The College of New Jersey

Apply     Visit     Give     |     Alumni     Parents     Offices     TCNJ Today     

International Human Subject Research Resources

General Data Protection Regulation (GDPR)

Illustration showing key elements of GDPR (effective 25 May 2018) – DPOs, Compliance, Data Breaches and Personal Data

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

There is a Research Participant Privacy Notice and a TCNJ GDPR Consent Form Template to help researchers successfully engage in research within the EU or with subjects from within the EU.

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.

Informed Consent Approaches

Resources that describe issues related to written consent and alternate consent formats (e.g., oral, pictorial).

Clinical Trials

Training

Resources that provide training on the ethical principles, standards, and procedures associated with human subjects research.

Top