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Question: |
Why
do I need IRB approval? I’m only intending to review charts
and not interact with human participants. |
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Answer: |
All
research that is conducted involving human participants must be reviewed
by the HUIRB. Although some types of research on human participants
may be eligible for an exemption, under federal regulations. Such
exemptions can only be determined by the HUIRB. |
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Question: |
What
do I have to do to renew my application? |
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Answer: |
A Status
Report Form must be completed for the study. The cover letter should
request a continuation and all pertinent documents/information should
be attached. Just like with the new submission, the original and three
copies should be forwarded to the IRB Office. The Status Report Form
can be downloaded from the HUIRB webpage. |
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Question: |
May
I pick my reviewers? |
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Answer: |
No.
The reviewers are chosen by the HUIRB staff. |
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Question: |
Can
you tell me who reviewed my protocol? |
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Answer: |
No.
The identity of the reviewers is anonymous. |
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Question: |
Can
I see what the reviewers said about my protocol? |
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Answer: |
A letter
will be generated informing you of the results of the review. |
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Question: |
Why
can’t you accept and review my protocol the day of the meeting,
after all the meeting hasn’t started yet. |
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Answer: |
The
protocols that are received prior to the deadline (Thursdays preceding
the meetings), are forwarded to the IRB members to allow them ample
time to thoroughly review them. |
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Question: |
How
many copies do you need? |
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Answer:
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In addition
to the original, three copies are needed. The original remains in
the files, while the primary reviewer, the secondary reviewer and
the reader each get the copies. |
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Question: |
How
long will it take to get approved? |
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Answer: |
After
the meeting, a letter or e-mail transmission should be received within
a week. |
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Question: |
I have
determined that I am exempt, so why can’t I just do my research?
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Answer: |
According
to the federal regulations under which the Board operates, exemption
is determined by the Board. |
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Question: |
Can
I pick up my letter after the meeting? |
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Answer: |
After
the meetings, which are concluded at night, the Minutes must be done
in order to compile all of the reviewers comments. As soon as a letter
is ready, the principal investigator is notified. |
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Question: |
What
if my Dean is unavailable, who’s going to sign my Face Page?
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Answer: |
Most
Deans have a designee who has signatory authority. If not, notify
the IRB office for guidance. |
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Question: |
Why
can’t I recruit study participants from my practice?
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Answer: |
Confidentiality
may be a concern. In the human participants section, describe in great
detail why this population cannot be found elsewhere. |
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Question: |
At what
point do I need to submit my application to the HUIRB, when the grant
is submitted to the funding source or when the funding is approved?
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Answer: |
It is
recommended that Principal Investigators submit simultaneously. |
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Question: |
Can
I come to the meeting to explain to the committee what I want to do?
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Answer: |
The
membership of the HUIRB has a wide range of expertise. If questions
are raised that cannot be adequately addressed, an Investigator may
be invited to a meeting. |
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Question: |
Can
I see a copy of my friend’s/colleague’s/someone else’
protocol? |
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Answer: |
All
protocols are held in strictest confidence. Only individuals listed
on the protocol can have access to the protocols. |
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Question: |
Since
I’m doing all of the work, why aren’t I the Principal
Investigator? |
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Answer: |
The
HUIRB only accepts applications from its’ own faculty. |
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