Ethical treatment of research participants

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Ethical treatment of research participants

• Honors Workshop
• Dr. Arcus

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What is Research?
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Research

• A systematic investigation, including research
  development, testing, and evaluation, designed to
  develop or contribute to generalizable knowledge
  (intended for publication or public
  dissemination).

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Research, cont

• Usually described in a formal protocol that sets
  forth an objective and a set of procedures to
  reach that objective.

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Research, cont

• Generally does not include operational activities
  such as defined practice activities in public
  health, medicine, psychology, education and
  social work, polls used for journalism or
  politics, and studies used only for internal
  management purposes such as program evaluation,
  quality assurance, quality improvement, fiscal or
  program audits or marketing studiesunless
  there is clear intent to contribute to
  generalizable knowledge.
• UML IRB

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Ethical execution

• Institutional Review Board
• Members
• Training certification
• University wide
• Human Subject research
• Other oversight of laboratories animal research

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Guiding principles

• Belmont Report Ethical Principles and
  Guidelines for the Protection of Human
  Participants of Research (1979)
• Report to the National Commission for the
  Protection of Human Participants of Biomedical
  and Behavioral Research

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Respect for Persons

• Incoporates the ethical convictions that
  individuals are treated as autonomous agents and
  persons with diminished autonomy are given
  protection.
• Includes voluntary consent to participate in
  research, informed consent to participate in
  research, protection of privacy and
  confidentiality, and the right to withdraw from
  research participation without penalty.

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Beneficence

• Do no harm
• An obligation to protect human participants from
  harm by assessing the risks and benefits of the
  research, designing studies so risk is minimized
  and potential benefits are maximized.

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Justice

• Requires that the potential risks of research
  should be born equally by the members of society
  that are likely to benefit from it
• Research does not systematically select specific
  classes or types of individuals simply because of
  their ease of availability or their compromised
  position as opposed to reasons directly related
  to the problem being studied
• Research does not systematically exclude a
  specific class or type of person who is likely to
  benefit from research participation or in whom
  the results of a specific kind of research are
  likely to be applied.

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Investigators

• Certified in ethical considerations
• NIH National Cancer Institute http//cme.cancer.go
  v/clinicaltrials/learning/humanparticipant-protect
  ions.asp
• CITI program

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Lets consider

• The Eye of the Storm
• http//www.pbs.org/wgbh/pages/frontline/shows/divi
  ded/
• Is it research?
• What special considerations?
• How would you approach the three principles?

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UML IRB

• Office for Institutional Compliance
• http//www.uml.edu/ora/institutionalcompliance/IRB
  
• Forms
• Links to training
• Manual