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The Ethical Conduct of Clinical Research Involving Children (2004)
Board on Health Sciences Policy (HSP)
Institute of Medicine (IOM)

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135
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Ethical Conduct of Clinical Research Involving Children

The NHRPAC work group engaged in such an effort and produced a table in which they categorized a number of common research procedures according to the level of risk presented by a single use of the procedure. That table is reproduced in Table 4.1.

Although NHRPAC has been disbanded, the successor SACHRP should be encouraged to continue its predecessor’s work to develop consensus assessments about the risk of common research procedures. To provide further guidance for investigators and reviewers of research, these consensus assessments should be accompanied by examples, citations of any relevant data, and explanations of the rationales for the categorization of procedures as involving either minimal risk or a minor increase over minimal risk.

The Office for Human Research Protections (OHRP) can also assist

TABLE 4.1 Common Research Procedures by Category of Risk

 

Category of Risk

Procedure

Minimal

Minor Increase over Minimal

More Than a Minor Increase over Minimal

Routine history taking

X

Venipuncture/fingerstick/heelstick

X

Urine collection via bag

X

Urine collection via catheter

 

X

 

Urine collection via suprapubic tap

 

 

X

Chest X-ray

X

Bone density test

X

Wrist X-ray for bone age

X

Lumbar puncture

 

X

 

Collection of saliva

X

Collection of small sample of hair

X

Vision testing

X

Hearing testing

X

Complete neurological exam

X

Oral glucose tolerance test

X

Skin punch biopsy with topical pain relief

 

X

Bone marrow aspirate with topical pain relief

 

X

Organ biopsy

 

 

X

Standard psychological tests

X

Classroom observation

X

NOTE: The category of risk is for a single procedure. Multiple or repetitive procedures are likely to affect the level of risk.

SOURCE: NHRPAC, 2002.

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