Human Subject Research and JIT Process at COMIRB
Human Subject
Research and JITs
CAT SUTHERLAND
ASSISTANT DIRECTOR, COMIRB
Topics
Human Subject Research
Exempt Categories
Secondary Research
JIT Process
Human Subject Research
•
a living person about whom an investigator
obtains
–
data through intervention and/or interaction
•
e.g., surveys, interviews, drug studies
–
identifiable private information
•
e.g., medical record review
Exempt
1. Education Research
Differences in curriculum, teaching styles, etc.
2. Surveys, interviews
3. Benign Behavioral Interventions
Playing music during a computer test vs. no music
4. Secondary Research
Study of previously collected data or samples
Not collected for the purposes of this research
Secondary Research
Gets tricky
If an investigator on current grant was involved in initial data or
sample collection, it is Human Subject Research.
Ability to access identifiers – whether or not they intend to
Exempt Category 4
If not involved, it might be non-Human Subject Research.
JIT Process
Pre-award sends me an email with the grant and any IRB approvals
that you have submitted to them
I go into the InfoEd submission and check that the grant is consistent
and is part of the InfoEd submission
If it is, I confirm
If it is not, I will likely email you for more information
This is where we see lots of Secondary Research apps needed.
Sometimes an amendment is needed to add the grant to the study.
Questions and Help
COMIRB@ucdenver.edu
303-724-1055
Catherine.Sutherland@cuanschutz.edu
Explore the world of Human Subject Research and Just-In-Time (JIT) process as explained by Assistant Director Cat Sutherland at COMIRB. Learn about exempt categories, secondary research, grant approvals, and the intricate JIT process. Get insights into education research, surveys, behavioral interventions, and more. Discover the complexities of secondary research and the critical role of investigators in research compliance. For queries and assistance, contact the dedicated team at COMIRB.
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Presentation Transcript
Human Subject Research and JITs CAT SUTHERLAND ASSISTANT DIRECTOR, COMIRB
Topics Human Subject Research Exempt Categories Secondary Research JIT Process
Human Subject Research a living person about whom an investigator obtains data through intervention and/or interaction e.g., surveys, interviews, drug studies identifiable private information e.g., medical record review
Exempt 1. Education Research Differences in curriculum, teaching styles, etc. 2. Surveys, interviews 3. Benign Behavioral Interventions Playing music during a computer test vs. no music 4. Secondary Research Study of previously collected data or samples Not collected for the purposes of this research
Secondary Research Gets tricky If an investigator on current grant was involved in initial data or sample collection, it is Human Subject Research. Ability to access identifiers whether or not they intend to Exempt Category 4 If not involved, it might be non-Human Subject Research.
JIT Process Pre-award sends me an email with the grant and any IRB approvals that you have submitted to them I go into the InfoEd submission and check that the grant is consistent and is part of the InfoEd submission If it is, I confirm If it is not, I will likely email you for more information This is where we see lots of Secondary Research apps needed. Sometimes an amendment is needed to add the grant to the study.
Questions and Help COMIRB@ucdenver.edu 303-724-1055 Catherine.Sutherland@cuanschutz.edu
