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Table 1 Ethical and methodological considerations according to the type of study personnel to be potentially included in a prophylactic Ebola vaccine clinical trial conducted in West Africa outside of the context of an active epidemic

From: Enrolling study personnel in Ebola vaccine trials: from guidelines to practice in a non-epidemic context

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