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:

• Research not involving greater than minimal risk [45 CFR 46.404].
• Research involving greater than minimal risk, but presenting the prospect of direct benefit to an individual subject. Research in this category can be approved, provided: (a) the risk is justified by the anticipated benefit to the subject; and (b) the relationship of risk to benefit is at least as favorable as any available alternative approach [45 CFR 46.405].
• Research involving greater than minimal risk with no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition. Research in this category is approvable provided: (a) the risk represents a minor increase over minimal risk; (b) the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational settings; and (c) the intervention or procedure is likely to yield generalizable knowledge about the subject's disorder or condition that is of vital importance for the understanding or amelioration of the subject's disorder or condition [45 CFR 46.406].
  Both parents must sign the parent form (for studies approved in this category) unless one parent is deceased, unknown, not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
• Research that is not otherwise approvable, but which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. Research that is not approvable under 45 CFR 46.404, 46.405, or 46.406 may be conducted or funded by DHHS provided that the IRB, and the Secretary of DHHS after consultation with a panel of experts, finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a significant problem affecting the health and welfare of children. The panel of experts must also find that the research will be conducted in accordance with sound ethical principles [45 CFR 46.407].
  Both parents must sign the parent form (for studies approved in this category) unless one parent is deceased, unknown, not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
• Children who are wards of the state can participate in research involving greater than minimal risk and of no direct benefit to the child only if the research is: (a) Related to their status as wards; or (b) Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards. If such research is approved, the IRB shall require 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 (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization. [45 CFR 46.409]

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:

• Prisoner
• Minimal Risk (as defined for prisoner research)

 

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:

• Minimal risk and no more than inconvenience to subjects and is a study of causes, effects and process of incarceration and of criminal behavior;
• Minimal risk and no more than inconvenience to subjects and is a study of prisons as institutional structures or of prisoners as incarcerated persons;
• Research on conditions affecting prisoners as a class (such as research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults). If the study is funded by DHHS, the DHHS Secretary must first consult with experts and publish in the Federal Register. The IRB will have to report to DHHS.
• Research with intent and probability to improve health or well being of subject. If the project is funded by DHHS and includes control groups which may not provide an y benefit, the study may proceed only after the DHHS Secretary has consulted with experts and published notice in the Federal Register. The IRB will have to report to DHHS.

 

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

• Advantages through participation, when compared to their current situation, are not so great that they impair the prisoners' ability to weigh risks;
• The risks from participation in the study are the same as those that would be accepted by non-prisoners;
• Procedures for selection is fair to all prisoners. There must be immunity from intervention by prison authorities, and the control subjects (if applicable) must be randomly selected;
• Language for obtaining informed consent must be understandable to all prisoners;
• Parole boards cannot take participation into consideration, and prisoners' informed participation will not impact parole;
• When studies need follow up, the provision for follow up must include a consideration of the length of individual sentences, and prisoners must be informed about follow up;
• IRB must find that the research falls in one of the permissible categories of research listed above.

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.