The CSS IRB will assure that additional protections are implemented, as necessary, to protect vulnerable research subjects (such as those with impaired decision-making capacity, neurological, developmental or psychiatric disorders; educational disadvantages; medical, social, or economic conditions; or other circumstances that might restrict the individual’s capacity to provide inform). The extent of additional protection afforded should depend upon the risk of harm and the likelihood of benefit.
The CSS IRB will assure that additional protections are implemented, as necessary, to protect vulnerable research subjects (such as those with impaired decision-making capacity, neurological, developmental or psychiatric disorders; educational disadvantages; medical, social, or economic conditions; or other circumstances that might restrict the individual’s capacity to provide inform). The extent of additional protection afforded should depend upon the risk of harm and the likelihood of benefit.
The CSS IRB does not currently review research involving prisoners. If this were to change, procedures consistent with the requirements of Subpart C of 45 CFR 46 will be developed.
If a subject were to become incarcerated while participating in a study that has not been approved for inclusion of prisoners, the IRB must be notified immediately so that the IRB can determine whether the subject may continue in the research, whether additional safeguards are needed, and other determinations.
The CSS IRB does not currently review research involving pregnant women. If a woman becomes pregnant while participating in a study that has not been approved for inclusion of pregnant women, the IRB must be notified immediately so that the IRB can determine whether the subject may continue in the research, whether additional safeguards are needed, and to make the determinations required by the regulations and these policies.