Getting to and through the IRB

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Getting to and through the IRB
Mary R. Lynn Assistant Director for Operations
OHRE Co-Chair, Public Health-Nursing
IRB University of North Carolina at Chapel Hill
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How to succeed

• Follow the directions
• Follow the directions
• Follow the directions
• Follow the directions

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And where are the directions?

• ohre.unc.edu
• One website for all of the
• campus IRBs

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What will you find there?

• Application form
• Consent form templates and examples of alternates
  to the standard consents
• Deadlines meeting dates
• Lots of additional information

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Where do you start?

• Read the application form all that is asked for
  is detailed there
• Ask your advisor for help with the form
• Fill out the application form
• Complete the consent form template (if needed)
• Call us if you still have questions at
• 966-3113.
• Can make an appointment with the IRB
  Coordinator for your likely IRB if have more
  questions.

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Anything Else?

• Complete the required IRB education at
  www.citiprogram.org. Be sure to print a copy of
  your certificate you get at the end of the
  program for safekeeping in case the automatic
  transfer of your completion does not work.
• The IRB database will verify that you have done
  the required education when you submit your
  application
• Be sure your advisor and your advisory committee
  members who are actively involved in designing
  your study have also done the required education

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Do students have additional requirements?

• Students must have their materials reviewed and
  co-signed by their faculty advisor

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Speaking of proposals

• All relevant proposals (1 copy) must be
  submitted with the IRB application. This applies
  to all researchers, whether students or faculty.
  

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Types of Review

• Exempt
• Expedited
• Convened Committee (Full Board)

Can be reviewed by Chair only
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Are applications for each type of review
handled in the same time frame?

• No
• Exempt and expedited - submit anytime (there are
  no deadlines that apply), expect feedback in 3-5
  days
• Full board submit at least 2 weeks before a
  scheduled meeting (check deadlines at
  ohre.unc.edu/dates.php), expect feedback within 3
  days after the meeting

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Feedback?

• Indeed
• Rare is the application that makes it through the
  first time with no issues to be resolved
• The purpose of the feedback is either to get
  clarification or the submission has not exactly
  conformed to the requirements (remember, follow
  the directions!)

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What do I do with the feedback?

• Whine and moan
• Address the issues and resubmit what is asked for
  in the feedback you receive

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Within a few days of the resubmission . . .

• You will usually receive an approval memo
  which includes information related to the IRB and
  its ongoing role with your research study

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With your approval youll also receive . . .

• Stamped consent forms and stamped flyers,
  recruitment materials, etc.
• You must copy the stamped consent forms and use
  them for the period of time between your approval
  and the renewal of the study.
• Other materials that you might receive with
  stamps are so marked to indicate their
  approval. You do not have to use these stamped
  materials with your participants but you must
  use the version that the IRB (stamped and)
  approved.

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Once its approved, Im on easy street?

• Maybe
• Exempt studies that remain unchanged will not
  have any ongoing interaction with the IRB. The
  only time an exempt study comes back to the IRB
  is, generally, when a change is made that alters
  the risk for subjects.
• All other studies that make any change in the
  approved application must submit a modification
  form (ohre.unc.edu/forms.php) for the change to
  be approved before the change can be implemented

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Anything else?

• Continuing renewal
• At least annually
• Substantive
• Has specific requirements and its own form
  (ohre.unc.edu/forms.php)

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How will I know when to renew?

• Your approval (or renewal) will include the date
  for renewal
• The IRB will notify you at least two months in
  advance of the renewal date
• BUT it is ultimately your responsibility to have
  your study renewed on time so make a note of the
  renewal date and plan ahead for it.

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And after I submit the renewal?

• If its full board it is reviewed by the whole
  committee at the next meeting, after which youll
  receive feedback changes may be needed so be
  sure to plan time before your approval expires
• If its expedited, you should hear about the
  renewal in a few days after it is submitted

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How long must studies stay active?

• The general rule is as long as there are human
  subjects to protect. Once a study is in data
  analysis only and there is no chance you will
  re-contact the subjects, it is possible that you
  might be able to close (terminate) the study.

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If I close it, can it be reopened?

• Not really need to submit a new application

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What about students studies?

• Students should submit their termination notice
  (see Renewal or Termination of IRB Approval of
  Human Subjects Research form at
  ohre.unc.edu/forms.php) before they graduate. If
  they do not do so the faculty advisor will be
  responsible for the renewal/termination.
• Exempt studies are never really opened since
  the IRB doesnt maintain contact with those
  projects. However, an email to the IRB when the
  study has ended helps the IRB with record keeping.

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Miscellaneous questions

• Must I submit an IRB application for secondary
  analysis of another researchers data?
• Yes, even if that researchers IRB approval is
  current but you will be able to submit a brief
  form referred to as the Determination Whether
  Research or Similar Activity Requires IRB
  Approval

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• If I am doing a secondary analysis and the
  researchers IRB approval is not current, does
  that protocol have to be reopened?
• No, your brief application using the
  Determination form will be sufficient.

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Important contact information

• OHRE/IRB webpage
• ohre.unc.edu or irb.unc.edu
• Phone number 966-3113
• Location is trailer 52 (near the entrance to the
  parking lot of the ACC)
• CB 7097