Risk Assessment of Common Procedures, continued.

Risk Assessment of Common Procedures

The table, below, includes examples of medical and research procedures that are commonly reviewed by the Nemours IRB.

The classification table below is a starting point for IRB determination of research risks. The IRB will assign a risk level for any given procedure in the context of the specific research considering the patient population, the investigator’s and research team’s experience, the study setting, and research design. The procedures are classified as minimal risk, minor increase over minimal risk, and more than minor increase over minimal risk. i

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

PROCEDURE / CATEGORY OF RISK / Comment
Minimal / Minor
Increase Over
Minimal / More than
Minor
Increase Over
Minimal
Routine History Taking / X
Routine Physical Exam / X
Hearing Testing / X
Complete Neurological Exam / X
Collection of Saliva / X
Collection of Small Sample of Hair / X
Breath Collection / X
Fasting <12 Hours, Health Child
Oral Glucose Tolerance Test / X
Tanner Staging
Venipuncture / finger stick / heel stick within specified blood volume guidelines / X / Risk is affected by many factors. Reference: Checklist for Blood Drawing Guidelines.
Intravenous line or heparin lock / X / X / X / Risk depends on age of the child, duration, number and volume of samples, and setting of the research.
Single IM or SC Injection / X / X / X / Risk depends on the substance injected.
Nasogastric Tube Insertion / X / Commensurate with prior experience and ability of the child to provide adequate assent and cooperation.
Urine Collection via bag / X
Urine Collection via Catheter / X
Urine Collection via Suprapubic Tap / X
Chest X-Ray / X
Bone Density Test (DEXA) / X
Wrist X-Ray for Bone Age / X
Lumbar Puncture / X
Vision Testing / X
Fundoscopic Eye Exam with Sedation / X / If procedural sedation – generally minor increase over minimal
Topical Pain Relief / X / X / Risk depends on age, weight, and history of child.
Skin Punch Biopsy w / Topical Pain Relief / X
Organ Biopsy / X
Small Amount of Additional Tissue Obtained at Surgery / X / X / Risk depends on any increased operative time, the specific organ or tissue, and the likelihood of bleeding and infection.
Pulmonary Function Test / X
Pulmonary Function Test, with Reversibility / X
Methacholine Challenge Testing / X / Risk depends on adequacy of resources and experience of staff.
Magnetic Resonance Imaging (MRI), un-sedated / X
Magnetic Resonance Imaging (MRI), sedated / X / If procedural sedation.
PET Scan
CT Scan / X
Endoscopy, with or without biopsy / X
Classroom Observation / X
Psychological test/survey/interview/ observation / X / Risk depends on the length of the instrument or observation and the nature of the questions, e.g., possibility of triggering unpleasant memories or emotions, assessment of illegal or socially stigmatized behavior.

iModified from Report from NHRPAC, Clarifying Specific Portion of 45 CFR 46 Subpart D that Governs Children’s Research. Accessed 6/19/2006.

Version May 13, 2008Page 1 of 2