Tips for Preparing a Review

This page includes descriptions of what information should be included in a review summary. Board members should use this and their reviewer worksheets and checklists as a guide when preparing their review summaries.  It addresses the following types of reviews:

A review summary should take 3 to 5 minutes to present to the Board. Additional discussion from board members may occur after the summary is presented. At the end of each review presented to the Board, the board reviewer must make a recommendation regarding approval or other determination for the study.

Things to Consider

When Requesting Modifications

  • Will a change in the application, consent, or protocol be likely to improve the welfare of research subjects to a meaningful degree?
    • If not, approve the study without the change
    • If so, require the change be made prior to approval
  • Are my revisions clear?
    • The IRB staff will be communicating your requests to the PI….Make sure it is clear what you are asking for and why.
    • Whenever possible, if you have to make changes to a study document (i.e., consent form, recruitment materials, protocol), use the “Tracked Changes” feature found in Microsoft Word and provide the exact wording for the change.
  • Don’t sweat the small stuff
    • Don’t worry too much about correcting typos, formatting, etc., unless the correction will significantly improve the document or change the meaning of the document.
    • Revisions should be substantive and meaningful

New Studies

Main Summary:

  • Summarize the purpose, design, and procedures of the study (typically 1 – 3 paragraphs).
  • Summarize any significant risks.
  • Summarize recruitment procedures (typically 1 – 3 sentences).
  • Summarize consent process and documentation (typically 1 – 3 sentences).
    • Discuss unique consent processes.
    • Always state how consent will be obtained.
  • Mention plans for data and safety monitoring, when applicable.
  • Mention extra precautions to protect privacy and confidentiality.
  • Mention when there is an increased risk to privacy and confidentiality compared to a normal study.
  • Summarize any concerns about the study or topics that need board discussion and provide specific revisions that are necessary.

Informed Consent Form

Elements of Consent Disclosure:

  • Are any Required Informed Consent Elements Missing?
    • If yes, please state which element is missing.
  • Ask for additional input from the committee.
  • Whenever possible, if you have to make changes to a study document (i.e., consent form, recruitment materials, protocol), use the “Tracked Changes” feature found in Microsoft Word and provide the exact wording for the change.

Vulnerable Populations:

Describe any vulnerable populations which are involved. Additional points that may need to be mentioned include:

  • Children:
    • What ages are included?
    • What is the assent process?
  • Cognitively Impaired Adults:
    • What are the circumstances or nature of the impairment (e.g. coma, permanent mental impairment, sedation, etc.)?
    • What is the consent/assent process?
  • Pregnant Women:
    • How long will they be enrolled (e.g. the entire pregnancy, portion of the pregnancy, after the birth, etc)?
    • Is the research studying the woman or the pregnancy?

End your presentation with a recommendation for the vote

Continuing Reviews

Main Summary:

  • Summarize the purpose of the study (1 – 3 sentences).
  • Summarize the study’s enrollment status:
    • # of local participants
    • Open, closed, or suspended
  • Summarize any Reports of New Information submitted in the past year
    • Have any of these been significant events/problems?
    • State whether or not these events/problems have been reviewed by the IRB
  • Mention any DSMB findings in the last year, if applicable.

Summarize any concerns about the study or topics that need board discussion and provide specific revisions that are necessary.

Informed Consent Form

Elements of Consent Disclosure:

  • Are any Required Informed Consent Elements Missing?
    • If yes, please state which element is missing.
  • Ask for additional input from the committee.
  • Whenever possible, if you have to make changes to a study document (i.e., consent form, recruitment materials, protocol), use the “Tracked Changes” feature found in Microsoft Word and provide the exact wording for the change.

End your presentation with a recommendation for the vote

modifications

Main Summary:

  • Summarize the purpose of the study (1 – 3 sentences).
  • Describe the changes that are being made.
  • State whether or not the risk/benefit ratio has changed.
  • State whether or not the changes are acceptable
  • Determine if re-consent is necessary
  • Summarize any concerns about the study or topics that need board discussion and provide specific revisions that are necessary

Informed Consent Form

Elements of Consent Disclosure:

  • Are any Required Informed Consent Elements Missing?

    • If yes, please state which element is missing.

  • Ask for additional input from the committee.

  • Whenever possible, if you have to make changes to a study document (i.e., consent form, recruitment materials, protocol), use the “Tracked Changes” feature found in Microsoft Word and provide the exact wording for the change.

End your presentation with a recommendation for the vote

reportable new information

Main Summary:

  • Summarize the purpose of the study (1 – 3 sentences).
  • Describe the problem or event.
  • Mention if other changes to the study have been submitted in conjunction with the reported event
  • Describe any corrective actions the investigator has implemented in response to the problem.
  • Assess if the problem or event represent an unanticipated problem involving risks to participants or others (UPIRSO).
  • Assess if this problem represents serious or continuing non-compliance.
  • State if any corrective actions need to be requested.  This may include:
    1. Communication with the subject
      1. A notification to be sent to currently enrolled subjects
      2. A letter to be sent to subjects previously enrolled regarding the additional information
      3. Re-consent currently enrolled subjects
    2. Revisions to the study documents
      1. Modifications to the current research protocol
      2. Changes in consent process or documents
    3. Actions on the study
      1. an audit to ensure compliance
      2. sending a letter of reprimand
      3. more frequent continuing review or monitoring
      4. monitoring of the consent process
      5. referral of the issue to other entities such as NU legal counsel, risk management or the research integrity officer
      6. request additional information prior to making a final decision
      7. suspension or termination of IRB approval, particularly if there are findings of serious or continuing non-compliance, or unexpected serious harm to subjects.