CTD Commitment to the Ethical Conduct of Research
Human Subject Research: In
recent years there have been a number of controversies related to the
conduct of human subject research in resource-poor regions of the world.
Certainly the conduct of research in a resource-poor setting, whether
at a U.S. or an international site, presents a number of unique
challenges that must be considered. While the processes for protection
of human subjects in research conducted in the U.S. are established,
these may not be easily and effectively applied at the international
site and local regulations and practices may differ. Investigators
affiliated with the UTMB Center for Tropical Diseases are committed to
the protection of human subjects in all research. We endeavor to comply
with all applicable U.S., international, and local regulations
governing the safe conduct of research. In addition to the regulations
established by the U.S. and international oversight agencies, we offer
the following recommendations related to international research, which
have been adapted from ““Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries””, May 2001, published by the National Bioethics Advisory Commission:
International Research Collaboration:
Effective collaborative research in tropical diseases often requires
the development of sustainable international partnerships, which may
involve multiple and diverse investigators and institutions. In the
absence of true partnerships, the ethical underpinnings and success of
the research is likely to be compromised. The UTMB Center for Tropical
Diseases seeks to promote strong and ethical international collaborative
partnerships among its UTMB members and their international
collaborators. We propose that ethical and successful international
collaboration is grounded in the following:
- Informed consent is central to the research process and must be
supported as a leading principle by both the U.S. and international
members of the research team.
- The means of informing participants about research and in the
methods of documenting consent in international and collaborative
research should be tailored to the local environment to ensure full
understanding of the research and compliance with all regulations.
- Testing of research participants for understanding of the research
should be incorporated into the enrollment and consent process.
Research should go forward only if participants understand what the
- All research studies concerning any topic, if they involve human subjects, must be reviewed by an appropriate ethics board.
- Studies involving international collaborations need to be reviewed in both/all countries.
- Investigators should ensure that U.S. IRBs understand the local
context and realities of life when research is conducted in a
- Review boards at the international site may not have extensive
experience in research ethics and may benefit from training and
- Collaborative research studies should be monitored at periodic
intervals to ensure that procedures stated in the protocol are being
carried out as planned.
- Capacity building should be integral to any study conducted in a resource-poor setting.
- The study population or community must benefit as a consequence of
the study, and mechanisms to ensure this must be discussed and/or
developed as part of the study proposal.
- Genuine trust-based partnerships between collaborators.
- Development and implementation of research that is beneficial to all collaborating investigators and institutions.
- Mutual commitment to appropriate recognition and professional advancement of all collaborating research personnel.
- Mutual understanding and sharing of values and practices.
- Appropriate and fair allocation of resources needed to conduct the research.
- Mutual understanding and commitment to short- and long-term research goals.
- Clear understanding of the roles of all collaborators and trainees.
- Proactive communication concerning, and commitment to,
appropriate and fair authorship of scientific communications and
- Agreement on mechanisms for data collection, management, sharing, and analysis.
- Mutual commitment to enhancement of scientific capacity of partnering investigators and institutions in resource-poor settings.
- Mutual respect for trainees of both partnering investigators.
- Mutual recognition that key parts of the research team may be working behind to scene to enable the research to be successful.
- Understanding of and adherence to the policies and legal framework of all partnering institutions.