NCPHS - Research Involving Children

In order to minimize risk, investigators should use the safest procedures consistent with good research design and should make use of information or materials obtained for diagnostic or treatment purposes whenever feasible. For example, if a blood sample is needed, it should be obtained from samples drawn for diagnostic purposes whenever it is consistent with research requirements to do so.

Adequate measures should be taken to protect the privacy of children and their families, and to maintain the confidentiality of data. The adequacy of procedures for protecting confidentiality should be considered in light of the sensitivity of the data to be collected (i.e., the extent to which disclosure could reasonably be expected to be harmful or embarrassing).

Subjects should be selected in an equitable manner, avoiding over utilization of any one group of children based solely upon administrative convenience or availability of a population living in conditions of social or economic deprivation. The burdens of participation in research should be equitably distributed among the segments of our society, no matter how large or small those burdens may be.

In addition to the foregoing requirements, research must satisfy the conditions of the following recommendations, as applicable.

RECOMMENDATION (3) RESEARCH THAT DOES NOT INVOLVE GREATER THAN MINIMAL RISK TO CHILDREN MAY BE CONDUCTED OR SUPPORTED PROVIDED AN INSTITUTIONAL REVIEW BOARD HAS DETERMINED THAT:

(A) THE CONDITIONS OF RECOMMENDATION (2) ARE MET; AND

(B) ADEQUATE PROVISIONS ARE MADE FOR ASSENT OF THE CHILDREN AND PERMISSION OF THEIR PARENTS OR GUARDIANS, AS SET FORTH IN RECOMMENDATIONS (7) AND (8),

Comment:

If the IRB determines that proposed research will present no more than minimal risk to children, the research may be conducted or supported provided the conditions of Recommendation (2) are met and appropriate provisions are made for parental permission and the children's assent, as described in recommendations (7) and (8) below. If the IRB is unable to determine that the proposed research will present no more than minimal risk to children, the research should be reviewed under Recommendations (4), (5) and (6), as applicable.