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 also receive approval from an independent Ethics Review Committee (ERC) in the country where the study will take place.
PAHOERC is made up of a group of professionals from different disciplines, observers from key departments, and a Secretariat that is part of the Regional Bioethics Program, within the Department of Health Services and Systems (HSS). Current PAHOERC members and observers are listed here.
What is subject to ethics review?
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). Obtaining PAHOERC approval is the obligation of those who work for the Organization (E-manual PAHO/WHO E-Manual Policy XV.3.1 WHO Research Ethics Review Committee).
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 the intervention, observation, or another interaction with the investigators.
PAHOERC is the entity responsible for determining whether a proposal meets the definition of "research involving human subjects" and must obtain approval from PAHOERC (through a three-member process). For more information, consult the PAHOERC Standard Operating Procedures (SOP).
If you want to know if your project constitutes “research involving human subjects” and requires ethics review, you can submit it to PAHOERC at any time through the ProEthos system as a “Consultation.”
If PAHOERC determines that a project does not constitute "research involving human subjects," it issues a decision that waves the ethics review process. If you have questions, write to us at firstname.lastname@example.org
How can I send my proposal to PAHOERC for ethics review?
Proposals must be submitted through ProEthos, PAHOERC's portal for review. You must first create an account in ProEthos and then submit the proposal following the system instructions. Other communications should be directed to PAHOERC@paho.org.
What is the PAHOERC review process and how long does it take?
PAHOERC adheres to a transparent process outlined in its Standard Operating Procedures (SOPs), which begins by sending the electronic proposal through ProEthos. The PAHOERC Secretariat maintains contact with the investigators and focal points throughout the process.
The specific steps in the process are:
1. Submit your proposal/consultation to PAHOERC: http://pahoerc.proethos.bvsalud.org (which replaces Manuscript Central since July of 2019).
2. Initial screening process (2 days) in which PAHOERC determines if the proposal is research with human subjects that requires review or is exempt from the process. Exempt proposals will receive a letter within 2-3 days of submission.
3. External peer review (approx. 10 days, if deemed necessary).
4. Committee review (2nd Thursday of every month).
5. Sending observations or decision (1-2 days after meetings).
PAHOERC accepts consultations and partial submissions (e.g. projects that are missing some documentation, such as proof of local ethics approval) at any time, and screens projects for review on a rolling basis. However, a proposal must be reasonably complete for PAHOERC to add it to an agenda for its meeting each month. Agendas for meetings are set during the first week of each month; investigators are encouraged to submit / complete their submissions no later than the first of the month to ensure a spot on the agenda.
Typically, complete proposal documentation includes:
- 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
PAHOERC may request additional information to complete the proposal, in accordance with the CIOMS International Ethical Guidelines for Health-related Research with Human Subjects (see Appendix I: Items to be included in a research protocol for a full list). The PAHOERC Secretariat will inform the responsible PAHO focal point/PI if the documentation is incomplete and give them opportunities to revise their submission, as appropriate.
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