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
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 |