8.4 Research Ethics and Human Subjects
5 min read•july 30, 2024
Research ethics in human subjects studies is crucial for protecting participants and maintaining scientific integrity. It evolved from historical abuses, leading to guidelines like the Nuremberg Code and . These established principles of respect, , and justice in research.
The Common Rule provides a regulatory framework for ethical research, emphasizing informed consent and IRB oversight. Researchers must balance scientific goals with participant rights, addressing challenges in and international contexts. IRBs play a vital role in ensuring ethical compliance.
Ethical Principles in Human Research
Historical Context and Need for Ethical Guidelines
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- Historical examples of unethical human subjects research (Tuskegee syphilis study, Nazi medical experiments) highlighted the need for ethical guidelines and oversight in research involving human participants
- The Nuremberg Code, established in 1947, set forth basic principles for ethical human subjects research
- Voluntary informed consent
- Minimization of risk
- Right of participants to withdraw from research
- The Belmont Report, published in 1979, identified three core ethical principles for human subjects research
- Respect for persons emphasizes the of research participants and the need for informed consent
- Beneficence requires researchers to maximize benefits and minimize risks to participants
- Justice demands fair and equitable selection of research participants and distribution of research risks and benefits
Regulatory Framework and Common Rule
- The Common Rule, a set of federal regulations based on the Belmont Report principles, governs human subjects research conducted or supported by most U.S. government agencies
- The Common Rule establishes requirements for informed consent, IRB review, and other ethical safeguards in human subjects research
- Researchers must comply with the Common Rule and other applicable regulations when conducting human subjects research
Informed Consent and Privacy
Elements and Process of Informed Consent
- Informed consent is a process that ensures research participants understand the purpose, procedures, risks, benefits, and alternatives to the research, and voluntarily agree to participate
- Informed consent typically involves providing participants with a written consent form that clearly explains the research in lay language
- Researchers must ensure that participants have the capacity to provide consent and are not coerced or unduly influenced to participate
- Key elements of informed consent include
- Description of the research purpose, procedures, duration, and any experimental aspects
- Disclosure of reasonably foreseeable risks or discomforts
- Description of potential benefits to participants or others
- Explanation of alternatives to participation
- Statement of confidentiality and any limits to confidentiality
- Contact information for the researchers and the IRB
- Statement that participation is voluntary and that refusal or withdrawal will not result in penalty or loss of benefits
Confidentiality and Privacy Protections
- Confidentiality refers to the obligation of researchers to protect participants' private information and prevent unauthorized access or disclosure
- Researchers should use secure data storage and transmission methods, limit access to identifiable data, and remove identifying information from research reports and publications
- Privacy concerns the control over access to oneself and one's information, and the right to be free from intrusion or interference
- Researchers should respect participants' privacy by obtaining consent for any invasion of privacy (observations, recordings, access to personal records)
- Research procedures should be designed to minimize intrusions on privacy and protect participants' dignity and autonomy
- In some cases, such as research on illegal activities or sensitive topics, confidentiality may be limited by legal or ethical obligations to report certain types of information (child abuse, imminent harm to self or others)
Ethical Challenges in Research
Research with Vulnerable Populations
- Vulnerable populations are groups of individuals who may have diminished autonomy or increased susceptibility to or in research (children, prisoners, individuals with mental illness or cognitive impairments, economically or educationally disadvantaged persons)
- Research with vulnerable populations requires special protections and considerations to ensure voluntary informed consent, minimize risks, and prevent exploitation
- Researchers should use age-appropriate consent procedures for children and obtain assent from children along with permission from parents or guardians
- Examples of vulnerable populations in research:
- Children may not fully understand the risks and benefits of research participation and may be more susceptible to coercion or undue influence from parents or authorities
- Prisoners may feel pressured to participate in research due to their incarceration and may have limited ability to provide voluntary informed consent
International Research and Cultural Considerations
- International research may involve different cultural, social, and regulatory contexts that present unique ethical challenges
- Researchers should be sensitive to local cultural norms, values, and practices, and engage in community consultation and collaboration
- Informed consent procedures should be culturally appropriate and may require translation or adaptation to ensure comprehension and voluntariness
- Researchers should ensure that the benefits and burdens of research are fairly distributed within the host community and that the research addresses local health needs and priorities
- Ethical imperialism, the imposition of Western ethical standards without regard for local cultural context, should be avoided in international research
- Examples of cultural considerations in international research:
- In some cultures, community leaders or family members may need to be involved in the in addition to individual participants
- Research on sensitive topics (sexual behavior, mental health) may be taboo or stigmatized in certain cultural contexts, requiring additional privacy protections and community engagement
Institutional Review Boards for Ethics
Role and Composition of IRBs
- Institutional review boards (IRBs) are committees that review and oversee human subjects research to ensure that it meets ethical standards and regulatory requirements
- IRBs are typically composed of scientists, non-scientists, and community members who have expertise in research ethics and relevant disciplines
- IRBs review research protocols, informed consent documents, and other study materials to assess risks, benefits, and ethical acceptability
- IRBs have the authority to approve, require modifications to, or disapprove research proposals based on their ethical assessment
- IRBs may require changes to study procedures, consent forms, or other aspects of the research to ensure adequate protections for participants
- IRBs also monitor ongoing research through periodic review and reporting requirements to ensure continued ethical compliance
IRB Review Process and Researcher Responsibilities
- Researchers must obtain IRB approval before initiating human subjects research and must comply with IRB requirements and decisions throughout the conduct of the study
- The IRB review process typically involves:
- Submission of a research protocol, informed consent documents, and other relevant materials by the researcher
- Review of the submission by IRB members to assess risks, benefits, and ethical acceptability
- Communication of the IRB's decision (approval, required modifications, or disapproval) to the researcher
- Ongoing monitoring and review of approved research by the IRB
- Researchers have a responsibility to:
- Design and conduct research in accordance with ethical principles and regulatory requirements
- Obtain informed consent from research participants and protect their rights and welfare
- Report any adverse events, protocol deviations, or other unanticipated problems to the IRB
- Seek IRB approval for any changes or modifications to the research protocol
- Exemptions from IRB review are available for certain categories of low-risk research (anonymous surveys, educational tests), but researchers must still ensure that their research meets ethical standards
Key Terms to Review (18)
Autonomy: Autonomy refers to the capacity and right of individuals to make informed decisions about their own lives and bodies, free from external control or interference. It emphasizes the importance of personal choice and self-determination, which are crucial in various ethical discussions around individual rights, moral responsibility, and consent.
Belmont Report: The Belmont Report is a foundational document in research ethics that outlines key principles and guidelines for conducting research involving human subjects. It emphasizes the importance of respect for persons, beneficence, and justice, ensuring that research is conducted ethically and that participants are protected from harm. This report is crucial for establishing ethical standards in research practices and safeguarding the rights of individuals involved in studies.
Beneficence: Beneficence refers to the ethical principle of acting in ways that promote the well-being of others and contribute to their overall good. It emphasizes the importance of taking positive actions to help others, ensuring that the benefits of one's actions outweigh any potential harm. This principle is fundamental in various ethical discussions, highlighting the responsibility individuals and professionals have towards the welfare of others.
Capacity to consent: The capacity to consent refers to an individual's ability to understand, appreciate, and make informed decisions regarding their participation in research or medical treatment. This concept is crucial in ensuring that participants are not only aware of the nature of the research but can also comprehend the potential risks and benefits involved, ensuring that their participation is voluntary and informed.
Children as research subjects: Children as research subjects refers to the involvement of minors in scientific studies, where they may provide data or participate in experiments. This topic raises important ethical considerations, particularly regarding consent, vulnerability, and the potential for coercion or harm. The inclusion of children in research demands rigorous adherence to ethical guidelines to ensure their safety and rights are protected.
Coercion: Coercion refers to the practice of persuading someone to do something by using force or threats. It is a critical concern in research ethics, particularly regarding human subjects, as it undermines the principle of voluntary participation and can compromise the integrity of the research process. Understanding coercion is essential for ensuring that participants are not manipulated or forced into participating against their will.
Confidentiality agreements: Confidentiality agreements, often called non-disclosure agreements (NDAs), are legally binding contracts that establish a confidential relationship between parties. These agreements are crucial in protecting sensitive information shared during research involving human subjects, ensuring that personal data and proprietary details remain private and secure.
Declaration of Helsinki: The Declaration of Helsinki is a set of ethical principles developed by the World Medical Association (WMA) to guide researchers in conducting biomedical research involving human subjects. It emphasizes the importance of informed consent, the welfare of participants, and the necessity of conducting research that is scientifically valid and socially valuable.
Deontological Ethics: Deontological ethics is a moral theory that emphasizes the importance of duty, rules, and obligations in determining the morality of actions. This approach asserts that certain actions are inherently right or wrong, regardless of their consequences, focusing on adherence to moral rules or principles as the foundation for ethical behavior.
Ethics review process: The ethics review process is a systematic evaluation that examines research proposals involving human subjects to ensure ethical standards are upheld. This process is crucial in protecting the rights, welfare, and dignity of participants by assessing potential risks, benefits, and informed consent procedures. It involves independent ethics committees or institutional review boards (IRBs) that scrutinize research to ensure compliance with ethical guidelines and regulatory requirements.
Exploitation: Exploitation refers to the unethical or unfair treatment of individuals or groups, often by taking advantage of their vulnerability or lack of power. This concept is particularly important in research ethics as it highlights the potential for harm when participants are used for the benefit of others without appropriate compensation, consent, or protection. Recognizing and addressing exploitation is crucial to ensuring that research is conducted ethically and responsibly, safeguarding the rights and dignity of human subjects involved.
Informed Consent Process: The informed consent process is a fundamental ethical requirement in research involving human subjects, ensuring that participants fully understand the nature, risks, and benefits of the study before agreeing to participate. This process emphasizes the importance of voluntary participation, where individuals are provided with sufficient information to make an educated decision about their involvement. It safeguards the autonomy of participants by ensuring they have the capacity to comprehend the information presented and can withdraw consent at any time without penalty.
Institutional Review Board (IRB): An Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects, ensuring that their rights, welfare, and safety are protected. IRBs are crucial in overseeing ethical standards in research by evaluating study protocols, informed consent processes, and potential risks to participants, thus helping to balance the pursuit of knowledge with the obligation to protect vulnerable populations.
Nonmaleficence: Nonmaleficence is the ethical principle that obligates individuals, particularly in healthcare and research, to avoid causing harm to others. This concept emphasizes the importance of safeguarding the well-being of participants and ensuring that any potential risks associated with research activities are minimized. It is closely tied to the responsibilities researchers have towards human subjects, reinforcing the necessity of conducting studies in a manner that protects individuals from physical, psychological, and emotional harm.
Plagiarism: Plagiarism is the act of using someone else's work, ideas, or intellectual property without proper attribution, presenting it as one's own. It undermines the integrity of research and scholarship by failing to acknowledge the original source, which is particularly critical in academic environments where trust and authenticity are paramount.
Research integrity: Research integrity refers to the adherence to ethical principles and professional standards in the conduct of scientific research. It encompasses honesty, transparency, accountability, and respect for all participants involved, especially human subjects, ensuring that research is conducted ethically and that results are reported truthfully.
Utilitarianism: Utilitarianism is an ethical theory that posits that the best action is the one that maximizes overall happiness or utility. It emphasizes the outcomes of actions and asserts that the moral worth of an action is determined by its contribution to overall well-being, leading to a focus on the consequences of decisions and policies.
Vulnerable populations: Vulnerable populations refer to groups of individuals who are at a higher risk of experiencing harm, exploitation, or marginalization due to their social, economic, or health-related conditions. These populations often face barriers that hinder their access to resources, healthcare, and protection under the law, making them particularly sensitive in research ethics discussions surrounding human subjects.