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HCS 420:
RESEARCH METHODS IN HEALTHCARE

Week 8

Ethical Issues in Healthcare Research

Chapter 14

Video

https://www.youtube.com/watch?v=zZ3l1jgmYrY

What is ethics?

Moral principles that govern a person's behavior or the conducting of an activity.

History

The Tuskegee Study?

Tuskegee Study

  • 1932 Study to document the natural history and long-term effects of untreated syphilis

  • Enrolled impoverished, poorly educated, African-American men

  • Deception and withholding of treatment

  • Led to major reforms in health research

Ethical Principles

Three ethical principles

(1) Respect for persons

All persons have the right to make their own decisions about research participation

Respect for persons

  • Investigators must obtain informed and voluntary consent from research participants

  • Allow participants to discontinue research at any time

  • Protect participants with impaired decision-making capacity

(2) Beneficence

Beneficence

  • The scientific knowledge to be gained must outweigh the inconvenience and risk experienced by research participants

  • Risks must be minimized

(3) Justice

Justice

  • The benefits and burdens of research must be distributed fairly

  • Disadvantaged and vulnerable populations (i.e. low income, limited education, etc.) should not be selectively targeted as participants if other populations would also be suitable

  • Equitable access to the benefits of research

Federal regulations and key definitions

“Subjects” vs “participants”, which is preferred?

“Participants”

It emphasizes that people are active “participants” in research, rather than “subjects” to be experimented upon.

What is research?

“Research”

“Systematic investigation designed to develop or contribute to generalizable knowledge”

What are “human subjects?”

“Human subjects”

“Living individuals about whom an investigator obtains either data through intervention or interaction with the individual or identifiable private information”

What is private information?

“Private Information”

(1) information that a person can reasonably expect is not being observed or recorded; (2) information that has been provided for specific purposes and that the individual can reasonably expect will not be made public

Institutional Review Board (IRB)

Federal regulations require that research with human participants be approved by an IRB


The IRB’s mission is to ensure that the research is ethically acceptable and that the welfare and rights of research participants are protected

What else does IRB do?

The IRB must determine that:

  • Risks to participants are minimized
  • Risks are reasonable
  • Selection of participants is equitable
  • Informed consent will be obtained
  • Confidentiality is maintained

Exceptions to Full IRB Review?

IRB: Exceptions

  • Research using surveys and interviews

  • Secondary analyses of de-identified existing records and specimens

  • Minimal risk research may undergo expedited review by a single reviewer (rather than the full committee)

Informed and Voluntary Consent?

Federal regulations require investigators to discuss several topics with potential participants

Topics to discuss include

  • The nature of the research project

  • The procedures of the study

  • The risks and potential benefits of the study

  • The alternatives to participating in the study

What are consent forms and what are they used for?

Consent Forms

Required to document that the process of informed consent has occurred.

To be valid, consent must be voluntary and informed

There must not be coercion or undue influence

How to Minimize Risks in Research?

Minimizing Risks

  • Confidentiality
  • Breaches can cause stigma or discrimination
  • Researchers can obtain confidentiality cert

  • The HIPAA Health Privacy Rule
  • Health Insurance Portability and Accountability Act
  • Protects individually identifiable health information or protected health information

Participants Requiring Additional Protection

Participants who Require Additional Protections

  • Cognitive or communicative impairments
  • Power differences
  • Social and economic disadvantages
  • Children
  • Prisoners
  • Pregnant women, fetuses, and embryos

Responsibilities of Investigators

Responsibilities

  • Scientific misconduct
  • Fabrication: making up results and recording or reporting them
  • Falsification: Manipulating research materials, equipment, or procedures or changing or omitting data
  • Plagiarism: Appropriating another person’s ideas, results, or words without giving appropriate credit

Responsibilities (Contd.)

  • Authorship
  • Guest/honorary authorship: Listed as authors despite having made only trivial contributions to the paper
  • Ghost authors: Make substantial contributions to a paper but are not listed as authors

  • Conflicts of interest
  • Financial: Certain financial ties might lead to bias in the design and conduct of a study (i.e. drug trials)
  • Dual role (clinician-investigator): Role might conflict if the same person serves both function

Ethical Issues in RCT design?

“Equipose”

There should be genuine uncertainty or controversy over which arm of the trial is superior, so that participants will not be significantly harmed when treatment is determined by randomization

Other Issues

Payment to research participants: could incentives constitute undue inducement?

It depends!