Table 1.
Research Activities and Human Subject Protection Information by Protocol Phase.
| Research Activity | Research Method | Target Population | Exemption Requested | Consent Information | Community Focus |
|---|---|---|---|---|---|
| Phase I Protocol | |||||
| Epidemiological Profile | Public use data; Secondary data analysis | Community | Yes | None | Direct |
| Area of Focus Determination | Public use data; Secondary data analysis | Community | Yes | None | Direct |
| Population of Focus Determination | Public use data; Secondary data analysis | Community | Yes | None | Direct |
| Partnership Development | Initial and In-depth Interview surveys | Community | Yes | None | Direct |
| Internal Organization Functioning | Survey and qualitative Interviews | Community; study staff | Yes | None | Direct |
| Phase II Protocol | |||||
| HIV+ ACASI | Computerized survey | HIV+ youth | No | Consent required; parental waiver; signed consent waiver | Indirect |
| Brief Venue Interview | Brief five-question interview | HIV− youth | No | Consent required; parental waiver; signed consent waiver | Indirect |
| Ethnographic Survey | Ethnographic survey | Community | Yes | None | Direct |
| HIV–ACASI | Computerized survey; anonymous HIV test | HIV− youth | No | Consent required; parental waiver; | Indirect |
| Working Groups | Survey and qualitative interviews | Community | Yes | signed consent waiver None | Direct |
| Internal Organization Functioning | Community researcher partnership interview; other surveys and qualitative interviews; survey and qualitative interviews | Community; study staff | Yes | None1 | Direct |
ACASI: Audio Computer-Assisted Self-Interviewing technology
1
Although the ethics committees were asked to exempt these interviews from research oversight, permission scripts were created to document that all interviewees were informed of the audio taping in the same manner, to allow for the interviewees to opt-out and to provide documentation of the interviewees acceptance of the audio taping.