10.1 Ethical principles in public health research

Public health research ethics revolve around three core principles: respect for persons, beneficence, and justice. These guide how studies are designed, conducted, and overseen by Institutional Review Boards to protect participants and ensure fair distribution of benefits and risks.

Applying these principles involves careful study design, participant selection, and data handling. Researchers must balance individual rights with public health needs, address conflicts between principles, and ensure informed consent and privacy protection throughout the research process.

Ethical Principles in Public Health Research

Core Ethical Principles

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• The Belmont Report, published in 1979, established three core ethical principles for research involving human subjects: respect for persons, beneficence, and justice
• Respect for persons involves recognizing the autonomy of individuals and protecting those with diminished autonomy (children, individuals with cognitive impairments)
• Beneficence requires researchers to maximize benefits and minimize risks to participants, ensuring that the research has a favorable risk-benefit ratio
• Justice entails the fair distribution of the benefits and burdens of research, ensuring that no group is unduly burdened or excluded from the potential benefits of the research
• These principles are codified in federal regulations (Common Rule, 45 CFR 46), which governs research involving human subjects conducted or supported by federal agencies

Institutional Oversight and Regulation

• Institutional Review Boards (IRBs) play a crucial role in ensuring that research protocols comply with ethical principles and federal regulations before the research commences and throughout the study
• IRBs review research proposals to assess the balance of risks and benefits, the adequacy of informed consent procedures, and the protection of participant privacy and confidentiality
• Researchers must obtain IRB approval before initiating their studies and must report any adverse events or protocol deviations to the IRB for review and guidance
• Federal agencies, such as the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA), provide oversight and enforcement of ethical regulations in research

Applying Ethical Principles in Research

Research Design and Conduct

• In the design phase, researchers must consider the ethical implications of their study objectives, methodology, and participant selection to ensure respect for persons, beneficence, and justice
• Researchers should design studies that minimize risks, maximize benefits, and ensure fair participant selection, avoiding unnecessary exclusion of underrepresented groups
• During the conduct of the research, investigators must adhere to the approved protocol, monitor participant safety, and maintain the confidentiality of data to uphold the principles of respect for persons and beneficence
• Researchers should have clear procedures in place for addressing adverse events, protocol deviations, and participant concerns or complaints

Dissemination and Translation of Findings

• Dissemination of research findings should be timely, accurate, and transparent, with due consideration for the potential impact on participants and communities, reflecting the principles of beneficence and justice
• Researchers should engage with stakeholders, including participants, community members, and policymakers, to ensure that the research findings are accessible, understandable, and actionable
• Translation of research findings into public health practice should be guided by the principles of beneficence and justice, ensuring that the benefits of the research are equitably distributed and that any potential harms are minimized
• Researchers should consider the long-term implications of their findings and work to build trust and collaboration with communities to facilitate the sustainable implementation of evidence-based interventions

Ethical Conflicts in Public Health Research

Balancing Competing Principles and Values

• Ethical conflicts may arise when the principles of respect for persons, beneficence, and justice appear to be in tension with one another or with other values (scientific validity, public health urgency)
• For example, during a public health emergency, the need for rapid research may conflict with the requirement for thorough informed consent processes, challenging the principle of respect for persons
• Balancing individual rights and autonomy with the collective good of public health can create ethical dilemmas, such as when research on a promising intervention may expose participants to significant risks
• Conflicts may also arise between the obligation to share research findings openly and the need to protect participant privacy and confidentiality, especially in research on sensitive topics or marginalized populations

Strategies for Resolving Ethical Conflicts

• Engaging in open dialogue with stakeholders, including participants, communities, and public health officials, to understand diverse perspectives and find common ground
• Seeking guidance from ethical frameworks, professional codes of conduct, and expert ethics committees or consultants to navigate complex ethical terrain
• Employing innovative research designs that minimize risks and burdens while maximizing benefits and scientific validity, such as adaptive designs or community-based participatory research
• Establishing clear protocols for addressing ethical issues that may arise during the research and having a plan for ongoing monitoring and adaptation as needed
• Building in safeguards to protect participant rights and welfare, such as independent data and safety monitoring boards or alternative consent processes for emergency research
• Fostering a culture of ethical reflection and deliberation among research teams, institutions, and funders to proactively identify and address potential ethical challenges

Informed Consent, Privacy, and Confidentiality

Informed Consent Process

• Informed consent is a process by which potential participants are provided with clear, comprehensive information about the research and voluntarily agree to participate, upholding the principle of respect for persons
• Informed consent should include details about the purpose, procedures, risks, benefits, and alternatives to the research, as well as the participants' rights to refuse or withdraw from the study at any time
• Researchers must ensure that the informed consent process is culturally and linguistically appropriate, taking into account the needs and preferences of diverse populations
• In some cases, alternative consent processes may be necessary, such as verbal consent for low-literacy populations or deferred consent for emergency research

Privacy and Confidentiality Protections

• Privacy refers to the right of individuals to control access to their personal information, while confidentiality involves the obligation of researchers to protect participants' identifiable data from unauthorized disclosure
• Maintaining privacy and confidentiality is essential for building trust with participants, minimizing potential harms, and ensuring the integrity of the research process, in line with the principles of respect for persons and beneficence
• Researchers should implement robust data security measures, such as encryption, secure storage, and access controls, to prevent breaches of participant privacy and confidentiality
• In some cases, such as research involving illegal behaviors or stigmatized conditions (HIV/AIDS, substance abuse), additional measures may be needed to protect participant privacy and confidentiality, such as obtaining a Certificate of Confidentiality or using anonymous data collection methods
• Researchers should have clear policies and procedures for sharing data with other investigators or institutions, ensuring that any data sharing complies with ethical and legal requirements for protecting participant privacy and confidentiality