The UC San Diego Research Ethics Program, as part of the Center for Clinical Research, offers five major services: Education, Consultation, Public Engagement, Policy Development, and Research.
The Research Ethics Program regularly offers a wide variety of courses, workshops, and seminars in general research ethics, plus more specialized topics including international research ethics, stem cell research ethics, and survival skills in academia. These courses, as well as train-the-trainer programs for faculty, are open to all CTRI researchers. More information can be found at: http://ethics.ucsd.edu/courses
Any individual or review group associated with the CTRI may request consultation with Research Ethics Program faculty. Research ethics issues include, but are not limited to, the conduct of research, interactions among researchers, and responsibilities to research subjects or society. The purpose of consultation is to clarify ethical challenges, possible courses of action, and strategies for mitigating future challenges. Consultations are usually advisory only.
The following categories are intended only as examples of possible topics for consults. The items listed are based on informal communication with staff of the NIH Bioethics Consultation Service, and on review of the NIH bioethics website.
Responsibilities to society
Global responsibilities of researchers
Recruitment and protections for research subjects
Research involving vulnerable populations
Informed consent documents and processes
Research Subject Advocacy
Balancing clinical care and clinical research
Adverse event reporting
Terminating clinical trials
Conflicts of interest
Credit and authorship
3. Public Engagement
The highest ethical standards in research depend on effective engagement with the public, including education and outreach. Ethics faculty are experienced in staging public forums for diverse purposes, including promoting understanding of science and ethics, to fostering informed recruitment of research subjects, and optimizing the ethical and scientific design of clinical research studies. Public forums can be valuable adjuncts to research by addressing challenging issues such as working with vulnerable populations, subject recruitment and informed consent. Ethics faculty also have a role in communicating with the public through interviews with journalists and publishing op-ed pieces. Opportunities for public engagement are facilitated by the overlapping roles of the UC San Diego Research Ethics Program with San Diego's Center for Ethics in Science and Technology and the San Diego Research Ethics Consortium.
4. Policy Development
Assistance is provided to research groups, departments, the CTRI, and the University in the development of research ethics policies, guidelines, or procedures. The assistance offered includes, but is not limited to, facilitation, writing, or providing models or suggestions.
Examples of Policies or Guidelines:
Policies for disclosure of financial conflicts of interest to collaborators and research subjects
Guidelines for determining authorship credit and order of authorship
Procedures for raising questions or reporting possible misconduct
Record-keeping, obtaining informed consent
CTRI research is strengthened by research activities to better understand and address ethical challenges in education, consultation, public engagement, and policy development. Ongoing research in research ethics includes a focus on the standards of responsible conduct of research, and the goals and effectiveness of research ethics education. Ethics faculty work with CTRI research faculty on grant writing and conducting research on ethical issues that are either central to or a part of clinical and translational research projects. In addition, ethics faculty can assist in the planning and writing of any required sections of grant proposals, particularly career development and fellowship awards, that require plans for research ethics education or addressing ethical challenges.