Ethical_and_Regulations_in_Clinical_Trials flashcards

Page 1: Introduction to Ethics and Regulations in Clinical Trials

• Course Code: MEDC0014

• Title: Ethics and Regulations in Clinical Trials

• Date: 06-Mar-2025

• Institution: UCL

Page 2: Learning Outcomes

• Articulate the ethical principles that underpin clinical trials.

• Identify the regulatory guidelines appropriate for different trial types.

• Understand and describe the informed consent process in clinical trials.

Page 3: Understanding Ethics

• Definition: Ethics involves moral principles;

• Inquiry of right vs. wrong.

• Application in various contexts: medical, environmental, business ethics.

• In clinical trials, ethics ensures the design, conduct, and analysis prioritize participant rights, dignity, and well-being, while maintaining scientific integrity.

Page 4: Ethics in Clinical Trials

• Ethics seeks to ensure participant protection in trial design and analysis.

• Design considerations: rights, dignity, and well-being of participants.

Page 5: Ethical Considerations

• Question: Can individual rights be disregarded for scientific benefits?

Page 6: Unethical Research Practices

• Historical context: disregard for participant rights leads to unethical outcomes.

• Notable unethical research cases often focused on perceived scientific advancements while neglecting consent, privacy, and autonomy.

Page 7: Importance of Ethical Guidelines

• Purpose of ethical guidelines:

  • Protect the rights, dignity, and well-being of research participants.

  • Ensure the production of reliable and credible data, which can influence clinical practice.

Page 8: Historical Context of Ethics in Trials

• Core values stem from the Hippocratic Oath, advocating for healing and doing no harm.

• An evolving landscape; there was a period lacking strict ethical regulations.

Page 9: Case Study - Guatemala Syphilis Experiments (1946-1948)

• Overview:

  • US-funded study infecting over 500 individuals without knowledge or consent to test penicillin.

• Ethical violations:

  • Lack of informed consent.

  • Participants suffered long-term health consequences.

• Long-term impact: US government apologized in 2010.

Page 10: Case Study - Willowbrook Hepatitis Experiments (1956-1970)

• Target Group: Children with intellectual disabilities.

• Ethical concerns regarding:

  • Coercion in parental consent.

  • Lack of fully informed consent for participants.

• Resulted in stricter regulations for vulnerable populations.

Page 11: Case Study - Henrietta Lacks (1951)

• Background:

  • Cells taken without consent from Henrietta Lacks during cervical cancer treatment.

  • HeLa cells later became vital for medical research.

• Ethical implications:

  • Family remained unaware of their use in research until decades later.

Page 12: Video Resource

• Title: Henrietta Lacks' Revolutionary HeLa Cells.

• Additional context available online.

Page 13: Historical Context Video

• Title: Ugly History: The U.S. Syphilis Experiment - Susan M. Reverby.

• Additional resource available online.

Page 14: Key Ethical Lessons from Unethical Experiments

• Highlights:

  • Informed consent issues.

  • Exploitation of vulnerable populations.

  • Consequences on trust in medical communities.

  • Need for clear ethical guidelines.

Page 15: Development of Ethical Guidelines

• Causal events leading to ethical framework:

  • Nuremberg Code (1947).

  • Declaration of Helsinki (WMA, 1964).

  • ICH GCP (1996).

  • Historical unethical practices influenced guideline development (e.g., Nazi experimentation, Tuskegee Study).

Page 16: Ethical Codes for Clinical Trial Conduct

• Outline of ethical frameworks influencing clinical trials.

• Further details available from UCL resources.

Page 17: Nuremberg Code (1947)

• Established post-WWII after prosecuting unethical medical practices.

• Key principles:

  • Voluntary consent is imperative.

  • Research must yield societal benefits.

  • Avoid unnecessary suffering.

  • Qualified personnel must conduct trials.

  • Termination of trials in case of harm to subjects.

Page 18: Declaration of Helsinki (1964)

• Developed by the World Medical Association; extends Nuremberg Code principles.

• Key principles include:

  • Ethical committee approval.

  • Voluntary and informed consent.

  • Scientific and social value of research.

  • Safety measures for participants, especially vulnerable groups.

  • Protection of participant privacy.

Page 19: ICH Good Clinical Practice (GCP)

• Established in 1996, it harmonizes international clinical trial standards.

• Key Framework:

  • Ensures ethical and scientific quality in trials.

  • Documents available on Moodle (full guidance and principles).

Page 20: 13 Core Principles of ICH GCP

• Principles include:

  • Accordance with Declaration of Helsinki.

  • Scientific justification.

  • Informed consent.

  • Qualified investigators.

  • Adequate resources and risk management.

  • Ethical and scientific review.

  • Compliance with protocols and confidentiality.

  • Quality assurance and regulatory compliance.

Page 21: Aims of Good Clinical Practice (GCP)

• Protect the rights, safety, and well-being of trial subjects.

• Ensure the credibility of clinical trial data.

Page 22: Foundations of Regulations Governing Clinical Trials

• Timeline of key regulations and frameworks:

  • 1996: ICH GCP established.

  • 2000: UK Research Governance Framework.

  • 2014: Clinical Trials Regulation launched in the EU.

  • 2022: New UK regulations post-Brexit.

Page 23: UK Regulatory Bodies for Clinical Trial Review

• Focus on the role of the Research Ethics Committee (REC).

  • Safeguarding trial subjects’ rights and safety.

Page 24: Roles of RECs

• Review vital elements of clinical trials:

  • Study relevance and value.

  • Adequacy of peer review and methods of participant selection.

  • Patient information and consent processes.

Page 25: Structure of REC Committees in the UK

• Over 80 NHS RECs serve as independent bodies with 15 diverse members.

• They remain impartial from sponsors and researchers.

Page 26: Health Research Authority (HRA) Overview

• Established to protect patient interests in health research.

• Ensures ethical review and compliance with national laws.

• Promotes transparency in findings and participant safety.

Page 27: Full Approval Process for Clinical Trials

• Requires initial reviews from multiple committees:

  • Ethics committees and other regulatory bodies.

Page 28: Approval Requirements for Different Trial Types

• Specific requirements based on trial categories (e.g., drug trials, gene therapy).

• Special considerations for vulnerable populations.

Page 29: Summary of Clinical Research Ethics

• Emphasizes the responsibility of researchers to prioritize rights and well-being.

• Necessity of valid study designs balanced against risks and benefits.