PAHO Ethics Review Committee (PAHOERC)

 What is subject to ethics review?

All research with human participants 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 participants includes, but is not limited to:

1. 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.
2. Human participants: 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 participants" 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 participants” 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 participants," it issues a decision that exempts the proposal from the ethics review process. If you have questions, write to us at 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): PAHOERC determines if the proposal is research with human participants that requires review or is exempt.
3. External peer review (approx. 10 days, if deemed necessary).
4. Committee review (2nd Wednesday of every month).
5. Sending observations or decision (1-2 days after meetings).

 What documentation is required for ethics review? 

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 are finalized during the first week of each month. 

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
• References
• 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.

What documentation is required for a consultation?

PAHOERC accepts minimal information about a project through ProEthos on a rolling basis so investigators may anticipate whether they will need to obtain ethics approval. ProEthos asks investigators to provide:

• Project title and team – including identifying a Principal Investigator, Responsible PAHO Officer, and PAHO Unit supporting the project.
• Objectives of the proposed project
• An abstract and keywords (~200 words)
• An upload of additional documents (could be a concept note, instruments, informed consent, etc.)

How can I view the status of all the proposals previously submitted to PAHOERC?

All proposals submitted to PAHOERC since 2007 can be accessed by PAHO staff or consultants via this internal site.