Do case studies need IRB approval?
3 min read
Asked by: Valerie Williams
Many IRB policies state that the analysis of a case series (more than 3 cases) meets the definition of human research and requires the submission and review by the IRB. Note that some journals may require acknowledgement from the IRB that review of a case study is not required.
Is a case study exempt from IRB?
As a result, case studies generally qualify for exempt review by the IRB provided that the study (a) does not involve a sensitive topic, (b) is conducted in a manner that protects subjects’ identity, and (c) does not involve at-risk or special populations.
Do I need a IRB for case study?
Yes. Under HIPAA, a case report is an activity to develop information to be shared for medical/educational purposes. Although the use of protected health information to prepare the paper does not require IRB review, the author of a case report must comply with HIPAA.
What studies do not need IRB approval?
Examples of Studies that Generally Do Not Require IRB Review
- Data collected for internal departmental or administrative purposes, such as teaching evaluations, student performance data, etc.
- Activities designed solely for quality improvement or evaluation of a program, course, etc.
What type of study requires IRB approval?
FDA regulations generally require IRB review and approval of research involving FDA-regulated products (e.g., investigational drugs, biological products, medical devices and dietary supplements) (21 CFR Part 56).
Do case studies need ethical approval?
Case studies typically involves an ethical clearance committee looking at the research aims and methodologies of researchers to make sure that the research will be conducted in a way that protects the dignity, rights and safety of the research participants, and that the research design is ethically sound and is likely
Are case studies human subjects research?
Case history or Case Study which are published and/or presented at national or regional meetings are not considered research if the case is limited to a description of the clinical features and/or outcome of a three or fewer patients and do not contribute to generalizable knowledge.
Does IRB need to review case report?
Case Report Form (CRF) pages. Note that while the IRB does not require (or necessarily want CRF pages), if the data that will be collected is not specified in the protocol, then the CRF pages may be submitted to supplement the protocol (eIRB Section 12.01 (1.0)). This is not ideal but is permitted.
Are case reports considered research?
Case Reports are not considered research under most circumstances. Although identifiable information about a patient may be collected in p reparing case reports, the intent of preparing case reports is usually related to patient care.
Do retrospective studies need IRB approval?
Do I need IRB approval to do a retrospective chart review? As a general matter, there is no retrospective IRB review. However, you should submit an application to the IRB for approval and include an explanation for why you did not think you needed IRB approval.
Do pilot studies need IRB approval?
Pilot studies, sometimes called feasibility studies, involving human subjects require the same scrutiny as full-scale research projects and therefore, must be submitted for IRB review and approval.
Do focus groups need IRB approval?
Purpose of the Focus Group
During the recruitment process, the PI should explain what a focus group is, how many people will be involved, and about the potential benefits and risks of participating. This recruitment script must be approved by the IRB before recruitment can begin.
