Table 29

Situations where reconsenting of research subjects may be necessary.

Situations Where Subject Reconsent May be Necessary

More specific purpose than indicated on original consent form

Secondary testing creates data with new risks

Genetics Testing

HIV testing

Security of original data compromised

Patient/Subject has turned 18

Scenario 4 – Question 8. A total of 6 interviews provided responses. Respondents were IRB directors, university and IRB legal counsel, and an Office of Research representative. Data was aggregated with interview statement as the unit of analysis.

Manion et al. BMC Medical Informatics and Decision Making 2009 9:31   doi:10.1186/1472-6947-9-31