When an investigator is considering the using of children as research participants there are several factors that must be considered. These include federal laws and regulations, relevant state laws, and institutional policies and procedures that must be considered in order to protect the rights and welfare of all children.

While all of the protections of the Common Rule (45 CFR 46) apply for children, additional federal regulations (45 CFR 46 subpart D) provide additional protection for children involved in research obtaining assent of the children and the permission of the parents/guardians. More specific provisions are based on the degree of risk involved in the proposed research and the nature and degree of anticipated benefit(s).

The University has recently approved a new Children Policy but before we can describe that new policy, it may be helpful to specify some terms that are relevant. The new Children Policy can be found at (http://www.hic.wayne.edu/hicpol/children.htm).

HIC Policy

There are three categories of research involving children that may be approved by Wayne State University’s (WSU) Institutional Review Boards (IRBs) based on the degree of risk and benefit to the child:

1. Research not involving greater than minimal risk (Category 1)

2.Research involving greater than minimal risk but with a potential for direct benefit to the individual subjects (Category 2)

3. Research involving greater than minimal risk and with no prospect of direct benefit to the child (Category 3) , but likely to yield generalizable knowledge about the child’s disorder or condition, will be considered on a case by case basis by the IRB. They will consider

Parental permission is usually the prerequisite to the recruitment of children into research projects. With a few exceptions, the permission of one parent or guardian is generally sufficient to enroll the child. However, the parental permission only constitutes half of the process of recruitment. Assent for the child is the second component of the informed consent process for enrolling minors.

In general, a child’s dissent should be respected. Every effort should be made to reach consensus between parent(s) and child. However, when the research offers the child the possibility of direct benefit important to his/her own health and may be available only through research (Category 2), the parent’s wishes generally prevail over the dissent from the child. With the exception of a category 2 research project, a general rule of thumb is a “no” from a child overrides a “yes” from the parent; but a “yes” from a child does not override a “no” from a parent unless the IRB has waived the requirements for parental permission

Obviously the IRB takes a very serious look at any research protocol in which the researchers are proposing either a waiver of assent by the child and/or the waiver of the parental permission. The following conditions must exist to obtain a waiver of assent and/or parental permission (45 CFR 46.116) unless they are waived by the IRB because of special circumstances.

1. the research involves no more than minimal risk to the participants;
2. the waiver or alteration will not adversely affect the rights and welfare of the participants;
3. the research could not practicably be carried out without the waiver or alteration; and
4. whenever appropriate, the subjects will be provided with additional pertinent information after participation.

If the IRB determines that a research project is designed for conditions or participant populations for which parental or guardian permission is not a reasonable requirement to protect the child, it may also waive the consent requirement based on Federal regulation 45 CFR 46.408(c). Under such circumstances, the IRB must determine an appropriate substitute mechanism for protecting the child:–A child advocate that would give authorization for the child to participate in the research project.

When considering enrolling a child ages 7-12 into a research project oral assent should be obtained as appropriate. The researcher should describe the study in a level that is understandable to the child. If the child agrees to participate in the research project, the person who described the study will sign the oral assent line in the parental permission form. If the child is 13-17 years old, written assent should be obtained as appropriate. Obviously, the language should be written at the appropriate grade level.

The HIC has also developed a child’s assent form that can be used with children ages 13-17: For more information contact: http://www.hic.wayne.edu/hicforms/assenttemplate.2.21.05.doc

If you have further questions you can contact the HIC Education Coordinator, Patti Webber, RN at (313) 577-9534 or email her at pwebber@wayne.edu .

–Patti Webber