Gender and Minority Inclusion
Children's Hospital Medical Center of Cincinnati General Clinical Research Center funding depends on compliance with National Institutes of Health guidelines.
The National Institutes of Health requires that clinical studies include both genders and minorities in such a way that results are applicable to the general population. Exceptions include studies of diagnoses or conditions that occur only in one gender or ethnic group.
In such studies, the protocol should include a scientific justification for any gender and minority group differences, and the investigator must explain what outreach program will be implemented to overcome this problem. Failure to address these issues in detail will result in mandated penalties for scientific priority.
Investigators should include one table for each study population. It is not sufficient to list only "Blacks" as minorities. All ethnic minorities must be listed. Investigators should also review recruitment into their studies at intervals to assess whether they are achieving the stated targets. If not, the investigator needs to develop an outreach program immediately.
The gender and minority compositions of each study will be reviewed at submission and annually for each protocol approved by the Scientific Advisory Committee. Lack of attention to recruitment will affect the ability of the research center to support a study and will adversely affect review of future applications to the research center.
To adequately complete the Gender and Minority Exclusion section of the protocol, several points must be addressed:
- State the diagnosis or condition being studied.
- Complete a table of the gender and ethnic group prevalence of the diagnosis or condition.
- Pay attention to whether the prevalence of disease differs from the United States population distribution.
- Include fair representation of the ethnic and gender groups that should have the highest incidence of the diagnosis or condition you are studying, regardless of what is shown in your catchment area.
- Explain your outreach strategy.
- If the diagnosis or condition prevalence is skewed toward women or minorities, there must be an outreach plan in place to include those women and minorities in the study. Use the national percentages of ethnic groups with that diagnosis or condition as your goal.
- If the diagnosis or condition prevalence is not skewed toward race or gender, you can match your local catchment area with respect to race and gender. You still must have an outreach strategy to ensure you include the minorities and women in your area. Please see the lists of minority composition from the 1990 census for our area, the composition serviced by the University and Children's Hospitals, and the United States population.
The following documents are available in the General Clinical Research Center. To obtain a copy, please contact Andrea Smith, administrative manager, 513-636-4273.
- The Federal Register, March 9, 1994, pages 11146-11151.
- "Questions and Answers Concerning the 1994 NIH Guidelines on the Inclusion of Women and Minorities as Subjects on Clinical Research," Sept. 7, 1994.
- "Outreach Notebook for the NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research."
Notes
Note changes from the previous guidelines, which requested that the investigator achieve ethnic balance according to the catchment area.
These guidelines apply to all clinical research involving human subjects, excluding Phase III clinical trials. If the study is a Phase III clinical trial, please contact James E. Heubi, M.D.,, program director, for additional instructions.
Contact Us
For more information, please contact Andrea Smith, administrative manager, 513-636-4273.
