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Special Population


Children

Prisoners

Decisionally Impaired Persons Pregnant Women, Fetus, and Human in vitro Fertilization

 

Children

The special vulnerability of children makes consideration of involving them as research subjects particularly important. To safeguard their interests and to protect them from harm, special ethical and regulatory considerations are in place for reviewing research involving children. Title 45 CFR Part 46, Subpart D provides for "Additional Protections for Children Involved as Subjects of Research." Research that is contrary to the rights and welfare of child-subjects is prohibited.

 

Definitions Used with Research with Children

The federal regulations and OSU policies require that the IRB classify research involving children into one of four categories and document their discussions of the risks and benefits of the research study.

In all cases, the IRB must determine that adequate provisions have been made for soliciting the assent of children and the permission of their parents or guardians [45 CFR 46.408].

The four categories of research involving children that may be approved by IRBs, based on degree of risk and benefit to individual subjects, are as follows:

 

Prisoners

Because the very fact of incarceration may make it difficult to ensure voluntary consent and confidentiality, special regulations are in place to provide protections pertaining to biomedical or behavioral research involving prisoners as subjects. [45 CFR 46, Subpart C]. These regulations apply whenever any human subject becomes a prisoner at any time during a study. OSU policy requires that all research involving prisoners be reviewed by the full board.

 

Definitions Used with Research Involving Prisoners:

 

For research that will involve prisoners to be approved, it must fall within the categories of research permissible by the regulations [45 CFR 46.306(a)(2)]. These categories are:

 

There are seven (7) conditions that must be met before the IRB can approve research using prisoners as subjects:

 

Decisionally Impaired Persons

The predominant ethical concern in research involving individuals with psychiatric, cognitive, or developmental disorders is that their disorders may compromise their capacity to understand the information presented to them. Diminished capacity may be due to psychiatric, organic, developmental, or other disorders that affect cognitive or emotional functions.

 

Other individuals who may be considered decisionally impaired with limited decision-making ability are persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseases affecting the brain, terminally ill patients, and persons with severely disabling physical handicaps. Investigators must take special care to consider issues such as the selection of subjects, privacy and confidentiality, coercion and undue influence, and the risks versus the benefits.

Pregnant Women and Fetuses

The federal regulations require the IRB to document specific findings for research in this category to minimize risk or harm to the fetus, and additional attention is required for obtaining informed consent. Research involving fetuses should be conducted when there is no reasonable alternative to obtaining the necessary scientific information.

 

Investigators are encouraged to consult 45 CFR Part 46, Subpart B for precise requirements regarding research with subjects in this category.

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