PAHO Ethics Review Committee (PAHOERC)
PAHOERC ensures that all research carried out with PAHO support, whether technical or financial, follows international standards for ethics review with human subjects. All research with human subjects must receive approval from an independent Ethics Review Committee (ERC) in the country where the study will take place. PAHOERC carries out a secondary review of research proposals to guarantee that PAHO is only involved in research that is ethical: that it benefits society, is methodologically sound, and accords to principles of respect for persons, beneficence, and justice.
PAHOERC is made up of an interdisciplinary group of professionals, observers who represent key departmental units, and a Secretariat. PAHOERC is housed within the Regional Program on Bioethics, under the Health Systems and Services (HSS) Department.
All research with human subjects that is financed by or receives technical support from PAHO requires PAHOERC review and approval (Directive No. HQ/FO 07-06) (WHO/PAHO E-Manual . Research with human subjects includes, but is not limited to:
- — Research: any social science, biomedical, behavioral, or epidemiological activity that entails systematic collection or analysis of data with the primary intent to develop or contribute to generalizable knowledge.
- — Human subjects: those who are made (i) individually identifiable through the collection, preparation, or use of biological or medical material or other records, by the investigator; or (ii) exposed to intervention, observation or another interaction with the investigators.
In general, the review process consists of an electronic submission of documents to PAHOERC and communication with its Secretariat thoughout the process of obtaining ethics review. Currently the average time a complete protocol takes to make it to a Committee meeting is 14 days.
The specific steps in the process are:
1. Submission of the complete research protocol through the electronic system: http://pahoerc.proethos.bvsalud.org (which replaced the manuscript central portal in July 2019)
2. Screening Process (2 days): This is when the decision will be made about whether the proposal will need to pass through the complete ethics review process or if it will be granted an exemption.
3. External peer review (approx. 10 days, when necessary)
4. Committee Review (2nd Tuesday of each month)
5. Send out PAHOERC Observations or Decisions (1-2 days)
A complete research proposal includes the following:
-Brief background and justification
-Objective and expected outcomes of the study and a brief declaration about its relevance
-Methodology, procedures, analysis plan
-Sampling methodology and sample-size calculations
-Limitations or delimitations
-Evaluation of the predicable risk-benefit for individuals and communities involved compared with the predicted benefits for each
-Budget and timeline
-Proof of approval by a local ethics committee or, if necessary, by the national authorities
-Declaration of funding sources, sponsors, institutional affiliations and any other possible source that could pose a potential conflict of interest.
-Informed consent documentation.
-Instruments that will be used during the study process (questionnaires)
-Curriculum vitae (2 pages) of the PI and co-investigators
Only complete protocols will be reviewed during in-person meetings. The PAHOERC Secretariat will inform the responsible PAHO personnel for the project if the documentation is incomplete.