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

Updated June 7, 2024

Prior IRB approval must be obtained for all amendments or modifications to w88 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 sports betting project must be submitted as subsequent Amendment packages for the existing project in IRBNet. Amendments may be submitted for Full Committee, Expedited, or Administrative w88 sports betting as outlined below or as described in IRB policy (see w88 sports betting Types).

Amendment packages requiring Full Committee w88 sports betting must be submitted and determined to be complete by the meeting deadline. Amendment packages submitted for Expedited w88 sports betting w88 sports betting be submitted at any time; meeting dates and deadlines do not apply to expedited reviews.

Requirements for Amending Approved Documents in w88 sports betting

For amendments that involve w88 sports betting 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 w88 sports betting in MSWord or another editable format.

Instructions for Amending/Modifying Existing Documents in w88 sports betting

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 w88 sports betting, modify the saved app/doc; include “track w88 sports betting” in the filename
Accept all w88 sports betting in the revised document; change “track w88 sports betting: to “clean” in the filename
Return to project in w88 sports betting and select Designer.
From Designer, select “Add New document” and add the document with track w88 sports betting
Again, from Designer use 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 w88 sports betting library.

Amendments for Full Committee or Expedited w88 sports betting

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

Mandatory Submission Requirements for Full Committee or Expedited w88 sports betting

Amendment packages for modifications to approved non-exempt projects in w88 sports betting must include the following:

Amendment Request Form
Electronic signature of the Principal Investigator (w88 sports betting)

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

Change in Project Title

Updated IRBNet record to reflect w88 sports betting title in the top table of the Project Overview screen to reflect change in Part I, Cover Sheet
Requires w88 sports betting to Part I, Cover Sheet
Likely requires w88 sports betting in recruitment and consent materials

Change in w88 sports betting

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 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 w88 sports betting PI in the top table of the Project Overview screen so change is reflected in Part I, Cover Sheet
Amended Part I, Cover Sheet to change w88 sports betting
Amendment Request Form if other w88 sports betting are requested along with the change in PI
Amended recruitment and consent materials (as applicable)
For w88 sports betting investigations, new Investigator Form 1572
Linked Training and Credentials for the replacement w88 sports betting to the project

Addition, Removal, or Change in Funding or Sponsor

Requires w88 sports betting to Part I, Cover Sheet
Likely requires w88 sports betting to recruitment and consent materials
May w88 sports betting new or modified Department of Defense w88 sports betting form for w88 sports betting conducted or supported by the Department of Defense (DOD)

Addition of Prisoners as Participants

Requires w88 sports betting to Part I, Cover Sheet
Requires w88 sports betting to the Protocol
Requires w88 sports betting with Prisoners form
Likely requires w88 sports betting to recruitment and consent materials

w88 sports betting to Study Purpose or Procedures

Require w88 sports betting to the Protocol
Likely require w88 sports betting to recruitment and consent materials
May w88 sports betting w88 sports betting with Specimens form if w88 sports betting involve blood or biological specimens
May w88 sports betting documentation of regulatory committee approval
May w88 sports betting addition or removal of study materials (e.g., surveys, questionnaires, instruments, data logs)
May require new or amended HIPAA Authorization or Waiver if w88 sports betting involve Protected Health Information

w88 sports betting Involving Drugs or Devices

Require w88 sports betting to Part I, Cover Sheet
Require w88 sports betting to the Protocol
w88 sports betting new or amended w88 sports betting with Drugs or w88 sports betting with Devices form
Likely w88 sports betting new or updated clinical protocol, investigator brochure, package insert or labeling, or device manual
Likely require w88 sports betting to recruitment and consent materials
If risk increases to greater than minimal, may require w88 sports betting in consent process to obtain signed consent
If risk increases to greater than minimal, may require changes in w88 sports betting Type

Changes that Increase Participant Risk or Reduce w88 sports betting Benefits

Require w88 sports betting to Part I, Cover Sheet
Require w88 sports betting to the Protocol
Likely require w88 sports betting to consent materials
If risk increases to greater than minimal, may require w88 sports betting in consent process to obtain signed consent
If risk increases to greater than minimal, may require changes in w88 sports betting Type

w88 sports betting Involving Participant Privacy, or Data Handling and Storage

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