Review ArticleREVIEWS AND CONTEMPORARY UPDATES
Open Access
How to Determine if a Project Is Human Subjects Research, a Quality Improvement Project, or Both
Pat F. Bass and John W. Maloy
Ochsner Journal March 2020, 20 (1) 56-61; DOI: https://doi.org/10.31486/toj.19.0087
Pat F. Bass III
1Office of Research, Louisiana State University Health Sciences Center Shreveport, Shreveport, LA
MD, MS, MPHJohn W. Maloy
2Assistant Vice Chancellor for Research Management, Louisiana State University Health Sciences Center Shreveport, Shreveport, LA
JDREFERENCES
- 1.↵Protection of human subjects. 45 CFR §46. US Department of Health and Human Services. www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML. Accessed August 20, 2019.
- 2.↵
- Morris PE,
- Dracup K.
- 3.Quality improvement activities FAQs. How does HHS view quality improvement activities in relation to the regulations for human research subject protections? Office for Human Research Protections. US Department of Health and Human Services. www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/quality-improvement-activities/index.html. Accessed August 20, 2019.
- 4.↵
- Lynn J,
- Baily MA,
- Bottrell M,
- et al.
- 5.↵Acquisition, protection, and disclosure of quality improvement organization information. 42 CFR §480.101. US Department of Health and Human Services. www.ecfr.gov/cgi-bin/text-idx?SID=3301ec960cd60d1c3e4ff8b10519bdce&mc=true&node=se42.4.480_1101&rgn=div8. Accessed August 20, 2019.
- 6.↵
- 7.↵
- 8.↵Human subject regulations decision charts. Office for Human Research Protections. US Department of Health and Human Services. www.hhs.gov/ohrp/regulations-and-policy/decision-charts/index.html#c2. Published February 16, 2016. Accessed November 7, 2019.
- 9.
- Grady C
- 10.↵Ethical, legal and regulatory framework for human subjects research. In: Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: National Academies Press; 2016:153-170. www.nap.edu/catalog/21824/optimizing-the-nations-investment-in-academic-research-a-new-regulatory. Accessed August 20, 2019.
- 11.↵
In this issue
How to Determine if a Project Is Human Subjects Research, a Quality Improvement Project, or Both
Pat F. Bass, John W. Maloy
Ochsner Journal Mar 2020, 20 (1) 56-61; DOI: 10.31486/toj.19.0087
Jump to section
- Article
- Abstract
- INTRODUCTION
- HUMAN SUBJECTS RESEARCH DEFINED
- QUALITY IMPROVEMENT DEFINED
- DISTINGUISHING BETWEEN HUMAN SUBJECTS RESEARCH AND QUALITY IMPROVEMENT PROJECTS
- PROJECTS THAT ARE BOTH QUALITY IMPROVEMENT AND HUMAN SUBJECTS RESEARCH
- PROJECTS THAT BEGIN AS QUALITY IMPROVEMENT BUT BECOME HUMAN SUBJECTS RESEARCH
- QUESTIONS TO HELP WITH THE DECISION
- CONCLUSION
- ACKNOWLEDGMENTS
- REFERENCES
- Figures & Data
- References
- Info & Metrics
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