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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 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:
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 director, 513-636-4273, firstname.lastname@example.org.
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