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Ethical Research Practice
Institutional Review Board

IRB Review Criteria
--Definition of Research
--Is It Research?
--Human Subjects
--Case Study 1
--Case Study 2
--Study Design
--Minimal Risk
--Risks & Benefits
--Confidentiality
--HIPAA
--Subject Selection
--Vulnerable Subjects
--Incentives
--Quiz

Informed Consent
Genetic Testing
Types of Review
Continuation & Final Reports
Serious Adverse Events
Frequently Asked Questions
Conclusion

Minimal Risk

The principle of minimal risk to human subjects is applied to all reviews of human subjects research. The U.S. Office for Human Research Protection defines minimal risk as the probability and magnitude of harm or discomfort anticipated in the proposed research is not greater than those that are ordinarily encountered in daily life. If the generally accepted medical management involves routine physical or psychological examinations or tests, this is considered minimal risk.

However, excessive testing that involves higher risks, such as repeated blood tests with the risk of blood volume depletion, radiographic tests increasing the level of radiation exposure or tissue sampling not required for diagnostic purpose would not fall into the category of minimal risk.

For more information about minimal risk, see the OHRP regulations on the Federal Regulations page.

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