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
- 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 research entails.
- 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 resource-poor setting.
- Review boards at the international site may not have extensive experience in research ethics and may benefit from training and mentorship.
- 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.
: 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:
- 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 publications.
- 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.