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THE HUMAN RESEARCH PROTECTION PROGRAM

THE COMMITTEE ON HUMAN RESEARCH

UCSF GUIDANCE ON RESEARCH TOPICS AND ISSUES

HUMAN RESEARCH PROTECTION PROGRAM (HRPP)
THE COMMITTEE ON HUMAN RESEARCH (CHR)

UCSF GUIDANCE ON RESEARCH TOPICS AND ISSUES

Vulnerable Subject Populations – Minors in Research

Discussion of Permitted Categories Examples

1) Minimal risk [45 CFR 46.404] Example: A study involving one venipuncture (no more than the lesser of 50 ml or 3 ml per kg in an 8 week period) in healthy 10-year-old subjects.

Other procedures that usually qualify as minimal risk include urinalyses, EEGs, allergy scratch tests, and minor changes in diet or daily routine.

Classifying a study with minors as “minimal risk” can depend on several factors. For example, a standard venipuncture may present minimal risk for a teenager who has had blood drawn before and can assent to or refuse the procedure, but the psychological and physical risks may be greater for a four-year-old who can’t understand study explanations and is afraid of being stuck with a needle. (See 45 CFR 46.110 and the related list of categories that qualify for expedited review.)

For an excellent discussion of issues involved in making this assessment, see
J. Sugarman’s article, “Determining the Appropriateness of Including Children in Clinical Research,” JAMA 2004; 291(4):494-496 .

2) Greater than minimal risk but prospect of direct benefit to subject [45 CFR 46.405] Example: A Phase II study using an experimental chemotherapeutic regimen for children with malignant brain tumors for whom standard therapy has failed.

Most clinical trials would fall into Category 2. However, it is sometimes difficult to determine what the “prospect of direct benefit” is, as in a study that includes a control group whose participants face less risk than the active group but also less prospect for benefit.

APPLICATION NOTE: If there are different groups of subjects in a proposed study, the protocol and consent form(s) should address the risks and benefits for each group.

3) Greater than minimal risk, no reasonable prospect of direct benefit to subject, but likely to yield generalizable knowledge about the subject’s condition [45 CFR 46.406] Example: A study testing new biomarkers of disease progression that involves 2 extra samples of cerebrospinal fluid over a year of therapy (beyond the 5-6 that would be done as part of the child’s routine care.)

According to the federal regulations, the CHR may approve the study only if the research carries no more than "a minor increase over minimal risk." The regulations do not further define this limitation. Also, the CHR may consider societal benefits as offsetting risks within Category 3, but only if those benefits would affect a specific group to which the subject belongs.

4) Greater than minimal risk, no reasonable prospect of direct benefit to subject ("not otherwise approvable"), but presents opportunity to understand, prevent, or alleviate serious problems affecting health or welfare of children [45 CFR 46.407] Example: A study examining sleep mechanisms in children to better understand sleep-related diseases. Involves
13- to 17-year-old adolescents undergoing 3 hospital visits for
IV infusion of acetate and glucose followed by MRI, in normal
and sleep-deprived groups.

The CHR cannot grant final approval for studies that fall into Category 4. It must forward the study to the federal regulators for review by a special panel, for public comment, and for a "no objection" statement (or a refusal of same) from the Secretary of Health and Human Services.

As noted, approvals in Category 4 are very rare. See OHRP’s “Special Protections for Children as Research Participants” for more information about the above and other examples of the handful of studies reviewed in this category nationwide.

 

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