HLTHAGE 1AA3: Ethics and Policy

• HLTHAGE 1AA3 covers Ethics and Policy, and its content has been created by Dr. Grace Spiro, accurate as of March 24/26, 2025

Ethics

• Ethics are norms for conduct that distinguish acceptable from unacceptable behavior
• Humans exist as an interdependent population
  • Health is multifaceted and epidemiology is interdisciplinary
• Fraud, deceit, or misrepresentation elicits universal disapproval and condemnation
• The most difficult ethical dilemmas in epidemiology are subtle and include judgements, philosophies, attitudes, and opinions

Epidemiology Ethics

• Epidemiology ethics are beyond those of other scientific disciplines:
  • Epidemiologic findings have direct and immediate societal relevance
  • Studies are often funded through public resources
  • Studies often involve human subjects, who generally do not derive personal benefit from participating in studies or from the study results

Investigators' Obligations

• Investigators are obligated to obtain truly informed consent from every subject
  • This is consistent with the principle of individual autonomy
  • A fully "informed” consent may not be possible if full disclosure of objectives could cause bias
  • Privacy and confidentiality must be considered
• Balancing individual rights and welfare of society is important
• There is a question of whether investigators should communicate study results to subjects at the study's completion

Belmont Report

• The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research authored the Belmont Report
• It is a leading work concerning ethics and health care research
• It protects subjects and participants in clinical trials or research studies
• It outlines 3 principles as beneficence, justice, and respect for persons

Beneficence

• Beneficence incorporates respecting decisions, protecting from harm, and making efforts to secure well-being, including:
  • Minimizing possible harms
  • Maximizing possible benefits

Justice

• Justice is fairness in distribution in relation to healthcare
• Justice includes formulations such as equal share, based on individual needs, individual effort, societal contribution, and merit

Respect for Persons

• Respect for persons incorporates treating individuals as autonomous agents and protecting those with diminished autonomy
• Lack of respect involves refusing to accept considered judgements, denying freedom to act on judgements, or withholding necessary information

Privacy and Confidentiality

• Medical records are used in epidemiologic studies to generate aggregate data or to identify individual patients for follow up
• Computerization of records has impacted privacy and confidentiality
• The ethical principle of autonomy argues for meaningful informed consent
  • Patient consent is required before investigators access medical records, requiring you to identify patients with disease before study inclusion
  • Data from medical records should be available to investigators without individual identifying information making follow-up difficult

Protecting Confidentiality

• Protecting confidentiality requires informed consent for all phases of research except review of medical records
• All obtained data is stored under lock and key
• Only study numbers are used for analysis; the key linking study numbers with individual names is kept separately under lock and key by an authority
• Individual identifying information is destroyed at the end of the study, except where retention is needed and approved
• All results are published in aggregate or group form

Data Access

• An appropriate balance must be achieved between the interests of the investigator versus society
• Considerations include when the study is complete and who paid for the study or is requesting the data
• Additionally, identifiers must be considered

Race and Ethnicity

• Race/ethnicity information is included to help identify specific subgroups for additional health resources
• Definitions of specific groups are not always straight forward and stigmatization must be considered
• These factors dictate when it may or may not be appropriate to include race

Conflict of Interest

• A potential conflict of interest is a nonscientific influence affecting a scientist's practice or decision-making
• Conflicts of interest can arise if the epidemiologist is working in academia, industry, or government
• Steps to reduce the influences should be in place
• Efforts to avoid publication bias, requirements for registering clinical trials and acknowledgement of sponsorship and possible COIs are used

Interpreting Findings

• Need to consider when and how risk is conveyed to the public
• It also requires understanding how the importance of a single study that shows an increased risk can be assessed
• Controversial findings spread quickly across social media, even before publishing in peer- reviewed journals
• Epidemiologists should communicate uncertainty and support public decision making
• Consideration needs to be given to whether epidemiologists should be both a researcher and an advocate for a specific policy

Importance of Policy

• A major role of epidemiology serves as the basis for developing policies affecting human health
  • Results in prevention and control of disease
  • Relevance to issues in both clinical practice and community health
  • Results in population approaches to disease prevention and health promotion

Policy

• Policy is how a society frames what it wishes to become, such as immunizing all children or limiting the use of tobacco
• Policymaking requires a balance between feasible decisions and what should be done, recognizing that zero risk is impractical and that there are considerations at federal, state and local levels
• Social change organizations often influence public policy

Policy example

• The Ontario COVID-19 Science Advisory Table consists of scientific experts and health system leaders that evaluate and report on emerging evidence to inform Ontario’s pandemic response
• The Science Advisory Table provides summaries of relevant evidence to public health and health care professionals, and the public
• The Science Advisory Table provides credible and independent scientific and technical advice to inform government and the broader public

Knowledge Translation

• Knowledge Translation is a dynamic and iterative process that includes synthesis, dissemination, exchange and ethically-sound application of knowledge to improve health, healthcare services and products, and healthcare systems as defined by CIHR

Key Principles of Knowledge Translation

• There are no single definitions, formulas or frameworks for Knowledge Translation
• Knowledge Translation is a series of overlapping social processes to creating contextualized knowledge
• Understanding of the research process and the policy process are key
• Context and the views of the user effect the knowledge that underlies KT
• KT is more than just research

Know-Do Gap

• Research evidence is almost never translated directly into policy, and is typically just one source
• A central component of KT is transforming research evidence into a contextualized input

Role of KT

• KT can lead researchers to the overlap between research and policy

Healthcare Context

• Evidence-practice and policy gaps result in suboptimal outcomes, iatrogenic harms, and unnecessary expenditure

Four Elements of Knowledge Translation

• Synthesis means the contextualization and integration of research findings
  • They must be reproducible and transparent with qualitative and/or quantitative methods
• Dissemination involves identifying the appropriate audience, tailoring the message and medium, and media engagement
• Exchange of knowledge is the interaction between the knowledge user and the researcher resulting in mutual learning
• Ethical-sound KT activities for improved health must be consistent with ethical principles and norms, social values, and legal regulatory frameworks