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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

Definition of Research

A common question that is posed to the Institutional Review Board (IRB) is the exact definition of research. Is Quality Assurance research? Are surveys conducted to improve patient satisfaction research? Are observations of patient behavior research? Are case studies considered to be research?

Research is defined in the Code of Federal Regulations and by the Henry Ford IRB as:

"A systematic investigation" designed to contribute to "generalizable knowledge".

It may involve:

  • Direct interactions or interventions with subjects
  • Indirect activities such as the analysis of specimens or data

Anytime a decision is made to test a hypothesis or compare variables involving human subjects to generate generalizable knowledge, you are doing research. All human subjects research requires review by the IRB. The IRB is a safeguard for protection of human subjects, and also serves to improve research standards and quality. For more information from the Code of Federal Regulations, see the Federal Regulations page.

Generally quality assurance projects or statistical comparisons for financial and operations management are not considered research. Retrospective case study descriptions do not normally require IRB approval if the treatment is part of normal clinical management. However, if there were a deliberate decision to conduct a single case study design with an experimental treatment intervention, this would require IRB approval.

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