TABLE 3

Categories of Research

Category 1: Research not involving greater-than-minimal risk to children
    To approve this category of research, the IRB must make the following determinations:
        the research presents no greater-than-minimal risk to the children; and
        adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians
Category 2: Research involving greater-than-minimal risk but presenting the prospect of direct benefit to the individual child subjects involved in the research
    To approve research in this category, the IRB must make the following determinations:
        the risk is justified by the anticipated benefits to the subjects;
        the relation of the anticipated benefit to the risk presented by the study is at least as favorable to the subjects as that provided by available alternative approaches; and
        adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians
Category 3: Research involving greater-than-minimal risk and no prospect of direct benefit to the individual child subjects involved in the research but likely to yield generalizable knowledge about the subject's disorder or condition
    To approve research in this category, the IRB must make the following determinations:
        the risk of the research represents a minor increase over minimal risk;
        the intervention or procedure presents experiences to the child subjects that are reasonably commensurate with those inherent in their actual, or expected, medical, dental, psychological, social, or educational situations;
        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 disorder or condition; and
        adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians
Category 4: Research that requires a special level of DHHS or FDA review beyond that provided by the IRB
    Research that the IRB believes does not meet the conditions of the above-listed categories but finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem that affects the health or welfare of children
    If the IRB believes that the research does not meet the requirements of the categories listed above but finds that it presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem that affects the health or welfare of children, it may refer the protocol to DHHS or FDA for review; the research may proceed only if, after consulting with a panel of experts in pertinent disciplines (eg, science, medicine, education, ethics, law) and after an opportunity for public review and comment, it is determined that either (1) the research, in fact, satisfies the conditions of category 1, 2, or 3 or (2) the following:
        the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem that affects the health or welfare of children;
        the research will be conducted in accordance with sound ethical principles; and
        adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians