resources for students and faculty
International Research Ethics
The University of Pittsburgh is committed to the ethical conduct of research, domestically and abroad. The University of Pittsburgh Research Conduct and Compliance Office (RCCO) is the primary resource for oversight and facilitation of ethical and regulation-compliant human and animal subject research. While RCCO consists of nine component offices, the Institutional Review Board (IRB) is most frequently involved with international research ethics and regulation. Michelle Lemenager, BS, CIP, Global Research Outreach Coordinator, is the primary point of contact for students who have questions about international research. She can be reached at email@example.com or 412-383-1480.
The Center for Global Health supports ethical and regulation-compliant international research by collaborating closely with RCCO and other University offices to identify needs, develop resources, and disseminate information. The center maintains a small library of print and video materials, which contains resources specific to ethics and regulations. Click here for a list of available materials. The center also sponsors events such as “Ask the IRB” sessions on international research. Check the calendar or sign up for the e-mail distribution list to receive notices of upcoming events.
Codes and Guidelines
International Compilation of Human Research Protections
The U.S. Department of Health and Human Services' Office for Human Research Protections (OHRP) maintains a compilation of over 1,000 laws, regulations, and guidelines on human subjects protections in over 100 countries and from several international organizations.
U.S. Department of Health and Human Services (DHHS)
- 45 CFR 46 Protection of Human Subjects
- 45 CFR 164.501, 164.508, 164.512(i) (See also 45 CFR 164.514(e), 164.528, 164.532) Health Information Privacy
U.S. Food and Drug Association (FDA)
- Title 21 CFR 11: Electronic records; electronic signature
- Title 21 CFR 54 : Financial disclosure by clinical investigators
- Title 21 CFR 50: Protection of human subjects—informed consent
- Title 21 CFR 56: Institutional review boards
- Title 21 CFR 312: Investigational new drugs
- Title 21 CFR 314: FDA approval to market a new drug
- Title 21 CFR 600: Biological products
- Title 21 CFR 601: Licensing
- Title 21 CFR 812: Investigational devices
- Title 21 CFR 814: Pre-market approvals (PMAs) of medical devices
Council for International Organizations of Medical Sciences (CIOMS)
CIOMS is an international, non-governmental organization established by the World Health Organization and UNESCO. CIOMS works to facilitate and promote international biomedical science activities. One publication of particular relevance to international research is International Ethical Guidelines for Biomedical Research Involving Human Subjects.
Family Health International
FHI, a non-profit global health and development organization, offers a number of publications that can be downloaded from their Web site. Of particular note are the Research Ethics Training Curriculum for Scientists, the Research Ethics Training Curriculum for Community Representatives, and the Communications Handbook for Clinical Trials.
National Institutes of Health (NIH)
The NIH’s Bioethics Resources on the Web provides a compilation of links to information on bioethical issues, including international human subjects research.
Nuffield Council on Bioethics
The Nuffield Council on Bioethics is an independent body that examines and reports on ethical issues in biology and medicine. The council’s project Research in Developing Countries resulted in a report and follow up discussion paper on the ethics of health research in developing countries.
United Nations Education, Scientific, and Cultural Organization (UNESCO)
UNESCO’s Ethics of Science and Technology program works to assist Member States in developing sound policies and decisions on ethical issues in science and technology and released the International Declaration of Bioethics and Human Rights in 2005. Of particular note are two capacity-building initiatives: Assisting Bioethics Committee and Ethics Education Program. UNESCO’s Global Ethics Observatory (GEObs) is a set of databases contains information on all currently available ethics resources worldwide.
U.S. Presidential Commission for the Study of Bioethical Issues
The commission advises the President on bioethical issues that may emerge from advances in biomedicine and related areas of science and technology and works with the goal of identifying and promoting policies and practices that ensure scientific research, health care delivery, and technological innovation are conducted in an ethically responsible manner.
World Health Organization (WHO)
The WHO’s Ethics and Health Initiative examines a range of bioethical issues—such as access to health services, organ transplantation, and research with humans—raised by WHO’s own activities. A number of publications on ethics and health—including research—can be downloaded from the publications page. To learn about bioethics activities in a specific WHO region, click on the appropriate link below.
World Medical Association (WMA)
The WMA is an international organization of over 95 medical associations. While it is best known for the Declaration of Helsinki, WMA has published a number of guidelines and reports that address standards in medical education, ethics, and science.