Section: Module 4: Lesson 1: Research governance and protocols for the protection of human subjects | Medical Ethics Online

Required Learning Resources

WMA Declaration of Helsinki- Ethical Principles for Medical Research Involving Human Subjects URL

Read the entire content. (20 minutes)

World Medical Association - 2024

Universal Declaration on Bioethics and Human Rights URL

Read the entire content. (23 minutes)

UNESCO - 2006

2016 International ethical guidelines for health-related research involving humans URL

Read Guidelines 4 (Risks and Benefits), 6 (Health Needs), 7 (Community Engagement), 9 (Informed Consent), 14 (Compensation for Harms), 15 (Vulnerable Persons), 16 (Adults Incapable of Consent), and 17 (Children and Adolescents) with their commentaries. (1 hour 45 minutes)

CIOMS - 2016

Standards and operational guidance for ethics review of health-related research with human participants URL

Read Standard 7 (Ethical Basis for Decision-Making) all subsections, and Standard 10 (Researchers' Responsibilities) sections 2-5. (35 minutes)

World Health Organization - 2011

The Belmont Report URL

Explore and interact with all tabs and links and read all content. (40 minutes)

U.S. Department of Health and Human Services - 2025

Recommended Additional Readings

Handbook for Good Clinical Research Practice, 2005 URL

(3 hours 36 minutes)

World Health Organization - 2005

EU Medicines for Human Use (Clinical Trials) Regulations URL

(1 hour 45 minutes)

Legislation Gov Uk - 2025

Human Subjects Research - Home page URL

(2 minutes)

NIH Grants and Founding - 2024

Ethical Research Involving Children Compendium URL

(7 hours 42 minutes)

Unicef - 2013

Introduction

Course Registration

Peer Corner

Pre-Test

Module 1: Rights and Responsibilities

Lesson Summary: Module 1: Rights and Responsibilities

Study Guide: Module 1: Rights and Responsibilities

Flashcards Module 1: Rights and Responsibilities

Microlearning Module 1: Rights and Responsibilities

Module 1: Lesson 1: Duties and obligations of the clinician, including introduction to patient right

Ethical Considerations in Clinical Research: A Comprehensive Review

Good Medical Practice

Good medical ethics, from the inside out—and back again

Patient Rights and Ethics

Patient-Physician Relationships

ICH E6 (R3) Guideline for good clinical practice (GCP)

Human Rights Act

UN Universal Declaration of Human Rights

Exploring patients’ rights awareness and implementations amongst hospitalized patients in Northern Palestine: insights from a local perspective

Privacy and confidentiality of emergency department patient information: Contemporary considerations and challenges

Module 1: Lesson 2: Autonomy, Consent, Confidentiality and the Role of the FamilyFile

The Belmont Report

Patient Rights and Ethics

Module 1: Essential Elements of Shared Decision Making [VIDEO]

Consent and shared decision-making

Informed Consent and Shared Decision-Making in Modern Medicine: Case-Based Approach, Current Gaps and Practical Proposal

Confidentiality: good practice in handling patient information

Introduction to Patient Confidentiality and Privacy | Lecturio [VIDEO]

Patient Confidentiality

Learning Activity 1: Rights and Responsibilities

TCPS 2 (2022) – Chapter 5: Privacy and Confidentiality

Informed Consent

Module 2: Ethico-Legal Frameworks

Lesson Summary: Module 2: Ethico-Legal Frameworks

Study Guide: Module 2: Ethico-Legal Frameworks

Flashcards Module 2: Ethico-Legal Frameworks

Microlearning Module 2: Ethico-Legal Frameworks

Module 2: Lesson 1: Ethical and Legal Frameworks

GLOSSARY OF TERMS RELATED TO ETHICS AND INTEGRITY IN EDUCATION

Principles of Clinical Ethics and Their Application to Practice

CIOMS – International Ethical Guidelines for Health-related Research Involving Humans (2016)

ICH harmonised guideline integrated addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2)

Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants

World Medical Association Medical Ethics Manual

A very short introduction to ethics [open access]

Medical Ethics: A very short introduction [open access]

30-second philosophies [open access]

Module 2: Lesson 2: Mental Health and questions around Capacity

Mental Capacity Act Code of Practice

Code of practice: Mental Health Act 1983

Mental Capacity Act, 2005

Code of practice: Mental Health Act 1983

Decision making and consent

Assessing decisional capacity in patients with substance use disorders

Mental health, human rights and legislation: guidance and practice

Convention on the Rights of Persons with Disabilities (CRPD)

The WHO QualityRights Tool Kit

Module 2: Lesson 3: Understanding Risk and Questions of Disclosure

Understanding and managing clinical risk, World Health Organisation,

Informed Consent

Decision-Making Capacity

Decision making and consent

Learning Activity 2: Ethico-Legal Frameworks

Handbook for good clinical research practice

Patient Safety Curriculum Guide

NHS Patient Safety Strategy: 2021 update

Module 3: Beginning and Ending of life

Lesson Summary: Module 3: Beginning and Ending of life

Study Guide: Module 3: Beginning and Ending of life

Flashcards Module 3: Beginning and Ending of life

Microlearning Module 3: Beginning and Ending of life

Module 3: Lesson 1: Advance Directives and the Right to Refuse Care

Mental Capacity Act (2005)

Article 21 and Constitutional validity of Right to Die

NHS Choices on end of life care

NHS Consent to treatment

Autonomy in Moral and Political Philosophy

The Ethics of Clinical Ethics

The Right to Refuse: Understanding Healthcare Providers’ Perspectives on Patient Autonomy in Emergency Care

Module 3: Lesson 2: Issues around the Beginning and End of Life, including DNR