Bioethics Resources for Investigators & Research Ethics Committees

A collection of resources for scientific investigators conducting research in the developing world, and ethics committees reviewing it.

• Guidelines and Regulations
  • Guidelines (non-regulatory)
  • Regulations
• Practical Aids
• Research Ethics Committees

Guidelines and Regulations

Guidelines (non-regulatory)

Human Subjects Research in General

These are the key non-regulatory documents that are likely to be cited by ethicists and research ethics committees.

• The Nuremberg Code
• The World Medical Association Declaration of Helsinki
• Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Biomedical Research Involving Human Subjects.
• The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (USA)
• PREVENT Project: Pregnant Women & Vaccines Against Emerging Epidemic Threats: Ethics Guidance for Preparedness, Research, and Response, September 2018

HIV/AIDS

• UNAIDS 2012. Ethical considerations in biomedical HIV prevention trials
• National Institutes of Health, USA. NIH Guidance for Addressing the Provision of Antiretroviral Treatment for Trial Participants Following their Completion of NIH-Funded HIV Antiretroviral Treatment Trials in Developing Countries

Research in Developing Countries

• The Nuffield Council. The Ethics of Research Related to Healthcare in Developing Countries. 2002. The Nuffield Council is a UK-based independent body that researches and reports on topical issues in bioethics. They published a follow-up discussion paper on this same topic in 2005.
• National Bioethics Advisory Commission, USA. Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries.

Research in Humanitarian Crises

• Post-Research Ethics Analysis (PREA) - A research project investigating ethical issues in health research in humanitarian crises.
• PREA tool - Provides researchers and other stakeholders with a pragmatic tool that assists learning lessons about the actual ethical challenges that develop during health research in humanitarian crises.
• R2HC Research Ethics Tool
  Elrha, September 2017        
• Disasters: Core Concepts and Ethical Theories [Open access]
  Springer Nature, supported by Disaster Bioethics/COST Action, 2018

Genetics and Genomics

• Human Genome Organisation (HUGO) - HUGO Ethics Committee. Statements on several issues, including genetics research and benefit sharing.
• UNESCO. Universal Declaration on the Human Genome and Human Rights.
• The Office for Human Research Protections (OHRP) in the US has guidance on the application of US regulations to genetic research and research on biological samples. See "Coded Private Information," "Biological Specimens," and "Tissue Storage/Repositories."
• The US National Institutes of Health also have guidance documents relating to Genome-Wide Association Studies (GWAS).
• National Bioethics Advisory Commission, USA. Research Involving Human Biological Materials: Ethical Issues and Policy Guidance.

Regulations

US Regulations

• Code of Federal Regulations Title 45 Part 46.
• Food and Drug Administration (FDA). Title 21 Part 50 Protection Of Human Subjects.
• A helpful FDA and HHS comparison chart showing the similarities and differences between FDA and HHS regulations.

Compilations of National Regulations

• ClinRegs from the National Institute of Allergy and Infectious Diseases (NIAID). A central resource for exploring and comparing international clinical research regulations.
• Global Research Ethics Map. Harvard School of Public Health. As of March 2009, provides guides to the human subjects protections in 11 countries: Botswana, Ghana, Kenya, Kuwait, Malawi, Nepal, Pakistan, Philippines, Senegal, South Africa, Tanzania.
• From the Office for Human Research Protections (OHRP) at HHS:
• International Compilation of Human Research Protections - Lists the approximately 1,100 laws, regulations, and guidelines that govern human subjects research in over 100 countries, as well as standards from a number of international and regional organizations.
• Compilation of European GDPR guidances
  as of July 24, 2018
• UNESCO Global Ethics Observatory includes a database containing ethics related legislation and guidelines from 34 countries.
  

Practical Aids

• WHO's Special Programme for Research and Training in Tropical Diseases (TDR). Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants. Provides guidance for setting up and developing standard operating procedures for research ethics committees and ethical review systems.
• Foreign Grants Information. NIH Office of Extramural Research (OER) has a website for foreign applicants and grantees. It goes through the grants process and includes a section on human subjects protections.
• OER also have a page providing HHS and NIH requirements and resources for all members of the extramural community involved in human subjects research
• The Elements of a Successful Informed Consent [Video] created by the Human Subjects Protection Team of the National Institute of Mental Health (NIMH) Office of the Clinical Director. This video is intended for use by novice clinical investigators and clinical research staff.

Research Ethics Committees

• Global Health Reviewers
  A "resource for all those involved in the ethical and regulatory review of research, particularly in resource-limited settings. A variety of materials and forums are provided to assist committee members from Ethics Review Committees, Institutional Review Boards, and Food and Drug Administration regulatory committees."
• Iberoamerican Bioethics Network
  The network, with headquarters at FLACSO-Argentina, has subcoordinator centers in Brazil, Mexico and Spain. The Iberoamerican Bioethics Network is a dependent of the IAB (International Association of Bioethics).
• Inventory of research ethics committees in Africa and for Latin America and the Caribbean
  From Health Research Web, the inventory includes contact information for each REC.
• IRB Primer: Incidental and Secondary Findings [Archive]
  From the from the archive of the U.S. Presidential Commission for the Study of Bioethical Issues, the IRB Primer is designed to help institutional review boards (IRBs) understand and implement the Bioethics Commission's recommendations regarding how to manage incidental and secondary findings ethically in the research setting.
• Research Ethics in Africa, by Mariana Kruger, Paul Ndebele, Lyn Horn
  This free e-book for research ethics committee members focuses on research ethics issues in Africa.
• Strategic Initiative for Developing Capacity in Ethical Review (SIDCER)
  A network of independently established regional fora for ethical review committees, health researchers and invited partner organizations with an interest in the development of ethical review. The regional fora are composed of Asia and Western Pacific (FERCAP), former Russian states (FECCIS), Latin America (FLACEIS), Africa (PABIN) and North America (FOCUS).
• Africa - The Pan-African Bioethics Initiative (PABIN) aims to strengthen ethical awareness and discussion across the African continent. They are currently surveying research ethics committees in Africa.
• Asia - The Forum for Ethical Review Committees in Asia and the Western Pacific Region (FERCAP) is a regional organization of researchers and members of ethics review committees.
• Latin America - The Latin American Forum of Research Ethics Committees in Health (FLACEIS) is located at FLACSO-Argentina. From its creation in 2002 there have been three or four lectures each year about issues relevant for research ethics committees.

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Updated April 2022