Human Participants in Research: What You Need to Know

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Human Participants in Research What You Need to
Know

• Joseph F. Hulgus, Ph.D
• Chair, IRB

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Why Have IRBs?

• Research holds the potential to harm people
• Nazi experimentation
• Tuskegee Syphilis Study
• Milgram Obedience Study
• Zimbardo Prison Study

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How Did This System Develop?

• 1964, Declaration of Helsinki
• 1953, NIH all in internal clinical research
  must be reviewed
• 1966, USPHS first extramural rules (revised in
  1971 and 1974)
• 1972, Public Law 93-348 - Establishment of the
  National Commission for the Protection of Human
  Subjects of Biomedical and Behavioral Research

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• 1979, Belmont Report Three general ethical
  principles
• Beneficence -To maximize benefits for science,
  humanity, and research participants and to avoid
  or minimize risk or harm.
• Respect - To protect the autonomy and privacy
  rights of participants.
• Justice - To ensure the fair distribution among
  persons and groups of the costs and benefits of
  research.

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• 1991, Code of Federal Regulations 45 CFR 46
  (The Common Rule)
• 3 Key Ideas
• Human subjects
• Systematic investigation
• Generalizable knowledge

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Whats Our System

• Three levels of review possible
• Exempt exempt from full force of federal code
• Expedited some federal code applicable, but
  does not require full board review
• Full Board Review any protocol with significant
  risk
• Keys on risk/benefit ratio

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Protocol Considerations

• Population (protected or not)
• Level of risk (greater than everyday risks or
  not)
• Confidentiality and Data Security
• Informed Consent

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Population

• Vulnerable populations receive extra
  consideration
• Children
• Prisoners
• Pregnant women
• Those in poverty
• Those with diminished capacity

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Level of Risk

• Minimal no greater risk than wound normally be
  encountered in daily life
• Mild somewhat greater than normal risk, but
  without significant consequences
• Moderate and above identifiable risks higher
  than everyday life that could have significant
  consequences

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Confidentiality

• Unless agreed to by participants, they should not
  be able to be identified
• Names
• Identifying numbers
• Extrapolation from demographics or other info
• Extends to how data will be managed and stored

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Informed Consent

• Key Elements
• Clear explanation of research purpose and
  procedures
• Description of any procedures which are
  experimental
• Benefits to the participant and/or society
• Risks even minor risks that would be significant
  to only a few
• Alternate procedures/treatments available for a
  condition
• Participation is voluntary and the participant
  can withdraw without penalty or loss of benefits
• Who to contact with pertinent questions

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• The amount of time required of the subjects
• Confidentiality of data and final disposition of
  data
• If the research involves more than minimal risk,
  a description of compensation and treatment that
  is available for injury and who to contact in the
  event of a research related injury
• A statement of acknowledgement of having read and
  understood the consent document, having the
  opportunity to have questions answered by the
  Principal Investigator (or appropriate
  individual) and consent to participate in the
  study followed by the signature of the
  participant
• Incorporating consent for any PHI used

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The Process at Missouri State

• Complete CITI training
• Complete application cover sheet

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Compose Body of Application

• Brief description of the purpose of the proposed
  project, including specific goals
• Research protocol, that includes
• Description of participants to be used,
  including
• General demographics of target sample
• Sample size
• Sampling procedures
• From where participants will be obtained
• How long procedures will take participants
• Procedures, including
• General progression of research
• How informed consent will be obtained/addressed
• Description of setting in which data is obtained
• How data will be kept secure and confidential
• Name and description of data gathering tool
  (attach a copy if possible)
• HIPAA considerations/procedures (if applicable)
• Description of any special situations/circumstance
  s needing to be addressed in the study
• Data disposition when the study is completed
• How resulting information will be
  used/disseminated/shared

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Body of Application (contd)

• Benefits Describe benefits to the individual
  and/or mankind from participation
• Risks Describe the risks to the participant.
  This includes physical, psychological, and/or
  sociological risks.
• Analysis of RiskBenefit Ratio When Relevant
  This is the researchers own evaluation of the
  balance between potential risks for participants
  and potential benefits from the project.
• Procedures for Minimizing Risk Describe
  precautions that will be taken to minimize the
  risks described above, including more detail
  about how data confidentiality will be
  maintained, and the final disposition of data.
• Procedures for obtaining informed consent (see
  guidelines for key elements to include in
  informed consent)

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Body of Application

• The project proposal shall end with the
  following, verbatim (including signature lines)
• I hereby agree to conduct this study in
  accordance with the procedures set forth in my
  project description, to uphold the ethical
  guidelines as set forth in the Code of Federal
  Regulations 45 CFR 46, 45 CFR 160 and 164, and
  the SMSU HIPAA Policy, and to report to the IRB
  any outcomes or reactions to the experiment which
  were not anticipated in the risks description
  which might influence the IRBs decision to
  sustain approval of the project.
• Signature of PI (Faculty)
• Signature of other Investigators
• Signature of Department Head

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Route of the Application

• Application first goes to College IRB
  representative for review
• If Exempt or Expedited, then goes to IRB Chair
  for review
• If Chair concurs, then goes to OSRP they
  generate letter
• If Chair doesnt concur, may go back to PI for
  changes/clarifications
• If risks are significant, may require a full
  board review

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So, Whats Up With the IRB?

• IRB meets monthly may call special meeting for a
  full board review, if needed
• Most applications take approximately 2 weeks to
  review
• The IRB averaged 372 reviews per year over the
  last 5 years
• IRB members spend approximately 15 hours a month
  on applications
• Is ALL VOLUNTEER

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Best Sources of Information

• IRB COLLEGE REPS ARE GOOD CONSULTANTS FOR YOU
  MAKE USE OF THEM!
• The OSRP Website has forms and other useful
  information (www.srp.missouristate.edu)