The discipline that deals with what is good and bad and with moral duty and obligation is

Presentation on theme: "Definition of Ethics (1) The discipline of dealing with what is good and bad, with moral duty and obligation A set of moral principles or values The principle."— Presentation transcript:

1 Definition of Ethics (1) The discipline of dealing with what is good and bad, with moral duty and obligation A set of moral principles or values The principle of conduct governing an individual or group Webster’s Ninth New Collegiate Dictionary

2 Definition of Ethics (2) A Dictionary of Epidemiology, 4th ed, 2001 (J.M. Last (ed)) The branch of philosophy that deals with distinctions between right and wrong – with the moral consequences of human actions

3 ETHICS Medical ethics - (patient-centered) Public health ethics – (community/population-centered) Research ethics - (subject-centered)

4 PRINCIPLES OF ETHICAL PRACTICE OF PUBLIC HEALTH (1) (adapted from PH Leadership Society, 2002) PH should address the causes of disease and requirements for health PH must respect the rights of individuals PH should seek input from communities PH should strive for health for all

5 PRINCIPLES OF ETHICAL PRACTICE OF PUBLIC HEALTH (2) PH should base policies on evidence PH should obtain community consent for implementation of policies/interventions PH should respond to health problems in a timely manner PH must respect diverse values, beliefs and cultures

6 PRINCIPLES OF ETHICAL PRACTICE OF PUBLIC HEALTH (3) PH programs should enhance the physical and social environment PH should protect the confidentiality of individuals and communities whenever possible PH must assure the professional competence of their employees PH should engage in collaborations that build public trust and are effective

7 PUBLIC HEALTH AND POWER The need to use power to ensure health What should be the limits of that power?

8 PUBLIC HEALTH ACTION (1) The quandry of Human Rights! –Incarceration of infectious individuals e.g. typhoid Mary –Quarantine of contacts (China H1N1) Right to privacy vs. mandatory disease reporting (STDs, HIV) Persuasion vs. coercion vs. manipulation

9 PUBLIC HEALTH ACTION (2) Personal autonomy vs. community action e.g. fluoridation of water Regulation of personal behavior e.g. mandatory condom use in brothels (Thailand, Nevada) Proportionality – cost versus benefit

10 CONFLICTING PUBLIC HEALTH GOALS Protect the uninfected Protect the infected

11 ETHICS The ethics of taking action vs. the ethics of avoiding action

12 Justification of Research in Humans (1) Impossible to reach important conclusions without studying humans Human physiologic studies, because animal responses often are not the same Epidemiological studies, because they depend on human susceptibilities and human interactions Drugs for treating humans because animal experiments don’t always predict human responses

13 Justification of Research in Humans (2) If you’re going to treat humans, you must study humans Corollary: If you’re going to treat certain kinds of humans, then you must perform studies with them, for example Children, mentally impaired, ethnic groups, elderly, women, and pregnant women)

14 History of the Ethical Research Movement

15 The Nuremberg Code (World War II) Informed consent is absolutely essential Qualified researchers must use appropriate research designs There must be a favorable risk/ benefit ratio Participants must be free to stop at any time

16 The Declaration of Helsinki World Medical Association (1964, 1975, 1983, 1989, 1996, 2002) “The well-being of the subject should take precedence over the interests of science and society” Consent should be in writing Use caution if participant is in dependent relationship with researcher Limited use of placebo, especially if treatment is available Greater access to benefit once research is concluded

17 Council for International Organizations of Medical Science (CIOMS) Guidelines 1993, 2002 Nuremberg => Helsinki => CIOMS Informed consent Research in developing countries Protection of vulnerable populations Distribution of the burdens and benefits Role and responsibilities of ethics committees

18 The Belmont Report (The U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978) Ethical Principles and Guidelines for the Protection of Human Subjects of Research: Respect for persons Beneficence Justice

19 Basic Principles of Research on Human Subjects (1) Respect for persons Choices of autonomous individuals should be respected People incapable of making their own choices should be protected Voluntary subjects need adequate information for decision-making

20 Basic Principles of Research on Human Subjects (2) Beneficence Participation in research is associated with a favorable balance of potential benefits and harms Maximize possible benefits, minimize potential harm

21 Basic Principles of Research on Human Subjects (3) Justice Participation in research is associated with a favorable balance of potential benefits and harms May not exploit or exclude vulnerable individuals who may benefit without good reason The risks must be shared across all groups in society

22 Assessment of Benefits and Risks

23 Assure That Benefits Outweigh Risks Research must be justified on the basis of a favorable benefit/risk assessment for the research participant. Benefits must outweigh risks This is similar to the principal of beneficence or “do no harm.” Researchers must protect participants from harm and maximize their well-being

24 Risk and Benefit Defined A “risk” refers to a harm or likelihood of a harm. The degree of severity of a possible harm may be unclear A “benefit” refers to a positive value that accrues to the participant and/or to the society. The precise degree of gain that might accrue to the participant and/or to the society may be uncertain

25 Types of Risks and Benefits Risks or harms and benefits may be physical (pain or injury), psychological, social, economic, or legal Risks or benefits of research may apply to individual participants, families, groups or organizations, communities, or nations Risks and benefits to the research participant usually carry the most weight

26 General Principles There is absolutely no justification for inhumane treatment of participants Risks to participants should always be reduced to the maximum extent possible If a significant risk is involved, justification of the research must be examined with particular care Whenever vulnerable persons are participants, the need to involve them must be carefully demonstrated

27 Informed Consent

28 What is Informed Consent? Informed consent is … “consent given by a competent individual who: has received the necessary information has adequately understood the information after considering the information, has arrived at a decision without having been subjected to coercion, undue influence or inducement, or intimidation”

29 Informed Consent as a Process Informed consent is a communication process: Between the researcher and the participant Starts before the research is initiated Continues throughout the duration of the study

30 Essential Elements of Informed Consent: Description of the Research That it is a research study Objectives of the study Expected responsibilities of participant Procedures involved Study duration (and possibility of early termination) Explanation of features of the research design, such as randomization or placebo

31 Essential Elements of Informed Consent: Description of Risks Includes physical, social, and psychological risks Anticipated or foreseeable risks, pain or discomfort, or inconvenience to the individual (or others) associated with the research Includes risks to health or well-being of subject’s spouse, partner, and/or family Culturally appropriate

32 Essential Elements of Informed Consent: Description of Benefits “Benefit to subject or others reasonably expected to result from the research” (Common Rule) This can include direct medical benefit to participants and expected benefits of the research to the community or larger society, or contributions to scientific knowledge Whether, when, and how any products or interventions proven by the research to be safe and effective will be made available to subjects once research is ended, and whether they will be expected to pay for them

33 Essential Elements of Informed Consent: Confidentiality Provisions that will be made to ensure respect for privacy of subjects and confidentiality of records in which subjects are identified Limits of confidentiality, what persons or organizations may have access to the information, and possible consequences of breaches of confidentiality When appropriate, policies about disclosure of results of genetic tests; e.g., certificate of confidentiality Special cultural circumstances

34 Essential Elements of Informed Consent: Compensation Available compensation in case of research- related injury, and whether there is any uncertainty about funding; whether there is compensation for death or disability What treatment is available and cost Whether payment will be provided for participation, and if so, how much (fair payment for time, travel or inconvenience) Must not be coercive

35 Essential Elements of Informed Consent: Participant Contacts Provide contact for research-related questions Provide contact for concerns about rights as a participant Contacts must be realistic and viable

36 Essential Elements of Informed Consent: Voluntary Participation Absolutely voluntary Right to discontinue at any time No penalty for refusal

37 Circumstances Must… Give subject sufficient opportunity to consider the decision Minimize possibility of coercion or undue influence

38 Language Must… Be understandable to subject or representative (test for comprehension) Language must NOT Waive subject’s rights Release investigator, sponsor, or institution from liability

39 FACTORS INFLUENCING VOLUNTARY CONSENT Vulnerability to incentives Impact of community pressure (e.g., routine community testing) Perceived power of investigators Inability to understand research requirements

40 RESEARCH IN POPULATIONS AND COMMUNITIES WITH LIMITED RESOURCES

41 Ethical requirements for International Public Health Research 1.Social or scientific value 2.Scientific validity 3.Fair subject selection 4.Favorable risk-benefit ratio 5.Independent review 6.Informed consent 7.Respect for potential and enrolled subjects

42 TWO RESPONSIBILITIES Prior to conducting research in a population or community with limited resources the researcher/sponsor should: 1) Ensure the research responds to the health needs and priorities of the target community. 2) Ensure any product developed will be made available to the community.

43 RESPONSIVENESS TO COMMUNITY HEALTH NEEDS It is not sufficient to determine disease prevalence and that new research is needed. If successful interventions result from the research they must be made available to the community. If this is not done, the research is exploitative.

44 MAKING A PRIOR AGREEMENT Before the research begins, a plan should be offered in which the proposed product is made available to the host nation upon completion of the study. Participants should include representatives of the nation’s government, local authorities, community members, and NGO groups.

45 COMPREHENSIVENESS OF THE AGREEMENT The agreement should include payments, royalties, distribution costs, subsidies, technology, and intellectual property. In some cases, international organizations, public and private, may also be included in the discussions.

46 THE ETHICS OF CONDUCTING RESEARCH IN DEVELOPING COUNTRIES  When, if ever, should investigators use the standards of care/ethics of developing countries vs. developed countries (e.g., Tanzania drug trials)?  Are investigators responsible for the health of their participants?  Can participants in developing countries understand informed consent (e.g., is there an expectancy of benefit or treatment even if not stated in the informed consent)?  Is it ethical to do research in developing countries on issues relevant to developed countries but not relevant to developing countries?

47 REQUIREMENTS FOR COMMUNITY APPROVAL Community must have legitimate, empowered spokesperson(s) Community must have a common health-related culture A communication network for the community must be in place

48 RESEARCH CONTROVERSIES IN DEVELOPING COUNTRIES Are placebo groups ethical? Should placebos reflect international or local standards of care? Should participants be assured care beyond the trials – if so, for how long? Should care be provided to the trial community? Should trials be evaluated for scale-up feasibility before implementation?

49 SEX WORKER DEMANDS Lifetime care if she becomes HIV-infected or suffers side-effects Health insurance for 30 years More counseling Free female condoms

50 EVALUATION OF “OPT- OUT”/ROUTINE TESTING HIV is primarily spread by persons who do not know they are infected A large proportion of those infected do not know their status Testing is associated with stigmatization, community rejection and family discord Cannot access treatment if don’t know HIV status

51 “OPT-OUT”/ROUTINE TESTING Ethical Issues Does routine testing violate human rights? Does respecting the right to refuse testing violate the human rights of others?

52 PRIVACY VS. CONFIDENTIALITY Explained in brief: Privacy is about people Confidentiality is about data

53 Definitions Privacy “a: the quality or state of being apart from company or observation : seclusion b : freedom from unauthorized intrusion ” Merriam-Webster Dictionary

54 Definitions Private Information 45 CFR 46.102(f): Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

55 Are we redefining privacy? "The way that people think about privacy is changing a bit... What people want isn't complete privacy. It isn't that they want secrecy. It's that they want control over what they share and what they don't." http://www.time.com/time/business/article/0,8 599,1990582-4,00.html#ixzz16pLIIMXI http://www.time.com/time/business/article/0,8 599,1990582-4,00.html#ixzz16pLIIMXI

56 IRB Considerations Methods to Protect Privacy Allow face-to-face interview participants to provide information in writing or by using a computer keyboard, instead of orally (e.g., ACASI) Use telephone touch tones for responses to sensitive telephone interview questions Participants can use headphones and portable audio player to listen to questions

57 Definitions Confidentiality “… pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original disclosure without permission.” OHRP IRB Guidebook, Chapter III-D.

58 IRB Considerations Confidentiality Risks Confidentiality protections should be comensurate with the potential risk of inadvertent disclosure of the information

59 IRB Considerations Confidentiality Risks A breach of confidentiality of sensitive research data may pose risk of: –Social stigmatization or discrimination –Damage to financial standing, employability or reputation –Prosecution for criminal behavior Sensitive data may be subject to subpoena if not protected by a Certificate of Confidentiality

60 IRB Considerations Methods to Maintain Confidentiality Restrict access to data (password protect, lock) If data stored on a computer; maintain on a standalone computer; no network connection Use encryption software, if data is accessed it is unable to be deciphered Minimize storage of subject identifiable data on a laptop computer which can be lost or stolen Certificates of Confidentiality – protects data from being subpoenaed Waiver of Documentation of informed consent

61 Definitions Anonymous Anonymous: Data collected from individuals who were not identified at the time of collection. Unlinked or anonymized : identifiers were available when the data were collected or stored, at some point, the identifiers were unlinked. Thus, unlinked data lack identifiers or codes that can link the data to identifying information or particular individuals. National Bioethics Advisory Commission (NBAC), Research Involving Human Biological Materials: Ethical Issues and Policy Guidance [NBAC Report], (Rockville, MD: NBAC, 1999).

62 IRB Considerations Anonymous – why does it matter? Collecting anonymous data or anonymizing data after collection may serve as most appropriate method to protect subjects’ confidentiality. Secondary analysis of anonymous data does not require IRB review or certification of exemption.

63 THREE CASE STUDIES

64 CLINICAL TRIAL TO PREVENT MATERNAL/CHILD TRANSMISSION OF HIV Without treatment, 30+% of infants born to HIV-infected mothers will be infected Long-term treatment used in rich countries costs several thousand dollars per mother Poor countries cannot afford long-term treatment Can short-term treatment reduce transmission?

65 CLINICAL TRIAL TO PREVENT MATERNAL/CHILD HIV TRANSMISSION Ethical issues Is a trial of short-term treatment ethical when it is known that long-term treatment is effective? Is it ethical to have a control group? What should the control group receive? What are the ethical responsibilities of the investigator towards participants, particularly in the control group?

66 PRE-EXPOSURE PROPHYLAXIS 90% of sex workers become HIV-infected within the first year of work Many clients reluctant to wear condoms No female controlled microbicide available Tenofovir is cheap, effective and not known to have many side effects Is a clinical trial of prophylactic tenofovir ethical?

67 A TRIAL OF PROPHYLACTIC TENOFOVIR USE Intervention group = sex workers – daily tenofovir Placebo = no medication Counseling and condoms to avoid HIV infection provided Outcome variable = HIV infection rate Approved by IRBs in UCSF and NCHADS Infected sex workers receive two years of treatment with tenofovir Trial proceeding in other developing countries

68 PRE-EXPOSURE PROPHYLAXIS Ethical concerns Is a clinical trial in poorly educated sex workers in a developing country exploitation? Should there be a control group? What should the control group receive, if anything? What responsibility does the investigator have for sex workers who become infected?

69 Cohen J: Cambodian leader throws novel prevention trial into limbo. Science 305:1092, 2004.

Which of the following terms is defined as the discipline dealing with what is good and bad or right and wrong or with moral duty and obligation?

Which term refers to the discipline that deals with what is good and bad or right and wrong?

What are the disciplines of ethics?

What is discipline and morality?