1. Distinguishing Clinical Practice and Quality Improvement
from Research Parker Nolen, MBA CIP Vince Green, MHA Priscilla
Keith, JD March 20, 2014
2. What is a Human Subject? What is Research? When is IRB
review required? Is it Clinical Practice or Research? How do I know
if I am conducting Research? What is the risk of Rogue Research?
QI/QA activities are Do QI/QA and Research overlap? Examples
Contact Information & Questions Overview 2
3. 45 CFR 46.102(f) defines a human subject as a living
individual about whom an investigator (whether professional or
student) conducting research obtains (1) data through intervention
or interaction with the individual, or (2) identifiable private
information. What is a Human Subject? 3
4. 45 CFR 46.102(d) defines research as a systematic
investigation, including research development, testing and
evaluation, designed to develop or contribute to generalizable
knowledge. What is research? 4
5. As a rule 5 HUMAN SUBJECTS GENERALIZABLE KNOWLEDGE IRB
REVIEW
6. Clinical Practice or Clinical Research? 6 Clinical Practice
Clinical Research No Protocol Specific Protocol All patients Only
some patients Documentation Much more documentation required Not
intended to publish/submit to FDA Publication or submission to FDA
is goal Billable to insurance May not be billable to insurance
HIPAA Authorization required Additional HIPAA Authorization
required Activities requiring IRB review
7. You are using a specific protocol to treat people The
protocol may or may not come from a Sponsor The protocol is used
only on some people with the same condition Documentation
requirements are more intense You plan to publish your treatment
results The treatment may not be billable to insurance How do I
know Im conducting research? 7 In these situations, IRB review is
required If youre not sure, contact the IRB Office for
guidance
8. Individual practitioners may be subject to civil and
criminal penalties or exclusion from the Medicare/Medicaid
programs. Community Health Network may also be subject to fines and
exclusion from these programs. Community Health Network may take
disciplinary action against non-compliant individuals. What is the
risk of Rogue Research? 8
9. Aimed at improving local systems of care or improving the
performance of institutional practice Designed to bring about
immediate improvements in health care delivery Intended to compare
a program/process/system to an established set of standards such as
standard of care, recommended practice guidelines, or other
benchmarks QI/QA Activities are: 9
10. Do QI/QA and Research Overlap ? 10 QI/QA Activity Research
Activity Activities requiring IRB review
11. QI/QA or Research? 11 Research QI/QA Purpose To test a
hypothesis OR to establish clinical practice standards where none
are already accepted To assess or improve a process, program, or
system OR to improve performance as judged by established/ accepted
standards Starting Point To answer a question or test a hypothesis
To improve performance Benefits Knowledge sought may or may not
benefit current subjects, but may benefit future patients Knowledge
sought directly benefits a process/ program/ system, and may or may
not directly benefit patients Risks/Burdens May put subjects at
risk Does not increase risk to patients, with exception of possible
privacy/confidentiality concerns Data Collection Systematic data
collection Systematic data collection End Point Answer a research
question Improve a program/ process/system Testing/Analysis
Statistically prove or disprove hypothesis Compare a
program/process/system to an established set of standards
