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Chapter 3: Ethical Issues in Health Promotion Research. Research and Ethics. Research involves testing theories to determine what “works” and what “doesn’t” In Health Promotion Research: Something that “works” may: Save lives Reduce disease Something that “doesn’t work” may: End lives

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research and ethics
Research and Ethics
  • Research involves testing theories to determine what “works” and what “doesn’t”
  • In Health Promotion Research:
    • Something that “works” may:
      • Save lives
      • Reduce disease
    • Something that “doesn’t work” may:
      • End lives
      • Increase disease
  • Thus, Health Promotion Research has potential to cause serious harm
    • Particularly to vulnerable populations
example tuskegee syphilis study
Example: Tuskegee Syphilis Study
  • Intended as a study of syphilis in African-American men
    • Experimentation with different treatments
  • During Great Depression resources became scarce
    • Treatment was not made available
  • Researchers changed study design
    • Study became a natural history study of untreated syphilis
    • Even when treatment became available it was still withheld from men in study
  • Study halted in 1973
tuskegee issues ramifications and resolutions
Tuskegee: Issues, Ramifications and Resolutions
  • Ethical issues present in Tuskegee study
    • No informed consent
    • Deception of subjects regarding purpose of medical procedures
  • Ramifications
    • Distrust of research among African-American community
      • May currently be an issue for AIDS research
  • Resolutions
    • Led to creation of National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research
      • Wrote Belmont Report
      • Basis for many federal regulations oin research
principles of belmont report respect for persons
Principles of Belmont Report: Respect for Persons
  • People are autonomous beings
    • Honoring capacity of individuals to make their own decisions
    • Treating individuals as more than a means to an end
  • Full disclosure of research goals
    • Can not trick subjects into participating
    • Must keep subjects informed throughout study
  • Increased protection for vulnerable groups
    • Children
    • Persons with cognitive disabilities
principles of belmont report beneficence
Principles of Belmont Report: Beneficence
  • Beneficence – doing good and avoiding harm
    • In research – maximizing benefits, minimizing risks
  • Health promotion activity should include diverse groups whenever possible
    • Federal policies demands that benefits of research be extended to women, minorities, children etc…
  • Causing risk to one may offset benefit to many
  • Who benefits from a program?
    • Cannot know for sure until research is conducted
    • Should consider immediate and future effects
      • Future generations
principles of belmont report justice
Principles of Belmont Report: Justice
  • Fair sharing of risks and benefits among groups
  • Cannot study one group to treat another
    • Overseas AIDS research by U.S.
  • Cannot exclude group from study with potential benefits
    • Only studying cardiovascular disease in men
      • Findings may not generalize to women
federal inclusion policies
Federal Inclusion Policies
  • Balance of access and protection
  • 1994 “NIH Guidelines On The Inclusion Of Women And Minorities As Subjects In Clinical Research”
    • Ensure that NIH funded research can elicit information on both genders, diverse races
      • In clinical trials examine differential effects
  • 1998 “NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects”
    • Ensure that children are included in studies unless there are scientific or ethical reasons not to
ethical codes of conduct
Ethical Codes of Conduct
  • Designed to set broad standards for both research and practice
    • Can evaluate behavior of individual professionals
    • Create a code of collective responsibility for profession
    • Contribute to socialization of new professionals
    • Establish standards to judge misconduct
  • Belmont Report provides a basis for health practice guidelines
difference between research and practice
Difference between Research and Practice
  • Ethical standards apply to both
  • Specific federal regulations apply to research only
  • Research is activity intended to contribute to generalizable knowledge
    • Direct benefit to subjects is not the goal
    • Understanding how to benefit others is the goal
  • Practice refers to interventions designed solely to help individual or group
    • Publication is not the goal
    • Surveys, etc.. are used solely to help better treat group
institutional review
Institutional Review
  • Research Institutions required to have Institutional Review Board (IRB)
    • IRB sets standards that must comply with federal regulations
    • Failure to comply can result in termination of federal research funding to institution
  • IRB provides ethical review for federally funded research involving human subjects
    • Institutions extend review to non federal research as well
irb functions
IRB Functions
  • For each study, IRB must:
    • Assess risks and benefits to human subjects
    • Ensure proper informed consent procedures
    • Provide protection for vulnerable populations
      • Pregnant women and fetus, Prisoners, Children
      • Other populations not specifically listed are often given special consideration
        • Persons with disabilities, cognitive impairments, the poor, etc…
    • Regulations cover practical matters as well
      • Composition of IRB
      • Elements of informed consent
types of irb review
Types of IRB Review
  • Exempt
    • Little or no risk to human subjects
      • Interviews or surveys, pre-existing data
    • IRB still must verify exempt status
  • Expedited
    • No more than minimal risk to subjects
      • Non or minimally invasive procedures
      • Continuing review of research
  • Full review
human subjects
Human Subjects
  • Federal regulations exist to protect human subjects
    • Human subjects defined as:
      • A living individual
        • Deceased persons not subject to regulations
      • About whom an investigator
        • Professional or student
      • Obtains either
        • Data through intervention or interaction with person
        • Identifiable private information
irb composition
IRB Composition
  • IRB must have five members of varying backgrounds
    • At least one:
      • Scientist
      • Non-scientist
      • Person not affiliated with institution
    • Should be diverse in terms of race, gender, culture and subject matter expertise
informed consent
Informed Consent
  • Ensuring that researchers obtain informed consent of subjects is a major IRB function
  • Informed consent includes
    • Full information regarding benefits and risks
      • Benefits are not compensation
      • Risks could include loss of privacy, mental or physical distress
    • Adequate comprehension
      • Written or explained at appropriate level
    • Free choice
      • Lack of coercion
documenting informed consent
Documenting Informed Consent
  • Traditional means is to have subject sign consent form
  • In some instances this may be waived
    • Impracticality
      • Telephone interviews or internet surveys
      • Review of existing health records that pose minimal risk
    • Loss of anonymity
      • Signature would identify participant
  • Verbal consent should be obtained whenever possible
vulnerable populations
Vulnerable Populations
  • Higher level of IRB scrutiny
    • Less likely to gain exempt or expedited status
  • Restrictions or prohibitions on certain types of research
    • Research involving greater than minimal risk
  • Alternative procedures for obtaining informed consent
    • May be provided by guardian
research with prisoners
Research with Prisoners
  • Why extend extra protection to prisoners?
    • They are easily abused
      • Example – Nazi abuse of prisoners during WW II
    • They have diminished autonomy
      • Can be easily coerced
  • Specific IRB regulations
    • Must have prisoner or representative on IRB when reviewing research involving prisoners
    • Research must be directed at issues related to prisoners
      • Not simply using prisoners as a sample of convenience
research with children
Research with Children
  • Children defined as persons not having reached legal age to give consent
    • Children required to give “assent”
    • Parent / guardian required to give consent
  • Hierarchy of four categories of research that may involve children:
    • Involves no more than minimal risk
    • Potential for direct benefit to subjects
    • Likely to yield generalizable knowledge about disease or disorder
    • Allows opportunity to understand, prevent or alleviate serious health condition
research in schools
Research in Schools
  • Family Educational Rights and Privacy Act (FERPA)
    • Deals with privacy of student educational records
  • Protection of Pupil Rights Amendment (PPRA)
    • Deals with administering surveys in schools
    • Parents must give consent before students can be given surveys on eight particular topics
health insurance portability and accountability act hipaa
Health Insurance Portability and Accountability Act (HIPAA)
  • Designed to ensure confidentiality of medical records and private health information
  • May affect health promotion research that takes place in health care delivery settings
  • Added protections for children and adolescents
  • Some exceptions for public health research
risks and benefits
Risks and Benefits
  • Risks in health promotion research are much different than in biomedical research
    • Risks to subjects in health promotion research often involve:
      • Invasion of privacy / embarrassment
      • Stress / discomfort
      • Loss of self esteem
  • Benefits may be direct or indirect
    • Understanding and / or preventing risky behavior
    • Raising awareness of behavior through filling out survey
partnering with communities
Partnering with Communities
  • Involvement with community improves understanding
    • Gives researcher a context for subjects
  • Involvement with community may help protect subjects
  • Communities can help disseminate findings
    • Ultimately improve health of community
  • Ethical abuses in past may cause communities to distrust researchers
practical advice
Practical Advice
  • Examine potential risks and benefits
    • Devise and explain plan for protecting subjects
  • Justify requests within context of federal regulations
  • Strive to understand research from subject’s point of view
    • Make informed consent form comprehensible
  • Maintain confidentiality
    • Remove identifying information
  • Work with and understand the community
summary
Summary
  • Ethical treatment of subjects is important in health promotion research
  • Core principles involve
    • Honesty
      • Full disclosure os risks and benefits, non coercion
    • Justice
      • Fair sharing of risks and benefits among groups
    • Beneficence
      • Striving to do good while avoiding harm
  • Federal regulations specify ethical codes of conduct for research
    • Administered through IRB’s
    • Special protections for vulnerable populations
questions to ponder
Questions to Ponder…
  • Why are federal regulations not applicable to health promotion practice?
  • What potential problems might coercion cause?
  • What other examples of vulnerable populations might exist?
  • What risks might exist in a health promotion research activity involving a weight loss intervention?
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