Education & Training
Training and educating innovative and effective translational researchers and staff requires helping them develop the ability to identify ethical challenges and address them, or get help. In recognition of the need for translational researchers to commit themselves to ethical conduct of research, the NIH requires trainees to receive education in the responsible conduct of research (RCR). BSAP provides RCR training for NIH trainees in a number of settings, for instance through a course offered each Fall term – G504, Research Ethics – that satisfies the didactic portion of the NIH requirement. Further, BSAP faculty help applicants for K-series grants formulate and then carry out extended training in RCR that spans the period of the award.
Seminar Series in Research Ethics
n collaboration with Children’s Health Services Research and the Department of Pediatrics, BSAP created the Pediatric Research Ethics Seminar Series (PRESS) in 2014. PRESS meets five times per year to cover topics in research ethics relevant to fellows and other trainees in pediatrics. Fellows present on topics relevant to their own studies, partnering with a BSAP faculty member. PRESS has dealt with cutting edge ethics topics in pediatrics, including:
- Confidentiality, consent and big-data research.
- Pediatric risk and comparative effectiveness research.
- Clinical trials in neonates.
- Undue influence in pediatric global health research.
This seminar series has multiple advantages. It allows trainees to continue their education and involvement in research ethics and responsible conduct of research, specifically tailored to their research interests and projects, and it allows them to transition from learners to active teachers and researchers in this area. The existence of the seminar series also allows students and fellows preparing K awards, or pediatric programs applying for F-level or T-level awards, to reference PRESS as a way that they or other trainees will receive continued training in RCR, beyond the didactic component. This “module” can be easily plugged into upcoming applications and then can be utilized for funded proposals. We have held PRESS four or more times per year high ratings for quality.
Courses in Responsible Conduct of Translational Research:
As an alternative to G504, the BSAP faculty recently created GRDM 506, Responsible Conduct of Translational Research, a one-credit course that has now been approved to be offered for the first time in Spring 2017.
GRDM 506 satisfies the need for a course to be offered at a different time and term from G504. In addition, the one-credit GRDM 506 may be more appropriate than the two- or three-credit G504 for trainees who are not pursuing a graduate degree or do not need the credits in ethics towards their degree. Finally, GRDM 506 will focus on topics in translational and precision health research, fitting the focus of many CTSI trainees. We anticipate that G504 and GRDM 506 will continue to be offered each year to provide students with a choice for how to complete the didactic component of the RCR requirement.
Translational Research Ethics: Applied Topics (TREATs)
The Bioethics and Subject Advocacy Program (BSAP) of the Indiana Clinical and Translational Sciences Institute (CTSI) is initiating a series of monthly presentations about ethics issues in translational research. The presentations – dubbed Translational Research Ethics: Applied Topics (TREATs) – will be 30 minutes long, with Power point slides, followed by questions and answers. TREATs will be held once a month, will be available for live streaming, and will be archived on the webpage of the BSAP program.
May 19: "Is it Ethical to Exclude People Who Can’t Speak English from Participating in a Study?" presented by Peter H. Schwartz MD, PhD, 12:00 - 1:00 p.m. - HITS 3139 (click link above and play slide show to hear presentation)
June 16: "Ethical Considerations in the Disclosure of Incidental Findings in Research (click for recording)" presented Kimberly A. Quaid, PhD, 12:00 - 1:00 p.m. - HITS 3139
July 21: "When Can A Minor Consent to Research?" (click here for recording) presented by Mary Ott, MD, MA, 12:00 - 1:00 p.m. - HITS 3139 - click here for summary document
August 11: "Data Safety Committee: What Are They And When Are They Needed? presented by Edward Liechty, MD - 12:00 - 1:00 p.m.
September 29 - "Does It Pay to Partner With Medical Device Companies? Considering COI" presented by Andrew O. Brightman, 12:00 - 1:00 p.m. - HITS 3139
October 27 - "The Program of Re-Consent in Pediatrict Biobanking" presented by Jane A. Hartsock, J.D., 1:00 - 2:00 p.m. - HITS 31319