RES-L04-Ethical Issues in Clinical Trials

What is the purpose of ethical considerations in clinical trials

To protect participants and ensure research integrity

What can ethical lapses in clinical research lead to

Harm, mistrust, and scientific invalidity

What are key ethical issues in clinical research

Informed consent, risk-benefit assessment, use of placebos, privacy, vulnerable populations, and conflicts of interest

What is informed consent

A fundamental ethical and legal requirement ensuring voluntary participation in research

What does informed consent involve

Providing comprehensive information about study purpose, procedures, risks, and benefits

What is the primary purpose of informed consent

To safeguard autonomy by enabling participants to make informed decisions

How does informed consent promote transparency

By building trust between researchers and participants

How does informed consent ensure ethical compliance

By adhering to biomedical research standards

How does informed consent provide legal protection

By protecting both researchers and participants

What are the key parts of an informed consent document

Introduction & purpose, study procedures, risks, benefits, confidentiality, voluntary participation, compensation, contact information

Why is confidentiality important in informed consent

To ensure privacy and data protection

Why is voluntary participation emphasized in informed consent

To stress freedom to withdraw at any time

What are the advantages of informed consent

Promotes autonomy, ensures ethical standards, fosters trust, and provides legal protection

What are the disadvantages of informed consent

Complexity, emotional influence, and information overload

When is informed consent required

For clinical research involving human participants, sensitive data, or privacy concerns

When may informed consent not be required

For anonymized, non-invasive research with no risk or studies involving minors with guardian assent

Give an example of informed consent in medical research.A clinical trial for hypertension medication

Give an example of informed consent in psychological research.Studies involving interviews or physiological tests

What is the main issue with informed consent in clinical research

Ensuring participants fully understand what they are consenting to

What historical study exemplifies a failure in informed consent

The Tuskegee Syphilis Study

What are the causes of inadequate informed consent

Lack of communication and involvement of vulnerable populations

What are the consequences of unresolved informed consent issues

Participants may be unknowingly exposed to harm, leading to legal repercussions and loss of public trust

What are solutions to improve informed consent

Simplify language, use visuals, allow questions, and provide extra protections for vulnerable groups

What is the primary issue in risk-benefit assessment

Weighing potential benefits against risks

Which clinical trial demonstrated inadequate risk disclosure

The Dalkon Shield trial

What are the causes of poor risk-benefit assessment

Pressure for quick results and biased risk assessments

What happens if risk-benefit assessments are not properly conducted

Participants may suffer harm, leading to lawsuits and invalid research

How can risk-benefit assessments be improved

Strict ethical reviews, continuous monitoring, and minimizing risks

What is the ethical concern with placebo use in research

Using a placebo when effective treatments exist

Which study is a notable example of unethical placebo use

The Tuskegee Syphilis Study

What are the causes of unethical placebo use

Desire for methodological rigor and belief in placebo necessity

What are the consequences of unethical placebo use

Participants may be denied treatment, leading to unnecessary suffering

How can ethical placebo use be ensured

Use only when no treatment exists, ensure informed consent, and require IRB approval

What is the key issue in privacy and confidentiality in research

Protecting sensitive participant data

Which historical case involved a breach of confidentiality

The HeLa cell research

What causes breaches in research privacy

Inadequate data security and poor consent practices

What are the consequences of failing to protect privacy

Discrimination, loss of trust, and legal repercussions

How can privacy and confidentiality be maintained

Strict confidentiality protocols, data anonymization, and explicit consent for data sharing

What is the main concern with vulnerable populations in research

Protecting individuals with limited ability to consent

Which unethical study targeted institutionalized children

The Willowbrook Hepatitis Study

What causes ethical issues in research on vulnerable populations

Coercion, undue influence, and lack of representation

What happens when vulnerable populations are not adequately protected

Exploitation, public outrage, and legal action

How can vulnerable populations be ethically included in research

Follow strict ethical guidelines, use legal guardians, and ensure independent oversight

What is the primary issue with conflicts of interest in research

Financial or personal interests influencing research integrity

Which study demonstrated a conflict of interest in pharmaceutical research

The GlaxoSmithKline Seroxat study

What are common causes of conflicts of interest

Ties to pharmaceutical companies and lack of transparency

What are the consequences of unresolved conflicts of interest

Biased results, unsafe treatments, and loss of credibility

How can conflicts of interest be managed in research

Declare conflicts, ensure independent oversight, and separate research from commercial interests

What is the role of ethical frameworks in clinical research

They balance scientific advancement with participant protection

What are the four core ethical principles in clinical research

Autonomy, beneficence, non-maleficence, and justice

What are the key ethical frameworks used in clinical research

Principlism, The Belmont Report, Utilitarianism, Virtue Ethics, Ethics of Care

What is Principlism in clinical research

A framework based on four key ethical principles

What are the four principles of Principlism

Autonomy, beneficence, non-maleficence, and justice

How does informed consent relate to Principlism

It ensures autonomy by allowing voluntary participation

What is a strength of Principlism

Provides clear, universal guidelines for ethical dilemmas

What is a limitation of Principlism

Lacks procedural guidance and may lead to conflicts between principles

What is the Belmont Report framework

A framework outlining ethical principles for human research protection

What are the three principles of the Belmont Report

Respect for persons, beneficence, and justice

How did the Tuskegee Syphilis Study violate the Belmont Report

It violated justice by exploiting vulnerable participants

What is a strength of the Belmont Report

Provides historical grounding and emphasizes fairness

What is a limitation of the Belmont Report

Limited in addressing modern challenges like global trials

What is the Utilitarian framework in clinical research

Evaluates actions based on outcomes, aiming for the greatest good

What are the key principles of Utilitarianism in research

Maximizing public health benefits and balancing risks and rewards

How did COVID-19 vaccine trials apply Utilitarianism

They prioritized collective benefit over individual risk

What is a strength of the Utilitarian framework

Supports public health goals and resource allocation

What is a limitation of the Utilitarian framework

Can overlook individual rights and justify unethical practices

What is Virtue Ethics in clinical research

A framework focusing on researchers' moral character rather than rules or outcomes

What are the key principles of Virtue Ethics

Emphasizes honesty, compassion, and integrity in research

How does Virtue Ethics promote ethical conduct

By encouraging ethical behavior across all aspects of research

What is a strength of Virtue Ethics

Encourages ethical behavior beyond rules and procedures

What is a limitation of Virtue Ethics

Lacks clear procedural guidance and is subjectively interpreted

What is the Ethics of Care framework

A framework emphasizing relationships, empathy, and responsibility toward participants

What are the key principles of Ethics of Care

Prioritizes participant well-being and promotes researcher-participant dialogue

How does Ethics of Care protect vulnerable participants

It ensures special considerations for children and terminally ill patients

What is a strength of the Ethics of Care framework

Addresses power imbalances and enhances participant protection

What is a limitation of the Ethics of Care framework

Limited applicability in large-scale studies and has a subjective nature