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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
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.
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
The following documents
are available in the Clinical Translational Research Center. To
obtain a copy, contact Amy Hartkemeyer, business manager, 513-636-4273,
email@example.com. The Federal Register,
March 9, 1994, pages 11146-11151.
For more information, contact Amy Hartkemeyer, business manager, 513-636-4273, firstname.lastname@example.org.
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