| Facts |
Ethical Context Considered |
Resolution |
|
| Many participants used to go to the Investigation Center to ask for medical consultations or opinions related to past clinical situations. |
ELSA-Brasil was subsidized by public fostering agencies to produce research. The complete assistance support would be redundant, in view of what is offered by the institutions, and it would require a much more complex structure. In addition, it would make costs become prohibitive. The principle of “Social Justice” (which guides the project) antecedes the principle of individual Beneficence (provided that it is not an urgency situation). |
After the results of the examinations, the doctors involved in the study only instructed the individuals about the need (or not) of consultations with specialists or gave them any other kind of support related to the problem. |
| Some participants refused to submit to certain examinations or to be interviewed. Others refused to provide blood samples for storage. |
ELSA-BRASIL complies with a protocol that aims to obtain, from each participant, measurements and information that are sufficient to the project’s objectives. If the participant refused or could not offer a “minimum set” of information, his/her contribution could not be include in the project. Again, the principle of Social Justice (which guides the project) antecedes the principle of individual Beneficence in such cases. |
The study could not have the participation of individuals who refused (or were not able) to submit to the “minimum set” of examinations Such interdiction does NOT apply to refusal to provide biological material for storage. |
| Examination results raised doubts and anxiety because of information that was not clinically contextualized (generally obtained through the internet or third parties). |
The principle of “non-maleficence”, in view of information that generates anxiety, implies responsibility for the full clarification of the released results. |
All the doubts were directly and fully clarified by the doctors involved in the project. |
| In some cases, the deadline established to release results was not met, mainly because of technical and logistic difficulties. |
The omission of information concerning the nature of delays might be considered as maleficence – some participants, perhaps symptomatic, might be waiting for the results to consult their doctors. |
The contingencies that generated delays were explained to the participants. The limitations deriving from the project’s structure, which is multicenter and not targeted at providing care, were also clarified. The participants who were symptomatic, but duly informed, could perform updated examinations outside the ELSA-Brasil. |
| The results of some examinations informed severe conditions (uremia, myocardial ischemia that was still unknown, severe anemia) which, if not informed immediately, would expose the participants to risks of severe complications. |
In this case, the principle of non-maleficence – related to omission concerning the participant’s health status – anteceded the privacy and confidentiality related to the principle of autonomy. |
The alarm conditions were previously stipulated. Upon arriving at the Investigation Center, the set of examinations was assessed by the doctors, who contacted the participants directly and immediately to guide them about their problems. |
| Participants who confided suicide ideation (identified by the CIS-R questionnaire) would need immediate psychiatric support. |
The confidentiality of the interview should be overruled. The principle of non-maleficence – related to omission – antecedes privacy and confidentiality, which are related to the autonomy principle. |
The specialists instructed the team on how to recognize the most urgent cases, which would require immediate psychiatric support. Such support was immediately contacted whenever necessary. |
| Electrocardiographic changes were identified in some participants, suggesting a disease with risk of sudden death. They should be immediately referred to the cardiac support, breaking the process’ confidentiality. |
Likewise, individual beneficence and security antecede privacy and confidentiality. |
The technicians were trained to recognize such changes and immediately contacted the cardiologist who supported the Investigation Center, so that he guided the participant and the team itself. |
| The complete list of examinations and measurements was previously provided for the participants. Only the results of measurements that were useful to clinical assessment were handed. The “experimental” measurements, which have not been consecrated by clinical practice yet, were not handed to everybody. Some participants demanded integral access to all examinations. |
Full access to examination results (related to beneficence and autonomy), even those that are not used in clinical practice yet (without evident normal ranges and, therefore, without evident correlation with pathological conditions) might generate doubts among participants, as well as among their doctors. It was decided that non-maleficence anteceded autonomy in this context. |
Whenever requested, the measurements that were not used in clinical practice were handed – which would comply with the principle of autonomy. Supplementary explanations were also provided, which could avoid the maleficence derived from doubts between participants and their doctors. |
