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Ethical principles
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Respect for persons: no research without informed consent of those involved, respect of autonomy, the requirement to protect those with diminished autonomy
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Direct or indirect undue influence regarding participation in the trial
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As with other participants in a clinical trial, the participation of study staff must always be voluntary
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Yes
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Yes
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Beneficence: do not harm and maximize possible benefits and minimize possible harms
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No particular consideration: the risks and benefits of the research are the same for all the participants
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Justice: respect for the principle of equality of human beings, fair treatment during investigations
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Breach of confidentiality regarding medical information
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Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information
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Yes
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No
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Methodological principles
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Subject selection
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Eligibility criteria
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As with other participants, any study staff enrolled must meet the eligibility criteria and participate in the information session, and give informed consent
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Yes
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Yes
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Selection of an adequate control group
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No particular consideration
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Number of subjects: statistical assessments of sample size
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No particular consideration
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Response variables: primary and secondary endpoints
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No particular consideration
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Methods to minimize or assess bias: randomization, blinding, compliance
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Imperfect blinding
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Maintaining blinding could be difficult due to the proximity to unblinded site personnel and potential knowledge of product-specific adverse events
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Yes
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No
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Dropout rate differences between arms
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The study staff enrolled as participants may have access to accumulating information during the trial to which other participants do not typically have access (e.g., overall adverse event rates)
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Yes
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No
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Analysis: the study protocol should have a specified analysis plan that is appropriate for the objectives and design of the study
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No particular consideration
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Other
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Disruption of trial operations
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During their participation in trial activities as participants, the staff are not available to perform their professional duties
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Yes
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Yes
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