HOW DO I SUBMIT A PROTOCOL FOR HUMAN SUBJECT
REVIEW?
1. Talk to the IRB Administrator.
a. Are you applying to the right IRB?
b. Does your study qualify as research?
c. Which form(s) do you need to complete?
d. What are the deadlines for submission?
e. How long will it take to get a response
from the IRB?
f. What other requirements does the
IRB have (e.g. training for
investigators, # copies to be submitted, conflict of interest,
…)
a. Answer every question fully.
b. Follow directions.
c. No handwritten documents.
d. Append to the application form(s):
1. final
protocol
2. data
collection instruments
3. surveys/questionnaires
4. recruitment
materials
5. other
pertinent information
e. Justify the sample size
statistical power analysis
3. Create an informed consent (and assent) document.
a. Write in language understandable
to the subject (6th grade
level).
b. Follow your institution's template
language.
c. Include timeline for procedures
duration of each visit, total duration of study.
d. Use proper grammar.
e. Spell check.
f. Information should match the
protocol.
g. Include local phone number
for subjects to call with questions.
h. Address HIPAA authorization
requirements either in this
document or separately.
4. Complete your annual training in protection on human
subjects (as per your institution)
5. Submit materials to IRB on time.
a. Submission after a deadline delays
review of your project.
b. Respond to IRB requests for information
promptly.
6. Don't start the study until you have an IRB-approval
letter in
hand!
7. After IRB approval, remember to:
a. Conduct study according to
approved protocol and IRB
conditions.
b. Get prior IRB approval for
changes / amendments.
c. Apply for re-approval before
your study's approval expires. You must reattach your approved
and stamped survey or consent for reapproval. It must be restamped
with the current year to be valid.
d. Tell the IRB when the study
is completed.
e. Retain records according to
federal & state regulations,
including those for HIPAA and special regulations for children.
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