Ethical Considerations in Human Subjects Research Stacey Berg, M. D

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Ethical Considerations in Human Subjects Research

  • Stacey Berg, M.D.

  • Texas Children’s Cancer Center

  • Definitions

  • IRB review

  • Informed consent

  • Confidentiality + HIPAA

  • Human material

  • Chart reviews

Definition of Research

  • Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge

Definition of Subject

  • Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains:

    • (1) data through intervention or interaction with the individual
    • (2) identifiable private information

Subjects involved?

Human Subjects Research

  • IRB approval

    • full board
    • expedited
  • Informed consent

    • full written consent
    • altered or waived consent

Research Exempt from Approval

  • Educational testing

  • Some surveys

  • Some studies of existing data or specimens

  • Study of public service programs

  • Taste and food quality evaluation

What does an IRB do?

  • Review, approve, require modifications or disapprove research

  • Review informed consent

  • Conduct continuing review

  • Have authority to observe consent process and research

Criteria for approval

  • Risks to subjects are minimized

  • Risks to subjects are reasonable relative to benefits

  • Selection of subjects is equitable

  • Provisions made for data, safety monitoring

  • Provisions made to protect confidentiality

  • Safeguards in place for vulnerable subjects

  • Informed consent will be sought, documented

Risks minimized

  • Background/importance of problem

  • Study design issues

    • Good endpoints
    • Justifiable sample size
    • Appropriate biologic correlates
    • Leverage clinical procedures
  • Less risky way to get answer?

Risk-benefit ratio favorable

  • How much risk?

    • To individual
    • To family?
    • To society?
  • How much benefit?

    • To individual
    • To society
  • Adequate data analysis plan

    • Protocol endpoints
    • Safety monitoring

Informed consent

  • Tell people why you’re doing this and what’s going to happen to them!

  • Risks (not underestimated)

  • Benefits (not oversold)

  • 7th grade language

Informed consent

  • What the research is

  • Procedures involved

  • Risks, benefits

  • Treatment/compensation for injury

  • Alternatives

  • Right to withdraw

  • Confidentiality

  • Contacts for questions

Informed consent

  • Unforeseeable risks

  • Circumstances for termination of participation

  • Additional costs

  • Procedures for withdrawal

  • Notification of new findings that might affect willingness to participate

  • Approximate number of subjects


  • Consider subject privacy

    • Where you’ll talk
    • How intrusive?
  • Safeguard confidentiality of data

    • Locked doors
    • Password protected files
  • Consider risks if confidentiality breached

    • Genetic info- parentage, insurance
    • Psychological harm
    • Job status
  • Who gets access, what circumstances

  • What happens to samples


  • Privacy rule

  • “Limiting the ways that health plans, pharmacies, hospitals and other covered entities can use patients’ personal medical information.”

  • Authorization to use PHI usually part of consent form

  • Applies in some settings where research regs don’t

Waiver of Consent?

Special types of research

  • Tissue samples only

    • Tissue banks complex
  • Databases

    • Do not need IRB approval for operational use
    • DO need IRB approval for research on data
  • Chart reviews

    • Need IRB approval (HIPAA)

Tissue Banks

  • Critical research resource

    • Genomics
    • Proteomics
    • Futuromics
  • Samples held indefinitely

  • Future uses unpredictable

  • Sample used in other studies

  • Clinical correlation valuable

Types of sample

  • Anonymous

  • Coded

    • A link exists
    • Tissue recipient does not have key
    • Repository does
  • Identified

    • Tissue recipient can connect tissue to donor

Kinds of IRB review

  • Anonymous samples

    • Can be exempt from IRB review
  • Coded or identified samples

    • IRB review required
    • Expedited review may apply if minimal risk
  • Samples all from decedents

    • Exempt from IRB review (not human subjects)
    • Still need HIPAA review

Consent considerations

  • Informed consent required

  • Special considerations

    • Subject contact:
    • What PHI being collected?
    • Duration of follow-up
    • Recontact re: future studies?
    • Sample use:
    • This study only?
    • Any study related to condition?
    • Unspecified future studies?

Waiver of consent?

  • Only if minimal risk

    • Confidentiality well protected
    • No release of PHI
    • Rights of subject not compromised
    • Adequate plan to reveal important findings
  • AND impracticable to get consent

Tissue Collection Exempt?

Chart Reviews

  • IRB approval

    • usually expeditable
  • Informed consent?

    • Not (usually) if retrospective review
    • Yes if prospective data collection
  • “Dear colleague” letter

    • passive approval from other MDs


  • If for TPO (or education), no IRB or HIPAA issue

  • If collecting PHI but not for research, need authorization (or waiver)

  • If collecting PHI for research, need informed consent (or waiver)


  • Effectiveness of programs

  • Improvements in health care delivery in particular settings

  • Not usually research if intended for internal program evaluation without generalization

  • Difficulty is in deciding when insight becomes “generalizable”

Helpful links

  • 45 CFR 46

  • Belmont Report

  • NIH guide on informed consent

  • Data monitoring

  • IRB Manual

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