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IRB Documents and Instructions
Office of Nursing Research
Guidelines for IRB Assistance
Contact: Tracey Wheeler Pangborn
Phone: 215.898.4318
Email:
traceywh@nursing.upenn.edu
Staff at the Office of Nursing Research (ONR) is available to assist
researchers with the IRB application process, including but not limited to:
- Assistance with a preliminary review of the research proposal with the
researcher present. The purpose of the preliminary review is to help identify
aspects of the study that need work before the final proposal is sent to the IRB. For instance, ONR can assist in identifying the elements of information
that are necessary to include in a consent document or a protocol summary.
This may involve a discussion with the researcher about the research plan or
the process of informed consent. ONR can not write proposals and informed
consents for researchers, but can assist with revisions.
- Assist researchers to determine if their study meets the criteria for
exempt, expedited or a full board review. Researchers should be aware that the
IRB office makes the final determination upon review of the proposal.
- Assist researchers to identify the correct forms that need to be filled
out with their IRB submission, provide guidance and answer questions about how
to fill out the forms.
- Help researchers prepare the IRB packet to make sure that all of the
necessary documents are included, to make copies and take the completed packet
to the Office of Regulatory Affairs.
- Assist in preparing the IRB application for Continuing Review or for
filing for an Amendment to a proposal.
- Assist the researcher with answering IRB stipulation letters and the
process of revisions.
ONR would like all researchers to save their electronic copies of their
applications in a distinctive folder on their shared drive on the network. ONR
will keep a hard copy of your proposal, human subject certification, IRB
letters and grant related information in a file should you require copies of
this information in the future.
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