My study involves a vulnerable population (e.g., minors, pregnant women, prisoners, mentally disabled, etc.). Do I need to do anything extra?
Investigators should be mindful of their intended subject population, and the consent form and accompanying consenting process should be developed toward a level of understanding appropriate for that population. The following sites pertain to research involving certain populations that have been viewed as “vulnerable”. If you are working with these subject populations, please refer to this guidance material: Fetuses and In Vitro Fertilization: http://www.hhs.gov/ohrp/irb/irb_chapter6.htm#g2 Women: http://www.hhs.gov/ohrp/irb/irb_chapter6.htm#g3 Children and Minors: http://www.hhs.gov/ohrp/irb/irb_chapter6.htm#g4 Cognitively Impaired Persons: http://www.hhs.gov/ohrp/irb/irb_chapter6.htm#g5 Prisoners:http://www.hhs.gov/ohrp/irb/irb_chapter6ii.htm#g6 Traumatized and Comatose Patients: http://www.hhs.gov/ohrp/irb/irb_chapter6ii.htm#g7 Terminally Ill Patients: http://www.hhs.gov/ohrp/irb/irb_chapter6ii.htm#g8 Elderly/Aged Persons: http://www.hhs.gov/ohrp/irb/irb_chapter6ii.htm#g9 Minorities
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