Institutional Review Board and YOU!. Choya Washington Division of Research Affairs Graduate & Research Affairs San Diego State University. Overview. What is the IRB/ Why is it needed? One of the Important Historical Events & how it can apply to what you may be doing The IRB and You.
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Institutional Review Board and YOU!
Division of Research Affairs
Graduate & Research Affairs
San Diego State University
YOU: A systematic investigation designed to develop or contribute to generalizable knowledge.. (hypothesis or research question to answer)_
(Helpful question for YOU, is the data to be collected specific to an individual)
Minimal Risk Expedited
Greater than Full Committee
Risk level Reviewers required Review level
Full Committee: greater than minimal risk
Deadline dates do not apply
the study would not solicit informationfrom a participant that, if disclosed, would reasonably place the subject at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
Anonymous online surveys of Counselors, Teaching Staff and Advisors -yes/no questions about current policies and if they think they’re working
Does the study solicit informationfrom a participant that, if disclosed, would place the subject at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
You- Proper access to a person’s information for research purposes? Sending out research information on your behalf.
FERPA Compliant-The Family Educational Rights and Privacy Act (FERPA). Generally, schools must have written permission from the parent or eligible student in order to release any information from a student's education record.
Informal Consent (Exempt)
Formal Informed Consent (Full Committee and Expedited)- these can be modified- English as a 2nd language, low literacy, etc.
Save yourself time and stress… use SDSU templates!
You- These forms can be modified to fit your population (low literacy, international, online, conversational, etc..)
Children in research
Parental Permission forms
Apart of data collection, access to links, contains links(Expedited)
Usually best to contact IRB prior to submitting or submit a questionnaire to email@example.com. The questionnaire can be found at: https://newscenter.sdsu.edu/researchaffairs/hrpp.aspx
If you have other affiliations…
Joint Students-CGU-see the next slide
If you will be conducting a study through another institution, you must receive their IRB approval before submitting to the SDSU IRB.
SDSU- CGU Joint Review
Ensure the Investigator Experience Section of the protocol also includes- your CGU co-chair's name and email address.
Not just a written form, but an on-going open discussion of participant rights and study details. Think about this especially with studies that include multiple data collection points (i.e. Pre and Post), time between different tasks, description of risks and your management plan
Inadequate consent forms-Language should be understandable to the audience it is written for
Inconsistent with protocol
Adequate Details so they are clear about whether or not to participate.-Consistent with the protocol.
How to use vIRB
Link to the tutorial
Link to Guidebook
Faculty Assurance forms-You (Have your faculty sponsor READ and APPROVE your protocol and supporting documents before submitting!!!). Protocol cannot be reviewed without this signed form.
Go to our website for tips
List yourself as the Principal Investigator (PI)
List your Thesis Chair (Masters) or Faculty Sponsor (Doctoral) as the Co-I
Office phone number
Upload all applicable documents:
Letters of Authorization
Informed Consent Forms
Grant Narrative (if funded)
The current vIRB system is most compatible with documents that are .doc (97-2003 document) and not .docx. Also consents must be submitted as Word documents.
IRB Contact Information
Phone: (619) 594-6622
Office: Gateway Center-3505
Office Hours online at: https://newscenter.sdsu.edu/researchaffairs/hrpp.aspx