Institutional Review Board: Policy and Procedure Manual

Institutional Review Board

Special Populations


The federal government has extensively regulated and provided additional safeguards with respect to research, development, and related activities involving "special populations"; these include pregnant women and fetuses, prisoners, and children. The following are guidelines for the inclusion of these special populations as subjects in research. If faculty, staff, and students need additional information and/or clarification regarding special populations, they are to contact the IRB Chair, the Chair's designee, or the Office of Grants and Contracts.

Pregnant Women and Fetuses

No research activities involving pregnant women and fetuses may be undertaken unless

1. Pregnant Women as Subjects

No pregnant woman may be involved as a subject in any research activity unless

Any activity permitted above may be conducted only if the mother and father are legally competent and have given their informed consent after having been fully informed regarding possible impact on the fetus. The father's informed consent need not be secured if

2. Fetuses in utero as Subjects

No fetus in utero may be involved as a subject in any research activity unless

Any activity permitted above may be conducted only if the mother and father are legally competent and have given their informed consent. The father's informed consent need not be secured if

3. Fetuses ex utero, Including Nonviable Fetuses, as Subjects

Until it has been ascertained whether or not a fetus ex utero is viable, a fetus ex utero may not be involved as a subject in any research activity unless

No nonviable fetus may be involved as a subject in any research activity unless

In the event the fetus ex utero is found to be viable, it may be included as a subject in the activity only to the extent permitted by and in accordance with the requirements included herein.

Any activity permitted above may be conducted only if the mother and father are legally competent and have given their informed consent, except that the father's informed consent need not be secured if

Activities involving a dead fetus, mascerated fecal material, or cells, tissue, or organs excised from a dead fetus shall be conducted only in accordance with any applicable state or local laws regarding such activities.

Prisoners

Inasmuch as prisoners may be under constraints because of their incarceration which could affect their ability to make a truly voluntary and uncoerced decision whether or not to participate as subjects in research, additional safeguards for their protection must be adhered to.

With respect to research involving prisoners, the IRB shall also meet the following specific requirements:

The following research involving prisoners is permitted:

Biomedical or behavioral research conducted or supported by DHHS may involve prisoners as subjects only if 1) the institution has certified to DHHS that the IRB has approved the research, and 2) and in the judgment of the agency, the research involves solely the following:

Children

Research involving children is permitted in the following instances when/if

1. Wards

Children who are wards of the state of any other agency, institution, or entity can be included in the research only if such research is:

If the IRB approves the research, it shall require the appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis. One individual may serve as advocate for more than one child. The advocate shall be an individual who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child's participation in the research and who is not associated in any way with the research, the investigator(s), or the guardian organization.

2. Requirements for Parental/Guardian Permission and for Assent by Children

The IRB shall require that adequate provisions are made for soliciting the permission of each child's parents or guardians. Where parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient if the research does not involve greater than minimal risk, or does involve greater than minimal risk, but presents the prospect of direct benefit to the individual subjects. If the research involves greater than minimal risk and no prospect of direct benefit to individual subjects, but is likely to yield generalizing knowledge about the subject's disorder or condition, the IRB will require both parents' permission. Exceptions would include: 1) one parent is deceased, unknown, incompetent, or not reasonably available, or 2) when one parent has legal responsibility for the care and custody of the child.

Permission by parents or guardians shall be documented in accordance with and to the extent required under the Informed Consent section of this manual. A sample Informed Consent Form for Children is at Child's Assent.

The IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent. In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved or for each child, as the IRB deems appropriate.

If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research.

When the IRB determines that assent is required, it shall also determine whether and how assent must be documented.


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