Research Ethics Explained

What are Ethics?

• Ethics are norms of conduct that guide people towards ideal human behavior
• Examples of unethical behaviors in academia are plagiarism, cheating, and fabrication
• Ethical standards are subjective, leading to different answers for the same problem
• Ethical problems in qualitative research are subtle and differ from those in quantitative research
• Qualitative research explores and describes people and their environments
• Researcher-participant relationships and power dynamics are embedded in qualitative research
• Conflicts can arise regarding researcher access to communities and the effects on participants
• The willingness to share experiences influences participation in research studies
• Researchers' roles as researchers and clinicians may present conflicting interests
• Ethics in social/health research include appropriate research and methodological designs, funding sources, and data reporting
• Researchers bear the ultimate responsibility for protecting participants, despite ethical review boards

What are Ethics? Continued

• Interviewing victims of violence can trigger painful memories, which presents an ethical dilemma
• Researchers must be aware of sensitive issues and potential conflicts of interest
• Interviews require confidentiality, informed consent, and privacy, while being aware of "old wounds" and secret sharing
• Three problems affect qualitative studies: researcher/participant relationship, subjective interpretations of data, and the study design
• Qualitative data collection relies on interviews, observations, written materials, and audiovisual material
• Researchers should negotiate participant access to collect data in the field
• Social interactions impact access to information and ethical dilemmas may arise unexpectedly
• Potential ethical issues to consider in protocols: informed consent, confidentiality, data analysis, researcher/participant relationships, and reporting outcomes
• A balanced research relationship promotes disclosure, trust, and ethical awareness

Ethical Principles and Guidelines for Research Involving Human Subjects

• Scientific research provides social benefits but raises ethical concerns
• Reports of human subject abuses during WWII prompted public concern
• The Nuremberg Code, from the War Crime Trials, ensures ethical research involving human subjects
• Codes consist of general and specific rules for investigators and reviewers
• Broader ethical principles formulate, critique, and interpret specific rules
• Three general prescriptive judgments are identified for research on human subjects
• These principles resolve ethical problems via an analytical framework

Respect for Persons

• Respect for persons means acknowledging autonomy and protecting those with diminished autonomy
• Autonomy is the ability to deliberate about personal goals and act under personal guidance
• Lack of respect for autonomy denies individual judgments or freedom, or withholds information
• Not all humans can self-determine due to illness, disability, or circumstances
• Immature or incapacitated individuals need protection as they mature or remain incapacitated
• Protection depends on the risk of harm and the likelihood of benefit
• The principle of respect for persons should be periodically reevaluated and situationally applied
• Research involving human subjects requires voluntary participation and adequate information
• Involving prisoners presents a dilemma due to potential coercion

Beneficence

• Beneficence means respecting decisions, protecting individuals from harm, and ensuring their well-being
• It is an obligation, going beyond simple kindness or charity
• Rules of beneficent actions: do no harm and maximize benefits while minimizing harms
• The Hippocratic maxim "do no harm" applies to medical ethics, extending to research
• The Hippocratic Oath directs physicians to benefit patients in their own judgement
• The principle affects investigators, society, research projects, and the research industry
• Beneficence in research involving children often justifies effective treatment and healthy development
• The principle is not always clear in balancing risk and benefit, especially in research involving children

Understanding the Principle of Justice in Research

• The principle of justice means fairness in distribution or "what is deserved"
• Injustice occurs upon undue burden or denied benefit
• Distinctions of experience, age, deprivation, competence, merit, and position can justify differential treatment
• Way to distribute burdens/benefits: equal share, individual need, effort, societal contribution, and merit
• Questions associated with justice include burdens falling on poor ward patients and exploitation of unwilling prisoners during the Nazi concentration camps
• Research subject selection must be scrutinized for bias or manipulability
• Research from public funds should involve those likely to benefit from its application

Informed Consent

• Informed consent is crucial for research, but there is debate over its scope
• The consent process consists of information, comprehension, and voluntariness
• Research codes ensure subjects receive sufficient information
• Necessary items include the procedure, purposes, risks/benefits, alternative procedures, and the right to ask questions/withdraw
• The information standard is "the reasonable volunteer"
• The information must be clear, understandable, voluntary, and not withheld

Informed Consent Continued

• The delivery context and manner of information is as pivotal as the information itself
• A subject's comprehension is determined by intelligence, rationality, maturity, and language
• Investigators must ensure subjects grasp the provided information
• Special provisions are warranted when comprehension is severely limited, such as intellectual immaturity or mental disability
• Valid consent requires voluntary agreement to participate within research
• Conditions must remain free of coercion and undue influence
• Unjustifiable pressures can often occur when those in authority or of great influence try to urge a course of action for a subject

Risks and Benefits Assessment

• Risk refers to the possibility of harm, while benefit refers to a positive value related to health or welfare
• Research risks and benefits affect individual subjects, their families, and society
• Risks to research subjects should be outweighed by the sum of the anticipated benefit both to the subject and society in the form of acquired knowledge

Risks and Benefits Assessment Continued

• Brutal or inhumane treatment of human subjects is never morally justified
• Risks are reduced to what is necessary to achieve research objectives
• When research presents significant risk of serious impairment, committees need to insist on justifying the risk
• When research involves vulnerable populations their appropriateness needs to be demonstrated
• All risks and benefits must be thoroughly explained in documents and procedures used during the informed consent process

Selection of Subjects

• Individual justice requires researchers to exhibit fairness, and to refrain from only offering research to favored patients or selecting "undesirable" individuals for risky research
• Social justice distinguishes between subject classes, considering each their capacity to bear burdens and the propriety of placing further burdens on those already burdened
• Seeks to apply principle of justice to consent requirements and risk/benefit assessments
• Necessitates fair procedures and outcomes in selecting subjects

Selection of Subjects Continued

• Injustice can appear in subject selection via institutionalized biases, even where individual subject selection is fair
• Distributive justice bears on subject selection when considering research's burdens and benefits
• Certain, vulnerable groups such as racial minorities, the economically disadvantaged, the very sick, and the institutionalized must be protected
• These groups should never be involved in research solely due to administrative convenience or because of illness or socioeconomic condition