Vulnerable
Populations
lChildren
lPrisoners
lPregnant Women and
Fetuses
| Subpart B – Stipulates
conditions whereby research can be
conducted on pregnant women |
|
| Covers areas related to
risk to health of mother, risk to fetus, viability of fetus and appropriate
levels of consent i.e. paternal consent required in some cases |
|
| Subpart D – Children not involved in research of
greater than minimal risk unless there is a prospect for direct benefit
(with not direct benefit – IRB must find that increase over minimal is minor
or presents experience commiserate with actual treatment and information is
of vital importance. |
|
| Consent (parental
permission) and Assent – must be yes/yes unless overriding benefit (life and
death) |
|
| Subpart C – Prisoner
advocate on the IRB |
|
| Research related to
prisoners – health problems prevalent in prisoners etc. |
|
| Incarceration |
|
| Criminal Behavior |