Outreach Notebook Frequently Asked Questions (FAQs)
on the Inclusion of Women and Minorities in Clinical Research
Preface
The Revitalization Act of 1993, required that the National Institutes of
Health (NIH) develop "Guidelines on the Inclusion of Women and Minorities As Subjects in Clinical Research". The
guidelines, first published in 1994 (Federal Register, March 28, 1994, 59FR14508-14513; http://grants.nih.gov/grants/guide/notice-files/not94-100.html, have been updated most recently in October 2001 (http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm).
Research applications and proposals to be supported by NIH must comply with
this statute and the policy and guidelines that implement it.
This document
contains a series of frequently asked questions with answers to assist in
the preparation of research applications, proposals, and progress reports
in accordance with the NIH Policy and Guidelines. The questions
cover areas listed in a table of contents for ease in finding specific topics
of interest. Although this document provides additional clarification and
explanation, it is important to read the NIH Guidelines.
If there are further
questions about this policy, please contact the NIH representative from the
appropriate Institute or Center which are listed at the end of this document.
The information contained in this document will be updated should there be
any significant changes in the NIH Guidelines.
This document is available
electronically on the ORWH website (www4.od.nih.gov) as well as the NIH web
page on Inclusion of Women and Minorities Policy Implementation http://grants.nih.gov/grants/funding/women_min/women_min.htm.
The NIH web page also includes links to other documents and references related
to the NIH policy on Inclusion.
Members of the NIH Tracking and Inclusion Committee are indebted to the diligence and work of the Subcommittee Reviewing Inclusion Issues.
NOTE: The Frequently Asked Questions (FAQs) have been numbered within sections A-G for easy reference. (April 2007).
Questions:
Table of Contents
- POLICY
A1. What is required by the 1993 NIH Revitalization Act?
A2. What is the NIH policy on the inclusion of women and minorities as subjects in research?
A3. What are the details for inclusion in NIH-defined Phase III clinical trials?
A4. Who is responsible for implementation of the policy and guidelines?
- DEFINITIONS
B1. Clinical Research
B2. NIH-defined Phase III Clinical Trial
B3. Valid Analysis
B4. Significant Difference
B5. Sex/Gender
B6. Racial and Ethnic Categories
B7. Outreach Strategies
- INFORMATION FOR SUBMITTING APPLICATIONS/PROPOSALS
C1. What should you consider in the design of a clinical research study?
C2. Can you design a clinical research study/respond to a contract solicitation that includes only one sex and/or one racial/ethnic group or subpopulation?
C3. Can you use existing cohorts that are deficient in women or minority participants?
C4. What type of information on the diversity of the target study population should you provide in your application/proposal?
C5. What additional information must you provide in your application/proposal for any NIH-defined Phase III clinical trial?
C6. What should you include in your application/proposal to describe your efforts for outreach to recruit and retain women and minorities in your study?
C7. What should you do if you are located in a geographic area that does not offer a study population with the diversity required by the policy on the inclusion of women and minorities in clinical research studies?
C8. Is increased cost an acceptable justification for not including women, minorities and subpopulations in clinical research studies?
C9. In multi-center clinical research studies, does each study site have to meet the inclusion requirements separately?
C10. Does the policy on the inclusion of women and minorities apply to foreign projects and contract proposals funded by the NIH?
C11. How do the Guidelines impact on Institutional Review Boards (IRBs)?
- INFORMATION ON REPORTING RACE AND ETHNICITY IN APPLICATIONS/PROPOSALS AND ACTIVE RESEARCH GRANTS AND CONTRACTS
D1. What if my new application/proposal involves analyzing secondary data in which the race and ethnicity categories do not comply with the new OMB guidelines?
D2. There are many ways of tabulating the multiple race and ethnicity responses, particularly since the race and ethnicity categories are not mutually exclusive. Do the numbers reported in the tables have to “add up”?
D3. Can the Targeted/Planned Enrollment Table or the Enrollment Inclusion Report be used to collect data from individuals?
D4. Can more detailed questions about ethnicity and race be asked than these guidelines indicate?
D5. What ethnic and racial categories should be used to estimate race and ethnicity, given the new OMB standards?
D6. Data collection began prior to the new standards and the questions do not comply with the new OMB standards. Should questions asked about race and ethnicity be changed in the middle of the study?
D7. Data collection began prior to the new standards, but race and ethnicity questions do comply with the new standards. Data for previous years has been submitted using the old standards. How should data be reported in this year’s progress report?
D8. How should race and ethnicity data be reported when the research involves a foreign population?
D9. How do the 1997 OMB revised standards differ from the previous standards?
D10. Where can I find examples of questions for collecting data on ethnicity and race from individuals that I could use in my research?
D11. When collecting and reporting population data, does the PI have to follow the OMB guidelines or can other terminology be used?
- NIH GRANTS AND COOPERATIVE AGREEMENTS: INFORMATION ON THE NIH PEER REVIEW PROCESS
E1. What will NIH reviewers look for in applications regarding the inclusion of women and minorities in clinical research?
E2. Are there additional elements that reviewers will look for when an NIH-defined Phase III clinical trial is proposed?
E3. Will the criteria for addressing the inclusion of women and minorities in the applicant’s plan affect the assigned score for scientific and technical merit?
- CONTRACTS: INFORMATION ON THE NIH PEER REVIEW PROCESS
F1. How does the inclusion policy for women and minorities in clinical research studies apply to the review of research contract proposals and projects?
- FUNDING INFORMATION
G1. How will conformance to the policy for inclusion of women and minorities in clinical research affect funding of grants and cooperative agreements?
G2. How will conformance to the policy for inclusion of women and minorities in clinical research affect funding of contracts?
G3. What reports need to be prepared using the data on inclusion of women and minorities?
G4. The policy requires inclusion and subpopulation data in the progress report for each NIH-defined Phase III clinical trial grant or contract. Does that mean that analyses need to be done every year?
G5. Where can I obtain additional information?
Questions and Answers
A. POLICY
A1. What is required by the 1993 NIH Revitalization
Act?
The 1993 NIH Revitalization Act, mandated that:
- NIH ensure women and minorities and their subpopulations are included in clinical research;
- for clinical trials, women and minorities and their subpopulations are included as subjects. In Phase III clinical trials, they must be included in numbers adequate to allow for valid analyses of differences in intervention effect (See this section; Questions 2 and 3 for further details on analysis plans);
- NIH establish guidelines for circumstances under which such inclusion is inappropriate;
- cost is not allowed as an acceptable reason for excluding these groups; and,
- NIH initiate programs and support for outreach efforts to recruit and retain women and minorities and their subpopulations as participants in clinical studies.
Guidelines developed in response to this law were published in the Federal Register in March 1994, and in the NIH Guide for Grants and Contracts in August 2000 and October 2001. NIH will not fund any grant, cooperative agreement or contract or support any intramural project which does not comply with this policy. Research awards covered by this policy require the grantee /contractor to report annually on cumulative enrollment of women and men, and on the race and ethnicity of research participants.
A2. What is the NIH policy on the inclusion of women and minorities
as subjects in research?
It is the policy of NIH that women and
members of minority groups and their subpopulations must be included in
all NIH-funded clinical research, unless a clear and compelling rationale
and justification establishes to the satisfaction of the relevant Institute/Center
Director that inclusion is inappropriate with respect to the health of
the subjects or the purpose of the research. Exclusion under other circumstances
may be made by the Director, NIH, upon the recommendation of an Institute/Center
Director based on a compelling rationale and justification. Cost is not
an acceptable reason for exclusion except when the study would duplicate
data from other sources. Women of childbearing potential should not be
routinely excluded from participation in clinical research. This policy
applies to research subjects of all ages in all NIH-funded clinical research
studies.
NIH-defined Phase III clinical
trials (see Definitions) must be designed and carried out to allow for valid
analysis of differences between men and women and racial/ethnic groups and
this must be communicated to applicants. Peer review groups will determine
whether each NIH-defined Phase III clinical trial has an appropriate study
design. Summary statements (grants/cooperative agreements) or peer review
evaluation reports (contracts) document the quality of the study design
and proposed analyses.
Applications/proposals/protocols for NIH-defined
Phase III clinical trials require a description of plans to conduct analyses
to address differences by sex/gender and racial/ethnic groups, including
subgroups if applicable. The final protocol(s) approved by the Institutional
Review Board (IRB) must include these plans for analysis. The award
will require that for each funded protocol, investigators must report in
their annual Progress Report cumulative subject accrual and progress in
conducting analyses for sex/gender and race/ethnicity differences. If
final analyses of sex/gender and race/ethnicity are not available at the
time of the Final Progress Report or Competing Continuation for the grant,
a justification and plan ensuring completion and reporting of the analyses
are required. If final analyses are required as part of the contract,
these analyses must be included as part of the deliverables. These requirements
will be cited in the terms and conditions of all awards for grants, cooperative
agreements and contracts supporting NIH-defined Phase III clinical trials.
A3. What are the details for inclusion in NIH-defined Phase
III clinical trials?
Applications/Proposals for an NIH-defined Phase
III clinical trial require a review of evidence to show whether or not
clinically important sex/gender and race/ethnicity differences in the
intervention effect are to be expected. This evidence may include,
but is not limited to, data derived from prior animal studies, clinical
observations, metabolic studies, genetic studies, pharmacology studies,
and observational, natural history, epidemiology and other relevant studies. Based
on prior studies, investigators must decide which of the following three
situations apply to their proposed clinical trial. (Note: For contracts,
this may be determined by the Government and one of these three scenarios
may be required by the statement of work in the solicitation.)
- Prior Studies Support the Existence of Significant Differences
If the data from prior studies strongly support the existence of significant
differences of clinical or public health importance in intervention effect
based on sex/gender, race/ethnic groups, and relevant subpopulation comparisons,
the primary question(s) to be addressed and the design of the trial must
specifically accommodate this. For example, if men and women are thought
to respond differently to an intervention, then the clinical trial must
be designed to answer two primary questions, one for men and the other for
women, with adequate sample size for each.
The Research Plan (for grant
applications) or Proposals (for contract solicitations) must include a description
of plans to conduct analyses to detect significant differences in intervention
effect (see DEFINITIONS - Significant Difference) by sex/gender, racial/ethnic
groups, and relevant subpopulations, if applicable. The final protocol(s)
approved by the Institutional Review Board (IRB) must include these plans
for analysis. The award will require that for each funded protocol, investigators
must report in their annual Progress Report cumulative subject accrual and
progress in conducting analyses for sex/gender and race/ethnicity differences.
If final analyses of sex/gender and race/ethnicity are not available at
the time of the Final Progress Report or Competing Continuation for the
grant, a justification and plan ensuring completion and reporting of the
analyses are required. If final analyses are required as part of
the contract, these analyses must be included as part of the deliverables.
These requirements will be cited in the terms and conditions of all awards
for grants, cooperative agreements and contracts supporting NIH-defined
Phase III clinical trials.
Inclusion of the results of sex/gender, race/ethnicity
and relevant subpopulations analyses is strongly encouraged in all publication
submissions. If these analyses reveal no differences, a brief statement
to that effect, indicating the groups and/or subgroups analyzed, will suffice.
- Prior Studies Support No Significant Differences
If the data from prior studies strongly support no significant differences of clinical or public health importance in intervention effect based on sex/gender, racial/ethnic and/or relevant subpopulation comparisons, then sex/gender and race/ethnicity will not be required as subject selection criteria. However, the inclusion and analysis of sex/gender and/or racial/ethnic subgroups is still strongly encouraged.
- Prior Studies Neither Support nor Negate Significant Differences
If the data from prior studies neither strongly support nor strongly negate
the existence of significant differences of clinical or public health importance
in intervention effect based on sex/gender, racial/ethnic, and relevant
subpopulation comparisons, then the NIH-defined Phase III clinical trial
will be required to include sufficient and appropriate entry of sex/gender
and racial/ethnic participants, so that valid analysis of the intervention
effects can be performed. However, the trial will not be required
to provide high statistical power for these comparisons.
The Research Plan (for grant applications) or Proposals (for contract
solicitations) must include a description of plans to conduct analyses
to conduct valid analysis (see DEFINITIONS - Valid Analysis) by sex/gender,
racial/ethnic groups, and relevant subpopulations, if applicable. The final
protocol(s) approved by the Institutional Review Board (IRB) must include
these plans for analysis. The award will require that for each funded protocol,
investigators must report in their annual Progress Report cumulative subject
accrual and progress in conducting analyses for sex/gender and race/ethnicity
differences. If final analyses of sex/gender and race/ethnicity are not
available at the time of the Final Progress Report or Competing Continuation
for the grant, a justification and plan ensuring completion and reporting
of the analyses are required. If final analyses are required as part of
the contract, these analyses must be included as part of the deliverables.
These requirements will be cited in the terms and conditions of all awards
for grants, cooperative agreements and contracts supporting NIH-defined
Phase III clinical trials.
Inclusion of the results of sex/gender, race/ethnicity
and relevant subpopulations analyses is strongly encouraged in all publication
submissions. If these analyses reveal no differences, a brief statement
to that effect, indicating the groups and/or subgroups analyzed, will suffice.
For all three situations, cost is not an acceptable reason for exclusion
of women and minorities from clinical trials.
A4. Who is responsible for implementation of the
policy and guidelines?
The entire scientific community has a responsibility
for implementing the policy as a partnership between research subjects,
principal investigators, institutional review boards, peer review groups,
NIH staff, NIH advisory councils, NIH Institute and Center Directors,
and the NIH Director.
Principal
investigators should assess the theoretical and/or scientific linkages between
sex/gender and race/ethnicity, and their topic of study in preparing their
applications/proposals and conducting their research. Institutional
Review Boards (IRBs) will review NIH protocols in terms of the inclusion
policy as part of their review for protection of human subjects. NIH
staff in the administrative review of applications, prior to peer review,
will check to see that inclusion is addressed. Any grant application proposing
clinical research that fails to address inclusion will be returned without
review.
Peer review groups will include a scientific and technical merit evaluation
of the proposed inclusion plan, assign appropriate scores and consider inclusion
as a factor in scoring.
For contract proposals, the review group determines
if the description of plans to conduct analyses to address differences by
sex/gender, racial/ethnic groups, and relevant subpopulations is adequate.
If the offeror has determined that inclusion of women and/or minority populations
is not feasible, the rationale and justification for exclusion will be examined
to determine if it is appropriate with respect to the health of the subjects
and/or the purpose of the research. If the rationale is not considered acceptable,
the offeror may or may not be excluded from the competitive range, based
on review of the other evaluation criteria. If the offeror is included in
the competitive range (for contract proposals) or if the government holds
discussion with the selected source (for sole-source acquisitions), they
will be given an opportunity to further discuss, clarify, or modify their
plan during discussions. If the plans are still considered unacceptable,
the proposal may not be considered further for award.
For both grants and
contracts, the advisory council/board of each IC shall prepare biennial
reports describing the manner in which the IC has complied with the provisions
of the statute.
NIH will provide educational opportunities for the extramural
and intramural community concerning this policy; monitor its implementation
during the development, review, award and conduct of research; and manage
the NIH research portfolio to address the policy.
B. DEFINITIONS
B1. Clinical Research
Clinical research is defined
as:
(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,
(3) Outcomes research and health services research.
http://www.nih.gov/news/crp/97report/execsum.htm
B2. NIH-defined Phase III Clinical Trial
NIH has developed a special
definition for an NIH-defined Phase III clinical trial to be used regarding
this policy when referring to a clinical trial. This
is to distinguish this type of trial from the other types of clinical research
funded by NIH, and from other definitions, e.g. by the Food and Drug Administration
(FDA).
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 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.
In determining whether a study fits the NIH definition of a Phase III clinical
trial, an essential consideration is trial outcome -whether it would contribute
to a change in the standard of care or contribute to a change in public
health policy, regardless of the number of participants in the study. This
NIH definition of a Phase III clinical trial is broad and encompasses the
wide range of research funded by NIH. It differs from the FDA definition
of Phase III clinical trials, which focuses primarily on a clinical investigation
of drugs, vaccines, biologics, and devices. Clinical trials of experimental
drugs covered in the FDA definition proceed through four phases (21 CFR
Section 312.21, 4-1-94 edition). For
additional information regarding the FDA definitions of the different phases
of clinical trials, check the NIH Clinical Trials Website at: http://clinicaltrials.gov.
B3. 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.
B4. 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.
B5. Sex/Gender
The term gender refers to the classification of research subjects into either or both of two categories: Women and men. Sex refers to biological sex, either male or female.
B6. Racial and Ethnic Categories
A. Minority Groups
A minority group is a readily identifiable subset of
the U.S. population that is distinguished by racial, ethnic, and/or cultural
heritage.
The Office of Management and Budget (OMB) Directive No. 15 http://www.whitehouse.gov/omb/fedreg/ombdir15.html defines
minimum standards for maintaining, collecting and presenting data on race
and ethnicity for all Federal reporting. NIH is required to use these definitions
to allow comparisons to other federal databases, especially the census and
national health databases. The categories in this classification are social-political
constructs and should not be interpreted as anthropological in nature.
When
an investigator is planning data collection on race and ethnicity, these
categories shall be used. The collection of greater detail is encouraged.
However, more detailed items should be designed in a way that they can be
aggregated into these required categories. Using respondent self-report
or self-identification to collect an individual’s data on ethnicity
and race, investigators should use two separate questions with ethnicity
information collected first followed by the option to select more than one
racial designation. Respondents shall be offered the opportunity to select
more than one racial designation. When data are collected separately, provision
shall be made to report the number of respondents in each racial category
who are Hispanic or Latino.
The following definitions apply for ethnic
categories.
Hispanic or Latino - a person of Cuban, Mexican, Puerto Rican,
South or Central American, or other Spanish culture or origin, regardless
of race. The term "Spanish origin" can also be used in
addition to "Hispanic
or Latino."
Not Hispanic or Latino
The following definitions apply for racial
categories.
American Indian or Alaska Native - a person having origins in any
of the original peoples of North, Central, or South America, and who maintains
tribal affiliations or community attachment.
Asian - a person having origins in any of the original peoples
of the Far East, Southeast Asia, or the Indian subcontinent including,
for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan,
the Philippine Islands, Thailand, and Vietnam. (Note: Individuals from
the Philippine Islands have been recorded as Pacific Islanders in previous
data collection strategies.)
Black or African American - a person having origins in any of
the black racial groups of Africa. Terms such as "Haitian" or "Negro"
can be used in addition to "Black
or African American."
Native Hawaiian or Other Pacific Islander - a person having origins
in any of the
original peoples of Hawaii, Guam, Samoa, or other Pacific Islands.
B. Majority
Group
White - a person having origins in any of the original peoples
of Europe, the Middle East, or North Africa.
NIH recognizes the diversity
of the U.S. population and that changing demographics are reflected in the
changing racial and ethnic composition of the population. The terms “minority
groups” and “minority
subpopulations” are
meant to be inclusive, rather than exclusive, of differing racial and ethnic
categories.
C. Subpopulations
Each racial and ethnic group contains subpopulations
that are delimited by geographic origins, national origins and/or cultural
differences. It is recognized that there are different ways of defining
and reporting racial and ethnic subpopulation data. The subpopulation to
which an individual is assigned depends on self-reporting of specific origins
and/or cultural heritage. Attention to subpopulations also applies to individuals
who self identify with more than one race or ethnicity. Researchers should
be cognizant of the possibility that these racial/ethnic combinations may
have biomedical, behavioral, and/or social-cultural implications related
to the scientific question under study.
B7. Outreach Strategies
These are outreach efforts by investigators
and their staff(s) to appropriately recruit and retain populations of
interest into research studies. Such efforts should represent a thoughtful
and culturally sensitive plan of outreach and generally include involvement
of other individuals and organizations relevant to the populations and
communities of interest, e.g., family, religious organizations, community
leaders and informal gatekeepers, and public and private institutions
and organizations. The objective is to establish appropriate lines of
communication and cooperation to build mutual trust and cooperation such
that both the study and the participants benefit from such collaboration.
C. INFORMATION FOR SUBMITTING APPLICATIONS/PROPOSALS
C1. What should you consider in the design of a clinical research
study?
In your clinical research study design for a research grant
or proposal in response to a contract solicitation, the appropriate numbers
of men, women, and members of racial/ethnic groups should be based on
the scientific question under study (research grants and cooperative agreements)
or on requirements set forth in the solicitation statement of work (contract). While
diversity and broad representation are strongly encouraged, it is not
expected that both sexes and members of every racial/ethnic group and
subpopulation will be included in every study or contract. Consider
how the following questions apply to your study before deciding the composition
of your target population:
- Is the scientific question/solicitation statement of work applicable equally to both men and women and to all racial/ethnic groups and their subpopulations?
- Is the condition under study or defined in the statement of work more prevalent or severe in one particular group?
- For research grants and cooperative agreements, have enough studies already been performed in one or more groups, leaving gaps that can be filled by focusing the research on certain population groups?
After answering these questions, determine the target population you need and your study design by considering the answers to the following:
- In order to obtain the appropriate diversity must I have access to participants from additional clinics or facilities? Will over-sampling of certain groups be possible?
- If a single clinic or facility is not adequate, can the needed participants be enrolled by going to hospitals or other clinical facilities in the nearby geographic region?
- If demographic limitations prevent answering scientific questions locally for the appropriate sex and minority groups, is it feasible or necessary to expand the geographic area or to establish satellite centers?
For contracts, the target population may be provided in the statement of work in the solicitation. You may need to address the above questions in preparing your response to the solicitation.
C2. Can you design a clinical research study/respond to a contract solicitation that includes only one sex and/or one racial/ethnic group or subpopulation?
YES. If you propose a study of only one sex or racial/ethnic group (or subpopulation), you must have a scientific justification for limiting the diversity of your study population, such as high prevalence of the condition, unique disease characteristics, or gaps in knowledge in the selected population. In
this case, you must justify why your study has a limited target population
and provide in your application information or reference to any published
reports about ongoing studies that address the appropriate diversity.
C3. Can you use existing cohorts that are deficient
in women or minority participants?
YES. Applicants/Offerors
can propose a study or analyses of an existing data base where
the cohort is deficient in sex/gender and/or racial/ethnic participation. However,
you must justify why you will use an existing cohort that lacks the diversity
required by the inclusion policy. The nature of the scientific
question, a requirement for data provided by the cohort, or addressing
a gap in knowledge may
be used to provide the basis of a justification.
C4. What type of information on the diversity of
the target study population should you provide in your application/proposal?
For
all clinical research studies, you must follow grant application instructions
(PHS 398) or the instructions contained in the statement of work in the
contract solicitation regarding the plans for recruitment and retention
of study participants. The research plan/proposal should include a description
of the composition of the proposed study population in terms of sex/gender
and racial/ethnic membership, and provide a rationale for selection of
such subjects as well as proposed outreach programs for their recruitment.
At a minimum, you should do the following:
- Describe the population characteristics of the disease or condition under study, including national and local demographics of the population, and demonstrate your knowledge and understanding of the racial/ethnic/cultural characteristics of the population. Provide any data, including references, regarding how the disease or condition may affect women, men, racial/ethnic groups and relevant subpopulations differentially.
- Address the treatment or intervention characteristics of the population
indicating whether clinically important sex/gender, racial/ethnic, and
relevant subpopulation differences exist in the intervention effect. Describe
and provide known data, including references.
- Describe your prior experience
and collaborations in recruitment and retention of the populations and
subpopulations to be studied including plans, arrangements and letters
of commitment from relevant community groups and organizations for your
planned study.
For all clinical research studies, you must also complete the table found
in the PHS 398 application “Targeted/Planned Enrollment Table” (http://grants.nih.gov/grants/funding/phs398/enrollment.pdf)
(PDF - 329 KB). Use this table to indicate the number of participants proposed
for your study according to the specific categories.
First describe the target
population in terms of ethnicity:
TARGETED/PLANNED ENROLLMENT: Number of Subjects |
|
Ethnic category |
Sex/Gender |
|
Females |
Males |
Total |
Hispanic or Latino |
|
|
|
Not Hispanic or Latino |
|
|
|
Ethnic Category Total |
|
|
|
Second, describe the target population in terms of race:
Racial Categories |
|
American Indian/Alaska Native |
|
|
|
Asian |
|
|
|
Native Hawaiian or Other Pacific Islander |
|
|
|
Black or African American |
|
|
|
White |
|
|
|
Racial Categories: Total of all Subjects * |
|
|
|
List any subpopulations that are proposed to be included in the study
as an attachment to the Targeted/Planned Enrollment Table.
For contracts,
the “Targeted/Planned Enrollment Table” will
be included as an attachment to the solicitation. See NCI RFP Workform at http://rcb.nci.nih.gov/forms/forms.htm
Additional
information about completing and using this table can be found in the NIH
Policy on Reporting Race and Ethnicity Data: Subjects in Clinical Research http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html.
C5. What additional information
must you provide in your application/proposal for any NIH-defined Phase
III clinical trial?
For an NIH-defined Phase III clinical trial, in
addition to the information above, you must also provide evidence to show
whether or not clinically important sex/gender, racial/ethnic, and relevant
subpopulation differences in the intervention effect are to be expected.
(Additional details on applying the Women and Minorities Inclusion Policy
for Phase III Clinical Trials can
be found in the section POLICY, Questions 2 and 3.)
- If prior studies support the existence of significant differences between
groups, your research plan/proposal must also include a description of
how analyses will be conducted to detect significant differences in the
intervention effect. 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 clinical difference
of potential importance that is not statistically significant.
- If the data from prior studies strongly support that there is no significant difference of clinical or public health importance in intervention effect between subgroups, then sex/gender and/or race/ethnicity will not be required as subject selection criteria. However, the inclusion and analysis of sex/gender and racial/ethnic subgroups is still strongly encouraged for the proposed trial.
- If data from prior studies neither strongly support nor strongly negate
the existence of significant differences of clinical or public health
importance in intervention effect based on sex/gender and/or racial/ethnic
comparisons , then your research plan/proposal for the NIH-defined Phase
III clinical trial must also include a description of plans to conduct
a valid analyses of the intervention effects in subgroups. For the purpose
of this policy, 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 from 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/or racial/ethnic groups.
For all Phase III Clinical Trials, the final protocol(s) approved by the
Institutional Review Board (IRB) must include these plans for analyses. For
research grants, applicants are strongly encouraged to contact Program Directors
for guidance prior to submitting their applications. For contracts, offerors
may contact the contracting officer ONLY for guidance prior to submitting
their proposals. The following table summarizes the inclusion requirements
for clinical research and for NIH-defined Phase III clinical trials.
Type of Study |
Include Women and Minorities? |
Include Minority Subpopulations? |
Design to Measure Differences? |
Clinical Research Studies |
YES |
YES |
Recommended but not required |
NIH-Defined Phase III Clinical Trials |
YES |
YES |
Required |
C6. What should you include in your
application/proposal to describe your efforts for outreach to recruit
and retain women and minorities in your study?
You should include
in your application/proposal a description of your proposed outreach plan
to recruit and retain the women and members of racial/ethnic groups and
relevant subpopulations in the target population. Outreach efforts often
include the involvement of organizations and persons relevant to the populations
and communities of interest, e.g., religious organizations, community
leaders, and public and private institutions. You should
take precautions to ensure that there is minimal possibility of coercion
or undue influence in any incentives offered to prospective participants
when recruiting or attempting to retain participants in studies.
NIH staff have prepared a notebook, NIH Outreach Notebook on the Inclusion of Women and Minorities in Clinical Research,
which addresses recruitment and retention of women and minorities in clinical
studies, provides relevant references, and discusses ethical issues. A
link to this notebook can be found at:
http://grants.nih.gov/grants/funding/women_min/women_min.htm
C7. What should
you do if you are located in a geographic area that does not offer a study
population with the diversity required by the policy on the inclusion of
women and minorities in clinical research studies?
In your application/proposal,
you are required to provide a clear and compelling description and rationale
for your proposed study population and its appropriateness for the purpose
of your research. When there is limited representation of women or
members of racial/ethnic groups you must also provide a satisfactory rationale
for lack of any diversity based on the health of the participants and the
scientific needs of the research being proposed. If you are aware of similar
research completed or underway employing populations complementary to those
available in your locale, you can present this as a rationale for limited
representation. If the appropriate diversity cannot be achieved in
your geographic area, you must address the feasibility of making collaborative
or other arrangements to include greater diversity, e.g., seeking
collaborators in other geographic areas where there is access to more diverse
populations.
C8. Is increased cost
an acceptable justification for not including women, minorities and subpopulations
in clinical research studies?
NO. The legislation states that the cost associated with
increasing the diversity of a clinical research study population composition
to include the appropriate representation of men, women, and members of
minority groups and their subpopulations is not an acceptable justification for excluding any group.
C9. In multi-center
clinical research studies, does each study site have to meet the inclusion
requirements separately?
NO. When multi-center clinical research studies are proposed, the
inclusion requirements may be met by combining recruitment from the multiple
sites. However, each clinical site must still describe its planned
recruitment, retention and outreach plans, which will be evaluated as part
of the initial review of the application or proposal. As
part of its funding plan, the NIH may select recruitment sites with high
minority and/or relevant subpopulation enrollments for inclusion in multi-center
studies to achieve inclusion of the most diverse study population.
See Question
4 under INFORMATION ON THE NIH PEER REVIEW PROCESS for additional discussion
of contract projects.
C10. Does the policy
on the inclusion of women and minorities apply to foreign projects and contract
proposals funded by the NIH?
YES. The NIH policy on inclusion of women in research conducted
outside the U.S. is the same as that for research conducted in the U.S. However,
for the population of the foreign country the definition of the minority
groups may be different than in the U.S. If there is scientific rationale
for examining subpopulation group differences within the foreign population,
investigators should consider designing their studies to accommodate these
differences.
C11. How do the Guidelines
impact on Institutional Review Boards (IRBs)?
IRBs have long had as
part of their responsibilities the examination of ethical issues and the
determination of equitable selection of subjects in accordance with the
regulations for protection of human subjects (45 CFR 46.111(a)(3)). The
inclusion of both men and women and of minorities in research (intramural
and extramural) is important, both to ensure that they receive an appropriate
share of the benefits of research and that they do not bear a disproportionate
burden. To the extent that participation in research offers direct benefits
to the participants, under-representation of men, women, or minorities denies
them the opportunity to receive this benefit. Moreover, for the purpose
of generalizing research results, investigators must include the widest
possible range of population groups.
D. INFORMATION ON REPORTING RACE AND ETHNICITY
IN APPLICATIONS/PROPOSALS AND ACTIVE RESEARCH GRANTS/CONTRACTS
Complete information on the NIH Policy on Reporting Data on Race and
Ethnicity: Subjects in Clinical Research can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01053.html.
The set of questions and answers below also are included as FAQ’s
in the NIH Policy on Reporting Data on Race and Ethnicity.
Note: The FAQ’s
below also apply to offers of research contracts.
However, information on the tables for reporting sex/gender and race/ethnicity
for research contracts should be used rather than those found in the PHS
398. See http://rcb.nci.nih.gov/forms/forms.htm
D1. What if my new application/proposal involves analyzing secondary
data in which the
race and ethnicity categories do not comply with the new OMB guidelines?
If
an investigator is using secondary data sets that do not conform to the
new OMB guidelines and does not plan to collect any new/additional data
from the subjects, this should be noted in the New Application. In this
circumstance, the investigator should complete the “Targeted/Planned
Enrollment Table” for a New Application and the “Inclusion
Enrollment Report” for
Continuation Applications, Competing Supplement Applications, and Annual
Grant Progress Reports if the data allow. However, if the existing data
do not allow accurate correspondence with the new categories, the investigator
should report the information using the prior categories and use the 4/98
Version of the Inclusion Table.
D2. There are many ways of tabulating the multiple
race and ethnicity responses, particularly since the race and ethnicity
categories are not mutually exclusive. Do the
numbers reported in the tables have to “add up”?
The numbers
in several parts of the two tables must be the same. In both the “Targeted/Planned
Enrollment Table” for a New Application and the “Inclusion
Enrollment Report ” for Continuation Applications, Competing Supplement
Applications, and Annual Progress Reports, the sum in “Ethnic
Category: Total of All Subjects” must equal the sum in “Racial
Categories: Total of All Subjects.” In addition, the “Racial
Categories: Total Hispanics or Latinos” in Part B of the “Inclusion
Enrollment Report Table” must equal the Total Hispanic or Latino number
reported in Part A of the “Inclusion Enrollment Report.” Footnotes
in the tables clearly identify which numbers must be the same.
D3. Can the Targeted/Planned Enrollment Table
or the Enrollment Inclusion Report be used to collect data from individuals?
Neither
the Targeted/Planned Enrollment Tablet nor the Enrollment Inclusion Report
should be used for collecting data from individuals. These tables are
only to be used for reporting aggregate data.
To collect data from an
individual respondent, investigators should use respondent self-report
or self-identification and use two separate questions. The
first question should be about ethnicity, followed by a question that provides
the option of selecting one or more racial designations. An example of a
format for collecting information from an individual can be found in the “Ethnic
Origin and Race” section of the Personal Data Form Page in the PHS
398 (rev. 5/01) http://grants.nih.gov/grants/funding/phs398/personal.pdf (PDF
- 168 KB)
D4. Can more detailed questions about ethnicity
and race be asked than these guidelines indicate?
The revised OMB guidelines
provide minimal standards for data collection. Indeed, researchers are encouraged
to explore collecting additional types of information on race and ethnicity
that will provide additional insights into the relationships between race
and ethnicity and health. For example, after asking the ethnicity and then
the race questions, researchers may opt to ask study participants who choose
multiple categories to identify the group that they identify with primarily.
Further questions identifying membership in subpopulations within the ethnic
and racial categories provided by OMB may also be considered. The scientific
question being addressed in the study should guide investigators’ decisions
regarding collection of any additional information on ethnicity or race.
Information on subpopulations may be reported by listing the information
in an attachment to the required table.
D5. What ethnic and racial categories should
be used to estimate race and ethnicity, given the new OMB standards?
Investigators
should use the categories described in the PHS 398 instructions and listed
in the table “Targeted/Planned Enrollment Table” for New Applications.
First, the investigator should report the anticipated total number of males
and females to be enrolled by Ethnicity (Hispanic or Latino, Not Hispanic
or Latino). Then, the investigator should report the anticipated total number
of males and females by Racial Categories (American Indian or Alaska Native,
Asian, Native Hawaiian or Other Pacific Islander, Black or African American,
White). The total number of subjects in the Ethnic Category section of the
table should equal the total number of subjects in the Racial Categories
section. Investigators do not need
to estimate the anticipated number of individuals reporting multiple racial
categories (either total number reporting multiple categories or number
reporting specific combinations) for New Applications. However, the investigator
must follow the OMB guidelines, which include allowing respondents to select
multiple race categories, once data collection commences.
D6. Data collection began prior to the new standards and the questions
do not comply with the new OMB standards. Should
questions asked about race and ethnicity be changed in the middle of the
study?
If data collection has already begun, we do not expect investigators to
change their questions on race and ethnicity prior to the completion of
the study. For Annual Progress Reports, in this circumstance, investigators
should note that the research project was initiated prior to the implementation
of the new reporting guidelines. If the data do not accurately correspond
with the new categories, the investigator may continue to use the format
in the 4/98 Version of the Inclusion Table.
D7. Data collection began prior to the new standards, but race and ethnicity
questions do comply with the new standards. Data for previous years has
been submitted using the old standards. How should data be reported in this
year’s
progress report?
If you began your data collection prior to the implementation
of the new standards but your questions on race and ethnicity comply with
the new standards, the choice is left up to the investigator as to how to
present the data for Annual Progress Reports. We suggest completion of the
new Inclusion Enrollment Report.
D8. How should race and ethnicity data be reported
when the research involves a foreign population?
Investigators are encouraged to design their data collection instruments
in ways that allow respondent self-identification of their racial and ethnic
affiliation. However, these items should be designed in a way that they
can be aggregated into the required categories. Also, the investigator can
report on any racial/ethnic subpopulations by listing this information in
an attachment to the required table. This may be particularly useful when
distinctive subpopulations are relevant to the scientific hypotheses being
studied.
When completing the tables, investigators should asterisk and
footnote the table indicating that data includes foreign participants. If
the aggregated data only includes foreign participants, the investigator
should provide information in one table with an asterisk and footnote. However,
if the study includes both domestic and foreign participants, we suggest
the investigator complete two separate tables – one
for domestic data and one for foreign data, with an asterisk and footnote
accompanying the table with foreign data.
D9. How do the 1997 OMB revised standards
differ from the previous standards?
OMB issued the previous standards
for maintaining, collecting, and presenting data on race and ethnicity in
1977. The minimum acceptable categories
were: American Indian or Alaska Native; Asian or Pacific Islander; Black,
not of Hispanic origin; Hispanic; White, not of Hispanic origin.
The 1997
OMB revised standards now include two ethnic categories (Hispanic or Latino
or Not Hispanic or Latino) and five racial categories (American Indian or
Alaska Native, Asian, Black or African American, Native Hawaiian or Other
Pacific Islander, and White). When using self-reporting or self-identification
to collect data on ethnicity and race, investigators should use two separate
questions with ethnicity information collected first followed by the option
to select more than one racial designation.
D10. Where can I find examples of questions for
collecting data on ethnicity and race from individuals that I could use
in my research?
There are several federal data instruments in the
public domain that include questions on ethnicity and race. One is
the “Ethnic Origin and
Race” section of the Personal Data Form in the PHS 308 (rev. 5/01) <http://grants.nih.gov/grants/funding/phs398/personal.pdf (PDF
- 168 KB)>.
This form includes questions that meet the minimum OMB standards by asking
the individual first about their ethnicity, followed by a question that
provides the option of selecting more than one racial designation.
You also
may want to explore collecting additional types of information on race and
ethnicity to provide greater insights into the relationships between race,
ethnicity, and health. For example, after asking about ethnicity and race,
you may want to ask study participants who chose multiple racial categories
to identify the group that they identify with primarily, e.g., “If
you selected more than one racial group, which one group would you say best
represents your race?” In addition, you may want to ask about
membership in subpopulations within the ethnic and racial categories provided
by OMB. For example, you may want to ask individuals who select American
Indian or Alaskan Native to identify the name of the enrolled or principal
tribe. Or,
you may want to ask about identification with specific subpopulations within
specific ethnic or racial categories, such as Puerto Rican, Cuban, Chinese,
Japanese, Korean, etc. The scientific question being addressed in your study
should guide your decision about collecting any additional information on
ethnicity and race.
Examples of federal data instruments that include more detailed questions
about ethnicity and race can be found at the US Census Bureau <http://www.census.gov/dmd/www/2000quest.html> and
through the National Health and Nutrition Examination Survey (NHANES), as
part of the Demographics Information collected in the Sample Person Questionnaire <http://www.cdc.gov/nchs/about/major/nhanes/questexam.htm >.
D11. When collecting and reporting population data, does
the PI have to follow the OMB guidelines or can other terminology be used?
Population
data reported to NIH must comply with the Office of Management and Budget
(OMB) Directive 15 for reporting population data on race and ethnicity.
However, discretion resides with the PI to design data collection instruments
that are culturally sensitive and appropriate. The instruments should
allow participants to self-identify his/her ethnicity and/or race; including
the option to identify several racial categories. Therefore,
the PI must aggregate the data into the OMB minimally required racial
and ethnic categories before reporting it to NIH.
For example, a
PI may decide to include the term “Chicano” in their data
collection instrument. The term “Spanish origin” can also
be used in addition to “Hispanic, Latino or Chicano.” The
investigator should determine the appropriate terms applicable for the
target Hispanic population. (For example, the terms Chicano or Latino
would be appropriate to use with California Mexican Americans but not
Puerto Ricans). Before reporting the data to NIH, the PI must aggregate
the data into the ethnic category, “Hispanic/Latino.”
In
situations where a participant wants to select more than one racial/ethnic
category, investigators can ask the participant to “check all race and
ethnicity that apply.” If more than one response is selected, a
statement should be added asking him/her to indicate a Race/Ethnicity that they
identify with primarily and report that as their primary race or ethnicity.
Asking for identification of the primary race/ethnicity decreases the number
of participants that are reported as “Unknown” or “Other.” If
possible, when these data are collected separately, the PI should report the
number of respondents in each racial category. In the case where participants
check more than one racial category but does not identify any primary race,
then the PI must aggregate the data and report it as "More
than one race."
E. NIH GRANTS AND COOPERATIVE AGREEMENTS:
INFORMATION ON THE NIH PEER REVIEW PROCESS
E1.What will NIH reviewers look for in applications
regarding the inclusion of women and minorities in clinical research?
Peer
reviewers will be asked to evaluate whether the research plan in the
application complies with the policy to include women and minorities
in clinical research studies, specifically they will evaluate it as
acceptable or unacceptable. Reviewers are instructed that their assessment
of the applicant’s plan should be factored into the score for
scientific and technical merit and they should provide a narrative text
to answer each of the following:
- Does the applicant propose a plan for the inclusion of minorities and both sexes for appropriate representation? (The research plan should describe the composition of the proposed study population in terms of sex/gender and racial/ethnic group, and provide a rationale for selection of such subjects.)
- Does the applicant propose justification when representation is limited or absent?
- Does the applicant propose exclusion of minorities and women on the basis that a requirement for inclusion is inappropriate with respect for the health of the subjects and/or with respect to the purpose of the research?
- Does the applicant propose plans for recruitment/outreach and retention of study participants, and are those plans appropriate and acceptable?
- For ongoing research projects, is the accrual data adequate in relation to target data?
E2. Are there additional elements that reviewers
will look for when an NIH-defined Phase III clinical trial is proposed?
YES. In
addition to the questions listed above, when an NIH-defined Phase III
clinical trial is proposed, the reviewers will evaluate the study design
and analysis plan:
- Has evidence been adequately evaluated in terms of whether clinically
important sex/gender and racial/ethnic differences in the intervention
effect are to be expected?
- Has the planned trial been designed to take into account these clinically
important sex/gender and/or racial/ethnic differences so that appropriate
numbers from each group are planned to be included in the study, including
the need to: (a) detect significant differences when available evidence
strongly indicates significant sex/gender and/or racial/ethnic differences;
or, (b) permit valid analyses when there is no clear-cut scientific
evidence to rule out significant differences between sex/gender and/or
racial/ethnic groups
in intervention effect?
E3. Will the criteria for addressing the inclusion
of women and minorities in the applicant’s plan affect the assigned
score for scientific and technical merit?
YES. The Scientific Review
Groups (SRGs) will treat the evaluation of the representation of women
and minorities and their subpopulations in a manner consistent with the
evaluation of all other factors that contribute to the overall priority
score. Below are the codes assigned to each application for both sex/gender
and minority groups. Any application given an unacceptable code “U”, results in a bar-to-funding
and must be resolved before the study is funded.
|
SEX/GENDER |
G1A |
Includes both genders, scientifically acceptable |
G2A |
Includes only women, scientifically acceptable |
G3A |
Includes only men, scientifically acceptable |
G4A |
Gender representation unknown, scientifically acceptable |
G1U |
Includes both genders, scientifically unacceptable |
G2U |
Includes only women, scientifically unacceptable |
G3U |
Includes only men, scientifically unacceptable |
G4U |
Gender representation unknown, scientifically unacceptable |
|
MINORITY |
M1A |
Includes minorities and non-minorities, scientifically acceptable |
M2A |
Includes only minorities, scientifically acceptable |
M3A |
Includes only non-minorities, scientifically acceptable |
M4A |
Minority representation unknown, scientifically acceptable |
M5A |
Includes only foreign subjects, scientifically acceptable |
M1U |
Includes minorities and non-minorities, scientifically unacceptable |
M2U |
Includes only minorities, scientifically unacceptable |
M3U |
Includes only non-minorities, scientifically unacceptable |
M4U |
Minority representation unknown, scientifically unacceptable |
M5U |
Includes only foreign subjects, scientifically unacceptable |
F. RESEARCH CONTRACTS: INFORMATION ON THE NIH PEER
REVIEW PROCESS
F1. How does the inclusion policy for women and
minorities in clinical research studies apply to the review of research
contract proposals and projects?
This inclusion policy applies to
NIH research and development contract projects as well as grant and cooperative
agreement projects. However there are several differences in procedures
for contract projects. The description of the planned contract
project is provided in the Request for Proposals (RFP), which includes
the statement of work and the evaluation criteria. When planning
and preparing the RFP, the NIH project officer must address many issues,
including determining whether the project is a clinical research study
and whether it is an NIH-defined Phase III clinical trial. In most cases,
the study design, sample size issues, and the inclusion requirements for
both sexes and members of racial/ethnic groups are also determined by
the NIH project officer. Outreach plans need to be addressed and
appropriate justifications provided when the requirement is for limited
representation. The required review criterion should also be included
as part of the evaluation criteria published in the RFP.
As an investigator
responding to the RFP, you must address the inclusion policy as reflected
in the RFP requirements and evaluation criteria. Peer reviewers
will evaluate proposals, looking at plans for recruitment, retention and
outreach for study participants, using the published review criteria. In
the case of NIH-defined Phase III clinical trials, they also will assess
the plan for valid analyses of sex/gender and racial/ethnic differences.
G. FUNDING INFORMATION
G1. How will conformance to the policy for
inclusion of women and minorities in clinical research affect funding of
grants and cooperative agreements?
Regardless of the priority score,
percentile ranking or program relevance of the proposed research, the NIH
funding components will not fund/award grants or contracts that do not
comply with this policy. The PI of any application selected for funding
that was considered by the Initial Review Group to have Unacceptable Gender
or Minority Inclusion will need provide a corrective plan to address the
deficiencies prior to award.
G2. How will conformance to the policy for inclusion of women and
minorities in clinical research affect funding of contracts?
Regardless
of the other merits of a proposal received in response to a solicitation,
the NIH will not award contracts that do not comply with this policy. All
issues regarding unacceptable gender or minority inclusion must be resolved
prior to award in the case of contracts.
G3. What reports need to be prepared using the data on inclusion
of women and minorities?
For all clinical research studies, applicants/offerors
need to provide information in applications, proposals and progress reports
using the following summary table format for planned enrollment of women
and minorities. For ongoing studies, awardees need to report annually
on the cumulative enrollment of the approved project/protocol(s). Using
the same format, the number of subjects enrolled in each study needs to
be provided. If more than one study/contract is being reported, the
awardee must provide a separate table for each study. Actual
accrual will be compared to the targets for inclusion that are found in
the original application/proposal.
The Inclusion Enrollment Report consists of two sections, Part A is the Total Enrollment Report indicating the number of subjects enrolled to date (cumulative):
By Ethnicity:
|
|
SEX/GENDER |
|
Ethnic Category |
Females |
Males |
Unknown/Not Reported |
Total |
Hispanic or Latino |
|
|
|
** |
Not Hispanic or Latino |
|
|
|
|
Unknown (Individuals not reporting ethnicity) |
|
|
|
|
Ethnic Category: Total of all Subjects |
|
|
|
* |
Then by Race:
Racial Categories
American Indian/Alaska Native |
|
|
|
Asian |
|
|
|
Native Hawaiian or Other Pacific Islander |
|
|
|
Black or African American |
|
|
|
White |
|
|
|
More than One race |
|
|
|
Unknown or Not Reported |
|
|
|
Racial Categories: Total of All Subjects |
|
|
* |
The second section of the report, Part B, is the Hispanic Enrollment Report indicating the number of Hispanics or Latinos enrolled to date:
Part B.: Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date (Cumulative) |
Racial Categories |
Females |
Males |
Unknown or Not Reported |
Total |
American Indian or Alaska Native |
|
|
|
|
Asian |
|
|
|
|
Native Hawaiian or Other Pacific Islander |
|
|
|
|
Black or African American |
|
|
|
|
White |
|
|
|
|
More than One Race |
|
|
|
|
Unknown or Not reported |
|
|
|
|
Racial Categories: Total of Hispanics or Latinos |
|
|
|
** |
* These Totals must agree
** These totals must agree
Inclusion Enrollment Report Format Page
HS398/2590 (Rev. 05/01)
For additional information about using and obtaining
these tables, please refer to the NIH Policy on Reporting Race and Ethnicity
Data: Subjects in Clinical Research http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html.
G4. The policy
requires inclusion and subpopulation data in the progress report for each
NIH-defined Phase III clinical trial grant or contract. Does that mean that
analyses need to be done every year?
NO. The progress report needs to report cumulative accrual data
annually and explain progress in conducting analyses for sex/gender and/or
racial/ethnic differences. If analyses of sex/gender and/or racial/ethnic
differences are not available at the time of the progress report, then a
justification and/or interim data analyses must be reported. Analyses should
be conducted when permitted by the study design and as described in the
analysis plan. For contracts, the schedule of deliverables will dictate
when reports and analyses are required.
G5. Where
can I obtain additional information?
For information about contract
policy, the contracting officer for the specific contract or the Division
of Acquisition Policy and Evaluation, Office of Acquisition Management and
Policy (301-496-6014), may be contacted.
Additional information about grants and cooperative agreements may be obtained
from NIH staff identified in Request for Applications (RFAs), Program Announcements
(PAs), or on awards. The following senior extramural staff from the NIH
Institutes and Centers may be contacted for further information about the
policy and relevant Institute/Center programs:
http://grants.nih.gov/grants/funding/women_min/wm_omb_policy_contacts.doc (MS
Word - 61 KB).
Return to Inclusion of Women and Minorities Page
|