Ethics in Research

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Ethics in Research

• HPRF 295
• San Jose State University
• November 10, 2004
• Colleen OLeary-Kelley, PhD, RN, CCRN

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Definitions

• Research
• Systematic investigation to produce generalizable
  knowledge
• Participation in activities involving analysis of
  specimens or data from people human subjects
  research

• Human Subject
• A living individual about whom an investigator
  obtains data
• through intervention or interaction with the
  individual or
• through identifiable private information

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Historical Ethical Issues Related to Research

• Instances of unethical research involving human
  subjects were discovered after World War II
• Experiments involving sterilization were
  conducted by the Nazi Party in Germany

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Historical Ethical Issues Related to Research

• Experimental research involved
• Sterilization procedures
• Development of vaccine for typhus
• Events were exposed post WW II
• 1946 Nuremberg trials
• Nuremberg Code developed as the first
  international standard for conduct of research

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Unethical Research in the U.S.

• Tuskegee Syphilis Study 1932-1973
• Designed to determine the natural history of
  untreated syphilis
• Men were recruited without informed consent
• Treatment was withheld

• Jewish Chronic Disease Hospital Study 1965
• Studies that examined the rejection of cancer
  cells
• No informed consent

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Unethical Research in the U.S.

• Radiation tests performed on mentally impaired
  boys 1946 to 1956
• Institutionalized boys were given radioactive
  milk to study the bodys ability to digest
  minerals

• Efforts to protect the rights of research
  subjects occurred in response to knowledge of
  these ethical violations

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Ethical Guidelines for Research

• In 1974, Congress mandated the National
  Commission for the Protection of Human Subjects
  of Biomedical and Behavioral Research
• Primary task identify the ethical principles to
  guide human research
• The Belmont Report published 1979

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The Belmont Report

• Identified three ethical principles to guide
  human research in the U.S.
• Respect for persons
• Beneficence
• Justice

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The Belmont Report

• Respect for persons
• People have the right to self-determination and
  the freedom to participate or not participate in
  research.
• Beneficence
• The investigator is obligated to maximize
  benefits and minimize risk of harm.

• Justice
• Equals must be treated equally and fairly. An
  injustice occurs when benefit to which a person
  is entitled is denied without good reason or when
  burden is unduly imposed.

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Additional Federal Regulations

• In the 1980s, regulations were further developed
  and revised
• Title 45 Code of Federal Regulations Part 46,
  Protection of Human Subjects (45 CFR 46)

• These regulations contain the ethical principles
  of the Belmont Report
• The minimal ethical and legal obligations for
  research involving human subjects are outlined

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Ethical Issues in Research

• Federal regulations are intended to ensure that
  clinical research is conducted ethically
• Universities require that all human subject
  research is conducted within guidelines
• Federal regulations provide two main protections
  for human subjects
• Institutional review board (IRB) approval
• Informed consent

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Institutional Review Board (IRB)

• A committee of scientific and non-scientific
  individuals, established according to federal
  requirements, with responsibilities for review
  and approval of human subjects research protocols
  and consent forms

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Institutional Review Board

• The primary responsibility of the IRB is to
  ensure that research is ethical and protects the
  rights of subjects
• The IRB must determine whether research studies
  meet federal regulatory standards

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Exceptions to IRB Review

• Expedited IRB review may be allowed for research
  that involves no more than minimal risk
• Recording data using noninvasive procedures
• Study of existing documents or records
• An expedited review does not automatically exempt
  the researcher from obtaining informed consent

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Informed Consent

• A process of carefully informing research
  subjects about a proposed course of treatment or
  research that includes an explanation of the
  potential risks and benefits and alternatives
• The researcher must disclose information that may
  influence a potential subjects decision to
  participate

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Informed Consent

• Informed consent must include
• Purpose and description
• Risks
• Benefits
• Alternatives
• Confidentiality
• Greater than minimal risk

• Contact information
• Voluntary participation
• No payment required

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Informed Consent

• It is more than the formality of a signature on a
  piece of paper
• Requirements for informed consent
• Voluntariness
• Understanding

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Informed Consent

• Written consent may be waived in some situations
• Research presents minimal risk
• Impractical
• Consent is deferred to legally authorized
  representative for those who are not capable of
  giving informed consent

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Research in Special Populations

• Scrutinize whether research question could be
  studied in a population capable of giving consent
• Additional federal requirements for groups unable
  to provide consent
• Children
• Prisoners
• Pregnant women, fetuses, embryos
• People with impaired decision-making capability

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Research in Special Populations

• Vulnerable populations must not be singled out
  because they are convenient samples
• Researchers who study such groups need to show
  that it is appropriate to involve vulnerable
  subjects in research

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Ethics in Nursing Research

• ANA Commission on Nursing Research published
  Human Rights Guidelines for Nursing in Clinical
  and Other Research
• Outlines code of ethics for nurse researchers and
  caregivers
• ANA, 1975 2002

• Protection of human rights
• Right to self-determination
• Right to privacy and dignity
• Right to anonymity and confidentiality
• Right to fair treatment
• Right to protection from discomfort and harm

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Scientific Fraud and Misconduct

• Fraud
• Fabrication or falsification of findings
• Misconduct
• Clinical practice based on false published data
• Unauthorized research
• may expose patients to unwarranted risk and may
  not protect human rights
• Conflict of interest

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Ethics in Clinical Trials

• Trials may be stopped early if findings show
  increased risk or benefit
• Cardiac Arrhythmia Suppression Trial
• stopped after 18 months because of increased
  mortality in experimental group compared to
  controls
• Physicians Health Study
• stopped after 4.8 years because a significant
  reduction in MI in the group treated with aspirin

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Online Resources

• Office for Human Research Protection (OHRP)
• OnlineEthics.org
• Hastings Center Report
• NIH bioethics resources