Codes and guidelines

Guide for research ethics committee members
This guide is intended to be used as a tool for research ethics committee (REC) members. The text has been elaborated by the Group of Specialists on Biomedical Research working under the authority of the Steering Committee on Bioethics of the Council of Europe.

Declaration of Helsinki
The Declaration of Helsinki, published in 1964 by the World Medical Association (WMA), established groundbreaking principles in research ethics by safeguarding the rights of human participants involved in health-related research.

Guideline for Good Clinical Practice
The Good Clinical Practice (GCP) guidelines set an international standard for ethical and scientific quality in the design, conduct, recording, and reporting of trials involving human subjects.

CIOMS guidelines
The Council for International Organizations of Medical Sciences (CIOMS) International ethical guidelines for health-related research involving humans provide a comprehensive ethical framework. They aim to protect human rights and dignity, particularly emphasising research in resource-poor settings and guiding stakeholders involved in research design.

Nuremberg Code
The Nuremberg Code, originating from the aftermath of World War II, establishes ethical principles for human experimentation, emphasising voluntary consent and avoidance of harm.

Belmont Report
Commissioned by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1974, the Belmont Report provides foundational ethical principles and guidelines for research involving human subjects.

WHO standards and operational guidance for ethics review of health-related research with human participants
This document offers guidance for research ethics committees (RECs) responsible for reviewing and overseeing the ethical aspects of health-related research. It serves as a resource for researchers designing and conducting studies involving human participants.

Oviedo Convention
The Oviedo Convention, ratified in Europe in 1997, safeguards human rights and dignity in the application of biology and medicine, particularly concerning research involving human subjects.

EU - Clinical Trials Regulation (CTR)
European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation entered into application on 31 January 2022. It aims to ensure the EU offers an attractive and favourable environment for carrying out clinical research on a large scale, with high standards of public transparency and safety for clinical trial participants.

OECD Recommendations on Responsible Innovation in Neurotechnology
These recommendations support ethical development and utilisation of neurotechnology by promoting transparency, accountability, and engagement with stakeholders within the research ecosystem.

Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals
These recommendations were developed to review best practice and ethical standards in the conduct and reporting of research and other material published in medical journals.

The Global Ethics Charter for the Protection of Healthy Volunteers in Clinical Trials
This charter, published by the VolREthics initiative in 2024, focuses on healthy volunteers involved in interventional clinical trials of drugs where there is no potential direct health benefit to the individuals involved.

WHO Guidance for best practices for clinical trials
This document is intended to provide guidance to WHO’s Member States and any staff members of non-State actor organizations whose work is related to clinical trials in any way, including the planning, conduct, analysis, oversight, interpretation and funding of all clinical trials to assess the effects of any health intervention for any purpose in any setting. Such staff members include those involved in educating others about clinical trials.

European Commission: Ethics in Social Science and Humanities
This document developed by the European Commission aims to help researchers in social sciences and humanities (SSH) identify and address ethical dimensions. It is also designed to help the wider research community deal with the ethical issues that may arise in interdisciplinary research using SSH methodology.

NESH Guidelines for Research Ethics in the Social Sciences and the Humanities
The National Committee for Research Ethics in the Social Sciences and the Humanities (NESH) is an independent advisory body responsible for developing national research ethics guidelines in Norway. The first edition of NESH’s guidelines was published in 1993, and revised editions have been published in 1999, 2006 and 2016.

British Sociological Association (BSA) - Statement of Ethical Practice
A set of ethical principles and guidelines designed to help sociologists navigate ethical dilemmas in their research.

Guidance Note for Researchers and Evaluators of Social Sciences and Humanities Research
The purpose of this guide is to provide advice and practical guidance to researchers and ethics reviewers of SSH research projects on how to deal with the ethical aspects of SSH research.

Code of Ethics for Research in the Social and Behavioural Sciences involving Human Participants
As accepted by the Deans of Social Sciences in the Netherlands, 23 May 2018. The Code of Ethics for the Social and Behavioural Sciences provides guidelines for research in the social and behavioural sciences involving human participants. It intends to support researchers and ethical review boards in ethical reflection.

Ethics guidelines for internet-mediated research developed by the British Psychological Society Internet-mediated research (IMR) can pose particular, sometimes non-obvious, challenges to compliance with existing ethical principles. This document outlines some of the key ethical issues that researchers and RECs should consider when conducting or evaluating a study.

Guidelines for research involving social media published by the Toronto Metropolitan University
The purpose of these guidelines is to provide researchers with information related to research involving social media platforms.

Ada Lovelace Institute: Looking before we leap. Expanding ethical review processes for AI and data science research
This report examines challenges faced by public and private-sector RECs in evaluating research ethics and societal impacts in AI and data science research. It aims to assist institutions developing AI research review processes by promoting a comprehensive approach to identify and mitigate risks.

Ethics Guidelines for Trustworthy Artificial Intelligence
These guidelines developed by the High-Level Expert Group on AI aim to ensure the ethical development and deployment of artificial intelligence (AI) technologies. They emphasise principles such as transparency, accountability, fairness, and societal well-being.

Ethics By Design and Ethics of Use Approaches for Artificial Intelligence
This approach advocates for embedding ethical considerations into the design and implementation phases of AI systems. It promotes proactive measures to address ethical issues throughout the lifecycle of AI technologies.

EU AI Act
The EU AI Act is legislative framework proposed by the European Union to regulate artificial intelligence (AI). It aims to establish legal requirements for AI systems, focusing on ensuring safety, fundamental rights protection, and ethical standards.

UNESCO Recommendation on the Ethics of Artificial Intelligence
This recommendation provides international guidelines for the ethical use and development of artificial intelligence (AI). It emphasises human rights, inclusion, diversity, and the promotion of human-centric AI technologies.

European Code of Conduct for Research Integrity
The European Code of Conduct promotes integrity in research across Europe, emphasising honesty, transparency, and accountability in all aspects of research practices.

Singapore statement on research integrity
This statement outlines principles for promoting integrity in research globally, emphasising honesty, fairness, accountability, and stewardship of research practices.

European Commission: Identifying serious and complex ethics issues in EU-funded research
This document guides researchers and ethics committees in identifying and addressing serious and complex ethical issues that may arise in EU-funded research projects.

European Commission: Ethics and data protection
These guidelines ensure that research involving personal data complies with ethical standards and data protection laws within the European Union (EU), safeguarding privacy and rights of research participants.

UNESCO Recommendation on Open Science
This recommendation promotes open access to scientific data, publications, and processes. It encourages transparency, collaboration, and inclusivity in research, aiming to advance scientific knowledge for the benefit of society.

Toolbox for Research Integrity (Sops4RI)
The SOPs4RI Toolbox is a structured collection of easy-to-use Standard Operating Procedures and Guidelines that Research Performing and Research Funding Organisations can use to develop their own Research Integrity Promotion Plans.

The TRUST Code
The TRUST Code, previously known as “Global Code of Conduct for Research in Resource-Poor Settings” is a resource for all researchers who want to ensure that international research is equitable and carried out without ‘ethics dumping’ and ‘helicopter research.

Cape Town Statement on fostering Research Integrity through Fairness and Equity
This code advocates for fair practice from conception to implementation of research and provides 20 recommendations aimed at all involved stakeholders.

South African Ethics in Health Research Guidelines: Principles, Processes and Structures (2024, 3rd Edition)
This guideline sets national ethical standards for conducting research with human participants and animals, ensuring responsible and ethical practices. It provides guidance on ethics review processes, expectations for Research Ethics Committees, and the regulatory framework in South Africa.