Reporting race and ethnicity of research participants : What you need to know

1. Reporting race and ethnicity of research participants: What you need to know

2. CCOP Minority Participation Committee September 25, 2013 Michael J. Fisch, MD, MPH Lynne Nguyen, MPH

3. Presentation Goals • NCORP relevance • NIH reporting changes • Strategies for developing your research and recruitment plans • Resources

4. Expansion to Cancer Care Delivery Research

5. 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

6. NIH Inclusion Policy The goal is not to satisfy any quotas for proportional representation based upon census data, but rather to • Ensure that individuals are included in clinical research in a manner that is appropriate to the scientific question under study • 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

7. NIH Inclusion Policy Applies to ALL projects meeting the NIH definition for clinical research, not just clinical trials, and includes: • Patient-oriented studies • Epidemiological and behavioral studies • Outcomes research and health services research

8. 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. • Excluded: in vitro studies that utilize human tissues that cannot be linked to a living individual. • Includes: • mechanisms of human disease • therapeutic interventions • clinical trials • development of new technologies

9. 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

10. 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-01-053.html

11. 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.

12. Current Targeted/Planned Enrollment Report

13. Modified Planned Enrollment Report

14. Current Inclusion Enrollment Report

15. Modified Cumulative Inclusion Enrollment Report

16. 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

17. 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

18. 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

19. 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

20. 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.

21. Developing the Recruitment Plan: Tell Your Story • Define the catchment area (geography) • Demographics of residents that live in the catchment area • Demographics of residents diagnosed with cancer in the catchment area • Demographics of your patients with cancer • Demographics of your patients that live in the catchment area • Demographics of your patients on clinical trials

22. MD Anderson Catchment Area 10-county population: 6.2M people; Texas population: 26.1M (Census 2012)

23. Texas: Ethnicity and Cancer Texas Population – US 2012 Census Texas Cancer Patients – Texas Cancer Registry (2005-09) MDA Texas Cancer Patients – MDA Tumor Registry (2007-11)

24. The Demographics of Texas Texas State Data Center

25. Texas: Race and Cancer Texas Population – US 2012 Census Texas Cancer Patients – Texas Cancer Registry (2005-09) MDA Texas Cancer Patients – MDA Tumor Registry (2007-11)

26. Calculating the Participation Rate Define the patient population (denominator) • Patients that were registered between 2007-2011 • And diagnosed with cancer (ICD-O codes ending in 2 or 3) • 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? • Count only the first instance of enrollment. This is a rate.

27. 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) • Patient disease stage • Availability of trials • Trials ending/starting • Eligibility criteria • Patient demographics (i.e. from out of town) Identify the most appropriate methodology to answer the question • Snapshot–in–time method • Cohort method Document!

28. Resources: NIH Grants InformationOffice of Extramural ResearchNational Institutes of HealthTelephone: 301-435-0714Email: GrantsInfo@nih.govWeb: 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

29. 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

30. 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!

31. 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

32. THANK YOU! Questions?