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human subjects protection office

Forms for Completion for the Protection of Vulnerable Populations in Research

Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research:

Form B204 Complete this form if the research involves pregnant women or fetuses
Form B205 Complete this form if the research involves nonviable neonates or neonates of uncertain viability
Form B206 Complete this form if the research involves, after delivery, the placenta, the dead fetus or fetal material
Form B207 Complete this form if the research is not approvable under category 204, 205, or 206 but presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of the pregnant women, fetuses, or neonates 

Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects:

Form C  Complete this form if prisoners will be involved in the research activities

Additional Protections for Children (and Decisionally Impaired Adults) Involved as Subjects in Research:

Form D404 Complete this form when the research involves no greater than minimal risk
Form D405 Complete this form when the research involves greater than minimal risk but presents the prospect of direct benefit to the individual subjects
Form D406 Complete this form when the research represents a minor increase over minimal risk and no prospect of direct benefit to individual subjects, but is likely to yield generalizable knowledge about the subject's disorder or condition
Form D407 Complete this form when the research is not approvable under D404, D405 or D406 but presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children

Additional Protections for Other Vulnerable Populations Involved in Research:

Form S Complete this form when UCHC students, UCHC employees, economically disadvantaged, educationally disadvantaged or terminally ill individuals are the focus of recruitment.  This form must also be completed, in conjunction with Form D, when decisionally impaired adults are to be involved in research.

 

  
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