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PAHO / WHO’s Requirement of Ethics Review of Human Subjects Research

PAHO / WHO’s Requirement of Ethics Review of Human Subjects Research

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PAHO / WHO’s Requirement of Ethics Review of Human Subjects Research

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  1. PAHO / WHO’s Requirement of Ethics Review of Human Subjects Research Carla Saenz, PhD Secretary, PAHO Ethics Review Committee (PAHOERC)

  2. Declaration of Helsinki (World Medical Association, 1964, last revision 2013) All research with human subjects must be reviewed and approved by an independent committee prior to its initiation. →(1) Ensure that research is ethical (Included in most national laws and regs)

  3. Additional PAHO / WHO requirement All research with human subjects in which the Organization is involved (through funding or technical cooperation) must be approved by PAHO ethics review committee (PAHOERC) prior to its initiation. → (2) Ensure that PAHO/WHO is only involved in ethical research (GIB 07-06, E-manual XV.3.1, D’s memo)

  4. PAHOERC → To ensure that all research in which PAHO is involved meets ethical standards Housed by Regional Program on Bioethics (HSS/HR) President: Ludovic Reveiz Vice President: Pilar Ramón Secretary: Carla Saenz 8 additional members, 2 observers www.paho.org/pahoerc (includes SOPs)

  5. Not just for clinical research Research: produce generalizable knowledge. Human subjects: people (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 intervention, observation or other interaction with investigators. Human subject research includes surveys, clinical records’ studies, interviews, focus groups...

  6. Five things you need to know Obtaining PAHOERC approval is duty of PAHO staff (not of non-PAHO researchers) New PAHO policy for publications: Research conducted without PAHOERC approval will not be published Human subjects research can be part of big (non-research) project. Only human subjects research component needs to be approved

  7. Five things you need to know Ethics approval cannot (and will not) be provided retrospectively. Decisions about whether a proposal is (not) human subject research (and thus exempted from review requirement) must be made by PAHOERC (not by researchers or supervisors). Official exemptions will be issued

  8. PAHOERC review process Electronic submission: http://mc.manuscriptcentral.com/paho Screening (2 days) [Exemptions issued] External peer review (about 10 days) Committee review (3rd Tuesday) Decision issued (1-2 days) - Average: 14 days for complete submissions - Continuous dialogue throughout review process

  9. Ensuring that PAHO only takes part of ethical research is everybody’s responsibility In all administrative and organizational processes, flag proposals that seem to involve research with human subjects: Has PAHOERC ethics approval been obtained? Support, questions, suggestions, information: pahoerc@paho.org