Protection of Human Subjects Regulations

Studies that are supported by federal funding must comply with 45CFR46, Protection of Human Subjects [26]. Subpart A of this regulation is the basic Department of Health and Human Services Policy for Protection of Human Research Subjects, and contains basic protections for human research subjects participating in clinical research. Expedited review for studies that represent minimal risk to study subjects is possible under this regulation. Federal regulations require that IRB give special consideration to protecting the welfare of particularly vulnerable subjects, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. Institutional Review Board approval is necessary and ensures that risks are minimized and reasonable with benefits to subjects of study participation. Institutional Review Boards' ensure that subject selection is equitable, require informed consent for studies, review protocols to ensure safety and subject confidentiality, and ensure protection of vulnerable subjects. Many IRBs follow federal regulations on the conduct of studies in pregnant women.

Subpart B of this regulation, modified in 2001, is critical to conducting studies in pregnant women and contains additional protections for human fetuses, pregnant women, and human in vitro fertilization (Table 3).

According to Subpart B, pregnant women can give informed consent and engage in research studies if (1) studies have been conducted on animals and nonpregnant women; (2) research meets the health needs of the mother and the risk to the fetus is the minimum necessary or minimal risk; and (3) research benefits the mother, fetus, or general knowledge. In general, maternal consent is all that is necessary for the participation of pregnant

TABLE 3 Protections of Human Subjects Regulations Pertaining to Pregnant Women

Benefits of study Consent required

General knowledge Maternal only

Maternal health Maternal only

Fetal health Maternal & paternal women in studies. However, for studies that benefit only the fetus, both maternal and paternal consent are required for maternal participation in such studies.

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