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Institutional Review Board (IRB)

Maintaining IRB Approval

Reporting Unanticipated Risks Involving Risks to Subjects or Others

All incidents, experiences, or outcomes that meet all of the following criteria should be reported promptly, but no later than 5 business days, to the IRB:

  • Unexpected
  • At least possibly related to participation
  • Increases risk

Unanticipated Problems that do not meet the above criteria will be returned to the researcher without IRB review.

The Columbia University policy for reporting Unanticipated Problems Involving Risks can be found here.

To submit an Unanticipated Problem Report in Rascal, please follow these steps:

  1. Go to the Rascal home page at https://www.rascal.columbia.edu.
  2. Select 'Human Subjects (IRB)' under 'Compliance'.
  3. Log in with your UNI and password.
  4. Retrieve your protocol by number.
  5. Select the 'Report an Unanticipated Problem' link from the menu on the left side.
  6. Complete and submit the Unanticipated Problem report

 

Modifying an Approved Protocol

All changes to the research protocol must be submitted for prospective IRB approval unless a change needs to be implemented immediately to remove or minimize an imminent harm to subjects.  In the latter situation, such changes should be submitted promptly to the IRB for review and approval, even though out of necessity they were already implemented.  Any change to the protocol, even for one subject, must be submitted for prospective IRB approval (e.g., change of a specific inclusion or exclusion criterion altering a subject's treatment that is prescribed by the protocol, etc.).  If such a change is identified at the time of enrollment and IRB approval is needed quickly, notify the staff of the appropriate IRB, in addition to submitting the modification in RASCAL. 

To submit a modification in Rascal, please follow these steps:

  1. Go to the Rascal home page at https://www.rascal.columbia.edu.
  2. Select 'Human Subjects (IRB)' under 'Compliance'.
  3. Log in with your UNI and password.
  4. Retrieve your protocol by number.
  5. Select the 'Create Modification' link from the menu on the left side.
  6. Complete and submit your modification.

Be sure to:

  • Explain why the modification is requested (in the Summary of Changes section).
  • Revise the protocol, consent forms, or other documents & fields as necessary.
  • Attach new documents.
  • Review the personnel section to ensure that the list is still current.

 

Renewing a Protocol in RASCAL

To submit your continuing review application in Rascal, please follow these steps:

  1. Go to the Rascal home page at https://www.rascal.columbia.edu.
  2. Select 'Human Subjects (IRB)' under 'Compliance'.
  3. Log in with your UNI and password.
  4. Retrieve your protocol by number.
  5. Select the 'Create Renewal' link from the menu on the left side.
  6. Complete and submit your renewal. All information that is required for a new protocol submission must be entered into Rascal for the renewal, e.g., the latest version of the sponsor protocol or grant application, investigator brochure, study instruments, and consent documents (both the last stamped consent and clean version(s) to be stamped for the next approval period). Include a copy of the Certificate of Confidentiality approval letter, if applicable and not previously submitted in RASCAL. If you require assistance with scanning of paper documents so that they can be attached in RASCAL, please contact the IRB office.
  • Be sure the latest versions of all relevant material are attached: e.g., funding proposal (grant or contract), sponsor protocol, investigator brochure (if the study involves an investigational drug), study instruments [i.e., questionnaire(s) or survey(s)], IND/IDE documentation, non-CU site approvals (e.g., permission to conduct the study), and consent forms.
  • Be aware that a pending modification may impede the submission of a renewal request. Withdraw pending modifications if submitting a renewal; incorporate the changes in the study description. Be sure to explain the changes, either in the study description, or in a cover letter.
  • Please file your renewal sufficiently in advance of the expiration date to allow time for the IRB review process. (At least 60 days in advance for Full Board studies; at least 30 days in advance for all others)
  • Research activities may continue uninterrupted ONLY if the renewal request is approved by the IRB prior to the expiration date. All research activities must cease on the expiration date if the renewal is filed, but not yet approved. When the IRB approves the renewal request, research activities may continue.

 

Protocol Deviations & Violations

Protocol Deviations & Violations: Columbia IRB policy requires that all protocol deviations/violations and/or instances of noncompliance with Columbia policies or IRB determinations be reported to the IRB by the Principal Investigator.  A protocol violation/deviation occurs when there is a variance in a research study between what is described in the protocol (reviewed and approved by the IRB) and the actual activities performed by the research team.

The IRB defines a protocol deviation as a change in the protocol for one or more subjects that is identified by the research team before the change is implemented.   A protocol violation is defined by the IRB as a protocol change or modification that was not approved by the IRB and is identified by the research staff after the change was implemented.  Protocol violations may be considered as noncompliance with the federal regulations for the protection of human subjects

 

How to Report a Protocol Deviation/Violation to the IRB:

If the Protocol Deviation / Violation is unanticipated and involves risks to subjects or others, submit it to the IRB within 5 business days as an Adverse Event Report in RASCAL. (see instructions above under "Reporting Adverse Events & Unanticipated Risks")

Protocol Deviations / Violations that do not involve risks to subjects or others should be submitted promptly as a Modification in RASCAL (see instructions above under "Modifying an Approved Protocol")

Whether you are submitting the Protocol Deviation / Violation as an Adverse Event or as a Modification, be sure to include the following information:

  • A complete description of the deviation/violation;
  • An explanation of how/why the deviation/violation occurred;
  • Whether the deviation/violation affected the:
    1. risk/benefit ratio for the subject(s)
    2. integrity of the research data
    3. subject's willingness to continue study participation; and
  • A description of the corrective measures that will be taken to prevent the recurrence of the deviation/violation and indicate what steps will be taken to avoid similar problems in the future.

- Interim Analysis/Safety Reports:

  • Submit promptly as a modification in RASCAL, providing a summary of findings "Summary of Changes" section and attaching all relevant documents.

- Suspensions:

  • Submit promptly as a modification in RASCAL, providing a summary of findings "Summary of Changes" section and attaching all relevant documents.

- Closing out a Project/Terminations:

  • A study should not be terminated until all subjects have completed the study and research-related activity has ceased, including subject follow-up, data collection, and/or data analysis.
  • Notification of 'Closure to Enrollment' should be submitted as a modification rather than a termination unless the above criteria are fulfilled.

To terminate a protocol in Rascal, please follow these steps:

  1. Go to the Rascal home page at https://www.rascal.columbia.edu.
  2. Select 'Human Subjects (IRB)' under 'Compliance'.
  3. Log in with your UNI and password.
  4. Retrieve your protocol by number.
  5. Select the 'File Termination Report' link from the menu on the left side.
  6. Complete and submit your termination.
  • The termination report should include:
    • Cumulative enrollment data and demographics
    • Summary of Amendments
    • Summary of Adverse Events
    • Patient Problems or Complaints
    • Protocol Deviations/Violations
    • Synopsis of Study Results
    • Papers Pending or Published (attach)

If you have questions about IRB review or procedures, contact the IRB office at (212) 870-3481. If you have technical questions, contact the RASCAL helpline at (212) 851-0213.




 


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