Potentially Vulnerable Subjects Involved: Check all applicable groups. Children/adolescents1 Mentally ill outpatients – Mentally ill inpatients – Cognitively impaired Elderly, if institutionalized Pregnant females Prisoners2 HIV+ Other: Recruitment Procedures: b. Are subjects in a subservient power a. How will you recruit subjects? Check all that apply: relationship to investigators or to Cary Institute Summer Ecology Camp parties with an interest in the research, Local schools, where: such as students in an instructor/ announcements investigator’s class or employees of the investigator? Letters to parents/guardians E-mail specify groups: – Yes No Radio/TV/newspaper ads If Yes, how will you ensure that their Other: participation is truly voluntary? [List all recruitment sites.] c. Describe incentives for subjects, if any (money, drawing, No incentives class points, etc.). d. List pro-rating for incentives for study drop-outs. Not applicable Consent Procedures: Check all that apply. Oral (attach script) If you plan to enroll non-English speaking participants, the consent form and assent Information letter used in survey research (attach) – document(s) must be translated into the Informed consent form (attach) appropriate language(s) and included with Assent form for children (attach) this submission. Assent form for subjects with intellectual disabilities (attach) For subject populations where competence to consent is highly questionable (e.g. some Not applicable psychiatric populations), explain how competency will be determined and by whom. Request waiver of written consent justify: – Request waiver of consent justify: –
Potentially Vulnerable Subjects Involved: Children/adolescents1 Mentally ill – outpatients Mentally ill – inpatients Cognitively impaired Elderly, if institutionalized Pregnant females Prisoners2 HIV+ Other: Check all applicable groups. Recruitment Procedures: a. How will you recruit subjects? Check all that apply: Cary Institute Summer Ecology Camp Local schools, where: announcements Letters to parents/guardians E-mail – specify groups: Radio/TV/newspaper ads Other: [List all recruitment sites.] b. Are subjects in a subservient power relationship to investigators or to parties with an interest in the research, such as students in an instructor/ investigator’s class or employees of the investigator? Yes No If Yes, how will you ensure that their participation is truly voluntary? c. Describe incentives for subjects, if any (money, drawing, class points, etc.). No incentives d. List pro-rating for incentives for study drop-outs. Not applicable Consent Procedures: Oral (attach script) Information letter – used in survey research (attach) Informed consent form (attach) Assent form for children (attach) Assent form for subjects with intellectual disabilities (attach) Not applicable Request waiver of written consent – justify: Request waiver of consent – justify: Check all that apply. If you plan to enroll non-English speaking participants, the consent form and assent document(s) must be translated into the appropriate language(s) and included with this submission. For subject populations where competence to consent is highly questionable (e.g. some psychiatric populations), explain how competency will be determined and by whom.
IRB%20Protocol%20Application%202016.docx