Beneficence - Protecting Human Subject Research Participants

Protecting Human Research Participantsstudy, the IRB may require some additional protections if they feel that the adolescents who will beinvolved in the study are vulnerable.No, the study does not involve a vulnerable populationCorrect!The regulatory definition of children depends both on the local laws and on the specific treatments orprocedures that will be involved in the research. Because the location in which the research will beconducted allows 12-year-olds to consent to the treatment, the participants in this research are notconsidered children under the HHS regulations and can provide informed consent to participate in thestudy. While the regulations do not require the additional protections of Subpart D for children in thisstudy, the IRB may require some additional protections if they feel that the adolescents who will beinvolved in the study are vulnerable.Previous Page 14 of 19Nexthttp://phrp.nihtraining.com/codes/14_codes.php (2 of 2)6/20/2008 9:40:07 AM