General Data Protection Regulation (GDPR)
The EU recently passed the General Data Protection Regulation which is a binding legislative act addressing the processing of personal data of individuals physically located with the European Union (“EU”). Research that occurs in within the boundaries of the EU, or with subjects from within the EU must comply with this legislation. Please review the GDPR and TCNJ Policy
The external informational resources linked below address important areas for the development, approval, training for and conduct of international human subjects research. Investigators and IRB members may find these resources helpful when considering the multitude of unique and complex issues related to international human subjects research.
There is also a YouTube Video that details the expectations of GDPR.
Resources for Developing Programs
The Office for Human Research Protections has developed a new resource for IRBs, researchers, and sponsors that are involved in human subjects research in Europe. Titled “Compilation of European GDPR Guidances,” the document lists the data protection authorities of all European countries that fall under the new E.U. General Data Protection Directive (GDPR). For each country, the compilation also provides the links to any general GDPR guidances, as well as specific guidances on the topics of Research, Legal Basis, Consent, and International Data Transfer.
The following organizations provide information about International Research Ethics Committee (REC) and IRB standards for accreditation and capacity building:
- SIDCER(link is external) – The Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) is a network of independently established regional forums for ethical review committees, health researchers, and invited partner organizations with an interest in the development of ethical review.
- AAHRPP(link is external) – The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP), helps organizations worldwide strengthen their human research protection programs and provides a list of accredited organizations both nationally and internationally.
- FERCAP(link is external) – Forum for Ethical Review Committees in the Asian and Western Pacific Region (FERCAP), aims to improve understanding and implementation of ethical review for behavioral and biomedical researchers in Asia and the Western Pacific region.
- CIOMS(link is external) – The Council for International Organizations of Medical Sciences (CIOMS) is an international, non-governmental, non-profit organization established jointly by WHO and UNESCO in 1949.
International Laws, Guidance, and Essential Country Data
These resources represent a compilation of research laws and regulations in most countries in the world along with essential country information that is useful for IRB members who are reviewing studies being conducted abroad.
- OHRP Compilation of International Human Subject’s Laws(link is external) – Web page containing a downloadable document listing over 1,000 laws, regulations, and guidelines on human subjects protections in over 100 countries and from several international organizations compiled by the HHS Office of Human Research Protections (OHRP).
- OISE: International Integrity Resources(link is external) – National Science Foundation (NSF) Office of International Science & Engineering (OISE) provides resources to assist in the development of training and oversight plans for the responsible and ethical conduct of research in international contexts and understanding international codes of conduct.
- World Bank Countries and Economies(link is external) – Comprehensive national data for developing countries around the world; e.g., Agriculture & Rural Development, Aid Effectiveness, Climate Change, Economic Policy & External Debt, Education, Gender, Health, Infrastructure, Labor & Social Protection, Poverty, and more.
- CIA World Fact Book(link is external) – Provides information on the history, people, government, economy, geography, communications, transportation, military, and transnational issues for 267 world entities.
- World Health Organization Country Information(link is external) – A webpage listing all the countries that are members of the United Nations and the World Health Organization. Includes population statistics, information on national health systems, mortality, disease burden, and the health profile of each country.
International Ethical Standards and Procedures
Resources that describe the ethical issues and standards in conducting international research.
- International Ethical Guidelines for Biomedical Research Involving Human Subjects (link is external)(pdf)
- Fogarty International Center Bioethics Information and Resources(link is external) – U.S National Institutes of Health (NIH) Fogarty International Center website listing various resources for REC members, researchers, students, and others working to strengthen research bioethics expertise in developing countries.
- Presidential Commission for the Study of Bioethical Issues: Moral Science(link is external) – Website listing reports and information evaluating of the current rules for protecting research participants (domestically and internationally) from harm or unethical treatment, with recommendations for 14 changes to current practices.
- Singapore Statement on Research Integrity(link is external) – Website promoting integrity in research on a global basis, with a common approach (statement) to the fundamental elements of responsible research practice.
- Responsible Conduct of Research in the Global Research Enterprise(link is external) – Report from the InterAcademy Council (IAC) & IAP global network of science academies describing basic values that govern research conduct and communication of results, including principles and guidelines to maintain the integrity of the research.
- Strategies for Protecting Human Research Subjects Globally(link is external) (pdf) – Conference presentation from Research Triangle Institute International summarizing issues in the conduct of international research from the point of view of the researcher and federal regulatory offices. Chapel Hill, North Carolina 2004.
Informed Consent Approaches
Resources that describe issues related to written consent and alternate consent formats (e.g., oral, pictorial).
- “How to Make Consent Informed: Possible Lessons from Tibet(link is external)” – Suellen Miller, Phouc V. Le, Sienna Craig, Vincanne Adams, Carrie Tudor, Sonam, Nyima, Droyoung, Mingkyi Tshomo, Lhakpen, Michael Varner (2007). IRB: Ethics and Human Research, Vol. 29, No. 6 (Nov. – Dec. 2007), pp. 7 – 14 Published by: The Hastings Center Stable. (JSTOR.org)
- “A pilot study of the quality of informed consent materials for Aboriginal participants in clinical trials(link is external)” – Russell FM, Carapetis JR, Liddle H, et al. Journal of Medical Ethics, 2005: 31 (8): 490-494. Accessed 25/07/2012. (PDF)
- “Informed Consent and Respecting Autonomy: What’s Signature Got to Do with It?(link is external)” – Wendler, D. and J. E. Rackoff (2001). World Medical Association (2009). Medical Ethics Manual, World Medical Association. (PDF)
- “How Informed is Consent in Vulnerable Populations?(link is external) Experience using a continuous consent process during the MDP301 vaginal microbicide trial in Mwanza, Tanzania.” – Vallely, A., Lees, S., Chagi, C., Kasindi, S., Soteli, S., Kavit, N., Vallely, L., McCormack, S., Pool, R., Hayes, R., MDP. BMC Ethics: 11 (10); 2010. (Biomedcentral.com)
- “A model designed to enhance informed consent: experiences from the HIV Prevention Trials Network(link is external)” – Woodsong, C. and Karim, Q.A. (2005). Am J Public Health 95(3). (National Center for Biotechnology Information)
- Reviewing Clinical Trials: A Guide for the Ethics Committee(link is external) (pdf) – Edited by Johann P.E. Karlberg (Clinical Trials Centre, Univ. of Hong Kong) and Marjorie Speers of AAHRPP. Sponsored by Pfizer, an AAHRPP accredited pharmaceutical company, through a “non-binding” grant.
- “What makes clinical research in developing countries ethical?(link is external)” Emanuel, E., Wendler, D., Killen, J., Grady, C. Journal of Infectious Disease; 930-937 (189); 2004.
- “The Ancillary-Care Obligations of Medical Researchers Working in Developing Countries(link is external)” PLoS Med 5(5): e90. Participants in the Georgetown University Workshop on the Ancillary-Care Obligations of Medical Researchers Working in Developing Countries (2008).
- Ethical Considerations in Biomedical HIV Prevention Trials(link is external) (pdf) – Excellent resource about conducting clinical trials internationally published by United Nations AIDS and the World Health Organization in 2007 (with additional information added in 2012). See the UNAIDS website (www.unaids.org)(link is external) for available foreign language translations.
- Ethical and Policy Issues in Int’l Research: Clinical Trials in Developing Countries(link is external) (pdf) – National Bioethics Advisory Commission report discusses ethical issues when conducting research in countries where human participant protection systems equivalent to the U.S. have not been established.
Resources that provide training on the ethical principles, standards, and procedures associated with human subjects research.
- Collaborative Institutional Training Initiative (CITI)(link is external) – The CITI Program website provides a selection of educational modules that can be used to satisfy instructional mandates for the protection of human subjects.
- Research Ethics Training Curriculum(link is external) – provides a basic and accessible level of training appropriate for individuals from different professional backgrounds and world regions; from FHI360, a non-profit human development organization.
- Johns-Hopkins Human Subjects Research Ethics Field Guide(link is external) – website with links to multi-lingual versions of the guide, which intended for staff who will be “engaged” in some aspect of a human subject research interaction or intervention.
- A Study Guide To “Ethically Impossible”: STD Research in Guatemala from 1946 to 1948 (link is external)– (PDF) set of case studies to promote guided ethics discussion based on real world examples; Presidential Commission for the Study of Bioethical Issues (2012), Washington, D.C.