Institutional Review Board

Preparing for Research  |  Levels of Risk

A.Overview

The type of IRB review required reflects the level of risk to the subject. Some protocols that are "Greater than Minimal Risk" may require a Data Safety Monitoring Board (DSMB).

B.Minimal Risk

The probability and magnitude of harms or discomforts anticipated in the research protocol are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological exams or tests. Examples of "Minimal Risk" activities include:

Collection of hair and nail clippings;

Collection of excreta and external secretions including sweat or uncannulated saliva;

Recording of data from subjects 18 years of age or older using physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the subject's privacy;

Weights, sensory acuity measurements, electrocardiography;

Electroencephalography, thermography, diagnostic ultrasonography, and electroretinography. It does not include exposure to x-rays or microwaves;

Venipuncture, in amounts not exceeding 450 milliliters in an 8-week period and no more than two venipunctures per week, from non-pregnant subjects 18 years of age or older;

Voice recordings made for research purposes;

Use of existing data, documents, records, pathological specimens, or diagnostic specimens;

Studies of perception, cognition, game theory, or test development, where the investigator does not manipulate subjects' behavior and the research will not involve stress to subjects;

C.Greater Than Minimal Risk

The probability and magnitude of harm or discomfort anticipated in the research protocol are greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological exams or tests, but these risks are considered to be acceptable when weighed against the anticipated benefits and the importance of the knowledge to be gained from the research.