Domestic 

Intramural 

Protocols 

Foreign 

Extramural 

Protocols 

% Foreign 

Extramural 

Protocols 

Foreign 

Intramural 

Protocols 

% Foreign 

Intramural 

Protocols 

Number of Protocols reporting 

females only 1,356 1,069 78.8% 131 9.7% 149 11.0%

7 0.5% 

% Protocols reporting females only 8.1% 7.8% Empty Cell 7.0% Empty Cell 14.7% Empty Cell 6.7% Empty Cell 

Number of Protocols reporting 

males only 624 434 69.6% 102 16.3% 85 13.6%

3 0.5% 

% Protocols reporting males only 3.7% 3.2% Empty Cell 5.5% Empty Cell 8.4% Empty Cell 2.9% Empty Cell 

Number of Protocols with Both 

Female and Male Enrollment 

(excluding sex-specific protocols) 

9,191 7,128 77.6% 1,399 15.2% 579 6.3% 85 0.9% 

% Protocols with Female and Male 

enrollment 55.1% 52.0% Empty Cell 75.3% Empty Cell 57.2% Empty Cell 81.0% Empty Cell 

Total Number of Protocols with 

Enrollment 11,171 8,631 77.3% 1,632 14.6% 813 7.3% 95 0.9% 

Total % 66.9% 63% Empty Cell 87.8% Empty Cell 80.3% Empty Cell 90.5% Empty Cell 

Protocols with zero enrollment 

(Enrollment data have not yet been 

submitted) 5,518 5,082 92.1% 227 4.1% 199 3.6% 10 0.2% 

% Protocols with zero enrollment 33.1% 37.1% Empty Cell 12.2% Empty Cell 19.7% Empty Cell 9.5% Empty Cell 

Total Number of Protocols 16,689 13,713 82.2% 1,859 11.1% 1,012 6.1% 105 0.6% 

Total % 100.0% 100.0% Empty Cell 100.0% Empty Cell 100.0% Empty Cell 100.0% Empty Cell 

* Clinical research studies include non-intervention clinical research, clinical trials, epidemiologic studies, behavioral studies, database studies, etc., based on the NIH definition of clinical research. "Total All Clinical Studies" includes NIH Defined Phase III Clinical Trials. 

34
Table 8B. ENROLLMENT 

REPORTED 

Total All 

Clinical 

Studies 

Domestic 

Extramural 

Protocols 

% Domestic 

Extramural 

Protocols 

Domestic 

Intramural 

Protocols 

% Domestic 

Intramural 

Protocols 

Foreign 

Extramural 

Protocols 

% Foreign 

Extramural 

Protocols 

Foreign 

Intramural 

Protocols 

% Foreign 

Intramural 

Protocols 

Enrollment in Protocols reporting 

females only 4,830,093 4,460,062 92.3% 159,063 3.3% 39,730 0.8% 171,238 3.5% 

% in Protocols reporting females 

only 25.2% 28.9% Empty Cell 6.6% Empty Cell 5.3% Empty Cell 32.0% Empty cell

Enrollment in Protocols reporting 

males only 396,076 338,422 85.4% 9,472 2.4% 22,741 5.7% 25,441 6.4% 

% in Protocols reporting males 

only 2.1% 2.2% Empty cell 0.4% Empty cell 3.0% Empty cell 4.8% Empty cell

Enrollment in Protocols excluding 

female-only and male-only 

enrollment protocols 13,912,569 10,633,061 76.4% 2,247,994 16.2% 693,049 5.0% 338,465 2.4% 

% in protocols excluding femaleonly and male-only enrollment 

protocols 72.7% 68.9% Empty cell 93.0% Empty cell 91.7% Empty cell 63.2% Empty cell

Enrollment Totals for all studies 19,138,738 15,431,545 80.6% 2,416,529 12.6% 755,520 3.9% 535,144 2.8% 

Total % 100.0% 100.0% Empty cell 100.0% Empty cell 100.0% Empty cell 100.0% Empty cell

Table 8C. MINORITY ENROLLMENT REPORTED** 

Total All 

Clinical 

Studies 

Domestic 

Extramural 

Protocols 

% Domestic 

Extramural 

Protocols 

Domestic 

Intramural 

Protocols 

% Domestic 

Intramural 

Protocols 

Foreign 

Extramural 

Protocols 

% Foreign 

Extramural 

Protocols 

Foreign 

Intramural 

Protocols 

% Foreign 

Intramural 

Protocols 

Minority Totals for all studies 5,783,543 4,304,509 74.4% 579,285 10.0% 614,724 10.6% 285,025 4.9% 

% Minority enrollment 30.2% 27.9% Empty cell 24.0% Empty cell 81.4% Empty cell 53.3% Empty cell

** See Page 4 for the Race and Ethnicity categories included in Minority Enrollment Data from the 1977 and 1997 U.S. OMB race/ethnicity categories. Foreign 

enrollment was reported using the U.S. race and ethnicity categories. NOTE: Percentages are reported with one decimal point; due to rounding, adding percentages may not equal 100%.

35
Table 9. Aggregate Enrollment Data for Extramural Research Protocols Funded in FY2008 and 

Reported in FY2009: Percent Analysis 

Table 9A. SUMMARY TOTALS: Old Form + New Form 

Sex /Gender Total 

Enrollment 

Minority 

Enrollment 

% Minority 

Enrollment 

Females (#) 10,188,246 3,022,938 29.67% 

Females (% of total) 62.94% 61.45% Empty Cell 

Males (#) 5,914,676 1,881,416 31.81% 

Males (% of total) 36.54% 38.25% Empty Cell 

Unknown (#) 84,143 14,879 17.68% 

Unknown (% of total) 0.52% 0.30% Empty Cell 

TOTAL (#) 16,187,065 4,919,233 30.39% 

Total (%) 100% 100.00% Empty Cell 

 

Table 9B. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 

I. Total of All Subjects by Race 

Sex/ 

Gender 

American 

Indian/ 

Alaska Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total 

Females (number) 91,643 1,090,555 1,073,690 29,381 6,939,461 108,399 728,852 10,061,981

% of total 0.57% 6.83% 6.73% 0.18% 43.48% 0.68% 4.57% 63.05%

% females in each race 0.91% 10.84% 10.67% 0.29% 68.97% 1.08% 7.24% 100.00%

% of each race females 68.59% 69.82% 53.28% 60.09% 62.98% 63.37% 72.24% 63.05%

Males (number) 41,411 469,956 933,867 19,392 4,072,005 61,291 215,172 5,813,094

% of total 0.26% 2.94% 5.85% 0.12% 25.52% 0.38% 1.35% 36.43%

% males in each race 0.71% 8.08% 16.06% 0.33% 70.05% 1.05% 3.70% 100.00%

% of each race males 30.99% 30.09% 46.34% 39.66% 36.95% 35.83% 21.33% 36.43%

Unknown (number) 553 1,387 7,798 123 7,831 1,358 64,951 84,001

% of total 0.00% 0.01% 0.05% 0.00% 0.05% 0.01% 0.41% 0.53%

% unknown in each race 0.66% 1.65% 9.28% 0.15% 9.32% 1.62% 77.32% 100.00%

% of each race unknown 0.41% 0.09% 0.39% 0.25% 0.07% 0.79% 6.44% 0.53%

Total (number) 133,607 1,561,898 2,015,355 48,896 11,019,297 171,048 1,008,975 15,959,076

% of each race in total 0.84% 9.79% 12.63% 0.31% 69.05% 1.07% 6.32% 100.00%

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

II. Total of All Subjects by Ethnicity 

Sex/ 

Gender Not Hispanic Hispanic or Latino 

Unknown /Not 

Reported 

Total 

Females (number) 8,658,138 728,314 675,529 10,061,981 

% of total 54.25% 4.56% 4.23% 63.05% 

% females in each race 86.05% 7.24% 6.71% 100.00% 

% of each race females 62.89% 61.08% 67.56% 63.05% 

Males (number) 5,093,038 459,455 260,601 5,813,094 

% of total 31.91% 2.88% 1.63% 36.43% 

% males in each race 87.61% 7.90% 4.48% 100.00% 

% of each race males 36.99% 38.53% 26.06% 36.43% 

Unknown (number) 15,669 4,596 63,736 84,001 

% of total 0.10% 0.03% 0.40% 0.53% 

% unknown in each race 18.65% 5.47% 75.88% 100.00% 

% of each race unknown 0.11% 0.39% 6.37% 0.53% 

Total (number) 13,766,845 1,192,365 999,866 15,959,076 

% of each race in total 86.26% 7.47% 6.27% 100.00% 

Total (%) 100.00% 100.00% 100.00% 100.00% 

Number of

Protocols with 

Enrollment Data 

Reported on New 

Form: 8,993

Total # Protocols 

with Enrollment 

Data: 9,444

36
III. New Form (Part B): Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Total of All Hispanic or Latino Subjects by Race 

Sex/ 

Gender 

American 

Indian/ 

Alaska 

Native Asian 

Black or 

African 

American

Hawaiian/ 

Pacific 

Islander White 

More Than

One Race

Unknown/ 

Other Total 

Females (number) 22,861 28,987 29,538 1,701 427,774 33,373 184,098 728,332 

% of total 1.92% 2.43% 2.48% 0.14% 35.87% 2.80% 15.44% 61.07% 

% females in each race 3.14% 3.98% 4.06% 0.23% 58.73% 4.58% 25.28% 100.00% 

% of each race females 58.60% 54.22% 33.76% 56.53% 63.93% 57.90% 65.09% 61.07% 

Males (number) 15,986 24,346 57,394 1270 240,495 24,228 95,902 459,621 

% of total 1.34% 2.04% 4.81% 0.11% 20.17% 2.03% 8.04% 38.54% 

% males in each race 3.48% 5.30% 12.49% 0.28% 52.32% 5.27% 20.87% 100.00% 

% of each race males 40.97% 45.54% 65.59% 42.21% 35.94% 42.03% 33.91% 38.54% 

Unknown (number) 168 129 566 38 820 39 2,836 4,596 

% of total 0.01% 0.01% 0.05% 0.00% 0.07% 0.00% 0.24% 0.39% 

% unknown in each race 3.66% 2.81% 12.32% 0.83% 17.84% 0.85% 61.71% 100.00% 

% of each race unknown 0.43% 0.24% 0.65% 1.26% 0.12% 0.07% 1.00% 0.39% 

Total (number) 39,015 53,462 87,498 3,009 669,089 57,640 282,836 1,192,549 

% of each race in total 3.27% 4.48% 7.34% 0.25% 56.11% 4.83% 23.72% 100.00% 

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 

Sex/Ge

nder 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B 

Female

s 

(numb

er) 3,005,540 

% of 

total 18.83% % 

females 

in each 

race 29.87% % of 

each 

race 

females 61.55% 

Males 

(numb

er) 1,862,314 

% of 

total 11.67% % 

males 

in each 

race 32.04% % of 

each 

race 

males 38.14% 

Unkno

wn 

(numb

er) 14,875 

% of 

total 0.09% % 

unknow

n in 

each 

race 17.71% % of 

each 

race 

unknow

n

0.30% 

Total 

(numb

er) 4,882,729 % of 

each 

race in 

total 30.60% Total 

(%) 

100.00% 

Number of 

Protocols with 

Enrollment 

Data Reported 

on Old form: 

451

Table 9C. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards 

Sex/ 

Gender 

American 

Indian/ 

Alaska 

Native 

Asian/ 

Pacific 

Islander 

Black or 

African 

American Hispanic White 

Unknown/ 

Other Total 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM

Females (number) 585 2,908 8,926 4,979 102,183 6,684 126,265 17,398

% of total 0.26% 1.28% 3.92% 2.18% 44.82% 2.93% 55.38% 7.63%

% females in each race 0.46% 2.30% 7.07% 3.94% 80.93% 5.29% 100.00% 13.78%

% of each race females 62.77% 59.30% 43.65% 48.72% 57.37% 49.95% 55.38% 47.66%

Males (number) 347 1,994 11,522 5,239 75,906 6,574 101,582 19,102

% of total 0.15% 0.87% 5.05% 2.30% 33.29% 2.88% 44.56% 8.38%

% males in each race 0.34% 1.96% 11.34% 5.16% 74.72% 6.47% 100.00% 18.80%

% of each race males 37.23% 40.66% 56.35% 51.27% 42.62% 49.13% 44.56% 52.33%

Unknown (number) 0 2 1 1 15 123 142 4

% of total 0.00% 0.00% 0.00% 0.00% 0.01% 0.05% 0.06% 0.00%

% unknown in each race 0.00% 1.41% 0.70% 0.70% 10.56% 86.62% 100.00% 2.82%

% of each race unknown 0.00% 0.04% 0.00% 0.01% 0.01% 0.92% 0.06% 0.01%

Total (number) 932 4,904 20,449 10,219 178,104 13,381 227,989 36,504

% of each race in total 0.41% 2.15% 8.97% 4.48% 78.12% 5.87% 100.00% 16.01%

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Legend

Bold: Percentage of Total No. of Participants in Research Protocols (Old or New Form) 

Italics: Percentage of Total No. of Participants Sorted by Sex/Gender (Row Total) 

Plain Typeface: Percentage of Total No. of Participants sorted by Race/Ethnicity (Column Total) 

Columns denoted with shading (American Indian/ Alaska Native, Asian, Black/ African American, Hawaiian/ 

Pacific Islander, Asian/ Pacific Islander, Hispanic and Unknown, More than one race and Unknown/Other) are 

summed to calculate Minority enrollment in Table 9A. 

37
Table 10: Overview of NIH Extramural and Intramural Clinical Research Reported in FY2010: Number of Sex-Specific Protocols, and

Domestic versus Foreign Protocols 

Table 10A. PROTOCOLS REPORTED 

Total All 

Clinical 

Studies* 

Domestic 

Extramural 

Protocols 

% Domestic 

Extramural 

Protocols 

Domestic 

Intramural 

Protocols 

% Domestic 

Intramural 

Protocols 

Foreign 

Extramural 

Protocols 

% Foreign 

Extramural 

Protocols 

Foreign 

Intramural 

Protocols 

% Foreign 

Intramural 

Protocols 

Number of Protocols reporting 

females only 1,373 1,089 79.3% 146 10.6% 128 9.3% 10 0.7% 

% Protocols reporting females 

only 8.0% 7.7% Empty Cell 7.6% Empty Cell 11.8% Empty Cell 8.5% Empty Cell

Number of Protocols reporting 

males only 691 491 71.1% 111 16.1% 85 12.3% 4 0.6% 

% Protocols reporting males only 4.0% 3.5% Empty Cell 5.7% Empty Cell 7.8% Empty Cell 3.4% Empty Cell

Number of Protocols with Both 

Female and Male Enrollment 

(Excluding sex-specific protocols) 

10,015 7,945 79.3% 1,407 14.0% 571 5.7% 92 0.9% 

% Protocols with Female and Male 

enrollment 58.1% 56.3% Empty Cell 72.8% Empty Cell 52.7% Empty Cell 78.6% Empty Cell

Total Number of Protocols with 

Enrollment 12,079 9,525 78.9% 1,664 13.8% 784 6.5% 106 0.9% 

Total % 70.0% 67.0% Empty Cell 86.1% Empty Cell 72.4% Empty Cell 90.6% Empty Cell

Protocols with zero enrollment 

(Enrollment data have not yet 

been submitted) 5,172 4,593 88.8% 269 5.2% 299 5.8% 11 0.2% 

% Protocols with zero enrollment 30.0% 32.5% Empty Cell 13.9% Empty Cell 27.6% Empty Cell 9.4% Empty Cell

Total Number of Protocols 17,251 14,118 81.8% 1,933 11.2% 1,083 6.3% 117 0.7% 

Total % 100.0% 100.0% Empty Cell 100.0% Empty Cell 100.0% Empty Cell 100.0% Empty Cell

* Clinical research studies include non-intervention clinical research, clinical trials, epidemiologic studies, behavioral studies, database studies, etc., based on the NIH definition of clinical research. "Total All Clinical Studies" includes NIH Defined Phase III Clinical Trials. 

38
Table 10B. ENROLLMENT 

REPORTED 

Total All 

Clinical 

Studies 

Domestic 

Extramural 

Protocols 

% Domestic 

Extramural 

Protocols 

Domestic 

Intramural 

Protocols 

% Domestic 

Intramural 

Protocols 

Foreign 

Extramural 

Protocols 

% Foreign 

Extramural 

Protocols 

Foreign 

Intramural 

Protocols 

% Foreign 

Intramural 

Protocols 

In Protocols reporting females 

only 4,440,402 4,004,391 90.2% 198,571 4.5% 52,143 1.2% 185,297 4.2% 

% in Protocols reporting females 

only 19.0% 21.1% Empty Cell 7.8% Empty Cell 4.1% Empty Cell 33.0% Empty Cell

In Protocols reporting males only 1,328,551 1,274,647 95.9% 11,609 0.9% 15,928 1.2% 26,367 2.0% 

% in Protocols reporting males 

only 5.7% 6.7% Empty Cell 0.5% Empty Cell 1.2% Empty Cell 4.7% Empty Cell

In Protocols excluding female-only 

and male-only enrollment 

protocols 17,594,682 13,695,325 77.8% 2,338,533 13.3% 1,210,359 6.9% 350,465 2.0% 

% in protocols excluding femaleonly and male-only enrollment 

protocols 75.3% 72.2% Empty Cell 91.8% Empty Cell 94.7% Empty Cell 62.3% Empty Cell

Enrollment Totals for all studies 23,363,635 18,974,363 81.2% 2,548,713 10.9% 1,278,430 5.5% 562,129 2.4% 

Total % 100.0% 100.0% Empty Cell 100.0% Empty Cell 100.0% Empty Cell 100.0% Empty Cell

Table 10C. MINORITY ENROLLMENT REPORTED** 

Total All 

Clinical 

Studies 

Domestic 

Extramural 

Protocols 

% Domestic 

Extramural 

Protocols 

Domestic 

Intramural 

Protocols 

% Domestic 

Intramural 

Protocols 

Foreign 

Extramural 

Protocols 

% Foreign 

Extramural 

Protocols 

Foreign 

Intramural 

Protocols 

% Foreign 

Intramural 

Protocols 

Minority Totals for all studies 7,510,763 5,423,294 72.2% 618,237 8.2% 1,165,228 15.5% 304,004 4.0% 

% Minority enrollment 32.1% 28.6% Empty Cell 24.3% Empty Cell 91.1% Empty Cell 54.1% Empty Cell 

** See Page 4 for the Race and Ethnicity categories included in Minority Enrollment Data from the 1977 and 1997 U.S. OMB race/ethnicity categories. Foreign 

enrollment was reported using the U.S. race and ethnicity categories. NOTE: Percentages are reported with one decimal point; due to rounding, adding percentages may not equal 100%.

39
Table 11. Aggregate Enrollment Data for Extramural Research Protocols Funded in FY2009 and 

Reported in FY2010: Percent Analysis 

Table 11A. SUMMARY TOTALS: Old Form + New Form 

Sex /Gender Total 

Enrollment 

Minority 

Enrollment 

% Minority 

Enrollment 

Females (#) 11,758,980 3,970,845 33.77% 

Females (% of total) 58.06% 60.27% Empty Cell 

Males (#) 8,344,426 2,577,783 30.89% 

Males (% of total) 41.20% 39.13% Empty Cell 

Unknown (#) 149,387 39,894 26.71% 

Unknown (% of total) 0.74% 0.61% Empty Cell 

TOTAL (#) 20,252,793 6,588,522 32.53% 

Total (%) 100% 100.00% Empty Cell 

Total # Protocols 

with Enrollment 

Data: 10,309

Table 11B. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 

I. Total of All Subjects by Race 

Sex/ 

Gender 

American 

Indian/ 

Alaska Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total 

Females (number) 200,172 1,280,862 1,443,812 85,453 7,609,654 116,266 975,655 11,711,874 

% of total 0.99% 6.36% 7.17% 0.42% 37.77% 0.58% 4.84% 58.12% 

% females in each race 1.71% 10.94% 12.33% 0.73% 64.97% 0.99% 8.33% 100.00% 

% of each race females 59.21% 69.40% 54.56% 58.11% 56.58% 58.26% 64.08% 58.12% 

Males (number) 137,288 561,819 1,192,524 61,491 5,817,603 82,192 436,197 8,289,114 

% of total 0.68% 2.79% 5.92% 0.31% 28.87% 0.41% 2.16% 41.14% 

% males in each race 1.66% 6.78% 14.39% 0.74% 70.18% 0.99% 5.26% 100.00% 

% of each race males 40.61% 30.44% 45.06% 41.82% 43.25% 41.19% 28.65% 41.14% 

Unknown (number) 612 2,983 10,087 106 23,225 1,099 110,620 148,732 

% of total 0.00% 0.01% 0.05% 0.00% 0.12% 0.01% 0.55% 0.74% 

% unknown in each race 0.41% 2.01% 6.78% 0.07% 15.62% 0.74% 74.38% 100.00% 

% of each race unknown 0.18% 0.16% 0.38% 0.07% 0.17% 0.55% 7.27% 0.74% 

Total (number) 338,072 1,845,664 2,646,423 147,050 13,450,482 199,557 1,522,472 20,149,720 

% of each race in total 1.68% 9.16% 13.13% 0.73% 66.75% 0.99% 7.56% 100.00% 

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 

II. Total of All Subjects by Ethnicity 

Sex/ 

Gender Not Hispanic Hispanic or Latino 

Unknown /Not 

Reported 

Total 

Females (number) 9,649,854 1,055,739 1,006,281 11,711,874 

% of total 47.89% 5.24% 4.99% 58.12% 

% females in each race 82.39% 9.01% 8.59% 100.00% 

% of each race females 58.11% 57.52% 58.91% 58.12% 

Males (number) 6,936,676 752,923 599,515 8,289,114 

% of total 34.43% 3.74% 2.98% 41.14% 

% males in each race 83.68% 9.08% 7.23% 100.00% 

% of each race males 41.77% 41.02% 35.10% 41.14% 

Unknown (number) 19,792 26,675 102,265 148,732 

% of total 0.10% 0.13% 0.51% 0.74% 

% unknown in each race 13.31% 17.93% 68.76% 100.00% 

% of each race unknown 0.12% 1.45% 5.99% 0.74% 

Total (number) 16,606,322 1,835,337 1,708,061 20,149,720 

% of each race in total 82.41% 9.11% 8.48% 100.00% 

Total (%) 100.00% 100.00% 100.00% 100.00% 

Number of

Protocols with 

Enrollment Data 

Reported on New 

Form: 10,139

40
III. New Form (Part B): Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Total of All Hispanic or Latino Subjects by Race 

Sex/ 

Gender 

America

n Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race

Unknown/ 

Other Total 

Females (number) 109,588 6,372 68,868 1,526 564,744 31,912 272,729 1,055,739 

% of total 5.97% 0.35% 3.75% 0.08% 30.77% 1.74% 14.86% 57.52% 

% females in each race 10.38% 0.60% 6.52% 0.14% 53.49% 3.02% 25.83% 100.00% 

% of each race females 54.01% 65.41% 41.37% 56.06% 59.36% 52.20% 61.85% 57.52% 

Males (number) 93,129 3,170 96,463 1147 372,988 28,968 157,058 752,923 

% of total 5.07% 0.17% 5.26% 0.06% 20.32% 1.58% 8.56% 41.02% 

% males in each race 12.37% 0.42% 12.81% 0.15% 49.54% 3.85% 20.86% 100.00% 

% of each race males 45.90% 32.54% 57.95% 42.14% 39.20% 47.39% 35.62% 41.02% 

Unknown (number) 175 199 1134 49 13733 250 11,135 26,675 

% of total 0.01% 0.01% 0.06% 0.00% 0.75% 0.01% 0.61% 1.45% 

% unknown in each race 0.66% 0.75% 4.25% 0.18% 51.48% 0.94% 41.74% 100.00% 

% of each race unknown 0.09% 2.04% 0.68% 1.80% 1.44% 0.41% 2.53% 1.45% 

Total (number) 202,892 9,741 166,465 2,722 951,465 61,130 440,922 1,835,337 

% of each race in total 11.05% 0.53% 9.07% 0.15% 51.84% 3.33% 24.02% 100.00% 

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 

Sex/Ge

nder 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B Female

s 

(numb

er) 3,964,038 

% of 

total 19.67% % 

females 

in each 

race 33.85% % of 

each 

race 

females 60.34% 

Males 

(numb

er) 2,565,360 

% of 

total 12.73% % 

males 

in each 

race 30.95% % of 

each 

race 

males 39.05% Unkno

wn 

(numb

er) 39,755 

% of 

total 0.20% % 

unknow

n in 

each 

race 26.73% % of 

each 

race 

unknow

n

0.61% Total 

(numb

er) 6,569,153 

% of 

each 

race in 

total

32.60% Total 

(%) 100.00% 

Table 11C. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards 

Sex/ 

Gender 

American 

Indian/ 

Alaska 

Native 

Asian/ 

Pacific 

Islander 

Black or 

African 

American

Hispanic White Unknown/

Other Total 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

Females (number) 185 978 2,745 2,899 38,859 1,440 47,106 6,807

% of total 0.18% 0.95% 2.66% 2.81% 37.70% 1.40% 45.70% 6.60%

% females in each race 0.39% 2.08% 5.83% 6.15% 82.49% 3.06% 100.00% 14.45%

% of each race females 49.47% 46.02% 27.26% 42.64% 48.19% 47.06% 45.70% 35.14%

Males (number) 189 1,075 7,284 3,875 41,381 1,508 55,312 12,423

% of total 0.18% 1.04% 7.07% 3.76% 40.15% 1.46% 53.66% 12.05%

% males in each race 0.34% 1.94% 13.17% 7.01% 74.81% 2.73% 100.00% 22.46%

% of each race males 50.53% 50.59% 72.33% 56.99% 51.31% 49.28% 53.66% 64.14%

Unknown (number) 0 72 42 25 404 112 655 139

% of total 0.00% 0.07% 0.04% 0.02% 0.39% 0.11% 0.64% 0.13%

% unknown in each race 0.00% 10.99% 6.41% 3.82% 61.68% 17.10% 100.00% 21.22%

% of each race unknown 0.00% 3.39% 0.42% 0.37% 0.50% 3.66% 0.64% 0.72%

Total (number) 374 2,125 10,071 6,799 80,644 3,060 103,073 19,369

% of each race in total 0.36% 2.06% 9.77% 6.60% 78.24% 2.97% 100.00% 18.79%

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Number of 

Protocols with 

Enrollment 

Data Reported 

on Old form: 

170

Legend

Bold: Percentage of Total No. of Participants in Research Protocols (Old or New Form) 

Italics: Percentage of Total No. of Participants Sorted by Sex/Gender (Row Total) 

Plain Typeface: Percentage of Total No. of Participants sorted by Race/Ethnicity (Column Total) 

Columns denoted with shading (American Indian/ Alaska Native, Asian, Black/ African American, Hawaiian/ Pacific 

Islander, Asian/ Pacific Islander, Hispanic and Unknown, More than one race and Unknown/Other) are summed to 

calculate Minority enrollment in Table 11A. 

41
Table 12. Aggregate Enrollment Data for Extramural Research Protocols Excluding Male-Only and 

Female-Only Protocols Funded in FY2008 and Reported in FY2009: Percent Analysis 

Table 12A. SUMMARY TOTALS: Old Form + New Form 

Sex/Gender Total 

Enrollment 

Minority 

Enrollment 

% Minority 

Enrollment 

Females (#) 5,688,454 1,759,483 30.93% 

Females (% of total) 50.22% 49.89% Empty Cell 

Males (#) 5,553,513 1,752,572 31.56% 

Males (% of total) 49.03% 49.69% Empty Cell

Unknown (#) 84,143 14,879 17.68% 

Unknown (% of total) 0.74% 0.42% Empty Cell

TOTAL (#) 11,326,110 3,526,934 31.14% 

Total (%) 100% 100.00% Empty Cell

Total # Protocols 

with Enrollment 

Data: 7,707

Table 12B. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 

I. Total of All Subjects by Race 

Sex/ 

Gender 

American 

Indian/ 

Alaska Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total 

Females (number) 44,382 433,527 816,068 26,622 4,011,827 75,247 226,437 5,634,110 

% of total 0.40% 3.87% 7.28% 0.24% 35.77% 0.67% 2.02% 50.23% 

% females in each race 0.79% 7.69% 14.48% 0.47% 71.21% 1.34% 4.02% 100.00% 

% of each race females 51.75% 52.20% 47.38% 57.97% 50.82% 55.27% 45.23% 50.23% 

Males (number) 40,828 395,569 898,353 19,179 3,875,190 59,547 209,270 5,497,936 

% of total 0.36% 3.53% 8.01% 0.17% 34.55% 0.53% 1.87% 49.02% 

% males in each race 0.74% 7.19% 16.34% 0.35% 70.48% 1.08% 3.81% 100.00% 

% of each race males 47.61% 47.63% 52.16% 41.76% 49.09% 43.74% 41.80% 49.02% 

Unknown (number) 553 1,387 7,798 123 7,831 1,358 64,951 84,001 

% of total 0.00% 0.01% 0.07% 0.00% 0.07% 0.01% 0.58% 0.75% 

% unknown in each race 0.66% 1.65% 9.28% 0.15% 9.32% 1.62% 77.32% 100.00% 

% of each race unknown 0.64% 0.17% 0.45% 0.27% 0.10% 1.00% 12.97% 0.75% 

Total (number) 85,763 830,483 1,722,219 45,924 7,894,848 136,152 500,658 11,216,047 

% of each race in total 0.76% 7.40% 15.35% 0.41% 70.39% 1.21% 4.46% 100.00% 

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 

II. Total of All Subjects by Ethnicity 

Number of 

Protocols with 

Enrollment Data 

Reported on New 

Form: 7,404

Sex/ 

Gender Not Hispanic Hispanic or Latino 

Unknown /Not 

Reported 

Total 

Females (number) 4,980,970 449,485 203,655 5,634,110 

% of total 44.41% 4.01% 1.82% 50.23% 

% females in each race 88.41% 7.98% 3.61% 100.00% 

% of each race females 50.55% 49.79% 44.38% 50.23% 

Males (number) 4,857,833 448,637 191,466 5,497,936 

% of total 43.31% 4.00% 1.71% 49.02% 

% males in each race 88.36% 8.16% 3.48% 100.00% 

% of each race males 49.30% 49.70% 41.73% 49.02% 

Unknown (number) 15,669 4,596 63,736 84,001 

% of total 0.14% 0.04% 0.57% 0.75% 

% unknown in each race 18.65% 5.47% 75.88% 100.00% 

% of each race unknown 0.16% 0.51% 13.89% 0.75% 

Total (number) 9,854,472 902,718 458,857 11,216,047 

% of each race in total 87.86% 8.05% 4.09% 100.00% 

Total (%) 100.00% 100.00% 100.00% 100.00% 

42
III. New Form (Part B): Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Total of All Hispanic or Latino Subjects by Race 

Sex/

Gend

er 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B Fema

les 

(num

ber) 1,751,433 

% of 

total 15.62% % 

femal

es in 

each 

race 31.09% % of 

each 

race 

femal

es 49.91% Male

s 

(num

ber) 1,743,017 

% of 

total 15.54% % 

males 

in 

each 

race 31.70% % of 

each 

race 

males 49.67% Unkn

own 

(num

ber) 14,875 

% of 

total 0.13% % 

unkn

own 

in 

each 

race 17.71% % of 

each 

race 

unkn

own 0.42% Total 

(num

ber) 3,509,325 % of 

each 

race 

in 

total 31.29% Total 

(%) 

100.00% 

Sex/ 

Gender 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race

Unknown/ 

Other Total 

Females (number) 16,377 25,246 25,141 1,408 259,664 25,744 95,923 449,503 

% of total 1.81% 2.80% 2.78% 0.16% 28.76% 2.85% 10.62% 49.78% 

% females in each race 3.64% 5.62% 5.59% 0.31% 57.77% 5.73% 21.34% 100.00% 

% of each race females 50.72% 50.80% 30.49% 52.13% 52.10% 54.81% 50.37% 49.78% 

Males (number) 15,741 24,322 56,761 1255 237,869 21,183 91,672 448,803 

% of total 1.74% 2.69% 6.29% 0.14% 26.34% 2.35% 10.15% 49.71% 

% males in each race 3.51% 5.42% 12.65% 0.28% 53.00% 4.72% 20.43% 100.00% 

% of each race males 48.75% 48.94% 68.83% 46.46% 47.73% 45.10% 48.14% 49.71% 

Unknown (number) 168 129 566 38 820 39 2,836 4,596 

% of total 0.02% 0.01% 0.06% 0.00% 0.09% 0.00% 0.31% 0.51% 

% unknown in each race 3.66% 2.81% 12.32% 0.83% 17.84% 0.85% 61.71% 100.00% 

% of each race unknown 0.52% 0.26% 0.69% 1.41% 0.16% 0.08% 1.49% 0.51% 

Total (number) 32,286 49,697 82,468 2,701 498,353 46,966 190,431 902,902 

% of each race in total 3.58% 5.50% 9.13% 0.30% 55.19% 5.20% 21.09% 100.00% 

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 

Table 12C. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards 

Number of 

Protocols with 

Enrollment 

Data Reported 

on Old form: 

303

Sex/ 

Gender 

American 

Indian/ 

Alaska 

Native 

Asian/ 

Pacific 

Islander 

Black or 

African 

American

Hispanic White Unknown/

Other Total 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

Females (number) 303 1,343 4,259 2,145 40,823 5,471 54,344 8,050

% of total 0.28% 1.22% 3.87% 1.95% 37.09% 4.97% 49.38% 7.31%

% females in each race 0.56% 2.47% 7.84% 3.95% 75.12% 10.07% 100.00% 14.81%

% of each race females 60.97% 48.66% 44.95% 43.99% 49.91% 51.36% 49.38% 45.72%

Males (number) 194 1,415 5,216 2,730 40,963 5,059 55,577 9,555

% of total 0.18% 1.29% 4.74% 2.48% 37.22% 4.60% 50.50% 8.68%

% males in each race 0.35% 2.55% 9.39% 4.91% 73.70% 9.10% 100.00% 17.19%

% of each race males 39.03% 51.27% 55.04% 55.99% 50.08% 47.49% 50.50% 54.26%

Unknown (number) 0 2 1 1 15 123 142 4

% of total 0.00% 0.00% 0.00% 0.00% 0.01% 0.11% 0.13% 0.00%

% unknown in each race 0.00% 1.41% 0.70% 0.70% 10.56% 86.62% 100.00% 2.82%

% of each race unknown 0.00% 0.07% 0.01% 0.02% 0.02% 1.15% 0.13% 0.02%

Total (number) 497 2,760 9,476 4,876 81,801 10,653 110,063 17,609

% of each race in total 0.45% 2.51% 8.61% 4.43% 74.32% 9.68% 100.00% 16.00%

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Legend

Bold: Percentage of Total No. of Participants in Research Protocols (Old or New Form) 

Italics: Percentage of Total No. of Participants Sorted by Sex/Gender (Row Total) 

Plain Typeface: Percentage of Total No. of Participants sorted by Race/Ethnicity (Column Total) 

Columns denoted with shading (American Indian/ Alaska Native, Asian, Black/ African American, Hawaiian/ 

Pacific Islander, Asian/ Pacific Islander, Hispanic and Unknown, More than one race and Unknown/Other) are 

summed to calculate Minority enrollment in Table 12A. 

43
Table 13A. Aggregate Enrollment Data for Extramural Research Protocols Excluding Male-Only and 

Female-Only Protocols Funded in FY2009 and Reported in FY2010: Percent Analysis 

Table 13A. SUMMARY TOTALS: Old Form + New Form 

Sex /Gender Total 

Enrollment 

Minority 

Enrollment 

% Minority 

Enrollment 

Females (#) 7,702,446 2,677,903 34.77% 

Females (% of total) 51.67% 52.65% Empty Cell 

Males (#) 7,053,851 2,368,203 33.57% 

Males (% of total) 47.32% 46.56% Empty Cell

Unknown (#) 149,387 39,894 26.71% 

Unknown (% of total) 1.00% 0.78% Empty Cell

TOTAL (#) 14,905,684 5,086,000 34.12% 

Total (%) 100% 100.00% Empty Cell

Table 13B. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 

I. Total of All Subjects by Race 

Sex/ 

Gender 

American 

Indian/ Alaska 

Native 

Asian 

Black/ 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total 

Females (number) 155,136 622,191 1,146,324 83,175 5,110,922 89,055 481,207 7,688,010

% of total 1.04% 4.18% 7.71% 0.56% 34.37% 0.60% 3.24% 51.69%

% females in each race 2.02% 8.09% 14.91% 1.08% 66.48% 1.16% 6.26% 100.00%

% of each race females 53.69% 55.94% 50.81% 57.55% 51.63% 54.40% 47.81% 51.69%

Males (number) 133,215 487,148 1,099,558 61,237 4,765,892 73,550 414,770 7,035,370

% of total 0.90% 3.28% 7.39% 0.41% 32.05% 0.49% 2.79% 47.31%

% males in each race 1.89% 6.92% 15.63% 0.87% 67.74% 1.05% 5.90% 100.00%

% of each race males 46.10% 43.80% 48.74% 42.37% 48.14% 44.93% 41.21% 47.31%

Unknown (number) 612 2,983 10,087 106 23,225 1,099 110,620 148,732

% of total 0.00% 0.02% 0.07% 0.00% 0.16% 0.01% 0.74% 1.00%

% unknown in each race 0.41% 2.01% 6.78% 0.07% 15.62% 0.74% 74.38% 100.00%

% of each race unknown 0.21% 0.27% 0.45% 0.07% 0.23% 0.67% 10.99% 1.00%

Total (number) 288,963 1,112,322 2,255,969 144,518 9,900,039 163,704 1,006,597 14,872,112

% of each race in total 1.94% 7.48% 15.17% 0.97% 66.57% 1.10% 6.77% 100.00%

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

II. Total of All Subjects by Ethnicity 

Sex/ 

Gender Not Hispanic Hispanic or Latino 

Unknown / 

Not Reported Total 

Females (number) 6,499,513 779,245 409,252 7,688,010 

% of total 43.70% 5.24% 2.75% 51.69% 

% females in each race 84.54% 10.14% 5.32% 100.00% 

% of each race females 52.49% 50.97% 42.57% 51.69% 

Males (number) 5,862,747 722,809 449,814 7,035,370 

% of total 39.42% 4.86% 3.02% 47.31% 

% males in each race 83.33% 10.27% 6.39% 100.00% 

% of each race males 47.35% 47.28% 46.79% 47.31% 

Unknown (number) 19,792 26,675 102,265 148,732 

% of total 0.13% 0.18% 0.69% 1.00% 

% unknown in each race 13.31% 17.93% 68.76% 100.00% 

% of each race unknown 0.16% 1.74% 10.64% 1.00% 

Total (number) 12,382,052 1,528,729 961,331 14,872,112 

% of each race in total 83.26% 10.28% 6.46% 100.00% 

Total (%) 100.00% 100.00% 100.00% 100.00% 

Number of 

Protocols with 

Enrollment Data 

Reported on New 

Form: 8,397

Total # Protocols 

with Enrollment 

Data: 8,516

44
III. New Form (Part B): Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Total of All Hispanic or Latino Subjects by Race 

Sex/ 

Gender 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total 

Females (number) 105,387 3,469 64,946 1,238 396,565 25,411 182,229 779,245 

% of total 6.89% 0.23% 4.25% 0.08% 25.94% 1.66% 11.92% 50.97% 

% females in each race 13.52% 0.45% 8.33% 0.16% 50.89% 3.26% 23.39% 100.00% 

% of each race females 53.27% 50.97% 40.39% 51.20% 51.75% 52.84% 52.61% 50.97% 

Males (number) 92,284 3,138 94,730 1131 356,065 22,429 153,032 722,809 

% of total 6.04% 0.21% 6.20% 0.07% 23.29% 1.47% 10.01% 47.28% 

% males in each race 12.77% 0.43% 13.11% 0.16% 49.26% 3.10% 21.17% 100.00% 

% of each race males 46.64% 46.11% 58.91% 46.77% 46.46% 46.64% 44.18% 47.28% 

Unknown (number) 175 199 1134 49 13733 250 11,135 26,675 

% of total 0.01% 0.01% 0.07% 0.00% 0.90% 0.02% 0.73% 1.74% 

% unknown in each race 0.66% 0.75% 4.25% 0.18% 51.48% 0.94% 41.74% 100.00% 

% of each race unknown 0.09% 2.92% 0.71% 2.03% 1.79% 0.52% 3.21% 1.74% 

Total (number) 197,846 6,806 160,810 2,418 766,363 48,090 346,396 1,528,729 

% of each race in total 12.94% 0.45% 10.52% 0.16% 50.13% 3.15% 22.66% 100.00% 

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 

Sex/Gender 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B 

Females 

(number) 2,674,675 

% of total 17.98% 

% females 

in each race 34.79% % of each 

race 

females 52.67% 

Males 

(number) 2,363,805 

% of total 15.89% 

% males in 

each race 33.60% 

% of each 

race males 46.55% 

Unknown 

(number) 39,755 

% of total 0.27% 

% unknown 

in each race 26.73% % of each 

race 

unknown 0.78% 

Total 

(number) 5,078,235 % of each 

race in 

total 34.15% Total (%) 

100.00% 

Table 13C. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards 

Sex/ 

Gender 

American 

Indian/ 

Alaska 

Native 

Asian/ 

Pacific 

Islander 

Black or 

African 

American

Hispanic White Unknown/

Other Total 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

Females (number) 51 485 1,457 1,235 10,067 1,141 14,436 3,228

% of total 0.15% 1.44% 4.34% 3.68% 29.99% 3.40% 43.00% 9.62%

% females in each race 0.35% 3.36% 10.09% 8.56% 69.74% 7.90% 100.00% 22.36%

% of each race females 42.86% 42.36% 39.73% 43.58% 43.31% 44.48% 43.00% 41.57%

Males (number) 68 588 2,168 1,574 12,771 1,312 18,481 4,398

% of total 0.20% 1.75% 6.46% 4.69% 38.04% 3.91% 55.05% 13.10%

% males in each race 0.37% 3.18% 11.73% 8.52% 69.10% 7.10% 100.00% 23.80%

 % of each race males 57.14% 51.35% 59.12% 55.54% 54.95% 51.15% 55.05% 56.64%

Unknown (number) 0 72 42 25 404 112 655 139

% of total 0.00% 0.21% 0.13% 0.07% 1.20% 0.33% 1.95% 0.41%

% unknown in each race 0.00% 10.99% 6.41% 3.82% 61.68% 17.10% 100.00% 21.22%

% of each race unknown 0.00% 6.29% 1.15% 0.88% 1.74% 4.37% 1.95% 1.79%

Total (number) 119 1,145 3,667 2,834 23,242 2,565 33,572 7,765

% of each race in total 0.35% 3.41% 10.92% 8.44% 69.23% 7.64% 100.00% 23.13%

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Number of 

Protocols with 

Enrollment 

Data Reported 

on Old form: 

119

Legend

Bold: Percentage of Total No. of Participants in Research Protocols (Old or New Form) 

Italics: Percentage of Total No. of Participants Sorted by Sex/Gender (Row Total) 

Plain Typeface: Percentage of Total No. of Participants sorted by Race/Ethnicity (Column Total) 

Columns denoted with shading (American Indian/ Alaska Native, Asian, Black/ African American, Hawaiian/ 

Pacific Islander, Asian/ Pacific Islander, Hispanic and Unknown, More than one race and Unknown/Other) are 

summed to calculate Minority enrollment in Table 13A. 

45
Table 14. Overview of NIH Phase III Extramural and Intramural Clinical Research Reported In FY2009: Number of Sex-Specific Protocols 

and Enrollment, and Domestic versus Foreign Protocols 

Table 14A. PROTOCOLS REPORTED 

Total of 

Phase III 

Clinical 

Studies 

Domestic 

Extramural 

Protocols 

% Domestic 

Extramural 

Protocols 

Domestic 

Intramural 

Protocols 

% Domestic 

Intramural 

Protocols 

Foreign 

Extramural 

Protocols 

% Foreign 

Extramural 

Protocols 

Foreign 

Intramural 

Protocols 

% Foreign 

Intramural 

Protocols 

Number of Protocols reporting 

females only 151 94 62.3% 2 1.3% 54 35.8% 1 0.8% 

% Protocols reporting females only 22.8% 21.4% Empty Cell 5.1% Empty Cell 30.2% Empty Cell 25.0% Empty Cell 

Number of Protocols reporting 

males only 48 25 52.1% 2 4.2% 21 43.8% 0 0.0% 

% Protocols reporting males only 7.3% 5.7% Empty Cell 5.1% Empty Cell 11.7% Empty Cell 0.0% Empty Cell 

Number of Protocols with Both 

Female and Male Enrollment 

(excluding sex-specific protocols) 431 298 69.1% 30 7.0% 100 23.2% 3 0.7% 

% Protocols with Female and Male 

enrollment 65.1% 67.7% Empty Cell 76.9% Empty Cell 55.9% Empty Cell 75.0% Empty Cell 

Total Number of Protocols with 

Enrollment 630 417 66.2% 34 5.4% 175 27.8% 4 0.6% 

Total % 95.2% 95% Empty Cell 87.2% Empty Cell 97.8% Empty Cell 100.0% Empty Cell 

Phase III Protocols with zero 

enrollment (Enrollment data have 

not yet been submitted) 32 23 71.9% 5 15.6% 4 12.5% 0 0.0% 

% Protocols with zero enrollment 4.8% 5.2% Empty Cell 12.8% Empty Cell 2.2% Empty Cell 0.0% Empty Cell 

Total Number of Phase III Protocols 662 440 66.5% 39 5.9% 179 27.0% 4 0.6% 

Total % 100.0% 100.0% Empty Cell 100.0% Empty Cell 100.0% Empty Cell 100.0% Empty Cell 

* An NIH-defined Phase III clinical trial is a broadly based prospective Phase III clinical investigation, usually involving several hundred or more human subjects, 

for the purpose of evaluating an experimental intervention in comparison with a standard or controlled intervention or comparing two or more existing treatments. Often the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care. 

46
Table 14B. ENROLLMENT 

REPORTED 

Total of 

Phase III 

Clinical 

Studies 

Domestic 

Extramural 

Protocols 

% Domestic 

Extramural 

Protocols 

Domestic 

Intramural 

Protocols 

% Domestic 

Intramural 

Protocols 

Foreign 

Extramural 

Protocols 

% Foreign 

Extramural 

Protocols 

Foreign 

Intramural 

Protocols 

% Foreign 

Intramural 

Protocols 

In Protocols reporting females only 141,892 123,187 86.8% 5 0.0% 11,234 7.9% 7,466 5.3% 

% in Protocols reporting females 

only 21.8% 28.8% Empty Cell 0.1% Empty Cell 5.4% Empty Cell 71.3% Empty Cell 

In Protocols reporting males only 65,516 59,488 90.8% 155 0.2% 5,873 9.0% 0 0.0% 

% in Protocols reporting males only 10.0% 13.9% Empty Cell 2.6% Empty Cell 2.8% Empty Cell 0.0% Empty Cell 

In Protocols excluding female-only 

and male-only enrollment protocols 444,892 245,220 55.1% 5,840 1.3% 190,823 42.9% 3,009 0.7% 

% in protocols excluding femaleonly and male-only enrollment 

protocols 68.2% 57.3% Empty Cell 97.3% Empty Cell 91.8% Empty Cell 28.7% Empty Cell 

Enrollment Totals for all studies 652,300 427,895 65.6% 6,000 0.92% 207,930 31.88% 10,475 1.6% 

Total % 100.0% 100.0% Empty Cell 100.0% Empty Cell 100.0% Empty Cell 100.0% Empty Cell 

14C. MINORITY ENROLLMENT REPORTED** 

Total of 

Phase III 

Clinical 

Studies 

Domestic 

Extramural 

Protocols 

% Domestic 

Extramural 

Protocols 

Domestic 

Intramural 

Protocols 

% Domestic 

Intramural 

Protocols 

Foreign 

Extramural 

Protocols 

% Foreign 

Extramural 

Protocols 

Foreign 

Intramural 

Protocols 

% Foreign 

Intramural 

Protocols 

Minority Total for all Phase III studies 291,949 95,512 32.7% 1,567 0.5% 187,194 64.1% 7,676 2.6% 

% Minority Enrollment 44.8% 22.3% Empty 26.1% Empty 90.0% Empty 73.3% Empty

** See Page 4 for the Race and Ethnicity categories included in Minority Enrollment Data from the 1977 and 1997 U.S. OMB race/ethnicity categories. Foreign 

enrollment was reported using the U.S. race and ethnicity categories. NOTE: Percentages are reported with one decimal point; due to rounding, adding percentages may not equal 100%.

47
Table 15. Aggregate Enrollment Data for Extramural Phase III Research 

Funded in FY2008 and Reported in FY2009: Percent Analysis 

Table 15A. SUMMARY TOTALS: Old Form + New Form 

Sex /Gender Total 

Enrollment 

Minority 

Enrollment 

% Minority 

Enrollment 

Females (#) 334,429 149,550 44.72% 

Females (% of total) 52.60% 52.90% Empty Cell 

Males (#) 271,016 132,454 48.87% 

Males (% of total) 42.62% 46.85% Empty Cell 

Unknown (#) 30,380 702 2.31% 

Unknown (% of total) 4.78% 0.25% Empty Cell 

TOTAL (#) 635,825 282,706 44.46% 

Total (%) 100% 100.00% Empty Cell 

Table 15B. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 

I. Total of All Subjects by Race 

Sex/ 

Gender 

American 

Indian/ Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total 

Females (number) 9,746 47,842 61,229 438 106,737 2,281 14,361 242,634

% of total 2.06% 10.11% 12.94% 0.09% 22.56% 0.48% 3.04% 51.28%

% females in each race 4.02% 19.72% 25.24% 0.18% 43.99% 0.94% 5.92% 100.00%

% of each race females 56.23% 51.53% 53.13% 51.05% 56.50% 48.82% 26.96% 51.28%

Males (number) 7,528 44,893 53,855 416 80,993 2,332 10,134 200,151

% of total 1.59% 9.49% 11.38% 0.09% 17.12% 0.49% 2.14% 42.30%

% males in each race 3.76% 22.43% 26.91% 0.21% 40.47% 1.17% 5.06% 100.00%

% of each race males 43.43% 48.35% 46.73% 48.48% 42.88% 49.91% 19.02% 42.30%

Unknown (number) 59 108 168 4 1,169 59 28,776 30,343

% of total 0.01% 0.02% 0.04% 0.00% 0.25% 0.01% 6.08% 6.41%

% unknown in each race 0.19% 0.36% 0.55% 0.01% 3.85% 0.19% 94.84% 100.00%

% of each race unknown 0.34% 0.12% 0.15% 0.47% 0.62% 1.26% 54.02% 6.41%

Total (number) 17,333 92,843 115,252 858 188,899 4,672 53,271 473,128

% of each race in total 3.66% 19.62% 24.36% 0.18% 39.93% 0.99% 11.26% 100.00%

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

II. Total of All Subjects by Ethnicity 

Sex/ 

Gender Not Hispanic Hispanic or Latino 

Unknown /Not 

Reported Total 

Females (number) 209,663 26,804 6,167 242,634 

% of total 44.31% 5.67% 1.30% 51.28% 

% females in each ethnicity 86.41% 11.05% 2.54% 100.00% 

% of each ethnicity females 53.85% 60.18% 15.72% 51.28% 

Males (number) 178,242 17,354 4,555 200,151 

% of total 37.67% 3.67% 0.96% 42.30% 

% males in each ethnicity 89.05% 8.67% 2.28% 100.00% 

% of each ethnicity males 45.78% 38.97% 11.61% 42.30% 

Unknown (number) 1,449 379 28,515 30,343 

% of total 0.31% 0.08% 6.03% 6.41% 

% unknown in each ethnicity 4.78% 1.25% 93.98% 100.00% 

% of each ethnicity unknown 0.37% 0.85% 72.67% 6.41% 

Total (number) 389,354 44,537 39,237 473,128 

% of each ethnicity in total 82.29% 9.41% 8.29% 100.00% 

Total (%) 100.00% 100.00% 100.00% 100.00% 

Number of 

Protocols with 

Enrollment Data 

Reported on New 

Form: 407

Total # Protocols 

with Enrollment 

Data: 592

48
III. New Form (Part B): Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Total of All Hispanic or Latino Subjects by Race 

Sex/ 

Gender 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race

Unknown/ 

Other Total 

 Females (number) 8,728 138 488 99 7,263 431 9,657 26,804 

% of total 19.60% 0.31% 1.10% 0.22% 16.31% 0.97% 21.68% 60.18% 

% females in each race 32.56% 0.51% 1.82% 0.37% 27.10% 1.61% 36.03% 100.00% 

% of each race females 57.00% 39.32% 52.08% 50.00% 63.24% 44.71% 63.15% 60.18% 

Males (number) 6,543 203 439 95 4,159 521 5,394 17,354 

% of total 14.69% 0.46% 0.99% 0.21% 9.34% 1.17% 12.11% 38.97% 

% males in each race 37.70% 1.17% 2.53% 0.55% 23.97% 3.00% 31.08% 100.00% 

% of each race males 42.73% 57.83% 46.85% 47.98% 36.22% 54.05% 35.28% 38.97% 

Unknown (number) 41 10 10 4 62 12 240 379 

% of total 0.09% 0.02% 0.02% 0.01% 0.14% 0.03% 0.54% 0.85% 

% unknown in each race 10.82% 2.64% 2.64% 1.06% 16.36% 3.17% 63.32% 100.00% 

% of each race unknown 0.27% 2.85% 1.07% 2.02% 0.54% 1.24% 1.57% 0.85% 

Total (number) 15,312 351 937 198 11,484 964 15,291 44,537 

% of each race in total 34.38% 0.79% 2.10% 0.44% 25.79% 2.16% 34.33% 100.00% 

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 

Sex/Gender 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B 

Females 

(number) 138,456 

% of total 29.26% 

% females 

in each race 57.06% % of each 

race 

females 53.72% 

Males 

(number) 118,577 

% of total 25.06% 

% males in 

each race 59.24% 

% of each 

race males 46.01% 

Unknown 

(number) 700 

% of total 0.15% 

% unknown 

in each race 2.31% % of each 

race 

unknown 0.27% 

Total 

(number) 257,733 % of each 

race in 

total 54.47% Total (%) 

100.00% 

Table 15C. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards 

Sex/ 

Gender 

American 

Indian/ 

Alaska 

Native 

Asian/ 

Pacific 

Islander 

Black or 

African 

American

Hispanic White Unknown/

Other Total 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

 Females (number) 351 2,094 6,053 2,596 78,830 1,871 91,795 11,094 

% of total 0.22% 1.29% 3.72% 1.60% 48.45% 1.15% 56.42% 6.82% 

% females in each race 0.38% 2.28% 6.59% 2.83% 85.88% 2.04% 100.00% 12.09% 

% of each race females 57.64% 64.85% 41.09% 40.53% 59.08% 43.64% 56.42% 44.42% 

Males (number) 258 1,134 8,676 3,809 54,596 2,392 70,865 13,877 

% of total 0.16% 0.70% 5.33% 2.34% 33.56% 1.47% 43.56% 8.53% 

% males in each race 0.36% 1.60% 12.24% 5.38% 77.04% 3.38% 100.00% 19.58% 

% of each race males 42.36% 35.12% 58.90% 59.47% 40.92% 55.80% 43.56% 55.57% 

Unknown (number) 0 1 1 0 11 24 37 2 

% of total 0.00% 0.00% 0.00% 0.00% 0.01% 0.01% 0.02% 0.00% 

% unknown in each race 0.00% 2.70% 2.70% 0.00% 29.73% 64.86% 100.00% 5.41% 

% of each race unknown 0.00% 0.03% 0.01% 0.00% 0.01% 0.56% 0.02% 0.01% 

Total (number) 609 3,229 14,730 6,405 133,437 4,287 162,697 24,973 

% of each race in total 0.37% 1.98% 9.05% 3.94% 82.02% 2.63% 100.00% 15.35% 

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 

Number of 

Protocols with 

Enrollment 

Data Reported 

on Old form: 

185

Legend

Bold: Percentage of Total No. of Participants in Research Protocols (Old or New Form) 

Italics: Percentage of Total No. of Participants Sorted by Sex/Gender (Row Total) 

Plain Typeface: Percentage of Total No. of Participants sorted by Race/Ethnicity (Column Total) 

Columns denoted with shading (American Indian/ Alaska Native, Asian, Black/ African American, Hawaiian/ 

Pacific Islander, Asian/ Pacific Islander, Hispanic and Unknown, More than one race and Unknown/Other) are 

summed to calculate Minority enrollment in Table 15A. 

49
Table 16. Overview of NIH Phase III Extramural and Intramural Clinical Research Reported In FY2010: Number of Sex-Specific Protocols 

and Enrollment, and Domestic versus Foreign Protocols 

Table 16A. PROTOCOLS REPORTED 

Total of 

Phase III 

Clinical 

Studies 

Domestic 

Extramural 

Protocols 

% Domestic 

Extramural 

Protocols 

Domestic 

Intramural 

Protocols 

% Domestic 

Intramural 

Protocols 

Foreign 

Extramural 

Protocols 

% Foreign 

Extramural 

Protocols 

Foreign 

Intramural 

Protocols 

% Foreign 

Intramural 

Protocols 

Number of Protocols reporting 

females only 140 93 66.4% 6 4.3% 40 28.6% 1 0.8% 

% Protocols reporting females only 18.8% 17.3% Empty Cell 14.0% Empty Cell 25.2% Empty Cell 25.0% Empty Cell

Number of Protocols reporting 

males only 61 32 52.5% 5 8.2% 24 39.3% 0 0.0% 

% Protocols reporting males only 8.2% 6.0% Empty Cell 11.6% Empty Cell 15.1% Empty Cell 0.0% Empty Cell

Number of Protocols with Both 

Female and Male Enrollment 

(excluding sex-specific protocols) 495 373 75.4% 31 6.3% 88 17.8% 3 0.6% 

% Protocols with Female and Male 

enrollment 66.6% 69.5% Empty Cell 72.1% Empty Cell 55.3% Empty Cell 75.0% Empty Cell

Total Number of Protocols with 

Enrollment 696 498 71.6% 42 6.0% 152 21.8% 4 0.6% 

Total % 93.7% 93% Empty Cell 97.7% Empty Cell 95.6% Empty Cell 100.0% Empty Cell

Phase III Protocols with zero 

enrollment (Enrollment data have 

not yet been submitted) 47 39 83.0% 1 2.1% 7 14.9% 0 0.0% 

% Protocols with zero enrollment 6.3% 7.3% Empty Cell 2.3% Empty Cell 4.4% Empty Cell 0.0% Empty Cell

Total Number of Phase III Protocols 743 537 72.3% 43 5.8% 159 21.4% 4 0.5% 

Total % 100.0% 100.0% Empty Cell 100.0% Empty Cell 100.0% Empty Cell 100.0% Empty Cell

* An NIH-defined Phase III clinical trial is a broadly based prospective Phase III clinical investigation, usually involving several hundred or more human subjects, 

for the purpose of evaluating an experimental intervention in comparison with a standard or controlled intervention or comparing two or more existing treatments. Often the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care. 

50
Table 16B. ENROLLMENT 

REPORTED 

Total of 

Phase III 

Clinical 

Studies 

Domestic 

Extramural 

Protocols 

% Domestic 

Extramural 

Protocols 

Domestic 

Intramural 

Protocols 

% Domestic 

Intramural 

Protocols 

Foreign 

Extramural 

Protocols 

% Foreign 

Extramural 

Protocols 

Foreign 

Intramural 

Protocols 

% Foreign 

Intramural 

Protocols 

In Protocols reporting females only 119,103 84,405 70.9% 5,095 4.3% 22,137 18.6% 7,466 6.3% 

% in Protocols reporting females 

only 15.5% 22.0% Empty Cell 51.6% Empty Cell 6.0% Empty Cell 71.1% Empty Cell

In Protocols reporting males only 62,315 56,117 90.1% 164 0.3% 6,034 9.7% 0 0.0% 

% in Protocols reporting males only 8.1% 14.7% Empty Cell 1.7% Empty Cell 1.6% Empty Cell 0.0% Empty Cell

In Protocols excluding female-only 

and male-only enrollment protocols 588,467 242,476 41.2% 4,610 0.8% 338,349 57.5% 3,032 0.5% 

% in protocols excluding female-only 

and male-only enrollment protocols 76.4% 63.3% Empty Cell 46.7% Empty Cell 92.3% Empty Cell 28.9% Empty Cell

Enrollment Totals for all studies 769,885 382,998 49.7% 9,869 1.28% 366,520 47.61% 10,498 1.4% 

Total % 100.0% 100.0% Empty Cell 100.0% Empty Cell 100.0% Empty Cell 100.0% Empty Cell

Table 16C. MINORITY ENROLLMENT REPORTED** 

Total of 

Phase III 

Clinical 

Studies 

Domestic 

Extramural 

Protocols 

% Domestic 

Extramural 

Protocols 

Domestic 

Intramural 

Protocols 

% Domestic 

Intramural 

Protocols 

Foreign 

Extramural 

Protocols 

% Foreign 

Extramural 

Protocols 

Foreign 

Intramural 

Protocols 

% Foreign 

Intramural 

Protocols 

Minority Total for all Phase III studies 447,187 89,006 19.9% 3,503 0.8% 346,979 77.6% 7,699 1.7% 

Total % 58.1% 23.2% Empty cell 35.5% Empty cell 94.7% Empty cell 73.3% Empty cell 

** See Page 4 for the Race and Ethnicity categories included in Minority Enrollment Data from the 1977 and 1997 U.S. OMB race/ethnicity categories. Foreign 

enrollment was reported using the U.S. race and ethnicity categories. NOTE: Percentages are reported with one decimal point; due to rounding, adding percentages may not equal 100%.

51
Table 17. Aggregate Enrollment Data for Extramural Phase III Research Protocols Funded in FY2009 

and Reported in FY2010: Percent Analysis 

Table 17A. SUMMARY TOTALS: Old Form + New Form 

Total # Protocols 

with Enrollment 

Data: 650

Sex /Gender Total 

Enrollment 

Minority 

Enrollment 

% Minority 

Enrollment 

Females (#) 392,053 240,290 61.29% 

Females (% of total) 52.31% 55.11% Empty Cell 

Males (#) 326,582 194,486 59.55% 

Males (% of total) 43.57% 44.61% Empty Cell 

Unknown (#) 30,883 1,209 3.91% 

Unknown (% of total) 4.12% 0.28% Empty Cell 

TOTAL (#) 749,518 435,985 58.17% 

Total (%) 100% 100.00% Empty Cell 

Table 17B. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 

I. Total of All Subjects by Race 

Sex/ 

Gender 

American 

Indian/ Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total 

Females (number) 7,735 62,107 141,753 482 125,544 3,122 18,294 359,037

% of total 1.15% 9.21% 21.03% 0.07% 18.62% 0.46% 2.71% 53.26%

% females in each race 2.15% 17.30% 39.48% 0.13% 34.97% 0.87% 5.10% 100.00%

% of each race females 49.70% 55.04% 56.21% 51.55% 55.66% 37.83% 31.10% 53.26%

Males (number) 7,770 50,641 109,659 449 99,388 5,071 11,248 284,226

% of total 1.15% 7.51% 16.27% 0.07% 14.74% 0.75% 1.67% 42.16%

% males in each race 2.73% 17.82% 38.58% 0.16% 34.97% 1.78% 3.96% 100.00%

% of each race males 49.93% 44.88% 43.49% 48.02% 44.06% 61.44% 19.12% 42.16%

Unknown (number) 57 95 762 4 622 60 29,279 30,879

% of total 0.01% 0.01% 0.11% 0.00% 0.09% 0.01% 4.34% 4.58%

% unknown in each race 0.18% 0.31% 2.47% 0.01% 2.01% 0.19% 94.82% 100.00%

% of each race unknown 0.37% 0.08% 0.30% 0.43% 0.28% 0.73% 49.78% 4.58%

Total (number) 15,562 112,843 252,174 935 225,554 8,253 58,821 674,142

% of each race in total 2.31% 16.74% 37.41% 0.14% 33.46% 1.22% 8.73% 100.00%

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

II. Total of All Subjects by Ethnicity 

Sex/ 

Gender Not Hispanic Hispanic or Latino 

Unknown /Not 

Reported Total 

Females (number) 319,083 30,441 9,513 359,037 

% of total 47.33% 4.52% 1.41% 53.26% 

% females in each ethnicity 88.87% 8.48% 2.65% 100.00% 

% of each ethnicity females 55.44% 57.61% 20.80% 53.26% 

Males (number) 254,960 22,090 7,176 284,226 

% of total 37.82% 3.28% 1.06% 42.16% 

% males in each ethnicity 89.70% 7.77% 2.52% 100.00% 

% of each ethnicity males 44.30% 41.80% 15.69% 42.16% 

Unknown (number) 1,516 311 29,052 30,879 

% of total 0.22% 0.05% 4.31% 4.58% 

% unknown in each ethnicity 4.91% 1.01% 94.08% 100.00% 

% of each ethnicity unknown 0.26% 0.59% 63.51% 4.58% 

Total (number) 575,559 52,842 45,741 674,142 

% of each ethnicity in total 85.38% 7.84% 6.79% 100.00% 

Total (%) 100.00% 100.00% 100.00% 100.00% 

Number of 

Protocols with 

Enrollment Data 

Reported on New 

Form: 599

52
III. New Form (Part B): Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Total of All Hispanic or Latino Subjects by Race 

Sex/Gender 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B 

Females 

(number) 237,669 

% of total 35.26% 

% females 

in each race 66.20% % of each 

race 

females 55.95% 

Males 

(number) 185,880 

% of total 27.57% 

% males in 

each race 65.40% 

% of each 

race males 43.76% 

Unknown 

(number) 1,209 

% of total 0.18% 

% unknown 

in each race 3.92% % of each 

race 

unknown 0.28% 

Total 

(number) 424,758 % of each 

race in 

total 63.01% Total (%) 

100.00% 

Sex/ 

Gender 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race

Unknown/ 

Other Total 

 Females (number) 6,516 144 565 104 9,497 642 12,973 30,441 

% of total 12.33% 0.27% 1.07% 0.20% 17.97% 1.21% 24.55% 57.61% 

% females in each race 21.41% 0.47% 1.86% 0.34% 31.20% 2.11% 42.62% 100.00% 

% of each race females 49.70% 40.00% 52.51% 50.98% 62.53% 20.70% 65.51% 57.61% 

Males (number) 6,553 206 501 96 5,644 2,444 6,646 22,090 

% of total 12.40% 0.39% 0.95% 0.18% 10.68% 4.63% 12.58% 41.80% 

% males in each race 29.67% 0.93% 2.27% 0.43% 25.55% 11.06% 30.09% 100.00% 

% of each race males 49.98% 57.22% 46.56% 47.06% 37.16% 78.81% 33.56% 41.80% 

Unknown (number) 41 10 10 4 46 15 185 311 

% of total 0.08% 0.02% 0.02% 0.01% 0.09% 0.03% 0.35% 0.59% 

% unknown in each race 13.18% 3.22% 3.22% 1.29% 14.79% 4.82% 59.49% 100.00% 

% of each race unknown 0.31% 2.78% 0.93% 1.96% 0.30% 0.48% 0.93% 0.59% 

Total (number) 13,110 360 1,076 204 15,187 3,101 19,804 52,842 

% of each race in total 24.81% 0.68% 2.04% 0.39% 28.74% 5.87% 37.48% 100.00% 

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 

Table 17C. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards 

Sex/ 

Gender 

American 

Indian/ 

Alaska 

Native 

Asian/ 

Pacific 

Islander 

Black or 

African 

American

Hispanic White Unknown/

Other Total 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

Females (number) 141 544 1,234 702 30,036 359 33,016 2,621 

% of total 0.19% 0.72% 1.64% 0.93% 39.85% 0.48% 43.80% 3.48% 

% females in each race 0.43% 1.65% 3.74% 2.13% 90.97% 1.09% 100.00% 7.94% 

% of each race females 48.45% 48.18% 18.53% 22.29% 47.36% 49.45% 43.80% 23.35% 

Males (number) 150 585 5,424 2,447 33,384 366 42,356 8,606 

% of total 0.20% 0.78% 7.20% 3.25% 44.29% 0.49% 56.19% 11.42% 

% males in each race 0.35% 1.38% 12.81% 5.78% 78.82% 0.86% 100.00% 20.32% 

% of each race males 51.55% 51.82% 81.47% 77.71% 52.64% 50.41% 56.19% 76.65% 

Unknown (number) 0 0 0 0 3 1 4 0 

% of total 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.01% 0.00% 

% unknown in each race 0.00% 0.00% 0.00% 0.00% 75.00% 25.00% 100.00% 0.00% 

% of each race unknown 0.00% 0.00% 0.00% 0.00% 0.00% 0.14% 0.01% 0.00% 

Total (number) 291 1,129 6,658 3,149 63,423 726 75,376 11,227 

% of each race in total 0.39% 1.50% 8.83% 4.18% 84.14% 0.96% 100.00% 14.89% 

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 

Number of 

Protocols with 

Enrollment 

Data Reported 

on Old form: 

51

Legend

Bold: Percentage of Total No. of Participants in Research Protocols (Old or New Form) 

Italics: Percentage of Total No. of Participants Sorted by Sex/Gender (Row Total) 

Plain Typeface: Percentage of Total No. of Participants sorted by Race/Ethnicity (Column Total) 

Columns denoted with shading (American Indian/ Alaska Native, Asian, Black/ African American, Hawaiian/ 

Pacific Islander, Asian/ Pacific Islander, Hispanic and Unknown, More than one race and Unknown/Other) are 

summed to calculate Minority enrollment in Table 17A. 

53
Table 18. Aggregate Enrollment Data for Intramural Research Protocols Funded in FY2008 and 

Reported in FY2009: Percent Analysis 

Table 18A. SUMMARY TOTALS: Old Form + New Form 

Sex /Gender Total Enrollment Minority 

Enrollment 

% Minority by 

Enrollment 

Females (#) 1,250,897 416,054 33.26% 

Females (% of total) 42.38% 48.14% Empty Cell 

Males (#) 1,655,970 443,986 26.81% 

Males (% of total) 56.10% 51.37% Empty Cell

Unknown (#) 44,806 4,270 9.53% 

Unknown (% of total) 1.52% 0.49% Empty Cell

TOTAL (#) 2,951,673 864,310 29.28% 

Total (%) 100% 100.00% Empty Cell

Total # Protocols 

with Enrollment 

Data: 1,727

Table 18B. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 

I. Total of All Subjects by Race

Sex/ 

Gender 

American 

Indian/ 

Alaska Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total 

Females (number) 9,820 176,141 72,500 654 740,001 78,852 90,893 1,168,861

% of total 0.35% 6.31% 2.60% 0.02% 26.52% 2.83% 3.26% 41.89%

% females in each race 0.84% 15.07% 6.20% 0.06% 63.31% 6.75% 7.78% 100.00%

% of each race females 46.97% 63.21% 26.63% 45.32% 41.77% 51.61% 31.07% 41.89%

Males (number) 11,064 102,131 195,873 789 1,020,111 73,920 172,687 1,576,575

% of total 0.40% 3.66% 7.02% 0.03% 36.56% 2.65% 6.19% 56.50%

% males in each race 0.70% 6.48% 12.42% 0.05% 64.70% 4.69% 10.95% 100.00%

% of each race males 52.92% 36.65% 71.95% 54.68% 57.58% 48.38% 59.03% 56.50%

Unknown (number) 24 369 3,849 0 11,536 19 28,963 44,760

% of total 0.00% 0.01% 0.14% 0.00% 0.41% 0.00% 1.04% 1.60%

% unknown in each race 0.05% 0.82% 8.60% 0.00% 25.77% 0.04% 64.71% 100.00%

% of each race unknown 0.11% 0.13% 1.41% 0.00% 0.65% 0.01% 9.90% 1.60%

Total (number) 20,908 278,641 272,222 1,443 1,771,648 152,791 292,543 2,790,196

% of each race in total 0.75% 9.99% 9.76% 0.05% 63.50% 5.48% 10.48% 100.00%

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

II. Total of All Subjects by Ethnicity 

Sex/ 

Gender Not Hispanic Hispanic or Latino 

Unknown /Not 

Reported Total 

Females (number) 967,503 61,626 139,732 1,168,861 

% of total 34.68% 2.21% 5.01% 41.89% 

% females in each ethnicity 82.77% 5.27% 11.95% 100.00% 

% of each ethnicity females 42.68% 55.73% 33.84% 41.89% 

Males (number) 1,283,484 48,930 244,161 1,576,575 

% of total 46.00% 1.75% 8.75% 56.50% 

% males in each ethnicity 81.41% 3.10% 15.49% 100.00% 

% of each ethnicity males 56.62% 44.25% 59.13% 56.50% 

Unknown (number) 15,715 23 29,022 44,760 

% of total 0.56% 0.00% 1.04% 1.60% 

% unknown in each ethnicity 35.11% 0.05% 64.84% 100.00% 

% of each ethnicity unknown 0.69% 0.02% 7.03% 1.60% 

Total (number) 2,266,702 110,579 412,915 2,790,196 

% of each ethnicity in total 81.24% 3.96% 14.80% 100.00% 

Total (%) 100.00% 100.00% 100.00% 100.00% 

Number of 

Protocols with 

Enrollment Data 

Reported on New 

Form: 1,335

54
III. New Form (Part B): Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Total of All Hispanic or Latino Subjects by Race 

Sex/ 

Gender 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race

Unknown/ 

Other Total 

 Females (number) 118 43 806 59 28,524 3,224 28,852 61,626 

% of total 0.11% 0.04% 0.73% 0.05% 25.80% 2.92% 26.09% 55.73% 

% females in each race 0.19% 0.07% 1.31% 0.10% 46.29% 5.23% 46.82% 100.00% 

% of each race females 64.48% 51.19% 21.87% 62.77% 47.33% 51.22% 72.18% 55.73% 

Males (number) 64 41 2,880 35 31,742 3,054 11,114 48,930 

% of total 0.06% 0.04% 2.60% 0.03% 28.71% 2.76% 10.05% 44.25% 

% males in each race 0.13% 0.08% 5.89% 0.07% 64.87% 6.24% 22.71% 100.00% 

% of each race males 34.97% 48.81% 78.13% 37.23% 52.67% 48.52% 27.80% 44.25% 

Unknown (number) 1 0 0 0 0 16 6 23 

% of total 0.00% 0.00% 0.00% 0.00% 0.00% 0.01% 0.01% 0.02% 

% unknown in each race 4.35% 0.00% 0.00% 0.00% 0.00% 69.57% 26.09% 100.00% 

% of each race unknown 0.55% 0.00% 0.00% 0.00% 0.00% 0.25% 0.02% 0.02% 

Total (number) 183 84 3,686 94 60,266 6,294 39,972 110,579 

% of each race in total 0.17% 0.08% 3.33% 0.09% 54.50% 5.69% 36.15% 100.00% 

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 

Sex/Gender 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B 

Females 

(number) 395,343 

% of total 14.17% 

% females 

in each race 33.82% % of each 

race 

females 47.85% 

Males 

(number) 426,633 

% of total 15.29% 

% males in 

each race 27.06% 

% of each 

race males 51.64% 

Unknown 

(number) 4,267 

% of total 0.15% 

% unknown 

in each race 9.53% % of each 

race 

unknown 0.52% 

Total 

(number) 826,243 % of each 

race in 

total 29.61% Total (%) 

100.00% 

Table 18C. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards 

Sex/ 

Gender 

American 

Indian/ 

Alaska Native 

Asian/ 

Pacific 

Islander 

Black or 

African 

American

Hispanic White Unknown/

Other Total 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

Females (number) 135 3,548 12,179 4,849 60,009 1,316 82,036 20,711

% of total 0.08% 2.20% 7.54% 3.00% 37.16% 0.81% 50.80% 12.83%

% females in each race 0.16% 4.32% 14.85% 5.91% 73.15% 1.60% 100.00% 25.25%

% of each race females 48.04% 52.58% 55.47% 53.39% 49.59% 54.86% 50.80% 54.41%

Males (number) 146 3,200 9,775 4,232 60,987 1,055 79,395 17,353

% of total 0.09% 1.98% 6.05% 2.62% 37.77% 0.65% 49.17% 10.75%

% males in each race 0.18% 4.03% 12.31% 5.33% 76.81% 1.33% 100.00% 21.86%

% of each race males 51.96% 47.42% 44.52% 46.60% 50.40% 43.98% 49.17% 45.59%

Unknown (number) 0 0 2 1 15 28 46 3

% of total 0.00% 0.00% 0.00% 0.00% 0.01% 0.02% 0.03% 0.00%

% unknown in each race 0.00% 0.00% 4.35% 2.17% 32.61% 60.87% 100.00% 6.52%

% of each race unknown 0.00% 0.00% 0.01% 0.01% 0.01% 1.17% 0.03% 0.01%

Total (number) 281 6,748 21,956 9,082 121,011 2,399 161,477 38,067

% of each race in total 0.17% 4.18% 13.60% 5.62% 74.94% 1.49% 100.00% 23.57%

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

Number of 

Protocols with 

Enrollment 

Data Reported 

on Old form: 

392

Legend

Bold: Percentage of Total No. of Participants in Research Protocols (Old or New Form) 

Italics: Percentage of Total No. of Participants Sorted by Sex/Gender (Row Total) 

Plain Typeface: Percentage of Total No. of Participants sorted by Race/Ethnicity (Column Total) 

Columns denoted with shading (American Indian/ Alaska Native, Asian, Black/ African American, Hawaiian/ 

Pacific Islander, Asian/ Pacific Islander, Hispanic and Unknown, More than one race and Unknown/Other) are 

summed to calculate Minority enrollment in Table 18A. 

55
Table 19. Aggregate Enrollment Data for Intramural Research Protocols Funded in FY2009 and 

Reported in FY2010: Percent Analysis 

Table 19A. SUMMARY TOTALS: Old Form + New Form 

Sex /Gender Total 

Enrollment 

Minority 

Enrollment 

% Minority by 

Enrollment 

Females (#) 1,343,852 452,629 33.68% 

Females (% of total) 43.20% 49.08% Empty Cell 

Males (#) 1,700,018 463,613 27.27% 

Males (% of total) 54.65% 50.27% Empty Cell 

Unknown (#) 66,972 5,999 8.96% 

Unknown (% of total) 2.15% 0.65% Empty Cell 

TOTAL (#) 3,110,842 922,241 29.65% 

Total (%) 100% 100.00% Empty Cell 

Table 19B. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 

I. Total of All Subjects by Race 

Sex/ 

Gender 

American 

Indian/ 

Alaska Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total 

Females (number) 11,067 181,870 91,854 2,038 780,240 82,887 110,830 1,260,786

% of total 0.38% 6.17% 3.12% 0.07% 26.47% 2.81% 3.76% 42.78%

% females in each race 0.88% 14.43% 7.29% 0.16% 61.89% 6.57% 8.79% 100.00%

% of each race females 47.79% 63.16% 30.30% 53.55% 42.69% 52.00% 32.40% 42.78%

Males (number) 12,060 105,762 205,788 1,767 1,040,096 76,408 177,574 1,619,455

% of total 0.41% 3.59% 6.98% 0.06% 35.29% 2.59% 6.03% 54.95%

% males in each race 0.74% 6.53% 12.71% 0.11% 64.23% 4.72% 10.97% 100.00%

% of each race males 52.08% 36.73% 67.87% 46.43% 56.91% 47.94% 51.91% 54.95%

Unknown (number) 30 300 5,549 1 7,299 94 53,644 66,917

% of total 0.00% 0.01% 0.19% 0.00% 0.25% 0.00% 1.82% 2.27%

% unknown in each race 0.04% 0.45% 8.29% 0.00% 10.91% 0.14% 80.16% 100.00%

% of each race unknown 0.13% 0.10% 1.83% 0.03% 0.40% 0.06% 15.68% 2.27%

Total (number) 23,157 287,932 303,191 3,806 1,827,635 159,389 342,048 2,947,158

% of each race in total 0.79% 9.77% 10.29% 0.13% 62.01% 5.41% 11.61% 100.00%

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

II. Total of All Subjects by Ethnicity 

Sex/ 

Gender Not Hispanic Hispanic or Latino 

Unknown /Not 

Reported 

Total 

Females (number) 1,028,074 70,601 162,111 1,260,786

% of total 34.88% 2.40% 5.50% 42.78%

% females in each ethnicity 81.54% 5.60% 12.86% 100.00%

% of each ethnicity females 43.63% 57.53% 34.64% 42.78%

Males (number) 1,314,404 52,052 252,999 1,619,455

% of total 44.60% 1.77% 8.58% 54.95%

% males in each ethnicity 81.16% 3.21% 15.62% 100.00%

% of each ethnicity males 55.78% 42.41% 54.07% 54.95%

Unknown (number) 14,036 70 52,811 66,917

% of total 0.48% 0.00% 1.79% 2.27%

% unknown in each ethnicity 20.98% 0.10% 78.92% 100.00%

% of each ethnicity unknown 0.60% 0.06% 11.29% 2.27%

Total (number) 2,356,514 122,723 467,921 2,947,158

% of each ethnicity in total 79.96% 4.16% 15.88% 100.00%

Total (%) 100.00% 100.00% 100.00% 100.00%

Number of 

Protocols with 

Enrollment Data 

Reported on New 

Form: 1,408

Total # Protocols 

with Enrollment 

Data: 1,770

56
III. New Form (Part B): Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Total of All Hispanic or Latino Subjects by Race 

Sex/ 

Gender 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race

Unknown/ 

Other Total 

 Females (number) 139 48 1,043 66 31,969 7,315 30,021 70,601 

% of total 0.11% 0.04% 0.85% 0.05% 26.05% 5.96% 24.46% 57.53% 

% females in each race 0.20% 0.07% 1.48% 0.09% 45.28% 10.36% 42.52% 100.00% 

% of each race females 64.95% 50.53% 25.51% 64.71% 49.65% 61.76% 71.50% 57.53% 

Males (number) 74 47 3,042 36 32,408 4,484 11,961 52,052 

% of total 0.06% 0.04% 2.48% 0.03% 26.41% 3.65% 9.75% 42.41% 

% males in each race 0.14% 0.09% 5.84% 0.07% 62.26% 8.61% 22.98% 100.00% 

% of each race males 34.58% 49.47% 74.41% 35.29% 50.33% 37.86% 28.49% 42.41% 

Unknown (number) 1 0 3 0 17 45 4 70 

% of total 0.00% 0.00% 0.00% 0.00% 0.01% 0.04% 0.00% 0.06% 

% unknown in each race 1.43% 0.00% 4.29% 0.00% 24.29% 64.29% 5.71% 100.00% 

% of each race unknown 0.47% 0.00% 0.07% 0.00% 0.03% 0.38% 0.01% 0.06% 

Total (number) 214 95 4,088 102 64,394 11,844 41,986 122,723 

% of each race in total 0.17% 0.08% 3.33% 0.08% 52.47% 9.65% 34.21% 100.00% 

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 

Sex/Gender 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B 

Females 

(number) 431,706 

% of total 14.65% 

% females 

in each race 34.24% % of each 

race 

females 48.84% 

Males 

(number) 446,154 

% of total 15.14% 

% males in 

each race 27.55% 

% of each 

race males 50.48% 

Unknown 

(number) 5,995 

% of total 0.20% 

% unknown 

in each race 8.96% % of each 

race 

unknown 0.68% 

Total 

(number) 883,855 % of each 

race in 

total 29.99% Total (%) 

100.00% 

Table 19C. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards 

Sex/ 

Gender 

American 

Indian/ 

Alaska 

Native 

Asian/ 

Pacific 

Islander 

Black or 

African 

American

Hispanic White Unknown/

Other Total 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

Females (number) 144 3,708 12,443 4,628 60,708 1,435 83,066 20,923 

% of total 0.09% 2.27% 7.60% 2.83% 37.09% 0.88% 50.75% 12.78% 

% females in each race 0.17% 4.46% 14.98% 5.57% 73.08% 1.73% 100.00% 25.19% 

% of each race females 46.75% 53.31% 55.35% 53.55% 49.49% 54.38% 50.75% 54.51% 

Males (number) 164 3,247 10,036 4,012 61,935 1,169 80,563 17,459 

% of total 0.10% 1.98% 6.13% 2.45% 37.84% 0.71% 49.22% 10.67% 

% males in each race 0.20% 4.03% 12.46% 4.98% 76.88% 1.45% 100.00% 21.67% 

% of each race males 53.25% 46.68% 44.64% 46.42% 50.49% 44.30% 49.22% 45.48% 

Unknown (number) 0 1 1 2 16 35 55 4 

% of total 0.00% 0.00% 0.00% 0.00% 0.01% 0.02% 0.03% 0.00% 

% unknown in each race 0.00% 1.82% 1.82% 3.64% 29.09% 63.64% 100.00% 7.27% 

% of each race unknown 0.00% 0.01% 0.00% 0.02% 0.01% 1.33% 0.03% 0.01% 

Total (number) 308 6,956 22,480 8,642 122,659 2,639 163,684 38,386 

% of each race in total 0.19% 4.25% 13.73% 5.28% 74.94% 1.61% 100.00% 23.45% 

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 

Number of 

Protocols with 

Enrollment 

Data Reported 

on Old form: 

362

Legend

Bold: Percentage of Total No. of Participants in Research Protocols (Old or New Form) 

Italics: Percentage of Total No. of Participants Sorted by Sex/Gender (Row Total) 

Plain Typeface: Percentage of Total No. of Participants sorted by Race/Ethnicity (Column Total) 

Columns denoted with shading (American Indian/ Alaska Native, Asian, Black/ African American, Hawaiian/ 

Pacific Islander, Asian/ Pacific Islander, Hispanic and Unknown, More than one race and Unknown/Other) are 

summed to calculate Minority enrollment in Table 19A. 

57
Table 20. Aggregate Enrollment Data for Intramural Phase III Research Protocols Funded in FY2008 

and Reported in FY2009: Percent Analysis 

Table 20A. SUMMARY TOTALS: Old Form + New Form 

Sex /Gender Total 

Enrollment 

Minority 

Enrollment 

% Minority by 

Sex 

Females (#) 11,319 8,402 74.23% 

Females (% of total) 68.70% 90.90% Empty Cell 

Males (#) 5,143 828 16.10% 

Males (% of total) 31.22% 8.96% Empty Cell 

Unknown (#) 13 13 100.00% 

Unknown (% of total) 0.08% 0.14% Empty Cell 

TOTAL (#) 16,475 9,243 56.10% 

Total (%) 100% 100.00% Empty Cell 

Table 20B. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 

I. Total of All Subjects by Race 

Sex/ 

Gender 

American 

Indian/ 

Alaska Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total 

Females (number) 129 6 594 0 368 2 9,169 10,268

% of total 0.96% 0.04% 4.42% 0.00% 2.74% 0.01% 68.25% 76.43%

% females in each race 1.26% 0.06% 5.78% 0.00% 3.58% 0.02% 89.30% 100.00%

% of each race females 73.30% 24.00% 60.55% 0.00% 58.60% 50.00% 78.91% 76.43%

Males (number) 47 19 374 1 260 2 2,451 3,154

% of total 0.35% 0.14% 2.78% 0.01% 1.94% 0.01% 18.24% 23.48%

% males in each race 1.49% 0.60% 11.86% 0.03% 8.24% 0.06% 77.71% 100.00%

% of each race males 26.70% 76.00% 38.12% 100.00% 41.40% 50.00% 21.09% 23.48%

Unknown (number) 0 0 13 0 0 0 0 13

% of total 0.00% 0.00% 0.10% 0.00% 0.00% 0.00% 0.00% 0.10%

% unknown in each race 0.00% 0.00% 100.00% 0.00% 0.00% 0.00% 0.00% 100.00%

% of each race unknown 0.00% 0.00% 1.33% 0.00% 0.00% 0.00% 0.00% 0.10%

Total (number) 176 25 981 1 628 4 11,620 13,435

% of each race in total 1.31% 0.19% 7.30% 0.01% 4.67% 0.03% 86.49% 100.00%

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

II. Total of All Subjects by Ethnicity 

Sex/ 

Gender Not Hispanic Hispanic or Latino 

Unknown /Not 

Reported 

Total 

Females (number) 1,282 7,553 1,433 10,268 

% of total 9.54% 56.22% 10.67% 76.43% 

% females in each ethnicity 12.49% 73.56% 13.96% 100.00% 

% of each ethnicity females 48.63% 98.27% 46.03% 76.43% 

Males (number) 1,341 133 1,680 3,154 

% of total 9.98% 0.99% 12.50% 23.48% 

% males in each ethnicity 42.52% 4.22% 53.27% 100.00% 

% of each ethnicity males 50.87% 1.73% 53.97% 23.48% 

Unknown (number) 13 0 0 13 

% of total 0.10% 0.00% 0.00% 0.10% 

% unknown in each ethnicity 100.00% 0.00% 0.00% 100.00% 

% of each ethnicity unknown 0.49% 0.00% 0.00% 0.10% 

Total (number) 2,636 7,686 3,113 13,435 

% of each ethnicity in total 19.62% 57.21% 23.17% 100.00% 

Total (%) 100.00% 100.00% 100.00% 100.00% 

Number of 

Protocols with 

Enrollment Data 

Reported on New 

Form: 27

Total # Protocols 

with Enrollment 

Data: 38

58
III. New Form (Part B): Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Total of All Hispanic or Latino Subjects by Race 

Table 20C. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards 

Sex/ 

Gender 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race

Unknown/ 

Other Total 

 Females (number) 1 0 0 0 2 0 7,550 7,553 

% of total 0.01% 0.00% 0.00% 0.00% 0.03% 0.00% 98.23% 98.27% 

% females in each race 0.01% 0.00% 0.00% 0.00% 0.03% 0.00% 99.96% 100.00% 

% of each race females 100.00% 0.00% 0.00% 0.00% 66.67% 0.00% 98.28% 98.27% 

Males (number) 0 0 0 0 1 0 132 133 

% of total 0.00% 0.00% 0.00% 0.00% 0.01% 0.00% 1.72% 1.73% 

% males in each race 0.00% 0.00% 0.00% 0.00% 0.75% 0.00% 99.25% 100.00% 

% of each race males 0.00% 0.00% 0.00% 0.00% 33.33% 0.00% 1.72% 1.73% 

Unknown (number) 0 0 0 0 0 0 0 0 

% of total 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 

% unknown in each race 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 

% of each race unknown 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 

Total (number) 1 0 0 0 3 0 7,682 7,686 

% of each race in total 0.01% 0.00% 0.00% 0.00% 0.04% 0.00% 99.95% 100.00% 

Total (%) 100.00% 0.00% 0.00% 0.00% 100.00% 0.00% 100.00% 100.00% 

Sex/Gender 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B 

Females 

(number) 8,283 

% of total 61.65% 

% females 

in each race 80.67% % of each 

race 

females 93.36% 

Males 

(number) 576 

% of total 4.29% 

% males in 

each race 18.26% 

% of each 

race males 6.49% 

Unknown 

(number) 13 

% of total 0.10% 

% unknown 

in each race 100.00% % of each 

race 

unknown 0.15% 

Total 

(number) 8,872 % of each 

race in 

total 66.04% Total (%) 

100.00% 

Sex/ 

Gender 

American 

Indian/ 

Alaska 

Native 

Asian/ 

Pacific 

Islander 

Black or 

African 

American

Hispanic White Unknown/

Other Total 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

Females (number) 1 20 69 29 922 10 1,051 119 

% of total 0.03% 0.66% 2.27% 0.95% 30.33% 0.33% 34.57% 3.91% 

% females in each race 0.10% 1.90% 6.57% 2.76% 87.73% 0.95% 100.00% 11.32% 

% of each race females 25.00% 32.26% 30.53% 36.71% 34.86% 41.67% 34.57% 32.08% 

Males (number) 3 42 157 50 1,723 14 1,989 252 

% of total 0.10% 1.38% 5.16% 1.64% 56.68% 0.46% 65.43% 8.29% 

% males in each race 0.15% 2.11% 7.89% 2.51% 86.63% 0.70% 100.00% 12.67% 

% of each race males 75.00% 67.74% 69.47% 63.29% 65.14% 58.33% 65.43% 67.92% 

Unknown (number) 0 0 0 0 0 0 0 0 

% of total 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 

% unknown in each race 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 0.00% 

% of each race unknown 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 

Total (number) 4 62 226 79 2,645 24 3,040 371 

% of each race in total 0.13% 2.04% 7.43% 2.60% 87.01% 0.79% 100.00% 12.20% 

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 

Number of 

Protocols with 

Enrollment 

Data Reported 

on Old form: 

11

Legend

Bold: Percentage of Total No. of Participants in Research Protocols (Old or New Form) 

Italics: Percentage of Total No. of Participants Sorted by Sex/Gender (Row Total) 

Plain Typeface: Percentage of Total No. of Participants sorted by Race/Ethnicity (Column Total) 

Columns denoted with shading (American Indian/ Alaska Native, Asian, Black/ African American, Hawaiian/ 

Pacific Islander, Asian/ Pacific Islander, Hispanic and Unknown, More than one race and Unknown/Other) are 

summed to calculate Minority enrollment in Table 20A. 

59
Table 21. Aggregate Enrollment Data for Intramural Phase III Research Protocols Funded in FY2009 

and Reported in FY2010: Percent Analysis 

Table 21A. SUMMARY TOTALS: Old Form + New Form 

Sex /Gender Total 

Enrollment 

Minority 

Enrollment 

% Minority 

Enrollment 

Females (#) 16,128 10,426 64.65% 

Females (% of total) 79.19% 93.07% Empty Cell 

Males (#) 4,226 763 18.05% 

Males (% of total) 20.75% 6.81% Empty Cell 

Unknown (#) 13 13 100.00% 

Unknown (% of total) 0.06% 0.12% Empty Cell 

TOTAL (#) 20,367 11,202 55.00% 

Total (%) 100% 100.00% Empty Cell 

Table 21B. New Form (Part A): Total of All Subjects Reported Using the 1997 OMB Standards 

I. Total of All Subjects by Race 

Sex/ 

Gender 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander 

White More Than 

One Race 

Unknown/ 

Other Total 

Females (number) 237 177 2,178 0 3,599 3 8,879 15,073

% of total 1.37% 1.02% 12.58% 0.00% 20.79% 0.02% 51.30% 87.09%

% females in each race 1.57% 1.17% 14.45% 0.00% 23.88% 0.02% 58.91% 100.00%

% of each race females 83.45% 88.94% 84.95% 0.00% 93.34% 60.00% 85.38% 87.09%

Males (number) 47 22 373 1 257 2 1,520 2,222

% of total 0.27% 0.13% 2.16% 0.01% 1.48% 0.01% 8.78% 12.84%

% males in each race 2.12% 0.99% 16.79% 0.05% 11.57% 0.09% 68.41% 100.00%

% of each race males 16.55% 11.06% 14.55% 100.00% 6.66% 40.00% 14.62% 12.84%

Unknown (number) 0 0 13 0 0 0 0 13

% of total 0.00% 0.00% 0.08% 0.00% 0.00% 0.00% 0.00% 0.08%

% unknown in each race 0.00% 0.00% 100.00% 0.00% 0.00% 0.00% 0.00% 100.00%

% of each race unknown 0.00% 0.00% 0.51% 0.00% 0.00% 0.00% 0.00% 0.08%

Total (number) 284 199 2,564 1 3,856 5 10,399 17,308

% of each race in total 1.64% 1.15% 14.81% 0.01% 22.28% 0.03% 60.08% 100.00%

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%

II. Total of All Subjects by Ethnicity 

Sex/ 

Gender Not Hispanic Hispanic or Latino 

Unknown /Not 

Reported Total 

Females (number) 6,000 7,712 1,361 15,073 

% of total 34.67% 44.56% 7.86% 87.09% 

% females in each ethnicity 39.81% 51.16% 9.03% 100.00% 

% of each ethnicity females 89.45% 99.18% 48.19% 87.09% 

Males (number) 695 64 1,463 2,222 

% of total 4.02% 0.37% 8.45% 12.84% 

% males in each ethnicity 31.28% 2.88% 65.84% 100.00% 

% of each ethnicity males 10.36% 0.82% 51.81% 12.84% 

Unknown (number) 13 0 0 13 

% of total 0.08% 0.00% 0.00% 0.08% 

% unknown in each ethnicity 100.00% 0.00% 0.00% 100.00% 

% of each ethnicity unknown 0.19% 0.00% 0.00% 0.08% 

Total (number) 6,708 7,776 2,824 17,308 

% of each ethnicity in total 38.76% 44.93% 16.32% 100.00% 

Total (%) 100.00% 100.00% 100.00% 100.00% 

Number of 

Protocols with 

Enrollment Data 

Reported on New 

Form: 35

Total # Protocols 

with Enrollment 

Data: 46

60
III. New Form (Part B): Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date 

Total of All Hispanic or Latino Subjects by Race 

Sex/ 

Gender 

American 

Indian/ 

Alaska 

Native 

Asian 

Black or 

African 

American

Hawaiian

/ Pacific 

Islander 

White More Than 

One Race

Unknown/ 

Other Total 

 Females (number) 1 0 0 0 190 0 7,521 7,712 

% of total 0.01% 0.00% 0.00% 0.00% 2.44% 0.00% 96.72% 99.18% 

% females in each race 0.01% 0.00% 0.00% 0.00% 2.46% 0.00% 97.52% 100.00% 

% of each race females 100.00% 0.00% 0.00% 0.00% 99.48% 0.00% 99.17% 99.18% 

Males (number) 0 0 0 0 1 0 63 64 

% of total 0.00% 0.00% 0.00% 0.00% 0.01% 0.00% 0.81% 0.82% 

% males in each race 0.00% 0.00% 0.00% 0.00% 1.56% 0.00% 98.44% 100.00% 

% of each race males 0.00% 0.00% 0.00% 0.00% 0.52% 0.00% 0.83% 0.82% 

Unknown (number) 0 0 0 0 0 0 0 0 

% of total 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 

% unknown in each race 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 

% of each race unknown 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 

Total (number) 1 0 0 0 191 0 7,584 7,776 

% of each race in total 0.01% 0.00% 0.00% 0.00% 2.46% 0.00% 97.53% 100.00% 

Total (%) 100.00% 0.00% 0.00% 0.00% 100.00% 0.00% 100.00% 100.00% 

Sex/Gender 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

NEW FORM 

Parts A+B 

Females 

(number) 10,306 

% of total 59.54% 

% females 

in each race 68.37% % of each 

race 

females 95.18% 

Males 

(number) 509 

% of total 2.94% 

% males in 

each race 22.91% 

% of each 

race males 4.70% 

Unknown 

(number) 13 

% of total 0.08% 

% unknown 

in each race 100.00% % of each 

race 

unknown 0.12% 

Total 

(number) 10,828 % of each 

race in 

total 62.56% Total (%) 

100.00% 

Table 21C. Old Form: Total of All Subjects Reported Using the 1977 OMB Standards 

Sex/ 

Gender 

American 

Indian/ 

Alaska 

Native 

Asian/ 

Pacific 

Islander 

Black or 

African 

American

Hispanic White Unknown/

Other Total 

Subtotal 

Using US 

Minority 

Categories 

(shaded): 

OLD FORM 

Females (number) 1 21 70 28 926 9 1,055 120 

% of total 0.03% 0.69% 2.29% 0.92% 30.27% 0.29% 34.49% 3.92% 

% females in each race 0.09% 1.99% 6.64% 2.65% 87.77% 0.85% 100.00% 11.37% 

% of each race females 20.00% 33.33% 30.43% 36.84% 34.79% 39.13% 34.49% 32.09% 

Males (number) 4 42 160 48 1,736 14 2,004 254 

% of total 0.13% 1.37% 5.23% 1.57% 56.75% 0.46% 65.51% 8.30% 

% males in each race 0.20% 2.10% 7.98% 2.40% 86.63% 0.70% 100.00% 12.67% 

% of each race males 80.00% 66.67% 69.57% 63.16% 65.21% 60.87% 65.51% 67.91% 

Unknown (number) 0 0 0 0 0 0 0 0 

% of total 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 

% unknown in each race 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 100.00% 0.00% 

% of each race unknown 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 

Total (number) 5 63 230 76 2,662 23 3,059 374 

% of each race in total 0.16% 2.06% 7.52% 2.48% 87.02% 0.75% 100.00% 12.23% 

Total (%) 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 

Number of 

Protocols with 

Enrollment 

Data Reported 

on Old form: 

11

Legend

Bold: Percentage of Total No. of Participants in Research Protocols (Old or New Form) 

Italics: Percentage of Total No. of Participants Sorted by Sex/Gender (Row Total) 

Plain Typeface: Percentage of Total No. of Participants sorted by Race/Ethnicity (Column Total) 

Columns denoted with shading (American Indian/ Alaska Native, Asian, Black/ African American, Hawaiian/ 

Pacific Islander, Asian/ Pacific Islander, Hispanic and Unknown, More than one race and Unknown/Other) 

are summed to calculate Minority enrollment in Table 21A. 

61
Table 22. NIH Sixteen-Year Trends for Protocol and Enrollment Data: 1995-2010* 

Table 22A Part I. Sixteen-Year Increases in Protocols and Enrollment Data 

FY Reported 1995 2010 

Relative Increase, 

2010 / 1995 

Total Protocols with Enrollment 3,188 12,079 3.8

Total Enrollment 1,021,493 23,363,635 22.9

Total Minorities 374,433 7,510,763 20.1

% Minorities 36.7% 32.1% 0.9

Table 22A Part II. Nine-Year Increases in Protocols and Enrollment Data: Foreign and Domestic 

FY Reported 2002 2010 

Relative Increase, 

2010 / 2002 

Total DOMESTIC Enrollment 10,192,401 21,523,076 2.1

Total FOREIGN Enrollment 946,083 1,840,559 1.9

*NOTE: Trend data vary over time because the data for each year represent the net total of data resulting from (1) studies continuing from the prior year; 

(2) the addition of new studies reported and (3) the subtraction of studies that are no longer reported. 

Table 22B. Sixteen-Year Summary of Total Number of Protocols Reported: FY 1995-2010 

FY 

Reported/ 

FY Funded 

Protocol 

Form* 

Number of Protocols 

with Enrollment data 

(Old + New Forms) 

Number of 

DOMESTIC Protocols 

with Enrollment data 

Number of 

FOREIGN Protocols 

with Enrollment data 

Percent 

Domestic 

Protocols 

1995/1994 Old 3,188 Not applicable Not applicable Not applicable

1996/1995 Old 6,036 Not applicable Not applicable Not applicable 

1997/1996 Old 5,692 Not applicable Not applicable Not applicable 

1998/1997 Old 7,602 Not applicable Not applicable Not applicable 

1999/1998 Old 8,285 Not applicable Not applicable Not applicable 

2000/1999 Old 9,390 Not applicable Not applicable Not applicable 

2001/2000 Old 10,212 Not applicable Not applicable Not applicable 

2002/2001 Old + New 8,945 8,463 482 94.6%

2003/2002 Old + New 10,216 9,578 638 93.8%

2004/2003 Old + New 10,125 9,760 365 96.4%

2005/2004 Old + New 10,233 9,862 371 96.4%

2006/2005 Old + New 10,758 10,294 464 95.7%

2007/2006 Old + New 10,914 10,463 451 95.9%

2008/2007 Old + New 11,045 10,548 497 95.5%

2009/2008 Old + New 11,171 10,263 908 91.9%

2010/2009 Old + New 12,079 11,189 890 92.6%

Figure 22a. Total Protocols by Year Reported 

62
Table 22C. Comparison of Domestic and Foreign Enrollment Reported in FY 2002-2010 

FY Reported/ 

FY Funded

Total Enrollment 

(Old + New Forms) 

Total 

DOMESTIC 

Enrollment 

Percent 

DOMESTIC 

Enrollment 

Total 

FOREIGN 

Enrollment 

Percent 

FOREIGN 

Enrollment 

2002/2001 11,138,484 10,192,401 91.5% 946,083 8.5%

2003/2002 14,772,254 11,911,357 80.6% 2,860,897 19.4%

2004/2003 18,923,920 14,359,793 75.9% 4,564,127 24.1%

2005/2004 15,722,752 12,669,858 80.6% 3,052,894 19.4%

2006/2005 14,830,930 11,425,701 77.0% 3,405,229 23.0%

2007/2006 17,448,458 16,180,588 92.7% 1,267,870 7.3%

2008/2007 15,412,355 14,134,627 91.7% 1,277,728 8.3%

2009/2008 19,138,738 17,848,074 93.3% 1,290,664 6.7%

2010/2009 23,363,635 21,523,076 92.1% 1,840,559 7.9%

Figure 22b. Relative Proportions of Domestic and Foreign Enrollment

63
Table 23. NIH Sixteen-Year Minority Trend Summary of NIH Extramural and Intramural Clinical Research Reported in FY 1995-2010 

Table 23A. SIXTEEN-YEAR SUMMARY TOTALS: Enrollment By Sex/Gender and Minority Categories in All Protocols (Old + New Forms) 

FY Reported/ 

FY Funded Form Females Males Unknown 

Total All 

Subjects 

(Old + New 

Forms) 

Subtotal: 

All Subjects Enrolled by US 

Minority Categories 

Number of Protocols 

with Enrollment data 

(Old + New Forms) 

1995/1994 Old 528,421 459,921 33,151 1,021,493 374,433 3,188 

% Reported in 1995 Empty cell 51.7% 45.0% 3.2% 100.0% 36.7% Empty cell 

1996/1995 Old 4,130,385 2,583,865 91,054 6,805,304 2,125,958 6,036 

% Reported in 1996 Empty cell 60.7% 38.0% 1.3% 100.0% 31.2% Empty cell 

1997/1996 Old 3,320,610 1,930,783 65,540 5,316,933 1,709,223 5,692 

% Reported in 1997 Empty cell 62.5% 36.3% 1.2% 100.0% 32.2% Empty cell 

1998/1997 Old 4,246,130 2,716,880 115,566 7,078,576 2,923,662 7,602 

% Reported in 1998 Empty cell 60.0% 38.4% 1.6% 100.0% 41.3% Empty cell 

1999/1998 Old 5,102,306 2,712,068 169,863 7,984,237 3,108,228 8,285 

% Reported in 1999 Empty cell 63.9% 34.0% 2.1% 100.0% 38.9% Empty cell 

2000/1999 Old 5,585,042 3,919,065 64,990 9,569,097 3,406,297 9,390 

% Reported in 2000 Empty cell 58.4% 41.0% 0.7% 100.0% 35.6% Empty cell 

2001/2000 Old 6,808,822 4,740,887 44,547 11,594,256 3,619,119 10,212 

% Reported in 2001 Empty cell 58.7% 40.9% 0.4% 100.0% 31.1% Empty cell 

2002/2001 Old + New 7,155,549 3,904,560 78,375 11,138,484 3,666,880 8,945 

% Reported in 2002 Empty cell 64.2% 35.1% 0.7% 100% 32.9% Empty cell 

2003/2002 Old + New 8,514,481 6,121,496 136,277 14,772,254 5,387,692 10,216 

% Reported in 2003 Empty cell 57.6% 41.4% 0.9% 100.0% 36.5% Empty cell 

2004/2003 Old + New 10,889,097 7,741,892 292,931 18,923,920 7,611,611 10,125 

% Reported in 2004 Empty cell 57.5% 40.9% 1.5% 100.0% 40.2% Empty cell 

2005/2004 Old + New 9,503,922 5,941,907 276,923 15,722,752 6,245,436 10,233 

% Reported in 2005 Empty cell 60.4% 37.8% 1.8% 100.0% 39.7% Empty cell 

2006/2005 Old + New 9,473,273 5,172,205 185,452 14,830,930 6,388,316 10,758 

% Reported in 2006 Empty cell 63.9% 34.9% 1.25% 100.0% 43.1% Empty cell 

2007/2006 Old + New 10,152,590 6,887,793 408,075 17,448,458 5,783,543 10,914 

% Reported in 2007 Empty cell 58.2% 39.5% 2.34% 100.0% 33.1% Empty cell 

2008/2007 Old + New 9,243,966 5,991,739 176,650 15,412,355 4,412,106 11,045 

% Reported in 2008 Empty cell 60.0% 38.9% 1.15% 100.0% 28.6% Empty cell 

2009/2008 Old + New 11,439,143 7,570,646 128,949 19,138,738 5,783,543 11,171 

% Reported in 2009 Empty cell 59.8% 39.6% 0.67% 100.0% 30.2% Empty cell 

2010/2009 Old + New 13,102,832 10,044,444 216,359 23,363,635 7,510,763 12,079 

% Reported in 2010 Empty cell 56.1% 43.0% 0.9% 100.0% 32.1% Empty cell 

Table 23A Comments: 1. Table 23A summarizes enrollment by sex/gender and minority race/ethnicity categories for the sixteen-year reporting period (1995-2010). The data are compiled from Tables 23B, 23C and 23D below, which provide the detailed distributions by sex/gender and race/ethnicity using the OLD Enrollment Form (Table 6B) and the NEW Enrollment Form (Tables 23C and 23D). 2. The Race and Ethnicity data in the OLD FORM and the NEW FORM cannot be combined by individual race and ethnicity categories because the categories reflect the different OMB Formats used based on the 1977 OMB standards (OLD FORM) and the 1997 OMB Standards (NEW FORM). 

64
Figure 23a. NIH Sixteen-Year Minority Trend Summary of NIH Extramural and Intramural Clinical 

Research Reported in FY 1995-2010 

65
Table 23 (cont’d): NIH Sixteen-Year Minority Trend Summary of NIH Extramural and Intramural Clinical Research Reported in FY1995-2010 

Notes: Tables 23B-DNOTE 1: The shaded portions of the Tables 23B, 23C and 23D below show the race/ethnicity categories that are identified as minority categories. The Data Reported in FY 2002 and later are from the new Population Tracking System that was deployed with data reported in FY 2002 and later, and allows separate reporting using the Old Form and the New 

Form, and separate reporting for Foreign and Domestic Data. NOTE 2: Data from Tables 23B, 23C and 23D are combined to provide the summary data in Table 23A.

Table 23B. OLD FORM: Total of All Subjects Reported Using the 1977 OMB Standards in a Combined Race/Ethnicity Format 

FY Reported/ 

FY Funded 

American 

Indian/ 

Alaska 

Native 

Asian/ 

Pacific 

Islander 

Black or 

African 

American 

Hispanic, 

Not White White Unknown/ Other Total 

Subtotal Using 

US Minority 

Categories 

(shaded): 

OLD FORM 

Number 

Protocols with 

Enrollment data 

(Old Form): 

1995/1994 11,221 38,952 234,976 89,284 540,313 106,747 1,021,493 374,433 3,188 

% Reported in 1995 1.1% 3.8% 23.0% 8.7% 52.9% 10.5% 100.0% 36.7% Empty cell 

1996/1995 146,319 617,211 823,102 539,326 4,114,249 565,097 6,805,304 2,125,958 6,036 

% Reported in 1996 2.2% 9.1% 12.1% 7.9% 60.5% 8.3% 100.0% 31.2% Empty cell 

1997/1996 36,638 321,479 864,102 487,004 3,199,778 407,932 5,316,933 1,709,223 5,692 

% Reported in 1997 0.7% 6.0% 16.3% 9.2% 60.2% 7.7% 100.0% 32.1% Empty cell 

1998/1997 85,957 1,237,030 1,096,218 504,457 3,713,759 441,155 7,078,576 2,923,662 7,602 

% Reported in 1998 1.2% 17.5% 15.5% 7.1% 52.5% 6.2% 100.0% 41.3% Empty cell 

1999/1998 71,436 1,429,022 1,081,210 526,560 4,470,966 405,043 7,984,237 3,108,228 8,285 

% Reported in 1999 0.9% 17.9% 13.5% 6.6% 56.0% 5.1% 100.0% 38.9% Empty cell 

2000/1999 82,728 1,525,392 1,209,769 588,408 5,588,942 573,858 9,569,097 3,406,297 9,390 

% Reported in 2000 0.9% 15.9% 12.6% 6.1% 58.4% 6.0% 100.0% 35.6% Empty cell 

2001/2000 105,067 1,495,279 1,199,625 819,148 7,314,449 660,688 11,594,256 3,619,119 10,212 

% Reported in 2001 0.9% 12.9% 10.3% 7.1% 63.1% 5.7% 100.0% 31.2% Empty cell 

2002/2001 45,843 1,222,296 702,234 398,657 4,044,052 321,349 6,734,431 2,369,030 6,187 

% Reported in 2002 0.7% 18.1% 10.4% 5.9% 60.1% 4.8% 100.0% 35.2% Empty cell 

2003/2002 36,579 730,542 472,426 288,523 3,238,284 278,901 5,045,255 1,528,070 4,903 

% Reported in 2003 0.7% 14.5% 9.4% 5.7% 64.2% 5.5% 100.0% 30.3% Empty cell 

2004/2003 29,387 307,052 342,188 214,322 2,348,529 172,130 3,413,608 892,949 2,782 

% Reported in 2004 0.9% 9.0% 10.0% 6.3% 68.8% 5.0% 100.0% 26.2% Empty cell 

2005/2004 22,375 254,598 229,615 134,972 1,267,089 102,405 2,011,054 641,560 1,786 

% Reported in 2005 1.1% 12.7% 11.4% 6.7% 63.0% 5.1% 100.0% 31.9% Empty cell 

2006/2005 19,648 131,786 148,948 78,596 883,041 63,231 1,325,250 378,978 1,391 

% Reported in 2006 1.5% 9.9% 11.2% 5.9% 66.6% 4.8% 100.0% 28.6% Empty cell 

2007/2006 5,372 51,742 238,004 83,192 1,097,387 48,630 1,524,327 378,310 1,098 

% Reported in 2007 0.4% 3.4% 15.6% 5.5% 72.0% 3.2% 100.0% 24.8% Empty cell 

2008/2007 1,930 16,258 99,164 28,819 460,533 19,715 626,419 146,171 915 

% Reported in 2008 0.3% 2.6% 15.8% 4.6% 73.5% 3.1% 100.0% 23.3% Empty cell 

2009/2008 1,213 11,652 42,405 19,301 299,115 15,780 389,466 74,571 843 

% Reported in 2009 0.3% 3.0% 10.9% 5.0% 76.8% 4.1% 100.0% 19.1% Empty cell 

2010/2009 682 9,081 32,551 15,441 203,303 5,699 266,757 57,755 532 

% Reported in 2010 0.3% 3.4% 12.2% 5.8% 76.2% 2.1% 100.0% 21.7% Empty cell 

66
Table 23 (cont’d): NIH Nine-Year Minority Trend Summary of NIH Extramural and Intramural Clinical 

Research Reported in FY 1995-2007: Enrollment by Race and Ethnicity 

Orientation to Tables 23C and 23D

1. The New Form consists of Parts A and B (Tables 6C and 6D) for reporting years 2002-2010. This Form is provided as part of the 

annual progress report. 

2. Table 23C displays the New Form Part A for reporting separate race and ethnicity data. 

3. Table 23D displays the New Form Part B, which is the Distribution of Hispanics reported by race, using the totals from the "Hispanic 

or Latino" column in Part A. 

23C. New Form Part A: Total of All Subjects Reported Using the 1997 OMB Standards for Separate Race and 

Ethnicity Formats 

I. Total of All Subjects by Race 

FY Reported/ 

FY Funded 

American 

Indian/ 

Alaska 

Native Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander White 

More 

Than One 

Race 

Unknown/ 

Other Total* 

2002/2001 77,734 354,049 547,776 21,636 2,651,541 30,955 720,362 4,404,053 

% Reported in 2002 1.8% 8.0% 12.4% 0.5% 60.2% 0.7% 16.4% 100.0% 

2003/2002 63,544 2,138,002 960,090 37,569 5,415,710 99,462 1,012,622 9,726,999 

% Reported in 2003 0.7% 22.0% 9.9% 0.4% 55.7% 1.0% 10.4% 100.0% 

2004/2003 98,047 4,345,396 1,379,857 54,452 8,065,069 186,241 1,381,250 15,510,312 

% Reported in 2004 0.6% 28.0% 8.9% 0.4% 52.0% 1.2% 8.9% 100.0% 

2005/2004 292,215 3,046,370 1,358,262 53,286 7,672,890 182,953 1,105,722 13,711,698 

% Reported in 2005 2.1% 22.2% 9.9% 0.4% 56.0% 1.3% 8.1% 100.0% 

2006/2005 141,567 3,463,202 1,251,339 38,460 7,089,017 321,554 1,200,541 13,505,680 

% Reported in 2006 1.0% 25.6% 9.3% 0.3% 52.5% 2.4% 8.9% 100.0% 

2007/2006 145,417 1,356,900 2,012,695 57,149 10,341,483 278,068 1,732,419 15,924,131 

% Reported in 2007 0.9% 8.5% 12.6% 0.4% 64.9% 1.7% 10.9% 100.0% 

2008/2007 134,494 1,168,053 1,835,035 48,560 9,651,267 181,941 1,766,586 14,785,936 

% Reported in 2008 0.9% 7.9% 12.4% 0.3% 65.3% 1.2% 11.9% 100.0% 

2009/2008 154,515 1,840,539 2,287,577 50,339 12,790,945 323,839 1,301,518 18,749,272 

% Reported in 2009 0.8% 9.8% 12.2% 0.3% 68.2% 1.7% 6.9% 100.0% 

2010/2009 361,229 2,133,596 2,949,614 150,856 15,278,117 358,946 1,864,520 23,096,878 

% Reported in 2010 1.6% 9.2% 12.8% 0.7% 66.1% 1.6% 8.1% 100.0% 

II. Total of All Subjects by Ethnicity 

FY Reported/ 

FY Funded 

Not 

Hispanic 

Hispanic or 

Latino** 

Unknown/ 

Not 

Reported Total* 

2002/2001 3,071,952 292,429 1,039,672 4,404,053 

% Reported in 2002 69.8% 6.6% 23.6% 100.0% 

2003/2002 8,162,259 611,641 953,099 9,726,999 

% Reported in 2003 83.9% 6.3% 9.8% 100.0% 

2004/2003 13,168,842 756,339 1,585,131 15,510,312 

% Reported in 2004 84.9% 4.9% 10.2% 100.0% 

2005/2004 11,804,164 773,939 1,133,595 13,711,698 

% Reported in 2005 86.1% 5.6% 8.3% 100.0% 

2006/2005 11,308,244 1,054,313 1,143,123 13,505,680 

% Reported in 2006 83.7% 7.8% 8.5% 100.0% 

2007/2006 13,017,124 1,169,092 1,737,915 15,924,131 

% Reported in 2007 81.7% 7.3% 10.9% 100.0% 

2008/2007 11,881,644 1,116,699 1,787,594 14,785,937 

% Reported in 2008 80.4% 7.6% 12.1% 100.0% 

2009/2008 16,033,547 1,302,944 1,412,781 18,749,272 

% Reported in 2009 85.5% 6.9% 7.5% 100.0% 

2010/2009 18,962,836 1,958,060 2,175,982 23,096,878 

% Reported in 2010 82.1% 8.5% 9.4% 100.0% 

* These totals must agree 

** The Hispanic enrollment totals must agree with totals in Table 23D. 

67
Table 23 (cont’d): NIH Nine-Year Minority Trend Summary of NIH Extramural and Intramural Clinical Research Reported in FY 1995-2007: 

Enrollment by Race and Ethnicity 

Table 23D. New Form Part B: Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date (Cumulative) 

FY Reported/ 

FY Funded 

American 

Indian/ 

Alaska 

Native Asian 

Black or 

African 

American 

Hawaiian/ 

Pacific 

Islander White 

More Than 

One Race 

Unknown/ 

Other 

Total 

Hispanic 

or Latino** 

Subtotal Using 

US Minority 

Categories 

(shaded): NEW 

FORM Parts A+B 

Number of 

Protocols with 

Enrollment 

data 

(New Form) 

2002/2001 4,867 1,305 13,066 101 159,252 7390 106,448 292,429 1297850 2,758 

% Reported in 2002 1.7% 0.4% 4.5% 0.0% 54.5% 2.5% 36.4% 100.0% 29.5% Empty cell

2003/2002 5,400 1,953 14,566 679 350,439 28,088 210,516 611,641 3859622 5,313 

% Reported in 2003 0.9% 0.3% 2.4% 0.1% 57.3% 4.6% 34.4% 100.0% 39.7% Empty cell

2004/2003 6,408 5,040 25,276 2,037 361,112 62,909 293,557 756,339 6718662 7,343 

% Reported in 2004 0.8% 0.7% 3.3% 0.3% 47.7% 8.3% 38.8% 100.0% 43.3% Empty cell

2005/2004 22,739 7,816 19,446 1,981 388,874 51,166 281,916 773,938 5603876 8,447 

% Reported in 2005 2.9% 1.0% 2.5% 0.3% 50.2% 6.6% 36.4% 100.0% 40.9% Empty cell

2006/2005 45,074 6,641 21,712 2,193 417,495 185,477 375,721 1,054,313 6009338 9,367 

% Reported in 2006 4.3% 0.6% 2.1% 0.2% 39.6% 17.6% 35.6% 100.0% 44.5% Empty cell

2007/2006 37,581 7,414 31,239 4,310 538,216 100,197 450,135 1,169,092 4356434 9,816 

% Reported in 2007 3.2% 0.6% 2.7% 0.4% 46.0% 8.6% 38.5% 100.0% 29.5% Empty cell

2008/2007 34,335 31,616 85,548 2,369 518,825 64,979 379,027 1,116,699 4265935 10,130 

% Reported in 2008 3.1% 2.8% 7.7% 0.2% 46.5% 5.8% 33.9% 100.0% 28.9% Empty cell

2009/2008 39,198 53,546 91,184 3,103 729,355 63,934 322,808 1,303,128 5708972 10,328 

% Reported in 2009 3.0% 4.1% 7.0% 0.2% 56.0% 4.9% 24.8% 100.0% 30.4% Empty cell

2010/2009 203,106 9,836 170,553 2,824 1,015,859 72,974 482,908 1,958,060 7,453,008 11,547 

% Reported in 2010 10.4% 0.5% 8.7% 0.1% 51.9% 3.7% 24.7% 100.0% 32.3% Empty cell

** These totals must agree with the Hispanic enrollment in Table 23C.II 

68
Table 23 (cont’d): NIH Nine-Year Minority Trend Summary of NIH Extramural and Intramural Clinical Research Reported in FY 1995-2007: 

Enrollment by Race and Ethnicity 

Table 23E. Comparison of Domestic and Foreign Enrollment & Protocols with Total Enrollment for the period FY2002-2010

FY 

Reported/ 

Funded 

Total 

Enrollment 

data 

(Old + New 

Forms): 

Total 

DOMESTIC 

Enrollment 

Percent 

DOMESTIC 

Enrollment 

Total 

FOREIGN 

Enrollment 

Percent 

FOREIGN 

Enrollment 

Number of 

Protocols 

with 

Enrollment 

data (Old + 

New 

Forms): 

Number of 

DOMESTIC 

Protocols 

Percent 

Domestic 

Protocols 

Number of 

FOREIGN 

Protocols 

Percent Foreign 

Protocols 

2002/2001 11,138,484 10,192,401 91.5% 946,083 8.5% 8,945 8,463 94.6% 482 5.4% 2003/2002 14,772,254 11,911,357 80.6% 2,860,897 19.4% 10,216 9,578 93.8% 638 6.2% 2004/2003 18,923,920 14,359,793 75.9% 4,564,127 24.1% 10,125 9,760 96.4% 365 3.6% 2005/2004 15,722,752 12,669,858 80.6% 3,052,894 19.4% 10,233 9,862 96.4% 371 3.6% 2006/2005 14,830,930 11,425,701 77.0% 3,405,229 23.0% 10,758 10,294 95.7% 464 4.3% 2007/2006 17,448,458 16,180,588 92.7% 1,267,870 7.3% 10,914 10,463 95.9% 451 4.1% 2008/2007 15,412,355 14,134,627 91.7% 1,277,728 8.3% 11,045 10,548 95.5% 497 4.5% 2009/2008 19,138,738 17,848,074 93.3% 1,290,664 6.7% 11,171 10,263 91.9% 908 8.1% 2010/2009 23,363,635 21,523,076 92.1% 1,840,559 7.9% 12,079 11,189 92.6% 890 7.4% 

Table 23E comments: 1. The Total Enrollment, Total Domestic and Total Foreign Enrollment increased overall from FY 2002 – 2010. 2. The Percent Domestic enrollment decreased from over 90% reported in FY2002 to less than 80% reported in FY2010. Percent Foreign enrollment has 

correspondingly increased during the same period. 

Figure 23b. NIH Nine-Year Minority Trend Summary of NIH Extramural and Intramural Clinical Research 

69
Table 23F. Comparison of Domestic and Foreign Minority Participation for FY 2002-2010 

FY Reported/ 

FY Funded 

FOREIGN 

Minority Enrollment 

FOREIGN 

Total Enrollment 

DOMESTIC 

Minority Enrollment 

DOMESTIC 

Total Enrollment 

2002/2001 777,461 946,083 2,754,820 10,149,869 

% Reported in 2002 82.2% 100.0% 27.1% 100.0% 

2003/2002 2,452,329 2,860,897 2,935,363 11,911,357 

% Reported in 2003 85.7% 100.0% 24.6% 100.0% 

2004/2003 4,147,255 4,564,127 3,464,356 14,359,793 

% Reported in 2004 90.9% 100.0% 24.1% 100.0% 

2005/2004 2,776,565 3,052,894 3,468,864 12,669,858 

% Reported in 2005 90.9% 100.0% 27.4% 100.0% 

2006/2005 3,087,181 3,405,229 3,301,135 11,425,701 

% Reported in 2006 90.7% 100.0% 28.9% 100.0% 

2007/2006 932,686 1,267,870 4,283,738 16,180,588 

% Reported in 2007 73.6% 100.0% 26.5% 100.0% 

2008/2007 864,945 1,277,728 3,521,691 14,134,627 

% Reported in 2008 67.7% 100.0% 24.9% 100.0% 

2009/2008 899,749 1,290,664 4,883,794 17,848,074 

% Reported in 2009 69.7% 100.0% 27.4% 100.0% 

2010/2009 1,469,232 1,840,559 6,041,531 21,523,076 

% Reported in 2010 79.8% 100.0% 28.1% 100.0% 

Table 23F Comments: 

1. In FY 2002, a single, large, foreign research study (R01TW005993) entitled “Monitoring tobacco mortality in 2M adults in 4 

countries” expanded enrollment to over 1.5 million participants, causing a sharp increase in foreign minority enrollment 

reported in FY 2003. 

2. In FY 2003, a single, large, foreign research study (R01TW005991) entitled “Strengthening monitoring of Indian tobacco 

mortality” expanded enrollment to over 2 million participants, causing a sharp increase in foreign minority enrollment 

reported in FY 2003. 

Figure 23c. Comparison of Domestic and Foreign Minority Participation for FY 2002-2010 

70