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For Researchers

Research Compass

Clinical Trial Activation Roadmap

ACTRI has developed a new roadmap tool to guide Principal Investigators and study team members through the process of activating clinical trials and/ or research studies at UCSD.

This comprehensive tool provides a step-by step approach to this complex process and has the advantage of offering additional resources such as links, notes, request forms, and documents to guide our users in a one-stop-shop.

Whether used as standard operating procedure or for training purposes, this resource is part of the vision of the ACTRI to facilitate research for faculty and study teams at UCSD.

 

 

 

Click the button below to explore the map above and learn about each individual step

Explore the roadmap more 

Types of Research at ACTRI

Basic Research

To develop new treatments for diseases such as cancer, heart disease and diabetes, physician-researchers first need a deep understanding of the molecular and cellular underpinnings of human development and disease. Discoveries made by our basic researchers provide the foundation for advances in the diagnosis, treatment and prevention of disease.

Clinical Research

We conduct hundreds of new clinical trials each year, varying in size from a single researcher looking at a dozen participants to trials that are part of multi-center national studies with several thousand participants. Clinical trials are designed to test the safety and effectiveness of a therapy or new medication when compared to either a placebo or standard treatments.

Translational Research

We foster “bench-to-bedside” research — taking the discoveries gained from the basic sciences and applying them to patient care. Our researchers have access to resources and expertise in study design, compound libraries, drug screening, genomics technologies, biorepository services, bioinformatics, regulatory issues and submissions, and many other capabilities needed to accelerate drug development.

Research Ethics

Research Ethics for ACTRI Education, Training and Career Development

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Education

 
The UC San Diego Research Ethics Program offers a variety of courses, workshops, and seminars. The topics covered are those associated with responsible conduct of research (RCR), which include, for example, conflict of interest, mentor/mentee responsibilities, data management and research subject protections (see: NIH RCR requirements). In addition, education may focus on more specialized topics including, for example, digital health (e.g., artificial intelligence, predictive analytics), gene editing and stem cell research. 

Courses

Scientific Ethics
Formal and informal training in research ethics is an important aspect of the professional development of scientists and engineers. The rules, cultures and disciplinary differences are sometimes obvious and other times nuanced and it is important to know how to navigate and discriminate between hard and fast rules and not so clear conventions. Research ethics education may also be a requirement of a funding agency. This 14-hour course is delivered over 7-sessions and may be used to satisfy a NIH or NSF training requirement; however, whether course completion is used for that purpose is determined by the advisor and/or department.
Ethics and Survival Skills [on hold]
Building Research Integrity and Capacity (BRIC)
Through a partnership with the UC San Diego Research Center for Optimal Digital Ethics in Health (ReCODE Health), researchers have access to instruction developed to increase research literacy among Community Health Workers/Promotores who assist with community and clinic-based research studies. The course is available on-line via: ReCODE Health, BRIC Course
Designing Research for Diversity
Through a partnership with the UC San Diego Research Center for Optimal Digital Ethics in Health (ReCODE Health) and ACTRI, researchers have access to instruction developed to increase awareness when planning to engage under-represented populations in research. This course is offered online and has been adapted for delivery through the CREST program. This course is available through CREST and online: ReCODE Health, Designing Research for Diversity Course
An Interactive Guide for Promotores de Salud/Community Health Workers 
This course is designed to increase research literacy and awareness of ethical research practices among community members involved in academic research. Our target learners are research team members, including Promotores and Community Health Workers, who assist with designing and implementing community and clinic-based health research. Learn more here.

Workshops

Train-the-Trainer
Train-the-trainer workshops are available for faculty who are interested in learning ways to promote ethical and responsible research.
Reproducibility and Rigor
With support from the ACTRI, the Research Ethics Program offers a two-hour workshop module on reproducibility to promote reflection and discussion about fostering reproducible research.
Ethics in Artificial Intelligence and Digital Health
Increasingly, digital tools and strategies are used in biomedical and behavioral research. A 2-hour workshop is available to learn about how pervasive sensors, social media platforms and mobile devices are being used with a focus on the related ethical, legal and social implications associated with “digital health” research.
Ethical Challenges in Research
We offer monthly workshops through the Office of Postdoctoral Scholar Affairs on topics associated with research ethics. See the Office of Postdoctoral Scholar Affairs website.

Teaching/Learning Resources

 

Services 

Consultation
The purpose of consultation is to clarify ethical challenges, possible courses of action, and strategies for mitigating future challenges. Consultations are a pathway to clarifying and resolving disputes, possible misunderstandings, or misconduct in the practice of research. Consultations might focus on regulated areas of research such as conflicts of interest and research subject protections as well as unregulated aspects of research such as collaborations, mentor/mentee relationships and our societal responsibilities.  
Public/Community Engagement
Identifying and confirming best practices with respect to ethical standards in research can benefit from engagement with the public. Research Ethics Program faculty are experienced in staging public forums to promote discussion of complex ethical issues. Unique challenges include, but are not limited to, designing research that will involve vulnerable populations and returning results to research participants. 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 further facilitated by the overlapping roles of the UC San Diego Research Ethics Program, the Institute for Practical Ethics and the San Diego Research Ethics Consortium.
Policy Development
Assistance is available to research groups, schools/departments, the ACTRI, and the University in the development of policies, guidelines, or procedures that support the responsible and ethical conduct of research. The assistance offered includes facilitation, writing, or providing models or suggestions.

 

Research

Research is strengthened through the conduct of both normative analysis and empirical research designed to study and inform best practices. Our research has received extra and intramural support for over 20 years. Current research is carried out with support from the National Institutes of Health, National Science Foundation and Patient Centered Outcomes Research Institute. Areas of interest include: 1- creating/testing decision-making tools to support ethical AI/digital health research; 2- fostering ethical and responsible research environments, 3- informing participant communications including informed consent and return of results, and 4- developing ethically sourced health data repositories.

In addition to leading research programs, our faculty work with ACTRI researchers to support grant proposals. This may include addressing ethical issues proactively and/or developing aims to conduct research on ethical issues that are either central to or a part of clinical and translational research projects. In addition, ethics faculty contribute to required sections of grant proposals, particularly career development and fellowship awards, that require plans for research ethics education or addressing ethical challenges. 

 

Research Ethics Program

 

Translational Science Benefits Model

The ACTRI uses the Translational Science Benefits Model to showcase the potential and demonstrated benefits of the research being conducted at UCSD. 

TSBM BenefitsThe Translational Science Benefits Model is a framework designed to help public health and clinical scientists demonstrate the impact of their work in the real world. The model identifies 30 benefits of clinical and translational science in four domains: ClinicalCommunityEconomic, and Policy.

 Learn more about the TSBM and how it is being used at ACTRI

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