The CTSTP is a 6-month certificate program that provides training in clinical and translational research. Sessions are presented by experienced clinical and translational researchers or individuals with special expertise in grants and contracts and regulatory issues across the CCTS Partner Network. CTSTP serves as a catalytic career launch for investigators at multiple stages and in a variety of roles, leading to new professional appointments, successful extramural funding, promotion and tenure.Course content represents the following modules: Clinical Trials, Epidemiology, Biostatistics, Ethics, Qualitative Research, Outcomes Research, Dissemination of Results, and AI and Machine Learning.
The CTSTP course can be taken for a certificate of completion or as the course EPI 680: Topics in Clinical Research.
WHO: Faculty, investigators at multiple stages, those interested in an academic career in research
WHEN: Wednesdays, 8-10 AM; January to June (starting Jan. 8, 2025)
WHERE: Online via Zoom
Applications are due by 5 PM (Central) on Friday, November 15, 2024
For more information about CTSTP, contact
For a full list of CCTS events, visit our upcoming eventsrecurring events page.
Subscribe to the CCTS Digest to stay informed of upcoming learning opportunities.
Ethics Research Oversight in the US; Current Practice and its Discontents:
The Topic of the January 31, 2018 ethics training session is ethics research oversight in the U.S. The goals are to understand the basics of the system of IRB oversight to which human subjects researchers are presently subject and to consider the pros and cons of that system. We will focus on the nuts and bolts of the present system and on a research mishap that led to considerable soul-searching about ethic research oversight, the death of Jesse Gelsinger in a University of Pennsylvania phase I gene transfer trial in 1999.
My hope is to conduct the session primarily as a discussion rather than as a lecture. Below are some questions for discussion and some resources to inform your thoughts about the questions. I recommend you look at the short slide presentations and consider how you might respond to the questions; I don’t expect you to read all the additional references but you may wish to dip into them to illuminate your responses to particular questions.
Questions for discussion will include:
In regard to the IRB system of research oversight:
In regard to the Penn gene transfer study:
Resources
Presentations
Slide presentation; “Research oversight; ethics and practice”
Slide presentation; “The Gelsinger Case”
Basic Background
McCarthy, Charles R. “The Origins and Policies that Govern Institutional Review Boards” in The Oxford Textbook of Clinical Research Ethics (Oxford University Press, 2008)
Steinbrook, Robert. “The Gelsinger Case” in The Oxford Textbook of Clinical Research Ethics (Oxford University Press, 2008)
Early Academic Skepticism
McDermott, W. “Opening Remarks” from “The Changing Mores of Biomedical Research; A Colloquium on Ethical Dilemmas from Medical Advances” Annals of Internal Medicine 1967;67 Suppl 7(3) Part II: 39-42.
Ingelfinger F. “The Unethical in Medical Ethics” Annals of Internal Medicine 1975;83: 264-69.
(Especially the section titled “bureaucracy of ethics”)
Criticism of the current system; it's too onerous
Whitney, Simon N. "The Python's Embrace: Clinical Research Regulation by Institutional Review Boards" Pediatrics 129.3 (2012): 576-578.
This piece reads ironically in light of what was to happen in 2013, when the OHRP issued its determination letter regarding the SUPPORT study. If you’re aware of the SUPPORT controversy, think about the author’s rationale for criticizing informed consent requirements in this study.
Criticism of the current system; it's insufficiently rigorous
Gelsinger, Paul, and Adil E. Shamoo. "Eight Years after Jesse's Death, Are Human Research Subjects Any Safer?" Hastings Center Report 38.2 (2008): 25-27.
The CCTS Training Academy promotes the continuous development of skills and knowledge for learners at all career stages in support of a vibrant, innovative, multidisciplinary research workforce to improve human health and health care. In support of career development, the CCTS offers short-term "immersion" opportunities or mini-sabbaticals. Questions? Contact the CCTS.
Take a Mini-Sabbatical and Boost Your Research
Our virtual training hub includes faculty focused on research, education, training and workforce development from all Partner sites. A new element in our collaboration is the sharing of training and research resources and experiences via mini-sabbaticals, exchanges and short-term "immersion" opportunities. Such opportunities are available at each institution within the CCTS Partner Network. The CCTS is also willing to host immersion/experiential learning at CTSA Consortium sites.
Each mini-sabbatical is designed to fulfill objectives based on the applicant's previous knowledge, experience, specific interests, and research and/or training goals. Most can be completed in less than a week. Applicants should contact the CCTS at
The request for applications for mini-sabbaticals is now live online. Learn more about the program by reading the request for applications. Also, browse sample projects.
- Describe their research as well as the contribution the mini-sabbatical is expected to make. (Please limit this description to no more than one page.)
- Provide a budget with justification
- Provide a biosketch or CV
Awards are capped at $2,000 per year, with up to $1,000 coming from the CCTS and matching funds coming from the Partner institution or, for those at the UAB Hub, a local source. Funds may be used to cover costs associated with travel and participation in the experiences.
Please plan to submit the application at least 8 weeks in advance of the desired visit time-frame.
SEQUIN Project
A joint project of four CTSA Hubs: UAB, UMass Medical School, NYU School of Medicine, and University of Rochester Medical Center (in its capacity as the CLIC Coordinating Center). SEQUIN Project, which stands for multi-CTSA mini-Sabbatical Evaluation and QUality ImprovemeNt, aims to evaluate and expand the use of mini-sabbaticals, immersion learning experiences ranging from 2-120 days, by the translational science workforce.
In addition to offering best practices to serve as a roadmap for the most effective mini-sabbatical programs, the SEQUIN Project also provides a living database to consolidate available opportunities. The CLIC site houses this database, allowing CTSA Program members to easily stay up to date right within the site. CCTS offers travel support to our investigators who wish to learn a new tool or research technique via a mini-sabbatical.
Highlighted herein:
· Defining "misconduct"
· Misconduct beyond the "FFP" definition
· Who engages in misconduct (and who doesn't)
· Causal factors of misconduct
· Objectives and audiences of RCR training programs
· The efficacy of RCR training programs
This seminar series convenes researchers and trainees interested in a broad spectrum of Health Disparities, Aging and Outcomes and Effectiveness Research. Speakers are invited to share research methods that may be applied to other areas of research, and secondary dataset information and availability, as well as analyses, results from the data, and other tips and techniques applicable to health services and health disparities research.
Goals for the overview of secondary data sets available for analysis:
- Present an overview of the dataset and its data elements
- Provide examples of research questions that can be addressed with dataset
- Include participation of junior investigators who have used data (if possible)
- Discuss protocol for access to data and resources for data management/analysis
Goals for the HSR/OER methods in current research projects, grants, and/or publications
- Present work with detail on research methods that may be applied to other areas of research
- Focus on scientific methods with attention for potential cross-pollination in terms of application/adaptation of methods and/or new collaboration
- Discuss research methods and tools with the potential for wider implementation. Ex: How can x technology or approach that has been used to successful study disease y in z setting translate or be applied to study another disease in another setting?
WHEN: These seminars are on the first Thursday of every month at noon; speakers begin presenting at noon (11:45am-1:15pm CT)
WHAT TO BRING: Speakers begin at noon with a light lunch served or you may bring your own. RSVP!
WHERE: UAB – Medical Towers 634 and by video conference connection at your office by request.
RSVP:
The seminars are broadcast via video conference (VC) to scholars and researchers at partnering institutions including Morehouse School of Medicine, Tuskegee University, Jackson State University, Creighton University, and the University of Alabama, and others. Individuals can connect to their own computers through VC software installation and a webcam.
For a full list of CCTS events, visit our upcoming events and recurring events page. Subscribe to the CCTS Digest to stay informed about upcoming learning opportunities.
