Ethical Concerns in Research

1
Chapter 5

• Ethical Concerns in Research

2
Historical Perspective on Ethics

• Nazi Experimentation in WWII
• medical experiments
• Nuremberg War Crime Trials
• Nuremberg Code basic principles to govern
  research involving human subjects
• Tuskegee Syphilis Study
• PHS project related to untreated syphilis
• Highlights deception and informed consent
• Human radiation experiments

3
Ethical Standards for the Protection of Research
Participants

• Nuremberg Code (1947) first set of guidelines
• Helsinki Declaration (1964) medical research
• Belmont Report (1979) fundamental document for
  current federal regulations in US
• Common Rule (1991) 45 C.F.R. 46
• Federal rules that govern research involving
  human participants in the US
• Institutional Review Boards (IRB)

4
Basic Principles of Belmont Report

• Respect for persons
• Proclaims individuals capable of
  self-determination thus voluntary consent is
  essential
• Beneficence
• Obligates researchers to maximize potential
  benefits and minimize possible harm
• Justice
• Requires the benefits and burdens of research be
  fairly distributed

5
Informed Consent

• Arguably the most important ethical standard
• Refers to telling research participants about all
  aspects of the research that might reasonably
  influence their decision to participate
• Four important elements
• Subjects are fully aware of nature and purpose of
  research project
• Consent is voluntarily given
• Person has legal capacity to give consent
• Responsibility for obtaining consent rests with
  researcher

6
Protecting Vulnerable Subjects

• Particular precautions must be taken to protect
  the welfare of subjects that might be considered
  especially vulnerable or at risk for some reason
• The following types of subjects might be
  considered to be vulnerable children,
  handicapped, cardiac rehab patients, welfare
  recipients, prisoners, pregnant women, patients
  in a mental hospital, etc.

7
Privacy Confidentiality

• Privacy refers to the capacity of individuals
  to control when and under what conditions others
  have access to their behaviors, beliefs, and
  values
• Confidentiality refers to treating subject
  information or responses in a manner so that it
  is not linked to any specific individual who
  participated in a study
• single-subject research requires particular
  caution
• Normally addressed through informed consent

8
Institutional Review Boards

• IRBs established by federal mandate to assure
  compliance with governmental regulations
• IRBs have authority to approve, require
  modifications, or disapprove research
• IRB approval required before any aspect of the
  research involving human subjects may commence

9
Categories of IRB Review

• Exempt from review
• Expedited review
• Full review
• Dependent upon amount of risk present

10
Criteria for IRB Approval

• Risks to subjects are minimized
• Risks to subjects are reasonable in relation to
  anticipated benefits
• Selection of subjects is equitable in relation to
  the purpose of the research and its setting
• Informed consent will be sought from each
  prospective subject or their legal representative
• Informed consent will be appropriately documented
• Provisions for monitoring data collected to
  ensure safety of subjects
• Provisions to protect privacy of subjects and to
  maintain confidentiality of data

11
Disclosure of Results

• Research investigations normally result in some
  disclosure of the results of the study (e.g.,
  paper, published article, presentation)
• The preeminent ethical obligation in this regard
  is not to disclose inaccurate, deceptive, or
  fraudulent research results
• To do so undermines the very nature of the
  scientific process!
• Proper establishment of authorship.

12
Scientific Misconduct

• According to the U.S. Public Health Service . . .
• Misconduct means fabrication, falsification,
  plagiarism, or other practices that seriously
  deviate from those that are commonly accepted
  within the scientific community for proposing,
  conducting, or reporting research

13
Ethical Obligations in Research

• Researcher is responsible for his/her subjects
• Researcher is responsible for his/her own actions
  and those of any research aides
• Subjects must provide informed consent
• Researcher protects subjects from harm, danger,
  and discomfort
• Maintain anonymity and confidentiality
• Subjects should not be coerced
• Researcher has responsibility after the
  investigation is complete to safeguard subject
  data
• Honest disclosure of results