Research Ethics in the Allied Health Professions

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Research Ethics in the Allied Health Professions

• Monika S. Markowitz, Ph.D.
• Director, Office of Education and Compliance
  Oversight
• Vice Presidents Office for Research
• Virginia Commonwealth University
• 
  
• 
  
  9/07

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Objectives

• Research ethics and its underlying principles
• Considerations by the IRB in ethics review of
  human subjects research
• Tensions within and between the ethical
  principles and challenges for review

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Research ethics

• A normative ethics Which moral norms for
  guidance and evaluation of conduct should we
  accept and why?
• Comprises morally informed policies and
  regulations

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History of Research Transgressions leads to
research oversight

• Nazi medical war crimes
• Nuremberg Code 1947
• Tuskegee Syphillis Study
• Jewish Chronic Disease Hospital
• Willowbrook

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National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research
1974
2007
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The Belmont Report
Respect for Persons
Beneficence
Justice
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The Belmont Principles1979

• Respect for Persons
• Individual autonomy
• Protection of individuals with diminished
  autonomy
• Beneficence
• Maximize benefits and minimize harms
• Do good, not just avoid harm
• Justice
• Equitable distribution of research costs and
  benefits

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How the Belmont Principles are to be enacted in
research

• Respect for persons informed consent
• 
  privacy confidentiality
• Beneficence benefit/risk
  (burden)
• 
  assessment
• Justice distribution
  of risk and
• 
  benefit
• 
  inclusion/exclusion

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Federal Regulations and Policy stemming from
ethical principles
45 CFR 46 DHHS Policy for Protection of
Human Research Subjects- Subpart A Originally
adopted January 13, 1981 Revised June 18,
1991 The Common Rule adopted by 17 federal
agencies, including FDA-regulated
research Federal-wide Assurance VCUs promise
to the federal government that research will be
compliant with regs
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Primary features of federal regulations informed
by ethical principles

• Requirement of prospective IRB review and
  approval of human subjects research
• Requirement for a formal informed consent process
  for research that is not exempt
• Risk is 1) minimized, and 2) reasonable in
  relation to anticipated benefits

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Primary features of federal regulations

• Additional requirements for 3 groups of
  vulnerable populations pregnant women, fetuses,
  and neonates prisoners children
• Requirement for continuing review on expedited
  and full board studies at least annually
• Additional requirements for drugs, devices,
  biologics or other research disciplines with
  specific regulation

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Primary features of federal regulations

• Requirement of IRB review and approval for human
  subjects research

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Institutional Review Board (IRB)

• Established to provide ethical review of research
• Assure that federal regulations are followed
• Members include researchers, non-researchers and
  members of the local community
• 5 IRBs at VCU
• Regulatory and ethical charge review and approve
  human subjects research to protect the rights
  and welfare of research participants
  
• 
  45CFR46.103(b)

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Activities needing IRB approval

• RESEARCH
• A systematic investigation designed to develop or
  contribute to generalizable knowledge.
• 45 CFR 46.102(d)
• HUMAN SUBJECT
• A living individual about whom an
  investigatorconducting research obtains
• 1) data through intervention or interaction with
  the individual, or
• 2) identifiable private information
• 45 CFR 46.102(f)

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Primary features of federal regulations

• Requirement of IRB review and approval for human
  subjects research
• Requirement for consideration of a formal
  informed consent process for research that is not
  exempt

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Elements of informed
consent

• Disclosure of relevant information
• Understanding of disclosure and recommendation
• Capacity to understand and decide
• Voluntariness

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Problems of disclosure and comprehensionHow much
to disclose and to what standard?
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Decision making capacity ability to make and
communicate a decision consistently over time
according to internalized values
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Is consent given voluntarily?
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Primary features of federal regulations

• Requirement of prospective IRB review and
  approval of human subjects research
• Requirement for a formal informed consent process
  for research that is not exempt
• Risk is 1) minimized, and 2) is reasonable in
  relation to anticipated benefits

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IRB Review Continuum
Level of potential risk determines route of
review for biomedical and social-behavioral
research

• Exempt Expedited Full

Low Risk
High No greater than minimal risk
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Definition of Minimal Risk45 CFR 46.102(i)

• Minimal Risk means that the probability and
  magnitude of harm or discomfort anticipated in
  the research are not greater in and of themselves
  than those ordinarily encountered in daily life
  or during the performance of routine physical or
  psychological examination or tests.

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• IRB considers the risk of criminal/civil
  liability, financial risk, employment risk,
  stigmatization, insurability, and embarrassment
  in deciding if risk is truly minimal.

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Privacy and Confidentiality

• When appropriate, there are adequate provisions
  to protect the privacy of subjects and to
  maintain the
• confidentiality of data 45CFR46111(a)
• Breaches of privacy and/or confidentiality are
  the main risk in social-
• behavioral research or
• research that is no greater
• than minimal risk

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Primary features of federal regulations

• Additional requirements for 3 groups of
  vulnerable populations pregnant women, fetuses,
  and neonates prisoners children

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Populations specifically protected in federal
regulations 45CFR46

• Pregnant women - Subpart B
• Prisoners Subpart C
• Children Subpart D

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Other considerations may also count as
Vulnerable

• Language
• Culture
• Current Events or Incidents
• Age (elderly)
• Age (adolescents)
• Educationally, economically disadvantaged

• Transient Cognitive Impairment
• Substance Use
• Health Status
• Students
• Employees

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Primary features of federal regulations

• Additional requirements for 3 groups of
  vulnerable populations pregnant women, fetuses,
  and neonates prisoners children
• Requirement for continuing review on expedited
  and full board studies at least annually
• Additional requirements for drugs, devices,
  biologics or other research disciplines with
  specific regulation

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Tension within respect for persons

• Presumptions of Informed consent, Assent, and
  Parental permission
• Presumption about the incapacity of certain
  vulnerable groups
• Presumption about the abilities of LARs
• Presumption about the extent to which potential
  subjects may be influenced to participate

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Tension within beneficence

• Definition of Minimal Risk45 CFR 46.102(i)
• Minimal Risk means that the probability and
  magnitude of harm or discomfort anticipated in
  the research are not greater in and of themselves
  than those ordinarily encountered in daily life
  or during the performance of routine physical or
  psychological examination or tests.

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Tension within beneficencerisk/benefit
assessment

• Which type of risk is
• more or less probable,
• more or less severe?
• Whose daily life,
• what kinds of
• procedures or tests
• are routine?
• Whose benefit?

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Tensions between ethical principles

• Respect for persons
• Beneficence

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Special Protections

• Some persons are in need of extensive protection,
  even to the point of excluding them from
  activities which may harm them
• other persons require little protection beyond
  making sure they undertake activities freely and
  with awareness of possible adverse consequence.
• The Belmont Report

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Paternalism in the system?

• Arguments
• Subjects give informed consent
• IRBs overinterpret probability and magnitude of
  risk thereby overprotecting subjects who should
  decide for themselves
• The point of regulations to protect research
  subjects is to assure that research protocols are
  consent-worthy that they agree with the values
  the agent her- or himself would deem relevant if
  she were in a position to accurately make such
  judgments.
• Miller Wertheimer, 2007, HCR, 37.3, 24-35.

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The Case of What you dont know wont hurt you

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The Case of What you dont know wont hurt you

• An Investigator wishes to determine the
  prevalence of repetitive behaviors in individuals
  with Alzheimers Disease
• PI proposes that nurses in chronic care
  facilities record the number and nature of such
  behaviors for individual residents
• PI decides the research should be exempt from IRB
  review under the federal regulations which allow
  such exemptions if the research is limited to
  observation of public behavior

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The Case of What you dont know wont hurt you

• Upon initial review by the IRB, the investigator
  is advised to resubmit the proposal for expedited
  review and requests a waiver of the requirement
  to obtain informed consent. The main reason for
  the waiver request is that the research could not
  practicably be carried out without the waiver
  because many of the patients, due to cognitive
  deficits, choose not to participate in any
  activities. Since this is a prevalence study,
  such nonparticipation would markedly weaken the
  findings. The PI does not feel the rights or
  welfare of the subjects are impacted if consent
  is waived.

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Tensions between ethical principles

• Justice
• Respect for persons Beneficence

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Vulnerable populations

• Arguments
• Justice and fairness requires their participation
• Research participation leads to benefit for the
  vulnerable group, but risk may be greater
• Informed decision making is often perilous
  potential subjects and/or use of LAR

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Non-English speaking persons

• Arguments
• Unfair to exclude them and bar them from possible
  benefit principle of justice
• Should have access to an informed consent process
  which includes translated form and interpreter
  throughout the research process respect for
  persons
• Poor communication of adverse events or problems,
  thus placing themselves and other subjects at
  greater risk beneficence

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Criteria For IRB Approval 45 CFR 46.111

• Minimized risks
• Reasonable risk/benefit relationship
• Equitable subject selection
• Informed consent process
• Informed consent documentation
• Data monitored for safety, if appropriate
• Confidentiality/privacy maintained
• Vulnerable populations protected

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Minimizing Research Risk

• Excerpt from an actual consent form describing
  risk
• The radiation to which you would be exposed in
  this study is no greater than that during a
  nuclear attack.