Experimental Design in Biomedical Sciences 8A 2024
Page 1: Introduction
Experimental Design in Biomedical Sciences 8/A
Page 2: Research Ethics
Overview of health research review processes.
Page 3: Clinical Research
What is Clinical Research?
Clinical research is a comprehensive study examining the safety and effectiveness of promising advances in patient care.
Aims to better understand, diagnose, and treat diseases.
What Does It Include?
Clinical trials for new medicines.
Questionnaires and surveys.
Observational studies where researchers watch participants.
Page 4: Historical Ethical Concerns in Research
The Thalidomide Tragedy (1962)
A drug marketed for morning sickness led to 10,000 infants with severe limb deformities in over 60 countries.
The Tuskegee Syphilis Study (1932-1972)
Inhumane experiments conducted by Nazi physicians during WWII.
African American men with syphilis were denied treatment to study the disease’s progression.
Page 5: Regulation of Research on Humans
Key Ethical Codes and Reports
Nuremberg Code (1954): Emphasizes voluntary participation.
Declaration of Helsinki (1964): Updates to the Nuremberg Code including obligations of investigators.
Belmont Report (1979): Guiding principles based on the Tuskegee Syphilis case:
Respect for Persons: Consent, privacy, and confidentiality.
Beneficence: Balance between benefits and risks.
Justice: Fair distribution of research burdens and benefits, protecting vulnerable populations.
1996 ICH-GCP guidelines: International standards for clinical trials.
Page 6: What is Bioethics?
Ethics: Determining the 'right thing' to do in various scenarios.
Bioethics: Focus on the ethical use of biology and medicine. Questions include:
Should we pay organ donors?
Should genetically modified crops be planted?
Is animal testing acceptable for human benefit?
Subcategories of bioethics include:
Medical ethics: Healthcare issues.
Research ethics: Conduct of research issues.
Environmental ethics: Human-environment relationship.
Public health ethics: Ethical issues in public health.
Page 7: Research Ethics
Definition
Values and principles guiding researchers on permissible studies and conduct.
Characteristics of Ethical Research
Participants are informed about the research.
Informed consent to take part.
Assurance of no harm to participants.
Protection of participant privacy.
Page 8: Research Ethics Committees (RECs)
Composed of individuals with diverse expertise beyond just scientists and doctors.
Members provide opinions on whether research protocols meet ethical standards.
Page 9: Ethical Assessment Process
Reference video: "Watch Processes, Papers, and Professors: how clinical research in young people gets approved."
Complete related exercise in provided document.
Page 10: Ethical Requirements for Clinical Research
Citations
Discusses what makes research ethical and includes framework for ethical clinical studies.
Page 11: Understanding Ethical Clinical Research
Informed consent is often viewed as essential but not sufficient for ethical research.
Article covers 7 requirements for evaluating the ethics of studies involving human subjects.
Page 12: Background to Ethical Clinical Research
Aim of clinical research: develop knowledge to improve health.
Requires respect for human subjects.
Ethical requirements minimize exploitation by ensuring respect for participants.
Page 13: The 7 Ethical Requirements
Social or scientific value.
Scientific validity.
Fair subject selection.
Favorable risk-benefit ratio.
Independent review.
Informed consent.
Respect for potential and enrolled subjects.
Page 14: 1 - Social or Scientific Value
Ensure responsible resource use and avoid exploitation.
Do not expose participants to harm without potential benefits.
Page 15: 2 - Scientific Validity
Essential to employ rigorous methodology for reliable outputs.
Justifying ethical values requires expertise in scientific principles.
Page 16: 3 - Fair Subject Selection
Establish fair criteria for inclusion/exclusion.
Protect vulnerable populations and maximize benefit versus risk.
Page 17: 4 - Favorable Risk-Benefit Ratio
Risks must be minimized while potential benefits maximized.
Benefits should outweigh risks for individuals.
Page 18: 5 - Independent Review
Conflicts of interest should be avoided; independent ethics committees provide necessary oversight.
Page 19: 6 - Informed Consent
Ensure participants understand risks and benefits; provide clarity on methodology.
Page 20: 7 - Respect for Potential and Enrolled Subjects
Uphold privacy and confidentiality.
Ensure participants can withdraw at any time.
Monitor welfare and inform about research outcomes.