520. Project Amendments: Overview of Requirements

Updated June 7, 2024

Amendments for Non-exempt w88 sports betting

Amendments (modifications) for approved non-exempt human w88 sports betting require prior approval by one of the following review processes:

  • Full Committee or Expedited Review by the IRB or
  • Administrative Review by w88 sports betting Integrity & Security staff (personnel and site changes only).

An exception to the requirement for prior approval applies when an immediate change is necessary to eliminate apparent immediate hazards to w88 sports betting participants or others. Such changes must be reported to the IRB in accordance with the IRB policy for reporting problems in w88 sports betting.

Amendments include the premature completion of a study. These may be reported as amendments or closure requests.

  • Requests to amend (or modify) an existing project are submitted as subsequent packages in IRBNet.
  • Protocol amendments should be incorporated into the current applications/researcher forms and recruitment and consent materials (as appropriate) to ensure that there is an historical record for each project document.
  • Review Types vary for minor and substantive amendments.

(See IRB Policy Manual Definitions for more information aboutmodifications, minorandsubstantive.)

Amendments Requiring Full Committee Review

The following types of amendments to approved w88 sports betting require review by the convened IRB:

  • Substantive amendments to w88 sports betting approved by Full Committee Review;
  • Substantive amendments to Clinical Investigations;
  • Sponsor-requested amendments to investigator brochure or clinical protocol that require substantive changes to study procedures or consent documents, or that suggest an increase in participant risk or decrease in w88 sports betting benefits;
  • Data Safety Monitoring Board (DSMB)-requested amendments that require changes to study procedures or consent documents for safety reasons;
  • Substantive amendments to w88 sports betting initially approved by expedited procedures when the new activities do not meet the criteria for expedited review per theDepartment of Health and Human Services (DHHS) categories of w88 sports betting eligible for expedited review; or
  • Substantive amendments to w88 sports betting initially approved by expedited procedures when the activities may increase participant risk or decrease w88 sports betting benefits.

For review of modifications to previously approved w88 sports betting by a convened IRB all members (including alternate members) receive and review all modified documents. The IRB use the criteria to approve modifications to previously approved w88 sports betting when the modifications affect one or more criteria or determine that any significant new findings that arise from the review process and that might relate to participants’ willingness to continue participation are provided to participants.

Amendments Eligible for Expedited Review

Minor amendments to w88 sports betting approved by Full Committee Reviewmaybe eligible for Expedited Review if the changes neither increase risk nor decrease w88 sports betting benefits. Minor amendment is any change that does not materially increase the risks, nor materially decrease the benefits of the study, nor materially decrease scientific merit. Minor modifications include changes that are editorial or administrative, do not affect criteria for IRB approval and fall within the list of categories of w88 sports betting eligible for expedited review.

Amendments, minor or substantive, to w88 sports betting approved by Expedited Review are eligible for Expedited Review if the amended w88 sports betting continues to meet the criteria for expedited review per the DHHS categories of w88 sports betting eligible for expedited review.

Amendments Eligible for Administrative Review

Two types of minor amendments to w88 sports betting approved by Full Committee or Expedited Review are eligible for Administrative Review:

  1. changes to w88 sports betting personnel other than the Principal Investigator (PI) and
  2. addition or removal of study sites.

Amendments to w88 sports betting Using an External IRB

Amendments to w88 sports betting using an external IRB are approved by the Reviewing IRB and do not require submission or notification to the University IRBs unless the changes substantively alter study procedures or the University PI’s role or increase participant risk. In such situations, the University PI is advised to consult with w88 sports betting Integrity & Security.

Amendments to Projects Previously Determined to Be Not Human w88 sports betting

University and affiliate investigators considering substantive changes to projects that were previously determined to not constitute human w88 sports betting are encouraged to discuss the proposed changes with w88 sports betting Integrity & Security by calling 775.327.2368.

Amendments to Exempt w88 sports betting

Changes to exempt w88 sports betting that may alter the exemption status, increase participant risk, result in the involvement of children or prisoners, or trigger additional IRB policy requirements (for example, requirements related to participant recruitment or informed consent) require w88 sports betting Integrity & Security review prior to implementation.

In limited instances, prior w88 sports betting Integrity & Security review may not be required for amendments to exempt w88 sports betting. Investigators are required to consult with senior w88 sports betting Integrity & Security staff before implementing minor or editorial changes to exempt studies to ensure the exemption status and the protocol documentation are appropriate and compliant with federal regulations and University policy.

Addition of Federal Funding to Exempt w88 sports betting

The addition of federal funding to w88 sports betting approved under the University’s IRB Flexibility Policy asFlex-Exemptmust be immediately reported to w88 sports betting Integrity & Security.

The Review Type may change from exempt to expedited review with assignation of an expedited review category and a progress report due date. Senior w88 sports betting Integrity & Security staff will consider the requirements and categories for review by expedited procedures and inform the PI if a new application or additional information is needed.