Helping researchers navigate clinical & translational research regulatory processes. Regulatory Foundations, Ethics, and Law Program

International Research

Overview

The Regulatory Foundations, Ethics, and Law Program facilitates the development and strengthening of international research initiatives. The program achieves this by providing education and training about regulatory concerns specific to international research within Harvard Catalyst's participating institutions and with global research sites.

Resources

For Investigators
  • International Research: Basic Topics to Consider [PDF]
    A brief presentation of key considerations for investigators when planning and conducting international research involving human subjects.
  • International Research 101 [PDF] Coming Soon
    A handbook of regulatory considerations in international research.
  • International Research Case Studies [PDF]
    Examples of regulatory issues specific to international research and suggestions for managing those issues.
  • Onsite Training and Education (Request Consultation)
    Request international on-site training as well as education to local research staff and/or ethics committee.
  • Study Monitoring and Regulatory Compliance for Global Health Research [PDF]
    (from Harvard T.H. Chan School of Public Health)
    A comprehensive presentation about monitoring and compliance for research at international sites.
  • Research Ethics Guidelines International Online Navigation Map (REGION-Map)
    (from Harvard T.H. Chan School of Public Health)
    A map linking investigators to country-specific documents and research resources.
  • Additional Resources
    • ClinRegs (National Institute of Allergy and Infectious Diseases (NIAID))
      A database of country-specific clinical research regulations from around the globe designed to save time and effort in planning and implementing clinical research.
    • International Compilation of Human Research Standards (Office for Human Research Protection (OHRP))
      A compilation of over 1,000 laws, regulations, and guidelines on human subjects protection in over 100 countries.
    • International Ethical Guidelines for Biomedical Research Involving Human Subjects [PDF] (Council for International Organizations of Medical Sciences (CIOMS))
      Guidelines to apply ethical standards in local circumstances, and establish or improve ethical review mechanisms in international research.
    • Global Health Trials
      Register for this open access, free web resource that enables individuals working on trials in resource-limited settings to work together to share guidance, tools, and resources. This site also provides valuable guidance materials, and training resources through the Global Health Trials e-Learning Centre.
    • International Research Ethics Online Training (adapted from the World Health Organization (WHO) by The Global Health Network)
      Consists of 14 modules and a substantial resource library covering a wide variety of issues. Modules vary in length but each should take no more than 30 to 45 minutes to complete. Optional quizzes accompany each module and must be completed to gain certification for successful completion of the entire course.
    • Family Health International (FHI) 360 Research Ethics Training Curriculum
      [PDF] [Web Version]
      This Research Ethics Training curriculum is available for download in PDF, web, or flash versions. The training includes case studies and test, evaluation, and certifications appropriate for both investigators and community members. Please check with your institution to determine which training(s) are appropriate to fulfill organizational requirements.
    • Harvard Global Support Services
      The Harvard Global Support Services webpage provides tools and guidance for those who study, research, and work overseas.
For Institutions
  • International Research: Basic Topics to Consider [PDF]
    A brief presentation of key considerations for investigators when planning and conducting international research involving human subjects.
  • International Research 101 [PDF] Coming Soon
    A handbook of regulatory considerations in international research.
  • International Research Case Studies [PDF]
    Examples of regulatory issues specific to international research and suggestions for managing those issues.
  • Study Monitoring and Regulatory Compliance for Global Health Research [PDF] (from Harvard T.H. Chan School of Public Health)
    A comprehensive presentation about monitoring and compliance for research at international sites.
  • Research Ethics Guidelines International Online Navigation Map (REGION-Map)
    (from Harvard T.H. Chan School of Public Health)
    A map linking investigators to country-specific documents and research resources.
  • Onsite Training and Education (Request Consultation)
    Request international on-site training as well as education to local research staff and/or ethics committee.
  • Post-Approval Monitoring Training (Request Consultation)
    Request training support for remote post-approval monitoring and quality assurance of research that is conducted internationally.
  • Additional Resources
    • ClinRegs (National Institute of Allergy and Infectious Diseases (NIAID))
      A database of country-specific clinical research regulations from around the globe designed to save time and effort in planning and implementing clinical research.
    • International Compilation of Human Research Standards (Office for Human Research Protection (OHRP))
      A compilation of over 1,000 laws, regulations, and guidelines on human subjects protection in over 100 countries.
    • International Ethical Guidelines for Biomedical Research Involving Human Subjects [PDF] (Council for International Organizations of Medical Sciences (CIOMS))
      Guidelines to apply ethical standards in local circumstances, and establish or improve ethical review mechanisms in international research.
    • Global Health Trials
      Register for this open access, free web resource that enables individuals working on trials in resource-limited settings to work together to share guidance, tools, and resources. This site also provides valuable guidance materials, and training resources through the Global Health Trials e-Learning Centre.
    • International Research Ethics Online Training (adapted from the World Health Organization (WHO) by The Global Health Network)
      Consists of 14 modules and a substantial resource library covering a wide variety of issues. Modules vary in length but each should take no more than 30 to 45 minutes to complete. Optional quizzes accompany each module and must be completed to gain certification for successful completion of the entire course.
    • Family Health International (FHI) 360 Research Ethics Training Curriculum
      [PDF] [Web Version]
      This Research Ethics Training curriculum is available for download in PDF, web, or flash versions. The training includes case studies and test, evaluation, and certifications appropriate for both investigators and community members.
    • International Post-Approval Monitoring and Quality Assurance [PDF]
      Novel approaches to post-approval monitoring and quality assurance of international research through remote review, where on-site review may not otherwise be possible.

Harvard Catalyst International Research Task Force

The International Research Task Force is available to offer expertise to investigators and institutions as needed. Learn more on our How We Work page.

Contacts

Sabune Winkler, JD
Director, Regulatory Foundations, Ethics, and Law Program
Email

Aaron Kirby, MSc
Associate Director, Regulatory Affairs Operations
Email

Hila Bernstein
Regulatory Affairs Officer
Email