Gender and Minority Inclusion
Cincinnati Children’s Clinical Translational 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 US 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 2010 census for our area, the composition serviced
by University and Children’s hospitals, Ohio and the US population.
The following documents
are available in the Clinical Translational Research Center. To
obtain a copy, contact Amy Hartkemeyer, business manager, 513-636-4273,
amy.hartkemeyer@cchmc.org. 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.”
Contact Us
For more information, contact Amy Hartkemeyer, business manager, 513-636-4273, amy.hartkemeyer@cchmc.org.
