An investigator wants to conduct a study about illicit drug use in young adults.
An investigator wants to conduct a study about illicit drug use in young adults. The study involves a one-time questionnaire, which includes some questions about recent experience using illicit substances such as Heroin, Cocaine, and Meth. The only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. How should the investigator proceed? An investigator wants to conduct a study about illicit drug use in young adults. The study involves a one-time questionnaire, which includes some questions about recent experience using illicit substances such as Heroin, Cocaine, and Meth. The only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. How should the investigator proceed? Pick the correct answer:
The investigator should request that the IRB approve a waiver of documentation of informed consent. Once the waiver of documentation of informed consent is approved, each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern.
The investigator should request that the IRB approve a waiver of informed consent because informed consent is not required in studies that involve questionnaires about illicit drug use.
The investigator should be concerned about a potential case of research misconduct and should not make any requests for waivers to the IRB.
The investigator should refrain from submitting this study to the IRB as it does not fit the definition of human subjects research.
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