Frequently Asked Questions
What is subject to ethics review?
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.
What are the international ethical guidelines for research with human subjects?
- Declaration of Helsinki of the World Medical Association (2013 revision): http://www.wma.net/en/30publications/10policies/b3/
- International Ethical Guidelines for Biomedical Research Involving Human Subjects of the Council for International Organizations of Medical Sciences (CIOMS): http://www.cioms.ch/publications/guidelines/guidelines_nov_2002_blurb.htm
- International Guidelines for Ethical Review of Epidemiological Studies of the Council for International Organizations of Medical Sciences (CIOMS): http://www.cioms.ch/publications/guidelines/1991_texts_of_guidelines.htm
What are the standards of each country for research with human subjects?
- International Compilation of Human Research Standards (2015 edition): http://www.hhs.gov/ohrp/international/index.html
How should ethics review committees function?
- 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
Which questions should guide the ethics review of research with human subjects?
- 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.)
Who is responsible for submitting to PAHOERC?
The responsible PAHO personnel directly or indirectly in contact with the Principal Investigator (PI), serving as PI, or working in the technical area related to the research proposal shall serve as the point of contact for PAHOERC’s review process of that protocol. If the responsible PAHO personnel is not PAHO staff, they will need to obtain approval from their first-level supervisor before serving as the point of contact for the research project and include the first-level supervisor’s name in their submission to PAHOERC. Responsible PAHO personnel duties are: 1. Ensuring that all PIs, whether internal or external researchers, are aware of the PAHOERC review requirement and do not initiate their research before obtaining a PAHOERC approval. 2. Ensuring a timely electronic submission of the research proposal to PAHOERC. 3. Coordinating with the PI and the research team as appropriate, ensuring that requests from the Secretariat are addressed throughout the PAHOERC review process and throughout the duration of the project in a thorough and timely manner. 4. Ensuring that the research is conducted in accordance with relevant national regulations and research integrity standards established by WHO’s Code of Conduct for responsible Research. 5.Transferring the current duties of the responsible PAHO personnel to the appropriate PAHO personnel in the event that he/she departs PAHO or is reassigned to different activities.
What should a research protocol contain?
- Abstract (less than 300 words)Brief background and justification for the study
- Study objective(s) and brief statements as to how the research question(s) are relevant for the context
- Methodology, including sampling methodology and relevant calculations, inclusion and exclusion criteria, participant selection process, variables, and data analysis plan that supports the objective(s) and research question(s).
- Limitations and delimitations of the study.
- Assessment of predictable risks and burdens to individuals and communities involved in the research, and a description of how they will be minimized and addressed.
- Instrument(s). Questionnaires, scripts for focus groups, ratings scales, diagrams, and tools to collect information that will be used with humans. Information about the prior validation of the instruments should be included, if available.
- Local Ethics Approval.
- Informed consent documentation
- Conflict of interest declaration statement
- List of all members of the research team
for PAHOERC it should also include:
- Curriculum vitae
- budget and timeline
- proof of clinical trial registration
What are my duties as a PAHOERC member?
Members are responsible for attending and participating in committee meetings. Members are expected to be fully prepared for the reviews they undertake. members should undergo training on research ethics within six months of beginning service on PAHOERC unless they have obtained prior research ethics training. They should strive to remain impartial and objective and keep demands for information and other material to a realistic level. They should use their expertise to make balanced judgments based on the evidence presented and must declare any conflicts of interest to the president or the secretariat before initiation of a review process. Member responsibilities shall be reflected in the staff members’ work objectives.
All PAHOERC members and the Secretariat are expected to contemplate the operations of PAHOERC to identify problems and to offer suggestions as well as contribute to the implementation of solutions that will improve the quality and efficiency of PAHOERC’s work.