PH146: Epidemiology Ethics in Research PDF

OUTLINE # ETHICS IN EPIDEMIOLOGIC STUDIES I. RESEARCH AND ETHICS A. Definition of Terms B. Universal Principles of Research Ethics II. ELEMENTS OF RESEARCH ETHICS A. Social Value B. Informed Consent C. Vulnerability of Research D. Participants E. Privacy Confidentiality F. Justice G. Transparency...

OUTLINE # ETHICS IN EPIDEMIOLOGIC STUDIES I. RESEARCH AND ETHICS A. Definition of Terms B. Universal Principles of Research Ethics II. ELEMENTS OF RESEARCH ETHICS A. Social Value B. Informed Consent C. Vulnerability of Research D. Participants E. Privacy Confidentiality F. Justice G. Transparency III. ELEMENTS OF INFORMED CONSENT A.Competence B.Disclosure C.Comprehension D.Voluntariness E.Consent F. Essential Information for Participants IV. GUIDELINES FOR CONDUCTING EPIDEMIOLOGICAL RESEARCH A.Requirement for Ethical Review ETHICS IN PUBLIC HEALTH I. PUBLIC HEALTH A. Definition of Public Health B. Public Health Ethics C. Public Health Surveillance SOURCES ● Saniel, O.P. Ethics in the Practice of Epidemiology [Lecture PPT]. PH 146 - Epidemiology, Department of Epidemiology and Biostatistics. https://drive.google.com/file/d/1A0zDnY1l-5WHeCMxWgL S9JzrWKfVn79n/view ● Saniel, O.P. Ethics in Health Research [Lecture PPT]. PH 146 - Epidemiology, Department of Epidemiology and Biostatistics. https://drive.google.com/file/d/1u5evF2p4WI9QhwcSjVOi qFz85i0QrZEH/view ETHICS IN EPIDEMIOLOGIC STUDIES DEFINITION OF TERMS ● RESEARCH ● INVOLVEMENT OF RESEARCH PARTICIPANTS ○ Any social science, biomedical, behavioral, or epidemiological activity ○ Entails systematic collection or analysis of data with the intent to generate new knowledge ● INVOLVEMENT OF RESEARCH PARTICIPANTS ○ Exposure to manipulation, intervention, observation or other direct interactions with investigators or indirectly through alteration of their environment ○ Ethical Issue: study participants become individually identifiable through investigators’ collection, preparation, or use of biological material or medical or other records UNIVERSAL PRINCIPLES OF RESEARCH ETHICS 1. Respect for Persons and Community ● Autonomy ● Dignity of people and the individual ● Respect of the community and the local culture ● Protection of persons with impaired or diminished autonomy 2. Beneficence and Non-Maleficence ● Protection of the physical, mental, and social well-being of study participants ● Benefits for the communities ● Ethical obligation to maximize benefits and minimize risks ● Sound research design; competent investigators ● Researchers’ primary responsibility is to protect the research participants ● Non-maleficence (i.e., do no harm) 3. Justice ● Ethical obligation to treat each person in accordance with what is “morally right and proper”; give each person what is due him/her ● Distributive justice – the equitable distribution of both burdens and benefits of participation in research ● Special protection for vulnerable groups ● Refrain from practices that are likely to worsen unjust conditions or contribute to new inequities ELEMENTS OF RESEARCH ETHICS 1. Social value 2. Informed consent 3. Vulnerability of research participants 4. Risks, benefits, and safety 5. Privacy and confidentiality of information 6. Justice 7. Transparency SOCIAL VALUE ● Participation of human subjects in research only justified if the study has scientific and social value ● Relevance of the study to an existing social or health problem ○ Can result to a better understanding of related issues ○ Can contribute to the promotion of well-being REFLECTING SOCIAL VALUE IN A RESEARCH PROPOSAL ● Significance of the study should be clearly described in the protocol ○ With an accurate and updated description of the status of the social/health problem ○ How the study will help arrive at a solution ● Study design and methodology should be able to generate information supporting the objectives ● Social value can only be realized if the study is scientifically sound. ● Dissemination plan for the study results and the audience to which it is intended INFORMED CONSENT ● A decision of a competent potential participant to be involved in research ● Reflects: ○ Voluntariness ■ Absence of coercion and undue influence ○ Comprehensibility of information ■ Use of native and non-technical language ○ Capacity to decide ■ Legal age and sound mind ● For participants who are incapable of giving his/her consent (or have diminished capacity to give informed consent), the researcher must: ○ Exert efforts to obtain his/her assent AND the consent of a legally authorized representative (LAR). ■ ASSENT – authorization of one’s own participation in research given by a minor or another participant who lacks the capability to give informed consent PH146: EPIDEMIOLOGY | GROUP C: VILLARUEL, SANTAMARIA, UBANTE, ZIALCITA 1 ● Informing potential participants shall not be simply a ritual recitation (or reading) a document. ○ Should be (whether orally, or writing, or other modes of communication) in a language and manner that suit the individual’s capacity and level of understanding ● Researcher ensures that the prospective participant has adequately understood the information. ✔ Each participant should be given the full opportunity to ask questions and be answered honestly, promptly, and completely. ESSENTIAL INFORMATION IN THE INFORMED CONSENT 1. That the individual is invited to PARTICIPATE IN A RESEARCH ● Who is the PI, from what institution ● Why/how the individual was chosen 2. That the person IS FREE TO REFUSE TO PARTICIPATE without penalty or loss of benefits to which he/she is entitled ● Explain: ○ Purpose ○ Procedures ○ How the research differs from routine medical or health care ● Expected duration of the individual’s participation (including the number and duration of visits to the research center) ● Any foreseeable risks, pain or discomfort, or inconvenience associated with participation ● Direct benefits, if any, to individuals participating ● Expected benefits to the community or to society, or contribution to scientific knowledge (i.e., indirect benefits, if any) ● Whether money (how much) or other forms of material goods (what kind), will be provided for the person’s participation ● Whether any intervention found to be safe and beneficial will be made available (when and how) to the research participants after completion ● Provisions to ensure respect for the privacy ● Confidentiality of records in which they are identified [including documentation of their participation (e.g., photos, audio recording and transcripts of interviews)]; ● Whether commercial products may be developed from biological specimens ○ Whether the research participant shall receive monetary or other benefits from the development of such products ● PHREB-accredited REC has approved or cleared the research protocol; and ● The contact information of persons designated to respond to the following: 1. Queries on the details of the protocol; 2. Issues related to the human rights of participants; 3. Related concerns and grievances; 4. Management of research-related injuries DOCUMENTATION OF CONSENT ● GENERAL RULE: documentation should include the actual signature or thumb mark of the potential participant. ● When IC form is not feasible or unacceptable to client: ○ Alternative: Description of the process (must be attested by a witness) ■ However, prior approval of the REC is needed. ○ Witness to support that the participant signed the informed consent ○ Documentation of signing VULNERABILITY OF RESEARCH PARTICIPANTS ● VULNERABLE PARTICIPANTS – persons incapable of deciding for themselves whether or not to participate in the research for reasons, such as: ○ Physical and mental disabilities ○ Poverty ○ Asymmetric power relations ○ Marginalization (e.g. stigmatized persons) K.G.S.V., J.H.D.S., D.A.A.U., A.B.O.Z_UPM CPH ● ○ Those at greater risk for some harms Vulnerable participants shall require special protection (because of certain characteristics that render them as such). EXAMPLES OF VULNERABLE POPULATIONS ● Children ● Elderly ● Dependent populations ○ e.g. subsidiary members of a hierarchical group ● Uncomprehending subjects ○ e.g. mentally retarded, uneducated, illiterate, senile, linguistically disadvantaged, inebriated, unconscious, dying persons) ● Mentally or behaviorally disabled ● Patients in emergency rooms ● Ethnic/racial minorities ● Homeless ● Nomads, refugees or displaced persons, persons traumatized by violence ● Patients with incurable diseases ● Individuals who are politically powerless ● Vulnerable groups shall NOT be included in the research, UNLESS the research: ○ Necessary for the welfare of the represented population, and ○ Cannot be performed on non-vulnerable persons. RISKS, BENEFITS, AND SAFETY ● The research is justified if: ○ Reasonable likelihood that the population, from which the participants are derived, stand to benefit ● All research involving humans shall be preceded: ○ Careful assessment of the predictable risks, burdens, and foreseeable benefits to the participants or to others ● Every precaution shall be taken to minimize the negative impact on the participants’ well-being (physical or psychological harm) ● Research should be conducted only if there is an acceptable positive benefit-risk ratio. MINIMAL RISK ● Classification of risk ● Probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests PRIVACY AND CONFIDENTIALITY OF INFORMATION ● Shall adhere to principles of transparency, legitimate purpose, and proportionality in the collection, retention, and processing of personal information (Data Privacy Act, 2012). ● Must respect participants’ right to privacy, unless otherwise required by law ● Shall refrain from identifying individuals or groups when release of information about them can expose them to possible harm or stigma unless required by law ● For some methods (e.g. FGDs) not possible for researchers to ensure confidentiality of information or anonymity of research participants. ○ In this case, the research shall ensure that the nature of the study and the questions would cause minimal harm should confidentiality or anonymity be breached. ● In likelihood or opportunity to observe the occurrence of illegal or harmful behavior (e.g. child abuse, substance use, self-harm, suicide ideation), the researcher shall: ○ Explicitly indicate the limits of confidentiality in the informed consent process (issue of disclosure). ○ ● Emphasize the right of the respondent to withdraw from the study or withdraw their data and to refuse to answer any questions. ○ Prepare a concrete and realistic protocol for reporting and referral in the event that imminent harm and/or criminal act is disclosed or discovered in the process of data collection. The researcher shall describe his/her data protection plan in the protocol (including steps to be taken) so that access to the data and the identities and privacy of the respondents can be protected 2017 NEGHHR SPECIAL GUIDELINES JUSTICE ● ● ● Fairness, impartiality or righteousness Requires ‘distributive justice’, or the equitable distribution of both the burdens and benefits of participation Important requirements for research to be ‘distributive’: ○ Should not worsen existing health and social inequities ○ Individuals and communities should have access to benefits related to participation in the study. ○ Fair selection in the choice of study populations, sampling, and assignments ○ Appropriate care should be given to participants regardless of their economic status, gender, race or creed ○ Just compensation for harms brought about by participation in research ○ Research participants should be reimbursed for lost earnings, travel costs, and other expenses incurred when taking part in the study. TRANSPARENCY ● Ethical research shall be characterized by transparency. ● Imperative that all parties to be transparent about matters relating to their involvement ● Promotes confidence in the research enterprise ● Entails disclosure of research results ○ Shall occur only when ALL of the following apply: ■ Findings are scientifically valid and confirmed ■ Findings have significant implications for the participants’ well-being ■ Course of action to address these concerns is readily available at the time when the research results are disclosed to its participants GUIDELINES RESEARCH ● ● ● ● FOR CONDUCTING EPIDEMIOLOGICAL Epidemiologic Research ○ To elucidate causes of diseases and other health-related states ○ Provide information that are utilized for the development and evaluation of interventions for disease prevention and control Major part involves collection of data from individuals: ○ Who will not gain any personal benefit ○ Often may not have a disease that needs treatment Assurance that research risks are minimal and benefits to society are worthwhile Does not usually involve intervention that may cause physical discomfort to eligible individuals ○ May only require individual’s time and attention ○ May encroach on the individual’s right to privacy and confidentiality ○ Possible psychological harms such as embarrassment, strong emotional reactions, and social risks K.G.S.V., J.H.D.S., D.A.A.U., A.B.O.Z_UPM CPH Figure 1. 2017 National Ethical Guidelines for Health & Health-Related Research ETHICS IN PUBLIC HEALTH DEFINITION OF PUBLIC HEALTH ● The science and the art of (1) preventing disease, (2) prolonging life, and (3) organized community efforts for: 1. The sanitation of the environment 2. The control of communicable infections, 3. The education of the individual in personal hygiene 4. The organization of medical and nursing services for the early diagnosis and preventive treatment of disease, and 5. The development of the social machinery to ensure everyone a standard of living adequate for the maintenance of health, so organizing these benefits as to enable every citizen to realize his birthright of health and longevity ● Public health is primarily concerned with the health of the entire population, rather than the health of individuals FEATURES OF PUBLIC HEALTH 1. An emphasis on the promotion of health and the prevention of disease and disability 2. The collection and use of epidemiological data, population surveillance, and other forms of empirical quantitative assessment 3. A recognition of the multidimensional nature of the determinants of health 4. A focus on the complex interactions of many factors –biological, behavioral, social, and environmental — in developing effective interventions Figure 1. Main determinants of health by Dalhgren and Whitehead PUBLIC HEALTH ETHICS ● Identification, analysis, and resolution of ethical problems arising in public health practice and research ● Concerns relate to the dual obligations of public health professionals to acquire and apply scientific knowledge aimed at restoring and protecting the public’s health while respecting individual autonomy ○ Ethics in public health involves an interplay between protecting the welfare of the individual, as in ● medicine, and the public health goal of protecting the public welfare Ensure a just distribution of public health resources ○ Has a broad scope include ethical and social issues arising in health promotion, disease prevention, epidemiologic research and public health practice FEATURES OF PUBLIC HEALTH MEASURES ● Sometimes mandatory or coercive: ○ Authorized by law ○ Activities that may infringe upon personal privacy or autonomy (eg., public health surveillance) ● Tension between concerns over 1) personal liberties and individual autonomy and 2) public health perspectives which may be UTILITARIAN, PATERNALISTIC, OR COMMUNITARIAN ○ Communitarian – may favor limiting individual autonomy for the sake of the common good or public interest ETHICAL ISSUES ● PH measures raise complex questions about the relationship between the state and the individuals and organizations affected by its policies. ● PH not generally concerned with issues at the individual level but with the population level ● Not always easy or appropriate to apply concepts such autonomy ○ Opposed to traditional bioethics literature PH PROGRAMS CHARACTERISTICS ● These are characteristics of PH programs carried out using the Stewardship Model. ● PH Goals should aim: ○ To reduce the risks of ill health that people might impose on each other ○ To reduce causes of ill health by regulations that ensure environmental conditions that sustain good health ○ To promote health not only by providing information and advice but also by programs to health overcome addictions and other unhealthy behaviors ● In terms of constraints, the programs should: ○ Not attempt to coerce adults to healthy lives ○ Minimize interventions that are introduced without the individual consent of those affected or without procedural justice arrangements which provide adequate mandate ○ Seek to minimize interventions that are perceived as unduly intrusive and in conflict with important personal values POLICY ISSUES AND ETHICS 1. Evidence on the causes of ill health – based on valid research 2. Efficacy and effectiveness of PH interventions 3. Risk assessments – “statistical view” vs. “social construct view” 4. Precaution and proportionality PUBLIC HEALTH SURVEILLANCE ● TWO TYPES: 1. Population Surveillance of Infectious Disease ■ Trends about disease incidence and prevalence ■ Data collection = anonymous 2. Notifiable Disease Surveillance ■ Individual cases of notifiable disease must be reported to the relevant authorities ● It is acceptable to collect, without consent, and use anonymized data for assessing and predicting trends of diseases as long as any invasion of privacy is reduced as far as possible K.G.S.V., J.H.D.S., D.A.A.U., A.B.O.Z_UPM CPH DEFINITION OF SURVEILLANCE ● Ongoing, systematic collection, analysis, and interpretation of outcome-specific data, with the timely dissemination of these data to those responsible for preventing and controlling disease or injury. ● Fundamental public health activity: measure and monitor changes in health status, risk factors, and health service access and utilization. ○ Effective dissemination of information is as important as data collection and analysis ● Collected information should have demonstrated utility. EMERGENCY INVESTIGATION ● ● RESPONSE AND OUTBREAK Public health activities undertaken in an urgent or emergency situation, ○ Due to imminent health threat to the population that demands immediate action. Primary purpose: determine the nature and magnitude of a public health problem in the community and to implement appropriate measures to address the problem. ○ Can we take action given the data that we have? If not, what data do we need? EARLY DETECTION, CASE FINDING, CONTACT TRACING ● Ultimate purpose: prevent further transmission of an infectious disease ● Issues that may surround these activities are the following: ○ Effectiveness of the screening tool/test that will be used for case finding ○ Acceptability of the procedure to the target population (e.g., not invasive) ○ Cost of the procedure and subsequent procedure ■ Will this lead to treatment? REVIEW QUESTIONS 1. 2. 3. 4. 5. 6. TRUE OR FALSE: Beneficence is the ethical obligation to treat each person in accordance with what is “morally right and proper. TRUE OR FALSE: The significance of the study should be able to generate information that will support the objectives of the study. A researcher has decided to determine the prevalence of Trichomoniasis among female sex workers with the aim of gaining the support of the local government towards efforts to strengthen treatment programs as well as to recognize the legal rights of these women. However, the said researcher has found out that one of their study participants is a teenage mother who has been recently homeless and is only temporarily seeking shelter in a local clinic. The researcher should: a. Include the said participant in the study because being homeless does not affect her eligibility. b. Include the said participant in the study because the research concerns the well-being of the female sex workers of the locality in general. c. Exclude the said participant from the study because she is too vulnerable to be considered. d. Exclude the said participant from the study because she will eventually get the help that she needs. At the height of the COVID-19 pandemic, a certain high-profile personality had visited a hospital knowing that they had tested positive and was still symptomatic. The said personality did not disclose their COVID-19 status at the time. When the hospital management became aware of this, they issued a notice to the public that those who visited the hospital on that day should be monitored for symptoms and tested for COVID-19. When rumors pointed out that the said individual was at fault, they decided to sue the hospital management, invoking privacy and confidentiality. What can be BEST concluded from the scenario? a. Suing the hospital was acceptable since it was well within the person’s legal rights. b. The hospital management should’ve been more strict with their COVID-19 protocols at the time. c. Suing the hospital was uncalled for since a person’s COVID-19 status at the time should align with the protocols stated by law. d. The hospital should have sued the individual back. Marcus had donated his biological samples as a voluntary participant in a research study on health and fertility in men. He later learns that the researchers had used his sample as part of another study examining health and DNA without his prior knowledge. What is true in terms of the ethical implications of the researchers' actions? a. Informed consent from Marcus was violated. b. There were no ethical mistakes because Marcus was not additionally harmed. c. Confidentiality of Marcus' identity was violated. d. With the additional analyses, there was no longer minimal risk to Marcus and exposing him to more than minimal risk was unethical on the part of the researchers. Handing the client a 12-page long informed consent document and having them sign it is considered informed consent. When IC form is not feasible or unacceptable to the client, a description of the process must be attested by a researcher. a. First statement is correct, while the second statement is incorrect. b. First statement is incorrect, while the second statement is correct. c. Both of the statements are correct. d. Both of the statements are incorrect. ANSWER KEY: 1) FALSE, 2) FALSE 3) B. 4) C 5) A 6) D K.G.S.V., J.H.D.S., D.A.A.U., A.B.O.Z_UPM CPH