KAAP 400 - Lecture 2

Why do ethics matter in research?

Ethics matter for accountability and trust, scientific quality, and compliance. Researchers must maintain high standards and be accountable to the public and regulatory bodies, especially when receiving federal funding. Ethical lapses like fabricating data or conducting poor-quality studies can produce invalid results. Researchers must also follow ethical guidelines, which are often legally required to receive research funding.

Why do research ethics matter, even if you never conduct research yourself?

Ethics ensure that research and the decisions based on it are made responsibly. Even if you never conduct a study, you will use data, rely on evidence, work with people, and make decisions influenced by research. For example, healthcare professionals use research and evidence-based practice to make informed decisions, such as knowing that insulin works as a treatment.

What are ethics?

Ethics are shared norms of conduct that guide decisions about acceptable and unacceptable behavior. They apply to all aspects of research.

What is human subject research, and how is it regulated?

Human subject research involves interacting with living people or using identifiable private information (e.g., health information or ZIP code). It requires scientific justification showing the potential benefits outweigh risks or discomfort. Human studies are reviewed by an Institutional Review Board (IRB), which oversees policies and procedures and protects participants’ rights, safety, and well-being. Examples include surveys, interviews, and clinical trials.

What is animal research, and how is it regulated?

Animal research follows different ethical principles than human research and requires scientific justification for using animals. Animal studies are reviewed by an Institutional Animal Care and Use Committee (IACUC), which oversees animal care, research protocols, use, and welfare. Animal research can help understand biological and health systems and is often used to test medications before human clinical trials. Examples include studying muscle physiology in rodents and testing medications in animals.

What types of research do not involve human subjects?

Research that does not involve human subjects includes publicly available or de-identified datasets, animal models (overseen by IACUC, not IRB), computer simulations/mathematical models, literature or archival reviews without identifiers, and bench science using cells, tissues, chemical assays, or commercially available cell lines without identifiers.

What exactly is a human subject?

A human subject is a living individual about whom a researcher obtains data through intervention, interaction, or identifiable private information.

• Intervention: Physical procedures or manipulations (e.g., exercise tests, clinical procedures).

• Interaction: Communication or contact for research (e.g., surveys, interviews, focus groups).

• Identifiable private information: Information that can readily identify a person (e.g., names, medical records, linked biospecimens).

Why do research ethics matter?

Research ethics protect participants, build trust in research, prevent unethical practices, and help researchers balance scientific progress with participant safety. Researchers often have more knowledge or authority than participants, which can create opportunities for harm or pressure, so ethical guidelines help ensure participants are safe, informed, and protected and that risks do not outweigh the potential benefits.

What was the Tuskegee Syphilis Study, and what did it teach us about research ethics?

The Tuskegee Syphilis Study (1932–1972) involved ~600 African American men in Alabama. Researchers did not obtain informed consent, participants did not know they were in a study, and those with syphilis were not properly informed or treated. Even after penicillin became the proven cure in the 1940s, researchers withheld or prevented treatment. The study led to major U.S. research reforms, including Institutional Review Boards (IRBs) and informed consent requirements.

What were Nazi medical experiments, and what ethical reforms resulted from them?

During World War II, ~25,000 concentration-camp prisoners were subjected to cruel medical experiments without consent, often causing death or permanent injury. Experiments included extreme cold/high-altitude exposure, deliberate infection, testing drugs/vaccines, forced sterilization, and invasive procedures. These atrocities led to the Nuremberg Code (1947), which established voluntary participation and avoidance of unnecessary suffering as key ethical requirements.

What was the Milgram Obedience Study, and what ethical concern did it raise?

In the early 1960s, Stanley Milgram studied obedience to authority by having participants believe they were giving painful electric shocks to a “learner” when instructed by an authority figure. The learner was actually an actor, and no real shocks were given. Researchers used verbal prods such as “Please continue” to see how far participants would go under pressure. The study raised concerns about deception and psychological harm, showing that researchers should not cause participants to believe they seriously harmed or killed someone.

What is the Nuremberg Code (1947), and what are its core principles?

Created after WWII in response to Nazi medical experiments, the Nuremberg Code established the first formal principles for ethical research with human subjects: voluntary informed consent, avoiding unnecessary suffering, ensuring benefits outweigh risks, using qualified researchers, and allowing participants to withdraw at any time without penalty.

What are the three core ethical principles of the Belmont Report (1979)?

The Belmont Report established three core principles for ethical research with human subjects: 1) Respect for persons, 2) Beneficence, and 3) Justice. These principles guide U.S. research involving humans, form the foundation of IRB review, and help identify ethical challenges and protect participants throughout the research process.

What does “Respect for Persons” mean in research ethics?

Respect for persons means recognizing participants’ autonomy and protecting those with diminished autonomy. Participants must be able to make informed decisions about participation. Informed consent ensures they understand the study’s purpose, procedures, risks, benefits, and right to withdraw at any time. Vulnerable populations, such as children or people with diminished decision-making capacity, require additional protections.

What are vulnerable populations in research, and why do they require special protections?

Vulnerable populations are groups more susceptible to coercion or undue influence, such as children, prisoners, pregnant individuals, and people with cognitive impairments. Researchers must provide additional protections to ensure fairness and safety and consider whether participation could be exploitative or harmful. Examples of unethical research include the Stateville Penitentiary Malaria Study (1940s), which offered prisoners shortened sentences and money to participate, and Project MKUltra (1953–1973), in which prisoners and volunteers were unknowingly given hallucinogenic drugs.

What is informed consent?

Informed consent is a process where researchers provide potential participants with the necessary information before they agree to participate. Participants must understand what the research involves, its risks, potential benefits, and their rights, including the right to withdraw at any time without consequence. Participants sign and receive a copy of the consent form, ensuring they understand the study and freely choose to participate.

What are the informed consent requirements for research involving children?

Research involving children requires parental consent and child assent. Assent is the child’s affirmative agreement to participate after the study is explained in an age-appropriate, understandable way. If the parent agrees but the child does not, the child cannot participate. Assent can also apply to participants who lack legal capacity for day-to-day decision-making, such as those with cognitive impairments.

What is the Belmont Report principle of beneficence?

Beneficence means “to do good” or “do no harm.” Researchers must maximize benefits and minimize harm, thoughtfully assessing, reducing, and justifying risks. They must consider physical, psychological, social, and privacy-related risks and ensure the anticipated benefits to the individual or society justify the risks.

What types of risks must researchers consider under the principle of beneficence?

Research risks go beyond physical harm and include psychological distress (anxiety/upset), embarrassment from sensitive questions, social stigma from being judged or labeled, and privacy breaches from shared or leaked data. Researchers must identify and minimize these risks and justify their methods, balancing risks against potential benefits.

What is the Belmont Report principle of justice?

Justice ensures fair selection and treatment of research participants. Groups should not be targeted because they are convenient, vulnerable, or powerless, and the benefits of research should be distributed equitably. Ethical research avoids exploitation and promotes fairness.

What is an Institutional Review Board (IRB)?

An IRB is an independent committee of scientists and non-scientists that reviews human-subject research to ensure ethical standards and federal/institutional regulations are met. It evaluates risks, consent procedures, and participant protections, safeguarding participants while allowing ethically sound research to proceed.

What does the Institutional Review Board (IRB) do, and what are the levels of IRB review?

IRBs review research design, consent/recruitment, risks, data protection, and vulnerable populations to protect participants and ensure ethical conduct. Review can be exempt (certain minimal-risk studies; still requires IRB confirmation), expedited (minimal-risk studies using non-invasive measures or existing data), or full board (more than minimal risk or vulnerable populations; reviewed by the full IRB).

What are privacy, confidentiality, and data security in research?

Privacy concerns how information is collected, while confidentiality concerns how information is stored and shared. Researchers must protect participant information using anonymization, secure storage, controlled access, passwords, encryption, and locked facilities. Data security protects research data from unauthorized access or breaches. Researchers have a duty to keep sensitive information safe and not disclose participants’ identities or private health information.

What is an adverse event (AE) in research, and what should happen if one occurs?

An adverse event (AE) is any unexpected harm to a research participant, such as an infection/injury, dizziness or fainting, or accidental disclosure of sensitive health/location data. Adverse events must be reported promptly to the IRB so it can reassess risks and make changes if needed.

What are continuing reviews and modifications to approved research studies?

Continuing review periodically evaluates ongoing studies to ensure participants remain protected by reviewing risks, consent procedures, adherence to the approved protocol, and study progress. Any changes to the study protocol, consent forms, or procedures must be submitted in writing and approved by the IRB before implementation to prevent unapproved risks and maintain ethical compliance.

What is non-compliance in research, and what are researchers’ responsibilities?

Non-compliance is failure to follow IRB-approved research protocols. Consequences can include suspension of research, loss or repayment of funding, and institutional penalties. All researchers, including students, have the same ethical obligations to maintain high professional standards. Students must complete required training, follow IRB protocols, and conduct research under faculty supervision to ensure ethical oversight.

What are ethical responsibilities beyond IRB approval?

Ethical research also requires honest data analysis, proper authorship, disclosure of conflicts of interest, and overall scientific integrity. IRB approval does not replace these broader responsibilities; all researchers must maintain integrity throughout their work and properly recognize others’ scientific contributions.

Why is peer review important in science?

Science is self-correcting, and peer review helps identify errors and ethical problems. In the Anil Potti case, questions raised in 2007 by two bioinformatic statisticians found that the data did not add up. Potti also falsely claimed to be a Rhodes Scholar. As a result, 11 papers were retracted and 7 were corrected, demonstrating the importance of peer review and integrity in both research and personal representation.

What is the Declaration of Helsinki (DOH)?

The Declaration of Helsinki, adopted in 1964 by the World Medical Association, establishes internationally accepted ethical principles for research involving human participants. It requires independent ethical review, emphasizes informed consent, risk-benefit assessment, and protection of vulnerable populations, and is often cited in research papers to demonstrate adherence to international ethical standards.

What ethical principles are violated when a medication study is conducted in a memory care center without consent, and how should participants be protected?

Respect for persons is violated because informed consent was not obtained, especially important because residents may be a vulnerable population. Researchers should obtain informed consent and assent, using clear, understandable language and signed forms. Additional safeguards are needed to protect participants with diminished autonomy.

What ethical principles are violated when patient health records are collected without anonymization and later leaked?

Confidentiality and privacy are violated. Researchers should minimize risk by using de-identified data and participant codes instead of identifying information. Failure to protect data can allow sensitive information to be exploited or used to impersonate participants.