1. Chapter 3: Ethical Issues in Health Promotion Research

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. Types of IRB Review Exempt Expedited Full review
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

14. 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

15. 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

16. 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

17. 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

18. 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

19. 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

20. 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

21. 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

22. 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

23. 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

24. 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

25. 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

26. 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

27. 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?