Transcript Committee on Human Research Processes Clinical Translational Research Fellowship Program Curriculum Core Objective • Clarify Committee on Human Research (CHR) processes for your study. – – – – Is it research? Is.

Committee on Human
Research Processes
Clinical Translational Research Fellowship Program
Curriculum Core
Objective
• Clarify Committee on Human
Research (CHR) processes for
your study.
–
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–
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Is it research?
Is it human subjects?
Type of review?
Resources
CHR Processes
• UCSF Human Research Protection
Training and Education Resources
– http://www.research.ucsf.edu/chr/Train/chrTrain.as
p#Basic
Prior to moving forward with your study
• Determine
– whether your study is a research study
– whether your study involves a human subject
– Type of CHR review
What is research?
• Research is the “systematic investigation,
including research development, testing and
evaluation, designed to develop or contribute
to generalizable knowledge.”
– http://www.research.ucsf.edu/chr/about/chrfaq.
asp
Is my quality improvement project research?
• If you are collecting data to disseminate/apply
to other populations, then generally CHR
approval is required.
• If you are conducting a quality improvement
project, CHR approval is not required.
• See website/decision algorithm for greater
detail:
– http://www.research.ucsf.edu/chr/Apply/RefGuide.asp
– http://www.research.ucsf.edu/chr/Guide/HSDecisTree.pdf
Definition of Human Subjects
• 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 [45 CFR 46.102(f)]
• If your study is a research study involving a
human subject, your study requires a CHR
approval.
Do students need to submit their proposal for
CHR review and approval?
• The Committee on Human Research (CHR)
must review all research that involve human
subjects performed by UCSF faculty, staff, or
students.
– http://www.research.ucsf.edu/chr/about/chrfaq.
asp
Types of CHR Review
• Full committee, expedited, and exempt are
three types of CHR review; the type of review
is based on the level of risk in your study
• Minimal risk is the probability and magnitude
of harm or discomfort anticipated in the
research. Minimal risks are not greater than
those ordinarily encountered in daily life or
during the performance of routine physical or
psychological examinations or tests.
Types of CHR Review
• Studies with greater than minimal risk
→ Full CHR review
Examples: randomized studies, studies using an
investigational drug
• Studies with no greater than minimal risk
→ Expedited or exempt CHR review
• For more details, see
– http://www.research.ucsf.edu/chr/Guide/AppCom
mRevGI.asp#Type
Do you need to do the on-line Collaborative
Institutional Training Initiative (CITI) Training?
• Yes, if you are “key personnel.”
• Key personnel are defined as:
• “…all individuals who contribute in a substantive way to the scientific
development or execution of the study at or on behalf of UCSF or
affiliated institutions. Typically, these individuals have doctoral or other
professional degrees, although other individuals should be included if
their involvement meets the definition of Key Personnel. In particular,
investigators and staff involved in obtaining informed consent are
considered Key Personnel.”
http://www.research.ucsf.edu/chr/Train/CITI_FAQ.asp#key
Prior to moving forward with your study
• If your research proposal is linked to an
existing research study, ask your mentor to
see their CHR documents.
– Carefully review the sections on risks, benefits
and vulnerable groups
– Review the consent forms.
• Will your study pose any new risks? Will new
tools be administered to subjects?
Prior to moving forward with your study
Can a minor modification to an existing
protocol be submitted?
or,
Do you need to submit a new application?
Where to go for help
• UCSF Human Research Protection Program
– http://www.research.ucsf.edu/chr/
• Your mentor
• CTSI Ethics Consultation
– http://ctsi.ucsf.edu/consult
Summary
• Research involving a human subject requires
CHR approval
• Many resources are available at UCSF for the
ethical conduct of research
CTRFP* Curriculum Core
• Rebecca Jackson MD, School of Medicine
• Barbara J. Burgel, RN, PhD, School of
Nursing
• George Sawaya MD, School of Medicine
• Susan Hyde DDS, MPH, PhD, School of
Dentistry
• Jaekyu Shin, PharmD, School of Pharmacy
• Joel Palefsky MD, School of Medicine
* Clinical Translational Research Fellowship Program