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Chapter 3: Ethical Issues in Health Promotion Research.

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Presentation on theme: "Chapter 3: Ethical Issues in Health Promotion Research."— Presentation transcript:

1 Chapter 3: Ethical Issues in Health Promotion Research

2 Research and Ethics Research involves testing theories to determine what works and what doesnt Research involves testing theories to determine what works and what doesnt In Health Promotion Research: In Health Promotion Research: Something that works may: Something that works may: Save lives Save lives Reduce disease Reduce disease Something that doesnt work may: Something that doesnt work may: End lives End lives Increase disease Increase disease Thus, Health Promotion Research has potential to cause serious harm Thus, Health Promotion Research has potential to cause serious harm Particularly to vulnerable populations Particularly to vulnerable populations

3 Example: Tuskegee Syphilis Study Intended as a study of syphilis in African-American men Intended as a study of syphilis in African-American men Experimentation with different treatments Experimentation with different treatments During Great Depression resources became scarce During Great Depression resources became scarce Treatment was not made available Treatment was not made available Researchers changed study design Researchers changed study design Study became a natural history study of untreated syphilis Study became a natural history study of untreated syphilis Even when treatment became available it was still withheld from men in study Even when treatment became available it was still withheld from men in study Study halted in 1973 Study halted in 1973

4 Tuskegee: Issues, Ramifications and Resolutions Ethical issues present in Tuskegee study Ethical issues present in Tuskegee study No informed consent No informed consent Deception of subjects regarding purpose of medical procedures Deception of subjects regarding purpose of medical procedures Ramifications Ramifications Distrust of research among African-American community Distrust of research among African-American community May currently be an issue for AIDS research May currently be an issue for AIDS research Resolutions Resolutions Led to creation of National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research Led to creation of National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research Wrote Belmont Report Wrote Belmont Report Basis for many federal regulations oin research Basis for many federal regulations oin research

5 Principles of Belmont Report: Respect for Persons People are autonomous beings People are autonomous beings Honoring capacity of individuals to make their own decisions Honoring capacity of individuals to make their own decisions Treating individuals as more than a means to an end Treating individuals as more than a means to an end Full disclosure of research goals Full disclosure of research goals Can not trick subjects into participating Can not trick subjects into participating Must keep subjects informed throughout study Must keep subjects informed throughout study Increased protection for vulnerable groups Increased protection for vulnerable groups Children Children Persons with cognitive disabilities Persons with cognitive disabilities

6 Principles of Belmont Report: Beneficence Beneficence – doing good and avoiding harm Beneficence – doing good and avoiding harm In research – maximizing benefits, minimizing risks In research – maximizing benefits, minimizing risks Health promotion activity should include diverse groups whenever possible Health promotion activity should include diverse groups whenever possible Federal policies demands that benefits of research be extended to women, minorities, children etc… Federal policies demands that benefits of research be extended to women, minorities, children etc… Causing risk to one may offset benefit to many Causing risk to one may offset benefit to many Who benefits from a program? Who benefits from a program? Cannot know for sure until research is conducted Cannot know for sure until research is conducted Should consider immediate and future effects Should consider immediate and future effects Future generations Future generations

7 Principles of Belmont Report: Justice Fair sharing of risks and benefits among groups Fair sharing of risks and benefits among groups Cannot study one group to treat another Cannot study one group to treat another Overseas AIDS research by U.S. Overseas AIDS research by U.S. Cannot exclude group from study with potential benefits Cannot exclude group from study with potential benefits Only studying cardiovascular disease in men Only studying cardiovascular disease in men Findings may not generalize to women Findings may not generalize to women

8 Federal Inclusion Policies Balance of access and protection Balance of access and protection 1994 NIH Guidelines On The Inclusion Of Women And Minorities As Subjects In Clinical Research 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 Ensure that NIH funded research can elicit information on both genders, diverse races In clinical trials examine differential effects In clinical trials examine differential effects 1998 NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects 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 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 Designed to set broad standards for both research and practice Can evaluate behavior of individual professionals Can evaluate behavior of individual professionals Create a code of collective responsibility for profession Create a code of collective responsibility for profession Contribute to socialization of new professionals Contribute to socialization of new professionals Establish standards to judge misconduct Establish standards to judge misconduct Belmont Report provides a basis for health practice guidelines Belmont Report provides a basis for health practice guidelines

10 Difference between Research and Practice Ethical standards apply to both Ethical standards apply to both Specific federal regulations apply to research only Specific federal regulations apply to research only Research is activity intended to contribute to generalizable knowledge Research is activity intended to contribute to generalizable knowledge Direct benefit to subjects is not the goal Direct benefit to subjects is not the goal Understanding how to benefit others is the goal Understanding how to benefit others is the goal Practice refers to interventions designed solely to help individual or group Practice refers to interventions designed solely to help individual or group Publication is not the goal Publication is not the goal Surveys, etc.. are used solely to help better treat group Surveys, etc.. are used solely to help better treat group

11 Institutional Review Research Institutions required to have Institutional Review Board (IRB) Research Institutions required to have Institutional Review Board (IRB) IRB sets standards that must comply with federal regulations IRB sets standards that must comply with federal regulations Failure to comply can result in termination of federal research funding to institution Failure to comply can result in termination of federal research funding to institution IRB provides ethical review for federally funded research involving human subjects IRB provides ethical review for federally funded research involving human subjects Institutions extend review to non federal research as well Institutions extend review to non federal research as well

12 IRB Functions For each study, IRB must: For each study, IRB must: Assess risks and benefits to human subjects Assess risks and benefits to human subjects Ensure proper informed consent procedures Ensure proper informed consent procedures Provide protection for vulnerable populations Provide protection for vulnerable populations Pregnant women and fetus, Prisoners, Children Pregnant women and fetus, Prisoners, Children Other populations not specifically listed are often given special consideration Other populations not specifically listed are often given special consideration Persons with disabilities, cognitive impairments, the poor, etc… Persons with disabilities, cognitive impairments, the poor, etc… Regulations cover practical matters as well Regulations cover practical matters as well Composition of IRB Composition of IRB Elements of informed consent Elements of informed consent

13 Types of IRB Review Exempt Exempt Little or no risk to human subjects Little or no risk to human subjects Interviews or surveys, pre-existing data Interviews or surveys, pre-existing data IRB still must verify exempt status IRB still must verify exempt status Expedited Expedited No more than minimal risk to subjects No more than minimal risk to subjects Non or minimally invasive procedures Non or minimally invasive procedures Continuing review of research Continuing review of research Full review Full review

14 Human Subjects Federal regulations exist to protect human subjects Federal regulations exist to protect human subjects Human subjects defined as: Human subjects defined as: A living individual A living individual Deceased persons not subject to regulations Deceased persons not subject to regulations About whom an investigator About whom an investigator Professional or student Professional or student Obtains either Obtains either Data through intervention or interaction with person Data through intervention or interaction with person Identifiable private information Identifiable private information

15 IRB Composition IRB must have five members of varying backgrounds IRB must have five members of varying backgrounds At least one: At least one: Scientist Scientist Non-scientist Non-scientist Person not affiliated with institution Person not affiliated with institution Should be diverse in terms of race, gender, culture and subject matter expertise 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 Ensuring that researchers obtain informed consent of subjects is a major IRB function Informed consent includes Informed consent includes Full information regarding benefits and risks Full information regarding benefits and risks Benefits are not compensation Benefits are not compensation Risks could include loss of privacy, mental or physical distress Risks could include loss of privacy, mental or physical distress Adequate comprehension Adequate comprehension Written or explained at appropriate level Written or explained at appropriate level Free choice Free choice Lack of coercion Lack of coercion

17 Documenting Informed Consent Traditional means is to have subject sign consent form Traditional means is to have subject sign consent form In some instances this may be waived In some instances this may be waived Impracticality Impracticality Telephone interviews or internet surveys Telephone interviews or internet surveys Review of existing health records that pose minimal risk Review of existing health records that pose minimal risk Loss of anonymity Loss of anonymity Signature would identify participant Signature would identify participant Verbal consent should be obtained whenever possible Verbal consent should be obtained whenever possible

18 Vulnerable Populations Higher level of IRB scrutiny Higher level of IRB scrutiny Less likely to gain exempt or expedited status Less likely to gain exempt or expedited status Restrictions or prohibitions on certain types of research Restrictions or prohibitions on certain types of research Research involving greater than minimal risk Research involving greater than minimal risk Alternative procedures for obtaining informed consent Alternative procedures for obtaining informed consent May be provided by guardian May be provided by guardian

19 Research with Prisoners Why extend extra protection to prisoners? Why extend extra protection to prisoners? They are easily abused They are easily abused Example – Nazi abuse of prisoners during WW II Example – Nazi abuse of prisoners during WW II They have diminished autonomy They have diminished autonomy Can be easily coerced Can be easily coerced Specific IRB regulations Specific IRB regulations Must have prisoner or representative on IRB when reviewing research involving prisoners Must have prisoner or representative on IRB when reviewing research involving prisoners Research must be directed at issues related to prisoners Research must be directed at issues related to prisoners Not simply using prisoners as a sample of convenience 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 defined as persons not having reached legal age to give consent Children required to give assent Children required to give assent Parent / guardian required to give consent Parent / guardian required to give consent Hierarchy of four categories of research that may involve children: Hierarchy of four categories of research that may involve children: Involves no more than minimal risk Involves no more than minimal risk Potential for direct benefit to subjects Potential for direct benefit to subjects Likely to yield generalizable knowledge about disease or disorder Likely to yield generalizable knowledge about disease or disorder Allows opportunity to understand, prevent or alleviate serious health condition Allows opportunity to understand, prevent or alleviate serious health condition

21 Research in Schools Family Educational Rights and Privacy Act (FERPA) Family Educational Rights and Privacy Act (FERPA) Deals with privacy of student educational records Deals with privacy of student educational records Protection of Pupil Rights Amendment (PPRA) Protection of Pupil Rights Amendment (PPRA) Deals with administering surveys in schools Deals with administering surveys in schools Parents must give consent before students can be given surveys on eight particular topics 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 Designed to ensure confidentiality of medical records and private health information May affect health promotion research that takes place in health care delivery settings May affect health promotion research that takes place in health care delivery settings Added protections for children and adolescents Added protections for children and adolescents Some exceptions for public health research Some exceptions for public health research

23 Risks and Benefits Risks in health promotion research are much different than in biomedical research Risks in health promotion research are much different than in biomedical research Risks to subjects in health promotion research often involve: Risks to subjects in health promotion research often involve: Invasion of privacy / embarrassment Invasion of privacy / embarrassment Stress / discomfort Stress / discomfort Loss of self esteem Loss of self esteem Benefits may be direct or indirect Benefits may be direct or indirect Understanding and / or preventing risky behavior Understanding and / or preventing risky behavior Raising awareness of behavior through filling out survey Raising awareness of behavior through filling out survey

24 Partnering with Communities Involvement with community improves understanding Involvement with community improves understanding Gives researcher a context for subjects Gives researcher a context for subjects Involvement with community may help protect subjects Involvement with community may help protect subjects Communities can help disseminate findings Communities can help disseminate findings Ultimately improve health of community Ultimately improve health of community Ethical abuses in past may cause communities to distrust researchers Ethical abuses in past may cause communities to distrust researchers

25 Practical Advice Examine potential risks and benefits Examine potential risks and benefits Devise and explain plan for protecting subjects Devise and explain plan for protecting subjects Justify requests within context of federal regulations Justify requests within context of federal regulations Strive to understand research from subjects point of view Strive to understand research from subjects point of view Make informed consent form comprehensible Make informed consent form comprehensible Maintain confidentiality Maintain confidentiality Remove identifying information Remove identifying information Work with and understand the community Work with and understand the community

26 Summary Ethical treatment of subjects is important in health promotion research Ethical treatment of subjects is important in health promotion research Core principles involve Core principles involve Honesty Honesty Full disclosure os risks and benefits, non coercion Full disclosure os risks and benefits, non coercion Justice Justice Fair sharing of risks and benefits among groups Fair sharing of risks and benefits among groups Beneficence Beneficence Striving to do good while avoiding harm Striving to do good while avoiding harm Federal regulations specify ethical codes of conduct for research Federal regulations specify ethical codes of conduct for research Administered through IRBs Administered through IRBs Special protections for vulnerable populations Special protections for vulnerable populations

27 Questions to Ponder… Why are federal regulations not applicable to health promotion practice? Why are federal regulations not applicable to health promotion practice? What potential problems might coercion cause? What potential problems might coercion cause? What other examples of vulnerable populations might exist? What other examples of vulnerable populations might exist? What risks might exist in a health promotion research activity involving a weight loss intervention? What risks might exist in a health promotion research activity involving a weight loss intervention?


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