Submission Process to the IRB part 2 Revisions to Protocol

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Submission Process to the IRB part 2Revisions
to Protocol
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This session will cover

• How to navigate the ORA/IRB web pages
• How to obtain the forms
• How to prepare and submit a request for revision
  to protocol for review by the IRB

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Navigating the ORA/IRB Web pages ORA Website
www.lifespan.org/research/
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Navigating the ORA/IRB Web pages IRB webpage
http//www.lifespan.org/research/irb/irb.asp

• From the ORA web page, select (IRB) Human
  Subjects

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Navigating the ORA/IRB Web pages IRB forms
webpage http//www.lifespan.org/research/irb/irbfo
rmslist.asp

• From the IRB webpage, select IRB Forms

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Navigating the ORA/IRB Web pages IRB forms
webpage http//www.lifespan.org/research/irb/irbfo
rmslist.asp

• From the IRB forms webpage, scroll down to the
  bottom of the list to Forms for Previously
  Approved Studies

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Steps to submitting a Request for Revision to
Protocol for review by the IRB

• 1. Determine which aspects of the project will
  be revised (e.g. protocol, consent forms,
  advertisements, personnel, etc)
• 2. Obtain required form for IRB review from the
  ORA website www.lifespan.org/research/irb/irbforms
  list.asp

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Steps to submitting a Request for Revision to
Protocol for review by the IRB

• 2. Complete the revision request form.
• 3. Be sure to answer all questions completely and
  correctly. Please note See Attached is not
  an acceptable response
• 4. Please be certain to include clean and
  highlighted or tracked copies of any documents
  which will be revised (such as consent forms,
  advertisements, abstract)

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Steps to submitting a Request for Revision to
Protocol for review by the IRB

• If the revision includes information that must
  be communicated to currently enrolled subjects
  (such as altered schedules, revised compensation,
  newly identified side effects), then you must
  describe the plan for notifying enrolled
  subjects and attach any documentation that will
  be used for this purpose.

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Steps to submitting a Request for Revision to
Protocol for review by the IRB

• 5. Does your request require Full Board or
  Expedited review?
• Revisions to currently approved projects usually
  qualify for expedited review if they do not
  present greater than minimal risk .
• Significant changes and/or revisions which alter
  the riskbenefit ratio for enrolled subjects
  require review by the convened (full board) IRB.

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Steps to submitting a Request for Revision to
Protocol for review by the IRB

• For Expedited Review Submit the original
  request and one complete copy (including
  attachments). Revision requests can be dropped
  off or sent by mail to the IRB Office (Aldrich
  507)
• Please allow two -three weeks for the processing
  and review of your request.
• For Full Board Review Submit 25 complete,
  collated copies of the revision request
  (including all attachments) on or before the
  deadline for the next full board IRB meeting.

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What happens after I submit my revision request
to ORA staff?

• 1. ORA committee staff review the submitted
  request for completeness. After the request is
  accepted, it is processed for review.
• Expedited Reviews
• Revision requests that are accepted for
  expedited review are sent to the IRB Chairperson.
  After review, the PI will be notified as to
  whether there are corrections to be made. If the
  request was approved as submitted, the approval
  documents will be sent by mail to the PI. Please
  Note The IRB Chairperson has the authority to
  refer any item to the full board for review.

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What happens after I submit my revision request
for full board review to ORA staff?

• Full Board Reviews
• Applications that are accepted for full board
  review are placed on the agenda for the next
  committee meeting (full board review).
• 2. IRB agendas include specific time assignments
  for each protocol that will receive full board
  review and are sent to investigators
  approximately one week before the meeting.
  Principal Investigators, or their
  representatives, are required to appear before
  the committee to address any questions or
  concerns raised by the reviewers.

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What happens after I submit my revision request
for full board review to ORA staff?

• After the IRB meeting, ORA committee staff
  prepare the minutes from the meeting and send a
  summary of the discussion and comments to the
  investigator.
• 4. Investigators make the committee required
  changes and return any requested
  information/clarifications to ORA committee staff.

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What happens after I submit my revision request
for full board review to ORA staff?

• 5. If the request was approved pending receipt
  of requested revisions, then ORA committee staff
  will verify that the requested changes were made
  and process approval documents

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Contacts for IRB Questions

• If you have any questions you can contact
• Patricia Houser, Manager Research Review
  Committees and Communication at
  phouser_at_lifespan.org 444-2099
• Adrienne McParlin, Coordinator Research Review
  Committees at amcparlin_at_lifespan.org 444-3527
• Jacqui Poore, Coordinator Review Committees and
  Compliance at jpoore_at_lifespan.org 444-2093
• Dawn Roux, Coordinator Research Review Committees
  at droux_at_lifespan.org 444-7547