A Guide to Doing Research in International Research Ethics
This subject guide supports researchers and students interested in the ethical issues of multinational research. These issues include: the obligations of wealthy nations to the countries and communities in which they conduct research, the impact of cultural differences on the interpretation and implementation of ethics oversight and guidelines, discrepancies between national regulations, and other topics.
Although the guide emphasizes resources for the Indiana University-Moi University Academic Research Ethics Partnership (IU-Moi AREP) and, therefore, gives special attention to issues in Kenya and other countries in east Africa, many of the resources described here are applicable to the broader study of ethical issues in biomedical research.
Because the IU-Moi AREP (like many international research studies) spans two academic institutions and two continents, this guide points (when possible) to resources that are freely available online.
(This guide was last updated November 28, 2012.)
BELIT - Bioethics Literature Database
A bibliographic database maintained by the German Reference Centre for Ethics in the Life Sciences (DRZE), BELIT provides access to about 350,000 records. Coverage includes holdings in German, French and American databases. To view records relevant to international research ethics, try browsing or combining keywords in the thesaurus.
The website, maintained by the Swedish Research Council and The Centre for Research Ethics & Bioethics at Uppsala University, provides summaries of (and links to) research guidelines. Use the search function or the sitemap to browse CODEX, try: Human Subjects Research and Medical Research.
Global Ethics Observatory (GEObs)
Developed by UNESCO, the GEObs databases are available (and free) in six languages (Arabic, Chinese, English, French, Russian, and Spanish) and records can be browsed by region. In addition to providing access to codes and regulations, this project emphasizes international networking:
- Database 1: Who's Who in Ethics - Individual experts in ethics around the globe
- Database 2: Ethics Institutions - Institutions, centers, commissions, and committees in the area of ethics
- Database 3: Ethics Teaching Programmes - Descriptions of existing teaching programmes within the field of ethics
- Database 4: Ethics Related Legislation and Guidelines - Descriptions of ethics related legislation and guidelines
- Database 5: Codes of Conduct - Codes of Conduct within the field of ethics
- Database 6: Resources in Ethics - Resources in ethics
Globethics.net is an international digital library of applied ethics resources. After registering, users have full text access to many electronic resources that address medical and research ethics issues. The collection currently provides free access to over 485,000 full text documents, including over 150 peer reviewed journals. This digital library is committed to providing ethics research resources to individuals in "developing and transition countries." To get full access to the library, create a free account and login. Here are a few of the relevant journals accessible to Globethics.net members:
- African Journal of Food, Agriculture, Nutrition and Development
- AIDS Research and Therapy
- Global Virtue Ethics Review
- International Journal of Ethics
- IRB: Ethics & Human Research
- Journal of Agricultural & Environmental Ethics
- Journal of Law, Medicine & Ethics
- Journal of Legal, Ethical and Regulatory Issues
- Journal of Medical Ethics
- Medical Ethics Advisor
- Philosophy, Ethics, and Humanities in Medicine
- The Internet Journal of Law, Healthcare and Ethics
- The Journal of Ethics
- The Nation (Kenya)
- Yale Human Rights and Development Law Journal
- Yale Journal of Health Policy, Law, and Ethics
International Bioethics Organizations Database
Maintained by the Bioethics Reference Library at Georgetown University, this database indexes bioethics centers and organizations. Search by keyword or browse by country.
PubMed (a service of the U.S. National Library of Medicine and the National Institutes of Health) provides free online access to the Medline database, covering over 18 million citations from 1948 to the present. Although full text access to the journals indexed in this database will depend upon your institution's subscriptions [use your library's portal; PubMed at IUSM], search results can be limited to records with links to free full text. For international research ethics articles, try the following searches:
- Research Ethics and International Issues | Links to Free Full Text
- Research Ethics and Developing Countries | Links to Free Full Text
- Research Ethics and Africa | Links to Free Full Text
- Research Ethics and Eastern Africa | Links to Free Full Text
- Research Ethics and Asia | Links to Free Full Text
- Research Ethics and Australia | Links to Free Full Text
- Research Ethics and Europe | Links to Free Full Text
- Research Ethics and Eastern Europe | Links to Free Full Text
- Research Ethics, Latin America and the Caribbean | Links to Free Full Text
The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Department of Health, Education, and Welfare, U.S. April 18, 1979.
Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects | [PDF – 48 KB]
Currently in the ninth revision (October 2013), this declaration of was developed by the World Medical Association and has influenced many national and international regulatory structures.
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
Used as guidance by the FDA, the ICH guidelines represent an effort to harmonize the pharmaceutical and clinical trials regulations in Japan, the United States, and European countries. The guidelines address four domains: Quality, Efficacy, Safety and Multidisciplinary.
The Council for International Organizations of Medical Sciences (CIOMS), 2002. International Ethical Guidelines for Biomedical Research Involving Human Subjects.
These guidelines aim to assist countries in policy development for ethical biomedical research. This most recent version also aims: "to reflect the conditions and the needs of low-resource countries, and the implications for multinational or transnational research in which they may be partners."
The Nuremberg Code
An outcome of the Nuremberg Trials at the end of Second World War, the Nuremberg Code is an essential document in the history of research ethics.
Universal Declaration on Bioethics and Human Rights, UNESCO
Adopted by UNESCO's General Conference on October 19, 2005, the Universal Declaration on Bioethics and Human Rights aims to provide a broad framework for protecting individuals and groups in a diverse range of countries.
Finding More Codes, Guidelines and Regulations:
Described above, this Web site indexes research guidelines.
German Reference Centre for Ethics in the Life Sciences (DRZE)
In addition to many useful resources (see the BELIT database, described above), the DRZE library provides a database of links to useful sites and tools on the Web site: Bioethics Links.
Global Ethics Observatory (GEObs): Database 5: Codes of Conduct
Developed by UNESCO and available in six languages, the GEObs provides a database of 151 "Codes of Conduct". GEObs results may be filtered by discipline, region, and country.
International Compilation of Human Research Protections
Compiled by the Office for Human Research Protections, U.S. Department of Health and Human Services, the current edition (2013) indexes "over 1,000 laws, regulations, and guidelines on human subjects protections in 104 countries and from several international organizations."
The Council for International Organizations of Medical Sciences (CIOMS)
The CIOMS is "an international, non-governmental, non-profit organization established jointly by WHO and UNESCO in 1949". Among other things, the organization develops and publishes international research ethics guidelines. See Codes, above.
The Eubios Ethics Institute
The Institute (in New Zealand and Japan) aims "to stimulate the international discussion of ethical issues, and how we may use technology in ways consistent with 'good life' (eu-bios)." Although lacking the bells-and-whistles of many Web sites, this site provides links to many useful, full text documents. The site provides excellent coverage of issues relevant to research in the Asia-Pacific region.
European Network of Research Ethics Committees – EUREC
EUREC was launched in 2005 and is "a network of national networks and associations of Research Ethics Committees (RECs) in Europe. The network aims at the development of high quality standards in clinical trials in order to protect human subjects." The research ethics regulations of the member countries and resources for RECs are indexed on this site.
The Global Forum on Bioethics in Research (GFBR)
The GFBR, an international partnership, holds annual meetings to focus on the ethics of human research in developing countries.
The International Association of Bioethics
An association of international bioethics networks, the IAB convenes the annual World Congress of Bioethics. The IAB also publishes two journals: Bioethics and Developing World Bioethics. (Subscriptions required for full access; free access to institutions in the developing world through World Health Organization's HINARI initiative.)
Nuffield Council on Bioethics
An independent organization, funded jointly by the Foundation, the Medical Research Council and the Wellcome Trust, many of the Council's publications and reports are available on this site, including: The Ethics of Research Related to Healthcare in Developing Countries, 2002. Limited print and CDROM copies of the Council's publications are available to "Developing Countries" at no cost. Also see the Council's 2005 follow-up report which includes a table comparing guidances.
UNESCO Social and Human Sciences: Ethics
In addition to access to its international standards and declarations [including: Universal Declaration on the Human Genome and Human Rights (1997), International Declaration on Human Genetic Data (2003), and Universal Declaration on Bioethics and Human Rights (2005)], the UNESCO SHS Ethics portal links to the organizations international committees and programs:
- Assisting Bioethics Committees (ABC)
- Ethics Education Programme (EEP)
- International Bioethics Committee (IBC)
- Intergovernmental Bioethics Committee (IGBC)
- World Commission on the Ethics of Scientific Knowledge and Technology (COMEST)
The World Medical Association (WMA)
An international organization serving physicians, the WMA publishes the Helsinki Declaration (see Codes, above). The WMA's Ethics Unit also publishes several relevant policy guidelines and the WMA Medical Ethics Manual (available in several languages).
The World Health Organization (WHO)
The WHO and its regional offices publish many documents and provide data of use to the study of ethical issues of international health research. Three sub-sites of the WHO are particularly relevant:
To keyword search WHO publications, select the "Search WHO publications" option on the Advanced Search page.
BBC News Africa
The BBC provides widely read news coverage of several regions, including Africa. The BBC News website also provides country portals with country-specific news and information. See Country Profile: Kenya. (The CIA World Factbook is also a good source of demographic information about countries; see, for example: Kenya.)
The website of the most widely read newspaper in Kenya. The publishers of the Daily Nation (Nation Media Group) also produce The East African, a newspaper for readers interested in the region.
Global Bioethics Blog
Edited by Stuart Rennie, Program manager of the NIH/Forgarty funded project "Strengthening bioethics capacity and justice in health", a collaboration of the University of North Carolina at Chapel Hill, the University of Louvain ( Belgium) and the Kinshasa School of Public Health (Democratic Republic of Congo).
The Web site for one of the most widely read newspapers in Uganda.
The New Vision
The Web site for one of the most widely read newspapers in Uganda.
The Research Ethics Blog
Written by ethicists Nancy Walton, Research Ethics Board Chair and Associate Professor at Ryerson University in Toronto, and Chris MacDonald, Associate Professor, Saint Mary's University in Halifax and author of the popular "Business Ethics Blog", this blog comments on recent news, academic publications, and policy developments relevant to the study and practice of research ethics.
The New York Times - Topics: Third World and Developing Countries
This page provides newsfeeds and a portal to archived articles and commentaries about the developing world.
SciDev.Net - Science and Development Network
This organization provides a Web site covering science news about research and technology in the developing world. Content may be browsed by region, search terms, and topical gateways. In addition to news, The Science & Innovation Policy: Research Ethics page provides links to key documents, policy briefs, guidelines, and governmental and international bodies.
The Web site of Kenya's second most popular newspaper (after Daily Nation, see above).
For general news about events in East Africa (and elsewhere), Google News provides country-specific news pages and feeds. See, for example:
This Google News search provides headlines (for the most recent 30 days) relevant to medical ethics and research ethics in East African countries: East Africa + Medicine + Ethics
Brody BA. The Ethics of Biomedical Research: An International Perspective. Oxford UP, 1998. 386 p. Google Books | WorldCat
Reviews research ethics policies throughout the world. Brody's commentary is informed by the "philosophical position of pluralistic casuistry".
Green RM, Donovan A, Jauss SA. Global Bioethics: Issues of Conscience for the Twenty-First Century. Oxford UP, 2009. Google Books | WorldCat
This book addresses the impact of globalization on the ethics of medical care and research across cultures and economies. The book examines standards of care, international norms, the role of religion, and other topics.
Hawkins J, Emanuel EJ, eds. Exploitation and Developing Countries: The Ethics of Clinical Research. Princeton UP, 2008. 327 p. Google Books | WorldCat
An investigation, by several contributors, of the concepts of exploitations and fair use in the context of research in developing contries. Given the Marxist history of moral thought about "exploitation", this is an attempt to use the concept with a "non-Marxist bent".
Häyry M, Takala T, Herissone-Kelly P, Morgan Capron A, eds. Ethics in Biomedical Research: International Perspectives. Rodopi, 2007. 248 p. Google Books | WorldCat
Partly the result of an international symposium held in Helsinki (2003), this book presents the research of a broad range of international voices with a primary focus on the ethical issues of research in developing countries.
Lavery JV, Grady C, Wahl ER, eds. Ethical issues in international biomedical research: a casebook. Oxford UP, 2007. 371 p. Google Books | WorldCat
This book provides 21 case studies (each with two commentaries) on the ethical issues of research in developing countries.
Macklin R. Double standards in medical research in developing countries. Cambridge University Press, 2004. 280 p. Google Books | WorldCat
The author argues that the standard of care for research in developing countries should be equivalent to the standard of care for research conducted in the sponsoring, industrialized country. Macklin also advocates for access to essential medications.
National Bioethics Advisory Commission (NBAC). Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries. Vol. I. Report and Recommendations of the National Bioethics Advisory Commission. Rockville, MD: NBAC, 2001. 154 p. [Full Report, PDF - 6MB | Additional formats and chapter sections]
This report of the NBAC addresses the ethical issuses relevant to the conduct of clinical trials in developing countries when these trials are subject to U.S. regulations.
National Bioethics Advisory Commission (NBAC). Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries. Vol. II. Commissioned Papers and Staff Analysis. Rockville, MD: NBAC, 2001. 370 p. [PDF - 2MB]
Volume II includes four papers (addressing equivalent protections, attitudes, culture and consent, and international perspectives on human subject protections) and one staff analysis of international regulations and guidelines.
Nuffield Council on Bioethics. The Ethics of Research Related to Healthcare in Developing Countries. London: Nuffield Council on Bioethics, 2002. 190 p.
This report proposes ethical standards for healthcare research in developing countries and focuses on standards of care, consent, ethical review, and benefit sharing.
Nuffield Council on Bioethics. The Ethics of Research Related to Healthcare in Developing Countries: A Follow-up Discussion Paper. London: Nuffield Council on Bioethics, 2005. 128 p.
This discussion paper records the results of a workshop held in Cape Town, South Africa (February 2004). The workshop emphasized: community participation, developing expertise, sustainability, and ongoing ethics feedback and review. Additional topics for review were identified, including public health research and intellectual property issues.
Plomer A. The Law and Ethics of Medical Research: International Bioethics and Human Rights. Routledge Cavendish, 2005. 158 p. Google Books
A comparative study of legislation and research ethic guidelines, this book focuses on differences in US, Canadian and UK human rights law. The final chapters, however, is devoted to research in the developing world.
IU Center for Bioethics Reports on International Research Ethics
Meslin, EM; Sidle, JE; Wools-Kaloustian, K; Were, E; Salmon, K; Chuani, C. International Research Ethics: A Needs Assessment of Research Ethics Capacity. Volume I: Final Report. Indiana University Center for Bioethics. June, 2005.
Meslin, EM; Sidle, JE; Wools-Kaloustian, K; Were, E; Salmon, K; Chuani, C. International Research Ethics: A Needs Assessment of Research Ethics Capacity. Volume II: The Responses. Indiana University Center for Bioethics. June, 2005.
The CITI International Training Platform
The online education module offers two tracks for international research ethics education: Track 1, International Modules (for international investigators) and Track 2, The U.S. Federal Modules (for non-U.S. investigators involved in U.S. funded research).
Ethical Issues in Global Health Research - Harvard School of Public Health
This website for an intensive workshop on international health research ethics, includes case studies, questions for discussion, and links to relevant documents.
International Research Ethics Education And Curriculum Development Award
A program of The Fogarty International Center (FIC), this NIH funding organization provides links to its many international research ethics education awardees by title and region.
Online Ethics Center
Although this site serves the ethics information needs of the National Academy of Engineering, many of the resources and links are useful to anyone interested in research ethics and research ethics education. In addition to the cases and materials on Responsible Research, see the items and articles for teaching ethics, Education.
Training and Resources in Research Ethics Evaluation (TRREE)
Funded by the European & Developing Countries Clinical Trials Partnership (EDCTP), TRREE provides access to free, online research ethics learning modules. The site also includes a useful bibliography of publications and web resources.
PubMed MEDLINE search: Teaching methods for research ethics education
Scope of International Medical Research (2011)
In 2011, a document was compiled for the IU Center for Bioethics that compiled data and references related to human subjects in international research. The pdf of the document can be accessed with the link below.
AAAS-National Academies Compilation of Resources on Scientific Misconduct and Research Integrity
Hosted by the The AAAS Scientific Freedom, Responsibility and Law Program (SFRL), this useful suite of Web guides and bibliographies includes a section for International Resources.
Bioethics Information and Resources, Fogarty International Center
The NIH Fogarty International Center's guide to web resources on international research ethics. The guide includes resources for education, a journal list, and valuable links to materials in other languages.
Voo T, Chin J, Campbell AV. Multinational Research. Bioethics Briefing Book. The Hastings Center.
One of the three dozen chapters in the Hasting Center's online briefing book, this overview provides a summary of the issues in international research and links to important documents and recent news stories. A print-friendly version is also available, PDF - 142 KB.
The Project for Scholarly Integrity, CGS
With support from the HHS Office of Research Integrity and the National Science Foundation, the Council of Graduate Schools has developed a rich index of Responsible Conduct of Research resource. Results can be filtered by "International Topics and Issues"
The IU – Moi AREP has developed an international research ethics bibliography specific to work being conducted in Kenya. The list includes publications considered particularly valuable to our partnership and we are hoping they may also be helpful for other students and researchers working in Kenya.
Friendly link to this page: http://bioethics.iu.edu/ireguide