Vulnerable Populations Checklists- Women, Fetuses, Neonates
|IRB-HSR# or UVA Study Tracking PI: |
|Reviewer: Meeting Date: |
| Pregnant Women, Human Fetuses |
| |CONDITION MET? |REVIEWER COMMENTS |
|45 CFR 46.204 Research involving pregnant women or fetuses | | |
|Pregnant women or fetuses may be involved in research only if ALL the | | |
|following conditions are met: | | |
|Where scientifically appropriate, preclinical studies, including | YES NO NA | |
|studies on pregnant animals, and clinical studies, including studies on | | |
|non-pregnant women, have been conducted and provide data for assessing | | |
|potential risks to pregnant women and fetuses; | | |
|The risk to the fetus is caused solely by interventions or | YES NO |Which criteria applies? |
|procedures that hold out the prospect of direct benefit for the woman or the | |The risk to the fetus is caused solely by interventions |
|fetus; or, if there is no such prospect of benefit, the risk to the fetus is | |The procedures hold out the prospect of direct benefit for |
|not greater than minimal and the purpose of the research is the development | |the woman or the fetus |
|of important biomedical knowledge which cannot be obtained by any other | |There is no prospect of benefit, the risk to the fetus is not|
|means; | |greater than minimal and the purpose of the research is the |
| | |development of important biomedical knowledge which cannot be|
| | |obtained by any other means; |
|Any risk is the least possible for achieving the objectives of | | |
|the research; |YES NO | |
|If the research holds out the prospect of direct benefit to the | YES NO |Which criteria applies? |
|pregnant woman, the prospect of a direct benefit both to the pregnant woman |NA |The research holds out the prospect of direct benefit to the |
|and the fetus, or no prospect of benefit for the woman nor the fetus when | |pregnant woman. |
|risk to the fetus is not greater than minimal and the purpose of the research| |There is a prospect of a direct benefit both to the pregnant |
|is the development of important biomedical knowledge that cannot be obtained | |woman and the fetus. |
|by any other means, her consent is obtained in accord with the informed | |There is no prospect of benefit for the woman nor the fetus, |
|consent provisions of the Federal Regulations (45CFR46 subpart A); | |the risk to the fetus is not greater than minimal, the |
| | |purpose of the research is the development of important |
| | |biomedical knowledge that cannot be obtained by any other |
| | |means, and the mothers consent will be obtained in accord |
| | |with the informed consent provisions of the Federal |
| | |Regulations (45CFR46 subpart A); |
|If the research holds out the prospect of direct benefit solely to the fetus | YES NO | |
|then the consent of the pregnant woman and the father is obtained in accord |NA | |
|with the informed consent provisions of the Federal Regulations (45CFR46 | | |
|Subpart A) , except that the father's consent need not be obtained if he is | | |
|unable to consent because of unavailability, incompetence, or temporary | | |
|incapacity or the pregnancy resulted from rape or incest. | | |
|Each individual providing consent is fully informed regarding the reasonably | YES NO | |
|foreseeable impact of the research on the fetus or neonate | | |
|For children (per state law person ................
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