ii. All the other conditions for ethical justification as set forth in this
document are satisfied
9.
Guiding principal 9. Potential harm. The nature, magnitude and probability
of potential harm resulting from the participation in an HIV prevention vaccine
trial should be specified in a research protocol fully as well as the modalities
by which to address these, including provision of the highest standard of care
to participants who experience adverse reaction to vaccine, compensation for
injury and referralfor psychosocial and legal support as necessary.
10.
Guiding principal 10: Benefits. The research protocol should outline the
benefits that persons participating in HIV vaccine research experiences as a
result of their participation. Care should be taken so that these are not
presented in a way that unduly influences freedom of choice in participation.
At a minimum participants should:
•
Have regular supportive contact with health care workers and counselors
throughout the course of the trial
•
Receive comprehensive information regarding HIV transmission and HIV
prevention
•
Receive access to HIV prevention methods including male and female
condoms
•
Have access to a prepaid care and treatment package for HIV and AIDS
if they become infected while enrolled in the trial
•
receive compensation for the time, travel and inconvenience of
participating in a trial
24
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