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Research Involving Children
Federal regulations protecting adults used in research also apply to children with two additional conditions: First, adequate provision must be made for soliciting the assent of children; second, the permission of their parent(s) or guardian(s) must be obtained.
If children involved as subjects in research are capable of giving assent, they must be asked whether or not they want to participate. If a child says "no" or refuses to cooperate, he cannot be forced into participating. The consent/assent procedures must be presented at a level appropriate to the child's level of understanding. The Board may require that an advocate for the child be present during the consent/assent procedures. When a project director asks a child if he/she wants to participate, a written summary of what is said to the child to obtain his/her permission must be presented to the Board for approval.
If the child is exposed to greater than minimal risk, the research will be approved only if:
| 1. | the procedure presents direct benefit to the individual subject; |
| 2. | the risk if justified by anticipated benefit to the subject; |
| 3. | the relation of anticipated benefit to the risk is at least as favorable to the subject as that presented by alternative approaches. |
In all projects involving children, a parent or guardian must sign a consent form unless the Board determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect subjects. An example would be neglected or abused children or older adolescents who can seek treatment/counseling on their own behalf. If parental permission is not required, an appropriate mechanism to protect the child should then be substituted. If a project is determined by the departmental reviewer to be "high risk," permission of both parents is required unless one parent is deceased, unknown, incompetent, not reasonably available or if only parent has legal responsibility for the care and custody of the child. Research involving children under the age of eight years requires full Board review regardless of the category of risk. In the case of some children the Board may approve a consent procedure that does not include or that alters some or all of the elements of informed consent taking into account the ages, maturity and psychological state of the children involved.
If a child is a ward of the state or any other agency, institution or entity the Board will approve the research only if it is related to the child's status as a ward or is conducted in schools, camps, hospitals, institutions or similar setting in which the majority of children are not wards. The Department of Health and Human Services requires that an advocate be appointed for wards. A person may serve as an advocate for more than one ward.
All research involving children at Kent State will be reviewed as either Level II or Level III. There is no Level I category for children except in the case of studying existing data that is publicly available or observation where the researcher does not participate in the activities being observed.
Ohio Revised Code Section 4301.69 prohibits the furnishing of intoxicating liquor to any persons under the age of 21 unless given by a physician in the regular line of his/her practice.
Pregnant women are protected by the same regulations that protect nonpregnant subjects. For research other than survey, interview, observation or other no risk research, careful considered will be given to the manner in which pregnant subjects are selected. The consent process for Level II and Level III research must be monitored by overseeing actual consent procedures and verifying the process through a sampling of the subjects. For some Level II and Level III research both the mother and father must give their consent after being fully informed regarding the impact on the fetus. (The father's consent is not necessary if his identity or whereabouts cannot be reasonably ascertained, if he is not reasonably available, the pregnancy resulted from rape, or the purpose of the activity is to meet the health needs of the mother.
No Level III research on pregnant subjects may be undertaken unless:
| 1. | appropriate studies on animals and nonpregnant individuals have been completed except where the purpose of the activity is to meet the health needs of the mother or the particular fetus, the risk to the fetus is minimal, and, in all cases, is the least possible risk for achieving the objectives of the activity. |
| 2. | individuals engaged in the activity will have no part in any decisions as to the timing, method, and procedures used to terminate the pregnancy or in determining the viability of the fetus at the termination of the pregnancy. |
| 3. | no procedural changes that may cause greater than minimal risk to the fetus or the pregnant woman will be introduced into the procedure for terminating the pregnancy solely in the interest of the activity. |
No inducements, monetary or otherwise, may be offered to terminate pregnancy for the purposes of the research.
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Prisoners
Regulations governing use of prisoners as subjects are more stringent because their ability to make truly voluntary and uncoerced decisions is affected by their incarceration. Research involving prisoners can only be approved by the Kent State HSRB if the protocol will also be reviewed by the prison's IRB.
Biomedical and behavioral research involving prisoners may be conducted only if it involves:
| 1. | study of the possible causes, effects and processes of incarceration and of criminal behavior, provided that the study presents no more than minimal risk and no more than inconvenience to subjects; |
| 2. | study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk and no more than inconvenience to subjects; |
| 3. | research on conditions particularly affecting prisoners as a class, provided the research is approved by the Secretary of the Department of Health and Human Services. |
The research projects listed above may be approved only if:
| 1. | any possible advantages accruing to the prisoner through his/her participation in the research when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison, are not of such a magnitude that his/her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired; |
| 2. | the risks involved in the research are commensurate with risks that would be accepted by nonprisoner volunteers; |
| 3. | procedures for the selection of subjects within the prison are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners. Unless the principal investigator provides to the Board justification in writing for following some other procedures, control subjects must be selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project; |
| 4. | the information is presented in language that is understandable to the subject population; |
| 5. | adequate assurance exists that parole boards will not take into account a prisoner's participation in the research in making decisions regarding parole, and each prisoner is clearly informed in advance that participation in the research will have no effect on his or her parole; and |
| 6. | where the Board finds there may be a need for follow up examination or care of participants after the end of their participation, adequate provision has been made for such examination or care, taking into account the varying lengths of individual prisoners' sentences, and for informing participants of this fact. |
Federal regulations require that the Board must have at least one person qualified to be a prisoner representative. If the research will be reviewed by a prison IRB or another IRB with a prisoner or prisoner representative as a member, the Department of Health and Human Services and Kent State University's Human Subjects Review Board will be satisfied that the requirement is met and a Kent State prisoner representative will not be necessary.