Chapter 3: Ethical Issues in Health Promotion Research

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 • 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?