Chapter 3 ethical issues in health promotion research
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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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Chapter 3: Ethical Issues in Health Promotion Research

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Chapter 3 ethical issues in health promotion research

Chapter 3: Ethical Issues in Health Promotion Research


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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