You cannot approach a potential study subject to recruit them for a research study if they have already refused to consent for that same study in the past. It does not matter how long ago they may have refused to consent—if they said “no”, you may not re-approach. However, you may recruit this potential subject for a different research study if you believe they may qualify.
Yes. A sponsor's waiver of inclusion criteria for an individual subject also requires IRB approval prior to implementation.
Enrollment occurs when the consent form is signed, not when the subject is randomized. Therefore, an estimate of screen failures should be incorporated into the target enrollment submitted to the IRB.
The advertisement policy clarifies that the specific dollar amounts are not to be included in study advertisements. Advertisements may state “You will be compensated for your study participation” but should not state the specific amount to be paid, or use bold or enlarged print or other means to emphasize compensation.
Because income from research participation is potentially taxable, the income must be reported to the IRS. The Personal Data Disclosure Form, available on the IRB web site, includes fields for both the Social Security Number and the Duke Unique ID. However, only one of the identifying numbers is required. For employees, list the Duke Unique ID so that the Social Security Number is not needed.