Do you need IRB for case series? When information on more than three patients is included, the case series is considered to be a systematic investigation designed to contribute to generalizable knowledge (i.e., research), and therefore submission is required to the IRB .
Are case studies IRB exempt?
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.
Is case series A research?
A case series (also known as a clinical series) is a type of medical research study that tracks subjects with a known exposure, such as patients who have received a similar treatment, or examines their medical records for exposure and outcome.
Do you need ethical approval for a case reports?
How do I report a case series?
- Title. The area of focus and “case report” should appear in the title.
- Keywords. Two to five key words that identify topics in this case report.
- Abstract. 3a. ...
- Introduction. ...
- Patient information. ...
- Clinical findings. ...
- Timeline. ...
- Diagnostic assessment.
What studies do not require IRB approval?
Publicly available data do not require IRB review. Examples: census data, labor statistics. Note: Investigators should contact the IRB if they are uncertain as to whether the data qualifies as “publicly available.”
What types of studies are exempt from IRB?
- Education research.
- Surveys, interviews, educational tests, public observations (that do not involve children)
- Benign behavioral interventions.
- Analysis of previously-collected, identifiable info/specimens.
- Federal research/demonstration projects.
- Taste and food evaluation studies.
Is case series an original article?
A case report with a literature review cannot be considered as an original research article . You can maybe consider publishing the case report first and then build on the idea for a separate original research article.
What is the difference between a case study and a case series?
Case studies are widely used in psychology to provide insight into unusual conditions. A case study, also known as a case report, is an in depth or intensive study of a single individual or specific group, while a case series is a grouping of similar case studies / case reports together.
Is case series the same as case control?
Case series have no control at all because only patients with a certain manifestation of outcomes are sampled (e.g., individuals with a disease or deceased individuals). In contrast, all case-control designs as well as self-controlled case-control designs have a control group.
Do you need ethical approval for a retrospective study?
Although recently published Code of Clinical Research declared that retrospective archive studies do not need ethics approval , all institutional ethics committee instructions still ask it for submission of scientific publication in our country (5).
Do I need ethical approval for a systematic review?
Because systematic reviews generally do not need ethics committee or institutional review board approval , nor are faced with any of the other multiple obstacles to the conduct of clinical research, they would seem an ideal endeavor for anyone seeking to improve their CV or impact score.
What is the difference between a case series and cohort study?
The only difference between cohort studies and case series in many definitions is that cohort studies compare different groups (i.e., examine the association between exposure and outcome), while case series are uncontrolled [3,4,5].
What defines a case series?
Listen to pronunciation. (kays SEER-eez) A group or series of case reports involving patients who were given similar treatment . Reports of case series usually contain detailed information about the individual patients.
Is a case series study qualitative or quantitative?
Case studies tend to focus on qualitative data using methods such as interviews, observations, and analysis of primary and secondary sources (e.g., newspaper articles, photographs, official records). Sometimes a case study will also collect quantitative data.
How do you determine if a study needs to go to IRB?
IRB review is determined by the level of Protected Health Information (PHI) associated with the data . Records With No PHI: If the decedent study will not have direct access to PHI, IRB review and approval is not required because the deceased individuals cannot be identified.
Can you publish research without IRB approval?
Please note, IRB approval cannot be granted retroactively, so research conducted for a classroom assignment without IRB approval can never be used as the basis for a publication . If there is a possibility that it might be used for a future publication, it is advisable to seek IRB approval.
When can a study be exempt from IRB review?
Research can qualify for an exemption if it is no more than minimal risk and all of the research procedures fit within one or more of the exemption categories in the federal IRB regulations . Studies that qualify for exemption must be submitted to the IRB for review before starting the research.
What types of studies require approval by an internal review board?
Is IRB approval required for qualitative research?
Qualitative research often does not need IRB , Meyer said. But when it does, there are some considerations particular to qualitative research that she highlighted. Lastly, there are a set of impending changes to IRB regulations and Meyer discussed how these may impact qualitative researchers.
Where can I publish a case series?
- Elsevier Journal Finder.
- Edanz Journal Selector.
- EndNote Manuscript Matcher.
- Springer.
How many patients do you need for a case series?
Conclusions. The concept of “case series” is not well defined in the literature and does not reflect a specific research design. We suggest that a case series should have more than four patients while four paitents or less should be reported individually as case reports.
Is a case series A retrospective study?
What level of evidence is a case series?
| Level Type of evidence | III Case-control study or systematic review of these studies | IV Case series | V Expert opinion; case report or clinical example; or evidence based on physiology, bench research or “first principles” |
|---|
Is case series A cross sectional study?
A case report is the description of the clinical story of a single patient. A cross-sectional study involves a group of participants on which data is collected at a single point in time to investigate the relationship between a certain exposure and an outcome .
Is case series an intervention study?
Case series is an observational, descriptive research design . It is most useful for describing the potential effectiveness of new interventions, for describing the effectiveness of interventions on unusual diagnoses, and for describing unusual responses (either good or bad) to interventions.
Do retrospective studies need IRB?
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.
What research is exempt from ethics approval?
Following are examples of types of research exempt from ethics review: Systematic reviews and meta-analysis of published and non-identifiable data . Studies that involve data available in the public domain. Experimental or laboratory studies that do not involve data collected from or about humans or animals.
What type of research requires ethical approval?
Is IRB required for meta-analysis?
Do you need ethics approval for meta-analysis?
Time trends in TSR will be calculated with cumulative meta-analysis. Ethics and dissemination No ethical approval will be needed because data from previous published studies in which informed consent was obtained by primary investigators will be retrieved and analysed.
Do I need ethical approval for secondary data analysis?
What are the essential component of case series?
- A compelling executive summary.
- The moment of discovery.
- Walk your reader through the implementation.
- Celebrate your customer’s results.
- Don’t get too caught up in using the perfect format.
How do you structure a case series?
Case reports should encompass the following five sections: an abstract, an introduction with a literature review, a description of the case report, a discussion that includes a detailed explanation of the literature review, and a brief summary of the case and a conclusion.
Can case series be presented by a single physician?
Single physician or hospital reports of outcomes . Multi-institutional registry. The size of a case series can range from two or three cases to hundreds or even thousands. An important distinction lies between a case series and a cohort study.
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.
