521. Submitting Amendments for Full Committee or Expedited w88 online sports betting

Updated June 7, 2024

Prior IRB approval must be obtained for all amendments or modifications to w88 online sports betting previously approved by the full committee or via expedited procedures unless immediate changes are necessary to protect participants or others. The latter requires reporting to the IRB.

Requests to amend or modify approved, non-exempt w88 online sports betting project must be submitted as subsequent Amendmentpackagesfor the existing project in IRBNet. Amendments may be submitted for Full Committee, Expedited, or Administrative w88 online sports betting as outlined below or as described in IRB policy (see w88 online sports betting Types).

Amendment packages requiringFull Committee w88 online sports bettingmust be submitted and determined to be complete by the meeting deadline. Amendment packages submitted forExpedited w88 online sports bettingmay be submitted at any time; meeting dates and deadlines do not apply to expedited reviews.

Requirements for Amending Approved Documents in IRBNet

For amendments that involve changes to approved documents, after logging-in to IRBNet and creating a new Amendment package for the approved project, investigators must complete the following steps:

Amended Applications, Researcher Forms, and Study Documents

When possible, study documents should be added to IRBNet in MSWord or another editable format.

Instructions for Amending/Modifying Existing Documents in IRBNet

From the list of study documents, download the application/document you are changing and save it to your computer where it can easily be found.
Using track changes, modify the saved app/doc; include “track changes” in the filename
Accept all changes in the revised document; change “track changes: to “clean” in the filename
Return to project in IRBNet and selectDesigner.
FromDesigner, select “Add New document” and add the document with track changes
Again, fromDesigneruse the pencil icon and replace the existing app/doc with the newly revised clean version.

Instructions with graphics for modifying a document are available in the IRBNet library.

Amendments for Full Committee or Expedited w88 online sports betting

Generally, the type of review for amendments mirrors that of the initial review: Full Committee or Expedited Review. For information about exceptions, see IRB policy for project amendments for non-exempt w88 online sports betting or Review Types; and the section below for Administrative Review for personnel changes and additions/deletions of study sites.

Mandatory Submission Requirements for Full Committee or Expedited w88 online sports betting

Amendment packages for modifications to approved non-exempt projects in IRBNet must include the following:

Amendment Request Form
Electronic signature of the Principal Investigator (PI)

Additional Requirements for Specific Amendments for Full Committee or Expedited w88 online sports betting

Change in Project Title

Updated IRBNet record to reflect new title in the top table of theProject Overviewscreen to reflect change inPart I, Cover Sheet
Requires changes toPart I, Cover Sheet
Likely requires changes in recruitment and consent materials

Change in PI

Changing the PI requires request by the current PI and endorsement and acceptance by the new PI. The PI change package is shared with the new PI if they are not already on the w88 online sports betting team and is signed by the existing PI (or Responsible Official (RO) if the existing PI is not available) and the new PI. The package consists of the following:

Updated IRBNet record to reflect new PI in the top table of theProject Overviewscreen so change is reflected inPart I, Cover Sheet
AmendedPart I, Cover Sheetto change PI
Amendment Request Formif other changes are requested along with the change in PI
Amended recruitment and consent materials (as applicable)
For clinical investigations, new Investigator Form 1572
Linked Training and Credentials for the replacement PI to the project

Addition, Removal, or Change in Funding or Sponsor

Requires changes toPart I, Cover Sheet
Likely requires changes to recruitment and consent materials
May require new or modifiedDepartment of Defense w88 online sports bettingform for w88 online sports betting conducted or supported by the Department of Defense (DOD)

Addition of Prisoners as Participants

Requires changes toPart I, Cover Sheet
Requires changes to theProtocol
Requiresw88 online sports betting with Prisonersform
Likely requires changes to recruitment and consent materials

Changes to Study Purpose or Procedures

Require changes to theProtocol
Likely require changes to recruitment and consent materials
May requirew88 online sports betting with Specimensform if changes involve blood or biological specimens
May require documentation of regulatory committee approval
May require addition or removal of study materials (e.g., surveys, questionnaires, instruments, data logs)
May require new or amended HIPAA Authorization or Waiver if changes involve Protected Health Information

Changes Involving Drugs or Devices

Require changes toPart I, Cover Sheet
Require changes to theProtocol
Require new or amendedw88 online sports betting with Drugsor w88 online sports betting with Devicesform
Likely require new or updated clinical protocol, investigator brochure, package insert or labeling, or device manual
Likely require changes to recruitment and consent materials
If risk increases to greater than minimal, may require changes in consentprocessto obtain signed consent
If risk increases to greater than minimal, may require changes in w88 online sports betting Type

Changes that Increase Participant Risk or Reduce w88 online sports betting Benefits

Require changes toPart I, Cover Sheet
Require changes to theProtocol
Likely require changes to consent materials
If risk increases to greater than minimal, may require changes in consentprocessto obtain signed consent
If risk increases to greater than minimal, may require changes in w88 online sports betting Type

Changes Involving Participant Privacy, or Data Handling and Storage

Require changes to theProtocol
Likely require changes to recruitment and consent materials
If risk increases to greater than minimal, may require changes in consentprocessto obtain signed consent
May require new or amended HIPAA Authorization or Waiver if changes involve Protected Health Information
May require new or amendedData Use Agreement
If risk increases to greater than minimal, may require changes in w88 online sports betting Type