Frequently Asked Questions

All research with human subjects conducted with PAHO’s financial or technical involvement must undergo PAHOERC review and receive written approval before its initiation (PAHO/WHO E-Manual Policy XV.3.1 WHO Research Ethics Review Committee). Financial involvement includes both monetary and in-kind donations that make it possible to conduct research. Technical involvement can include, but is not limited to, intellectual contributions to the research project, even if PAHO personnel is not listed as investigators. Alternatively, research with human subjects that is conducted with financial or technical involvement from PAHO may also proceed if it obtains approval from the World Health Organization Ethics Review Committee (WHO-ERC).

A proposal must meet the following two conditions to be considered “research with human subjects:”
Research: any social science, biomedical, behavioral, or epidemiological activity that entails systematic collection or analysis of data with the intent to develop or contribute to generalizable knowledge.
Human subjects: human beings (i) who become individually identifiable through investigator’s collection, preparation, or use of biological material or medical or other records, or (ii) who are exposed to manipulation, intervention, observation, or other  interaction with investigators either directly or through alteration of their environment.

• World Medical Association Declaration of Helsinki (2013) revision: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
• International Ethical Guidelines for Health-related Research Involving Humans
  https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf
  

• International Compilation of Human Research Standards (2019 edition): https://www.hhs.gov/ohrp/sites/default/files/2019-International-Compilation-of-Human-Research-Standards.pdf

• Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants published by WHO: http://whqlibdoc.who.int/publications/2011/9789241502948_eng.pdf?ua=1

• Social value: Can the study lead to improvements in health or well-being? What is the potential value of the research for each of the prospective beneficiaries?

• Scientific validity: Is the investigation methodologically valid and scientifically (and statistically) sound? Will the study generate valid and reliable data that can be generalizable? Is the study feasible? Does the study design ensure participants the health-care interventions they are entitled to? If not, are there methodologically compelling reasons and are participants protected from serious harm?

• Fair participant selection: What are the criteria to include and exclude participants? Is selection of participants based on scientific criteria? Are research participants selected to minimize risks and maximize potential benefits? If participants are vulnerable, are there any safeguards to protect them? Are the risks and potential benefits of the study fairly distributed?

• Favorable risk-benefit ratio: Can the risks for participants be minimized? Can potential benefits for individuals and society be improved? Do the potential benefits for society and individuals outweigh the risks?

• Informed consent: Is the information provided to potential participants accurate, clear, relevant and complete? Are the recruitment procedures, consent process and incentives appropriate for their culture and context? Is there an appropriate plan for obtaining permission for those that can?t consent for themselves? Are the participants being made aware of their right to refuse to participate and are they actually free to refuse?

• Respect for participants: How will the health and well-being of participants be monitored to minimize harms? How will their privacy be protected? Can participants withdraw from the study without penalty? What are the plans of care after the study is completed? Will participants be given any new information (including the results of the study)?

(Adapted from (1) Emanuel E, Wendler D, Grady C. An ethical framework for biomedical research. In: Emanuel E et al. eds. The Oxford textbook of clinical research ethics. New York, NY: Oxford University Press; 2008: 123-135. (2) Emanuel E, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000;283:2701-27711. (3) Emanuel E, Wendler D, Killen J, Grady C. What makes clinical research in developing countries ethical? The benchmarks of ethical research. JID 2004;189:930-937.)