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An investigator’s use of focus groups can qualify for exemption from IRB Review [CFR 46.104]. Focus groups are considered to be in the same category as surveys and interviews; data collected must come are from adults (at least 18 years old) and must not be both sensitive and identifiable.In some cases, researchers may need to audio or video record a focus group session for either transcription or coding purposes. The consent form should always disclose which activities will be recorded, how the recordings will be stored and used, and whether the recordings will be deleted after a set amount of time.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.”
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Do focus groups need consent?
In some cases, researchers may need to audio or video record a focus group session for either transcription or coding purposes. The consent form should always disclose which activities will be recorded, how the recordings will be stored and used, and whether the recordings will be deleted after a set amount of time.
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.”
Preparing for Focus Groups: Qualitative Research Methods
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What projects require 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).
Does all research need IRB approval?
IRB approval is required regardless of the site of the study or the source of funding (if there is funding).
What are the ethical issues of focus groups?
Ethical issues
A particular ethical issue to consider in the case of focus groups is the handling of sensitive material and confidentiality given that there will always be more than one participant in the group.
What are limitations of focus groups in research?
Limitations of focus groups include the tendency for certain types of socially acceptable opinion to emerge, and for certain types of participant to dominate the research process.
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.
See some more details on the topic Do you need IRB approval for focus groups? here:
Focus Group Instructional Guidelines from an IRB perspective
Submitting to the IRB Focus Group Discussion Topics should be included. Informed Consent (if applicable) OR. Cover Letter (investigator must request a waiver …
Best Practices for Focus Groups | IRB Blog – Teachers College …
In most cases, researchers collecting survey data and individual interviews should guarantee their participants confidentiality. However, …
Guidance on Research Involving Surveys, Interviews, and …
Survey, interview, and focus group research can often qualify for exemption from IRB Review as defined in the federal Common Rule 45 CFR …
Guidance on the Use of Focus Groups – Boise State University
In the consent form and during the consent discussion, participants should be informed of the topic that will be discussed during the focus group session. The …
Do you need IRB approval for independent research?
If you plan to publish your research in a traditional peer-reviewed journal, you will usually need an IRB review. If you plan to develop pharmaceuticals that will require FDA approval, you will need IRB review. If you plan to get federal funding for your work, you will need IRB review.
Does my project need IRB approval?
The Regulations
IRB review and approval is required for projects that: Meet the definition of research. Involve human subjects and. Include any interaction or intervention with human subjects or involve access to identifiable private information.
What qualifies as human subjects research?
Research involving existing data, documents, records, pathological specimens, diagnostic specimens, or tissues that are individually identifiable is considered “research involving human subjects.”
How do focus groups work? – Hector Lanz
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Do quality improvement projects need IRB approval?
Does a quality improvement project that involves research need to be reviewed by an IRB? Yes, in some cases. IRB review is needed if the research involves human subjects, is not exempt, and is conducted or supported by HHS or otherwise covered by an applicable FWA.
What is the difference between conducting research that requires an IRB approval and a classroom project involving human participants?
Federal regulations and university policies require IRB approval for research with human subjects. This applies whether research is conducted by faculty or students. However, many class projects are conducted for educational purposes and not as research, and thus, do not require IRB approval.
Is focus group A qualitative research?
Focus group discussion is frequently used as a qualitative approach to gain an in-depth understanding of social issues. The method aims to obtain data from a purposely selected group of individuals rather than from a statistically representative sample of a broader population.
Are focus groups qualitative or quantitative?
Focus groups are a qualitative data collection method, meaning that the data is descriptive and cannot be measured numerically. When should you use focus groups for evaluation? To get more in-depth information on perceptions, insights, attitudes, experiences, or beliefs.
What are the pros and cons of focus groups?
- Advantage: Easily Measure Customer Reaction. …
- Disadvantage: Not as In-Depth as Other Market Research. …
- Advantage: Time-Saving Opportunity. …
- Disadvantage: Expense. …
- Disadvantage: Moderator Bias.
Are focus groups valid?
Conclusion: Focus groups can be a useful tool for collecting trustworthy and reliable information through a process that promotes interaction among student participants. They can support quantitative data from students and be used to support curriculum reform.
What is a drawback of using focus groups in social science research?
What is a drawback of using focus groups in social science research? May not be as efficient in covering maximum depth on a particular issue.
How might focus groups be misused?
Misuse: Focus groups can be misused and abused by considering the results as conclusive rather than exploratory. 2. Misjudge: Focus group results can be more easily misjudged than the results of other darn collection techniques. Focus groups are particularly susceptible to client and researcher biases.
Do you need IRB for interviews?
Activities involving interaction with living human subjects, including interviews, oral histories, and public observation, may or may not require IRB review. Activities focused solely on deceased persons or employing only archival, historical, literary, or existing visual sources do not require IRB review.
How To Run A Successful Focus Group in 5 Easy To Follow Steps
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Does qualitative research require approval?
If you are conducting research that involves human participants, you will need to get approval from Amherst’s IRB before you collect your information. The goal of review and approval is to ensure that there is no/minimal risk to participants, and that they are fully aware of their rights under federal regulations.
What is IEC in clinical research?
IRBs can also be called independent ethics committees (IECs). An IRB/IEC reviews the appropriateness of the clinical trial protocol as well as the risks and benefits to study participants.
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