IRB APPLICATION DESCRIPTION OF RESEARCH OR TRAINING PROJECT

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IRB APPLICATION
DESCRIPTION OF RESEARCH OR TRAINING PROJECT
Instructions to Principal Investigator
To assist the IRB with your request, please complete this form, attach appropriate documents, and
return to the IRB Coordinator, Ms. Stephanie Hurt at [email protected] Complete each section and
answer any specified questions. If a certain section or question is not relevant to your protocol, do not
leave blank; type in “Not Applicable.” For more information, please see the IRB Submission Guide for
current policies and procedures.
Note that this form is intended to be completed online. The form fields appear small, but will expand
to fit all information entered in.
PI Name
Title of Protocol
Brief Summary / Abstract
Specific Hypotheses
Subject Population(s)
Please provide background information such as gender, age, clinical condition, and other relevant
characteristics.
Study Procedure
What are the proposed procedures or interventions? Please describe all.
Application for Approval of Human Research
VCOM Institutional Review Board
Form Updated 3/21/2016
Page 2 of 4
How many subjects will be recruited?
How will the selection process be done?
Describe randomization (or other method for intervention and control groups).
What are the procedures and methodologies? Please describe in detail.
Attach copies of any questionnaires, tests, instruments, etc. to end of this form.
How will the data obtained be utilized to test the proposed hypotheses?
How was the Estimated Number of Subjects Selected?
Will Studying this Number Result in Definitive Answers to Major Research Questions?
Investigator Experience
Cite your experience with this type of research. List Co-Investigators and indicate their relevant
experience.
Benefits or Advantages
Outline possible direct and indirect benefits or advantages the proposed study may provide to an
individual subject, group of subjects, or society. If there are no direct benefits to individuals, clearly
state this up front. Note: Money is not considered a benefit.
Risks, Discomfort and Inconveniences
Protection for Subjects
Describe measures to protect subjects from and minimize possible risk of harm, discomfort, or
inconvenience.
Conflict of Interest
Is there any conflict of interest for the PI or other study personnel?
Application for Approval of Human Research
VCOM Institutional Review Board
Form Updated 3/21/2016
Page 3 of 4
Privacy and Confidentiality
At what stage will identifiers be removed from the data?
If identifiers must be retained, explain why.
When will the research data be destroyed?
If data will not be destroyed until the end of the study, describe where and in what format and for how
long it will be stored.
How might you use stored human material in the future, and how would you obtain the subjects’
permission for future use of their data? How and when will the human material be destroyed?
Are any of your data sources covered entities under HIPAA? If so, please identify the institution and
explain what arrangements have been made to comply with the HIPAA Privacy Rule in order to access
subject’s protected health information.
(Please see http://privacyruleandresearch.nih.gov/pr_08.asp for information on protected health information.
Subject Recruitment
Explain all procedures in detail.
Informed Consent
Explain this process in detail.
Use of Study Results
Explain how study results will be used. Will the results be given to subjects or added to their medical
records?
Alternatives to Joining Study
Explain any appropriate alternatives to participation that subjects should consider. If there is no
treatment alternative, or the only alternative is not to participate, say so.
Application for Approval of Human Research
VCOM Institutional Review Board
Form Updated 3/21/2016
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Please attach the following documents to the end of this form:
Copy of Research Protocol
Copy of Human Subjects Training certificate(s) for all personnel involved in study.
All consent material including Consent Form, information sheets, HIPAA authorization (if
relevant), waiver of consent request (if relevant).
 All recruitment materials including letters and/or postcards, flyers, brochures, tapes of
television or radio advertisements, etc.
 All data collection instruments including questionnaires, focus group questions, etc.
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Application for Approval of Human Research
VCOM Institutional Review Board
Form Updated 3/21/2016
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