Nondisclosure Agreement - Focus Group Testing
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FAQ
Teleconference focus groups are generally recorded. The tapes are listened to multiple times and transcribed into a script. Focus Group that take place in person are generally either video taped or recorded.
Risks and Confidentiality: The nature of a focus group is such that confidentiality cannot be guaranteed. The researchers must provide participants with the procedures in place to maintain confidentiality of the research data and they must inform participants not to repeat what is said in the focus group to others.
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.
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).
Some examples of Exempt research are: anonymous or identifiable surveys or interviews. passive observation of public behavior with or without the collection of identifiers. retrospective and prospective medical chart reviews (allowable under specific criteria for UCI Healthcare Workforce)
There are two main ways to ensure that the privacy of participants is being respected: (1) by conducting anonymous research, and (2) by conducting confidential research.
Research can be approved as exempt if it is no more than minimal risk and fits one of the exempt review categories as defined by federal regulation 45 CFR 46. Studies that may qualify for Exempt must be submitted to the IRB for review. Exempt reviews are conducted by a member of IRB staff.
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.
In its most basic form, a nondisclosure agreement is a legally enforceable contract that creates a confidential relationship between a person who holds some kind of trade secret (or other information) and a person to whom the secret will be disclosed. NDAs protect sensitive information.
