Harvard
School of Public Health
Ethical Issues in Global Health Research:
Blending Cultures, Building Capacity,
and Bolstering Collaboration
Boston, MA
Ethical Issues in Global Health Research:
Research involving human participants is invaluable in advancing knowledge and practice in the biomedical, social,
and behavioral sciences. Working with human participants can also pose ethical dilemmas and regulatory challenges.
Ethical codes, guidelines, and regulations have been developed in the United States and abroad to provide ethical
guidance and regulatory requirements for researchers and reviewers in this work. Such guidance tries to address
a variety of complex and nuanced situations but may not recognize all of the intricate regulatory and sociocultural
aspects of human research participants in other cultures.
In the United States, human research must conform to US federal regulations for the protection of human research
participants. International research sponsored by US federal agencies must also abide by these regulations. However,
there is no such regulatory protection for research that American organizations may conduct internationally. These
researchers must balance ethical issues with other considerations when determining how to provide equivalent
protections to their human research participants. Differences in national regulatory environments and cultures also
create unique ethical challenges which researchers must address before conducting their investigations.
THE PROGRAM
The Ethical Issues in Global Health Research:
Blending Cultures, Building Capacity, and Bolstering
Collaboration executive program at Harvard School
of Public Health explores points to consider in
human research and provides you with tools to
address these challenges. The program convenes
faculty involved in clinical research, ethics, and law
to address the complex issue of human research
protection in international settings.
Topics explored in this program include ethical issues in
research design, tissue banking, and genetic research as
well as specific guidance on challenges facing vulnerable
populations. The program also includes such topics
as institutional review board efficiency, standards and
challenges facing ethics review boards, and the alignment
of ethics with business goals.
Participants from diverse public and private
organizations involved in reviewing and conducting
biomedical, social, behavioral, and public health
research gain hands-on training in equivalent
protection of research participants to apply within
their organizations. Small group discussions of case
studies on topics such as the informed consent
process in different cultural settings, informal round
table exchanges of real-world examples, and mock
ethics review committee meetings build capacity to
conduct, review, and oversee global health research.
This dynamic program is designed for individuals
working in a field of research involving human
participants (especially global health research)
looking to expand their ability to effectively conduct
research abroad. Participants explore ethical issues,
address specific challenges, and obtain tools
to increase their efficiency and effectiveness in
reviewing, conducting, and monitoring global health
research.
Scan this code with your
smartphone to learn more.
Register Now: ecpe.sph.harvard.edu/EGHR
Blending Cultures, Building Capacity, and Bolstering Collaboration
FACULTY
The Program Director for Ethical Issues in Global Health Research is Delia Y. Wolf, MD, JD, MSCI. Dr. Wolf’s past
and present work focuses on establishing and improving a range of research compliance programs at organizations
throughout the United States and around the world. Her research interests include legal, ethical, and practical issues
in conducting and managing clinical research in different countries.
Dr. Wolf is a medical doctor, a licensed attorney, and a Certified IRB Professional with a Master of Science in Clinical
Investigation. She also completed a fellowship in Medical Ethics at Harvard Medical School, where she concentrated
on ethical issues in conducting clinical research in international settings.
As a former clinical researcher, IRB chair, and director for a research compliance program at Massachusetts
General Hospital and Brigham and Women’s Hospital for more than a decade, Dr. Wolf has extensive experience in
conducting, organizing, developing, and overseeing the full spectrum of clinical research.
Dr. Wolf is the Assistant Dean and Executive Director for the Office of Regulatory Affairs and Research Compliance
(ORARC) at Harvard School of Public Health (HSPH). She is responsible for the development and implementation of
policies and procedures and ensuring faculty and institutional regulatory compliance in the areas of human research
at HSPH, Harvard Medical School, and Harvard School of Dental Medicine. She also oversees efforts in international
research compliance, including global research ethics training.
In her role as the Executive Director of ORARC, Dr. Wolf is also responsible for establishing and implementing
a comprehensive Human Research Protection Program, which includes IRB review, quality assurance, quality
improvement, compliance, education, and outreach to the research community in the US and abroad.
Dr. Wolf will be joined by a world-class team of faculty specializing in research oversight, institutional review, law, and
bioethics from Harvard School of Public Health, Harvard Medical School, Massachusetts General Hospital, Boston
Children’s Hospital, and Brigham and Women’s Hospital.
CURRICULUM
In the Ethical Issues in Global Health Research program, participants explore complex issues in research
ethics, obtain practical tools for improving the efficiency and effectiveness of institutional review boards, and
discuss the unique issues facing researchers working with participants globally. Hands-on workshops, breakout
sessions, and case studies allow participants to practice what they learn and ensure that they return to their
organizations ready to improve its ethics review process. After participating in the course, participants will be
able to:
΄ Understand US regulations and identify ethical guidelines applicable to international research
΄ Apply equivalent protection concepts in reviewing international research
΄ Address challenges in reviewing, conducting, and overseeing global health research
΄ Protect vulnerable populations through culture-specific safeguards
΄ Increase efficiency and effectiveness in the global health research review process
΄ Monitor research with new tools and approaches for countries outside the United States
Curriculum subject to change
LEARN MORE
For information on program dates, program fee, credits, and accommodations:
Visit ecpe.sph.harvard.edu/EGHR.
Register Now: ecpe.sph.harvard.edu/EGHR
Ethical Issues in Global Health Research:
Blending Cultures, Building Capacity, and Bolstering Collaboration
WHO SHOULD PARTICIPATE
Program participants will come from both public and private organizations involved in global health research such as
universities, public policy institutes, health care organizations, pharmaceutical and biomedical research companies,
and non-governmental organizations in the global health arena.
Anyone involved in conducting, reviewing, and overseeing global health research is encouraged to attend Ethical
Issues in Global Health Research. Participants in this dynamic program are individuals working in the field of human
research, especially global health research, who wish to address ethical challenges facing health researchers
globally. Expected participants include:
΄ Anyone who reviews, approves, or manages international research, including Institutional Review Board chairs,
members, and administrators
΄ Ethics committee chairs and administrators
΄ Investigators conducting human research including biomedical, social behavioral, public health, and communitybased research
΄ Study coordinators and/or project managers responsible for managing multisite research
΄ Research ethicists, educators, and graduate students
΄ Quality assurance and improvement staff responsible for auditing and monitoring research
This program focuses specifically on the ethical issues in international research. This program is most applicable
to those involved in conducting, managing, or overseeing research in different countries and cultural settings.
The mission of Harvard School of Public Health is to advance the public’s
health through learning, discovery, and communication.
This program is cosponsored with PRIM&R:
To pursue this mission, the School produces knowledge through research,
reproduces knowledge through higher education, and translates knowledge
into evidence that can be communicated to the public, policy makers, and
practitioners.
677 Huntington Avenue ΄Boston ΄ MA 02115-6096
phone: 617.432.2100 ‡ fax: 617.432.2242
email: [email protected] ‡ web: https://ecpe.sph.harvard.edu
REFERENCE CODE:68:D͹I3
Sign Up to Receive More Information: ecpe.sph.harvard.edu/EGHR