Table 1. Type of research studies and approvals/exemptions.

Type of studies		Details about the need for approvals
Studies involving interaction or intervention
	1. Clinical Trials- pilot, all phases and designs	A pilot study with an intention to contribute to general knowledge (fits the criteria for research)
		All phases of clinical trials require separate approvals.
	2. All interventional studies	Even those using standard of care or non-pharmacologic interventions need approval.
	3. Diagnostic tests and devices	Analysis of data and biologic specimens need approvals.
	4. Medical records review	Those identifying private identifying information need approvals.
	5. Case reports	1–3 cases don’t require IRB approvals, preferably patient consent should be taken for it nevertheless.
		Case series need approvals as they are hypothesis testing.
	6. Quality improvement and cost benefit analysis	Whenever it fits the definition of research, i.e., intent to generalize knowledge present.
	7. Product evaluations	Whenever it fits the definition of research, i.e., intent to generalize knowledge present.
	8. Public health surveillance	Those mandated by law, e.g., reporting of communicable diseases are exempt from IRB review.
Studies not involving direct interaction or intervention
	1. Use of preexisting medical records or stored specimens	IRB review required if identifying information is recorded.
	2. Databases, registries, biobanks of biomedical specimens	IRB review required for confidentiality purposes.
Surveys/Interviews		Collection of identifying or sensitive information requires IRB approval.

IRB = Institutional Review Board.