The fact that a research proposal is approved, both in its technical aspects and with regard to ethics and human rights, does not imply that the Committee's functions end up in a simple approval.
The Committee, by procedures determined by the Coordination of Research, shall ensure compliance with ethical issues related to human rights, taking into consideration the following aspects:
Implementation of the research
a.The Ethics Committee shall be informed by the principal researcher or by the head of field research, about problems, resistance to participate, adverse events and reactions of individuals, family and community at the beginning, intermediate and final phase ofIn long-term studies, the report must be at least annually. The reason for this requirement is that the Committee on Ethics and Human Rights, once approved the certificate stands institutional surety in the field. The report will be done through an objective internal memorandum that includes the following information:
- Identify whether or not there is a problem in the information collection phase.
- If the project has been developed in the time specified in the protocol
- Subjects of the study: how many people were invited to participate in the study, how many people accepted, how many refused, how many retired (Annex – template of Monitoring Report)
b.Regarding adverse events occurring during the implementation of the study, the principal researcher must report the number of cases of serious adverse events in the next 24 hours and submit a detailed report within 72 hours.
c.Supervision: at least once in the field research period (hospital, nursery, community) any of the members will be delegated for a monitoring visit to verify that the implementation phase complies with the principles and rules of ethics and respect for minimum human rights contained in this manual.
Ethical Aspects for Data Analysis and Presentation of Research Results
To ensure that data collected in the execution of research as well as its interpretation is being carried out in adherence to the highest ethical standards of basic research from its beginning, the principal researcher shall send an analysis plan of results to the Ethics Committee. As the stages of research are met a copy of the already analyzed results and its initial interpretation will be sent.
The Committee will discuss the plan, as well as the preliminary report containing the interpretation of the results.
Since there are not, from a legal point of view, issues to be convicted for misuse, alteration, distortion or biased interpretation of data, the Ethics Committee established in this regard, the following rules:
a.Data collection should be governed based on the hypothesis, the established methodology and instruments contained in the originalAny alteration of these terms, for any reasons, shall be reported to the coordination of research prior to the change.
b.In the data collection phase, if for rejection reasons some individuals, families, or communities of the original sample must be eliminated, the proposal must include from its beginning the alternatives to be taken to overcome this obstacle.
c.If during the data collection phase over 25% of individuals, families or communities reject the study sample, the researcher shall immediately notify the Ethics Committee, convening a special session to modify the methodology or procedures.
d.In the analysis phase, the analysis plan should establish ranges including expected behavior of the sample. It is considered unethical to alter data in order to match cases with outlying values within the range of the sample. Also, if a substantial proportion of cases fall outside expected ranges, this should be analyzed and presented in a separate report.
e.Regarding the report, it is appropriate that before its publication, the researcher or researchers consider the following recommendations:
i) In individual cases, submit individual reports to participants.
ii) In the case of a community or an institution, the report should be discussed with members of the community or institution.
iii) In case of a report involving aspects of management, administrative, technical or policy of a sector or program, it shall be discussed with the highest authorities of the country to which it pertains.
It is also important to take into account the following rules:
iv)Avoid the identification of the subject individuals in the study, whose cases have revealed information identifying a state of deterioration and distress.
v)Avoid mentioning the names of those responsible for an institution or community, that typifies the state of discomfort, damage or conditions that stigmatize or point out findings contained in research
f.Dissemination ofNo report relating to an investigation shall be published or disseminated unless it counts with the approval of the Institute and, when appropriate, the authority of the affected sector.
g.In the report, in addition to the inherent scientific merits of principal researchers, the merits of staff field, authorities or groups that have provided the research should be recognized in written form.Other cases not contained in these recommendations, must be discussed specifically by the members of the Committee in plenary.