Understanding Human Subjects Research at SDSU

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HUMAN SUBJECTS
RESEARCH
 
The SDSU Institutional Review Board (IRB)
 
Course Outline
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Lesson One: Is it
Research?
 
Is it a systematic investigation?
Is the intent to produce generalizable
knowledge?
The answer must be yes to 
both.
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Lesson One: Is it
Research?
 
The reason that the proposal must it be 
both
a systematic investigation 
and
 designed to
produce generalizable knowledge is:
Systematic investigations are often used in other
endeavors that are 
not research
.
Some examples:
Quality Assessment/Quality Improvement
Case studies
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Lesson One: Is it
Research?
 
It’s generalizable when
The intent is to add to a corpus of theoretical
knowledge within a discipline
In general, it is designed to benefit those other
than the research participants
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Recap of
Lesson One
 
Research is both.
(1)A systematic investigation.
(2) 
Intended
 to produce
generalizable knowledge.
Intent 
to publish (in and of
itself) ≠
 
research.
Generally benefits those other
than the participants
QA/QI or case studies are 
not
research
 (but are often
published as QA/QI projects).
 
Lesson Two: 
Am I Researching H
uman
Subjects?
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Lesson Three: What
are the Common
Pitfalls?
 
No supporting documents
Faculty Advisor not included on the
application.
Inconsistency between the application and the
supporting documents
Not including all required elements of
informed consent
Not including human subjects training
certificates for all study team members
 
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Where do I find SDSU
IRB Information?
 
https://research.sdsu.edu/research_affairs/
human_subjects
o
Link to CITI training
o
Link to general steps to submission
o
Link to SDSU IRB Standards and Practices
o
Submission deadlines
o
Link to forms (e.g. consent templates and
checklists)
 
How do I Submit
My Research
Proposal in InfoEd?
 
Human Subjects Guidebook
Video Guidance on SDSU IRB SharePoint
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Recap
 
Research is defined as both a systematic investigation and
it’s intent is to contribute to generalizable knowledge.
Publication (in and of itself) 
≠ Research
Systematic investigations can be used in QA/QI and case
studies and QA/QI or case studies are not research
Defined human subject
Common submission pitfalls
The SDSU website is where additional information can
be found.
There is both a guidebook and videos to help you
navigate InfoEd
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Who Can I
Contact?
 
Human Subjects Regulations:
Anne Dodge-Schwanz
Pat Gordon
InfoEd or CITI training:
Justin Dean
 
Contact information:
619-594-6622 or irb@sdsu.edu
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THANK YOU!
 
I will now answer questions that were sent to me in
advance as well as and any additional questions.
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Explore the process of conducting human subjects research at SDSU through lessons on recognizing research activities, determining involvement with human subjects, identifying common pitfalls in proposal submissions, finding IRB information, and submitting proposals. Gain insights on the importance of systematic investigation and producing generalizable knowledge, as well as common pitfalls to avoid when submitting research proposals.


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  1. HUMAN SUBJECTS RESEARCH The SDSU Institutional Review Board (IRB)

  2. Course Outline Lesson 2. Lesson 3. Lesson 1. Is It Research? Am I Researching Human Subjects? What are the Common Pitfalls in research proposal submissions? Lesson 4. Lesson 5. Where do I find SDSU IRB Information? How do I submit my proposal in InfoEd?

  3. Lesson One: Is it Research? Is it a systematic investigation? Is the intent to produce generalizable knowledge? The answer must be yes to both.

  4. Lesson One: Is it Research? The reason that the proposal must it be both a systematic investigation and designed to produce generalizable knowledge is: Systematic investigations are often used in other endeavors that are not research. Some examples: Quality Assessment/Quality Improvement Case studies

  5. Lesson One: Is it Research? It s generalizable when The intent is to add to a corpus of theoretical knowledge within a discipline In general, it is designed to benefit those other than the research participants

  6. Recap of Lesson One Research is both. (1)A systematic investigation. (2) Intended to produce generalizable knowledge. Intent to publish (in and of itself) research. Generally benefits those other than the participants QA/QI or case studies are not research (but are often published as QA/QI projects).

  7. Lesson Two: Am I Researching Human Subjects? A living individual about whom an investigator conducting research: Obtains private identifiable information through interaction and uses, studies or analyzes the information Obtains, uses, studies, analyzes, or generates identifiable private information

  8. Lesson Three: What are the Common Pitfalls? No supporting documents Faculty Advisor not included on the application. Inconsistency between the application and the supporting documents Not including all required elements of informed consent Not including human subjects training certificates for all study team members

  9. Where do I find SDSU IRB Information? https://research.sdsu.edu/research_affairs/ human_subjects Link to CITI training o Link to general steps to submission o Link to SDSU IRB Standards and Practices o Submission deadlines o Link to forms (e.g. consent templates and checklists) o

  10. How do I Submit My Research Proposal in InfoEd? Human Subjects Guidebook Video Guidance on SDSU IRB SharePoint

  11. Recap Research is defined as both a systematic investigation and it s intent is to contribute to generalizable knowledge. Publication (in and of itself) Research Systematic investigations can be used in QA/QI and case studies and QA/QI or case studies are not research Defined human subject Common submission pitfalls The SDSU website is where additional information can be found. There is both a guidebook and videos to help you navigate InfoEd

  12. Who Can I Contact? Human Subjects Regulations: Anne Dodge-Schwanz Pat Gordon InfoEd or CITI training: Justin Dean Contact information: 619-594-6622 or irb@sdsu.edu

  13. THANK YOU! I will now answer questions that were sent to me in advance as well as and any additional questions.

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