Institutional Review Board (IRB) Challenges in QI & Research
The AHRQ’s Practice-Based Research Network Resource Center hosted a webinar on Wednesday, May 27th from 1:30pm-3:00pm EST. Presenters discussed (1) how to distinguish between clinical research and quality improvement (QI), (2) how to identify the need for IRB approval in the grey zone between QI and clinical research, and (3) how bulleted fact sheets and Q&A sessions for patients enrolled in clinical trials can be applied to quality improvement efforts.
This Live series activity, AHRQ Practice-Based Research Network Resource Center National Webinars, from 09/10/2014 - 09/10/2015, has been reviewed and is acceptable for credit by the American Academy of Family Physicians. Physicians should claim only the credit commensurate with the extent of their participation in the activity. This webinar has been approved for 1.25 elective CME credit(s).
Moderator: Rebecca Roper, MS, MPH, Director, Practice-Based Research Network Initiative, Agency for Healthcare Research and Quality.
Critical Reference Material:
- Quality Improvement vs Research. Retrieved from https://irb.research.chop.edu/quality-improvement-vs-research
- Nosowsky, R. Quality Improvement or Research Worksheet. Quality Improvement or Research worksheet (PDF - 1.11 MB)
- What is research? Retrieved from https://irb.research.chop.edu/what-research
- Who is a Human Subject? Retrieved from https://irb.research.chop.edu/who-human-subject
- Ogrinc, G., Nelson, W. A., Adams, S. M., & O'Hara, A. E. (2012). An instrument to differentiate between clinical research and quality improvement. IRB, 35(5), 1-8.
- Kass, N. E., Taylor, H. A., Ali, J., Hallez, K., & Chaisson, L. (2014). A pilot study of simple interventions to improve informed consent in clinical research: Feasibility, approach, and results. Clinical Trials, 1740774514560831.
- Starr, S. R., Kautz, J. M., Sorita, A., Thompson, K. M., Reed, D. A., Porter, B. L., ... & Ting, H. H. (2015). Quality Improvement Education for Health Professionals A Systematic Review. American Journal of Medical Quality, 1062860614566445.
- Whicher, D. M., Kass, N. E., Audera-Lopez, C., Butt, M., Jauregui, I. L., Harris, K., ... & Saxena, A. (2014). Ethical Issues in Patient Safety Research: A Systematic Review of the Literature. Journal of patient safety.
- See the chapter about vulnerability on pages 85-93 (PDF - 2.07 MB) of a 2001 National Bioethics Advisory Committee Report (see full citation below).
- National Bioethics Advisory Commission. Ethical and Policy Issues in Research Involving Human Participants-Volume 1 Report and Recommendations of the National Bioethics Advisory Commission. Bethesda, MD: National Bioethics Advisory Commission; 2001.
- Additional resources to help differentiate between quality improvement and research on The Children’s Hospital of Philadelphia (CHOP)’s IRB website
- The AHRQ PBRN Resource Center Webinar Strategies to Support Cooperation of Multiple Organizations’ Institutional Review Boards (IRBs)
- Presentation Slides (PDF - 3,574 KB)