Reporting race and ethnicity of research
participants: What you need to know
CCOP MINORITY
PARTICIPATION COMMITTEE
September 25, 2013
Michael J. Fisch, MD, MPH
Lynne Nguyen, MPH
Presentation Goals
• NCORP relevance
• NIH reporting changes
• Strategies for developing your research and recruitment
plans
• Resources
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Expansion to Cancer Care Delivery
Research
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Why Focus on Cancer Disparities Research
in NCORP?
• Persistent disparities
• Cancer incidence, mortality, and quality of life
• Access to and quality of care
• Increase in the number of underserved/underrepresented
populations
• Determinants of disparities (social factors, health care
systems, co-morbidities) disproportionately affect
outcomes for underserved populations
• Challenging to fully and equitably implement new
technologies and targeted therapies for the underserved
Need for further research to reduce disparities and improve
outcomes for underserved populations across the continuum of care
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NIH Inclusion Policy
The goal is not to satisfy any quotas for proportional
representation based upon census data, but rather to
1. Ensure that individuals are included in clinical research
in a manner that is appropriate to the scientific question
under study
2. 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.
http://grants.nih.gov/grants/funding/women_min/women_min.htm
http://orwh.od.nih.gov/research/inclusion/reports.asp
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NIH Inclusion Policy
Applies to ALL projects meeting the NIH definition for
clinical research, not just clinical trials, and includes:
1.
Patient-oriented studies
2.
Epidemiological and behavioral studies
3.
Outcomes research and health services research
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Patient-Oriented Studies
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.
1.
Excluded: in vitro studies that utilize human tissues
that cannot be linked to a living individual.
2.
Includes:
o mechanisms of human disease
o therapeutic interventions
o clinical trials
o development of new technologies
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Inclusion Enrollment Form Changes
• Addition of the “More than one race” category
• Modified layout of the Planned Enrollment Report and the
Cumulative Inclusion Enrollment Report
• Both forms are structured data forms and replace the
need to attach enrollment tables as pdf files on
electronically submitted competing grant applications.
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-092.html
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Standards for Race and Ethnicity
Office of Management and Budget (OMB) sets minimum
standards for maintaining, collecting, and presenting data
on race and ethnicity
• Key points:
• Five racial categories and two ethnic categories
• Race and ethnicity are distinct concepts
• Individuals may identify with more than one racial category
• Self-identification is the preferred method
• Individuals always have the option to not identify
• Additional details:
• OMB Statement:
http://www.whitehouse.gov/omb/fedreg_1997standards
• NIH Policy on Reporting Race and Ethnicity:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01053.html
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Racial and Ethnic Categories as Defined by OMB
• 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
• 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.
• White: A person having origins in any of the original peoples of Europe, the Middle
East, or North Africa.
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Current Targeted/Planned Enrollment Report
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Modified Planned Enrollment Report
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Current Inclusion Enrollment Report
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Modified Cumulative Inclusion Enrollment Report
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Why the changes to the reporting formats?
• Addition of “More than one race” to Planned
Enrollment Report
• Better alignment with the Census
• Better alignment of the NIH formats for reporting planned and
actual enrollment
• Change in layout
• Simplify the reporting formats
• Clarify that race and ethnicity are distinct concepts and each
participant should be given the option to identify with both
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Transition Plans: When to Use Which
Form?
• Applicants will use the modified Planned and
Cumulative Inclusion Enrollment Reports when
submitting (new or continuing) COMPETING
submission packages starting with September 2013
receipt dates*
*Note: SBIR/STTR packages will start using the modified layout after September 7, 2013
• Investigators will continue to use the current
Inclusion Enrollment Report for non-competing
continuation (e.g., progress) reports until further
notice
• For more information please see the recent NIH
Guide Notice: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-092.html
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The Research Plan
The Research Plan (for grant applications) or Proposals
(for contract solicitations) MUST include a description of
plans to conduct analyses to conduct valid analysis by
sex/gender, racial/ethnic groups, and relevant
subpopulations, if applicable.
• 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.
www.grants.nih.gov/grants/funding/women_min/outreach_qa.htm#1056
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Research Plan
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.
www.grants.nih.gov/grants/funding/women_min/outreach_qa.htm#1056
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Exclusion of a Population
Difficulty recruiting a particular segment of the population is
generally not a valid reason for not including them in your
population. Depends on the size of the research project
(funding, availability of the population of interest)
Need to address why a population is excluded in the
recruitment plan.
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Developing the Recruitment Plan: Tell
Your Story
1. Define the catchment area (geography)
2. Demographics of residents that live in the catchment
area
3. Demographics of residents diagnosed with cancer in the
catchment area
4. Demographics of your patients with cancer
5. Demographics of your patients that live in the
catchment area
6. Demographics of your patients on clinical trials
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MD Anderson Catchment Area
MDA Patient Population
2007-2011
International
3%
Other U.S.
39%
Houston
Metro 10County Area
30%
Other Texas
28%
10-county population: 6.2M people; Texas population: 26.1M
(Census 2012)
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Texas: Ethnicity and Cancer
Not Hisp/Lat
19%
Hisp/Latino
11%
5%
86%
95%
MDA All Pts
MDA ~Texas
14%
38%
81%
86%
62%
Texas Pop
Texas Ca Pts
Texas Population – US 2012 Census
Texas Cancer Patients – Texas Cancer Registry (2005-09)
MDA Texas Cancer Patients – MDA Tumor Registry (2007-11)
MDA TX Pts
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The Demographics of Texas
Anglo
Hispanic
72.6%
57.2%
60.2%
63.5%
66.4%
67.1%
53.0%
45.0%
45.0% 43.1%
44.4%
44.0%
41.6%
40.5% 38.6%
39.5%
41.3% 38.0%
38.4%
47.8%
35.3%
30.5%
26.7%
24.2%
22.4%
20.6%
20.3%
16.7%
Texas State Data Center
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Texas: Race and Cancer
White
Black
Other
4%
11%
4.9%
7.7%
5%
5%
5%
10%
81%
86%
86%
90%
86%
Texas Pop
Texas Ca Pts
MDA All Pts
MDA ~Texas
MDA TX Pts
7%
12%
Texas Population – US 2012 Census
Texas Cancer Patients – Texas Cancer Registry (2005-09)
MDA Texas Cancer Patients – MDA Tumor Registry (2007-11)
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Calculating the Participation Rate
Define the patient population (denominator)
a. Patients that were registered between
2007-2011
b. And diagnosed with cancer (ICD-O
codes ending in 2 or 3)
c. Excluded 2nd opinions, preventive
screenings
Identify the numerator – Of the patients with
cancer that came in between 2007-2011,
how many enrolled in a clinical trial?
a. Count only the first instance of
enrollment. This is a rate.
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Understand Your Data
Always confirm data with people “on the floor”
Explore factors that may affect accrual rate to clinical trials
(patient’s ability to participate on a clinical trial)
o Patient disease stage
o Availability of trials
o Trials ending/starting
o Eligibility criteria
o Patient demographics (i.e. from out of town)
Identify the most appropriate methodology to answer the
question
o Snapshot–in–time method
o Cohort method
Document!
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Resources: NIH
Grants Information
Office of Extramural Research
National Institutes of Health
Telephone: 301-435-0714
Email: GrantsInfo@nih.gov
Web: http://grants.nih.gov/grants/oer.htm
OR
For more information and staff contacts, please see
the OER webpage for the Inclusion of Women and
Minorities in Clinical Research:
http://grants.nih.gov/grants/funding/women_min/women_min.htm
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Resources: NIH
• The amended policy
• Podcasts & narrated slide decks on reporting
•
•
•
•
race/ethnicity
FAQs
Planned Enrollment Report, Inclusion Enrollment Report
FAQs
Dr. Sally Rockey’s blog “Rock Talk” (NIH Deputy Director
for Extramural Research) http://1.usa.gov/1fd83U9
http://grants.nih.gov/grants/funding/women_min/women_min.htm
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Other Resources
• State Cancer Profiles (NCI)
www.statecancerprofiles.cancer.gov/index.html
• US Census Fast Facts
www.quickfacts.census.gov/qfd/index.html
• State Cancer Registry (Texas State Data Center)
• State Data Center (Texas State Data Center)
• Local, state, regional and national organizations
(survivorship, advocacy, health services, minority
professional associations)
• Your CCOP Research Base!
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Community Collaborations
To avoid “drive-by” research, research must:
• Be mutually beneficial to collaborators
• Include sharing of resources
• Include sharing of ideas and decisions
• Include dissemination of results, knowledge to
collaborators
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THANK YOU!
Questions?