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 Increase disease Thus, Health Promotion Research has potential to cause serious harm Particularly to vulnerable populations

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 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 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 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 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 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 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 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 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 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 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

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 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 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 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 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 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 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 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) 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 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 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 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 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… 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?