Campus Map/Tour Request Information Employment A-Z Index Directories
EDU Site
A Bold Heart Centennial Campaign

Office of Research and Sponsored Programs:<br /> Failure to Report: Deviation or Violation

Failure to Report: Deviation or Violation

 

Time Frame

ORSP / IRB Action Taken

If PI Responds

If No Response

First notification

 

The IRB, ERC, or IACUC Administrator contacts the PI via email or phone in order to inquire about the protocol changes.

The PI must submit a revised application and other related documents within one week of the email or phone call.

Case resolved

See below

1 week

Following the notification

The PI receives written notification from the Director of Research Compliance.  This written notification is posted on IRB Net, mailed to the PI, and mailed to the Sponsor.  The notification letter will contain a request to meet in-person in order to reach a resolution.

An in-person meeting will be held in order to provide clarity on procedures and requirements to the PI.  The PI must submit any changes within 2 business days.

See below

2 weeks

Following the notification

The IRB will review the revisions/changes. 

Case resolved

(if the revisions are approved)

See below

3 weeks

Following the notification

If the study is a FULL review: it is brought to next IRB meeting for a vote to suspend the research. 

If the study is an EXPITED review: it is brought to the reviewers for a decision to suspend the research.

Case resolved

(if the revisions are approved)

See below

Suspension of research

The PI receives a Notification of Suspension from the Director of Research Compliance.  This notice is posted on IRBNet, mailed to the PI, and mailed to the Sponsor.  In addition this notice is mailed to other institutional entities that are affected by the research.  Research may not resume until the required documents are submitted and administrative approval is obtained.

Case resolved

(if the revisions are approved)

Termination

 

Revised 6/15/11

 


Office of Research and Sponsored Programs | Keith J. O'Neill Center for Healthy Families, Room 214 | (570) 340-6088 | research@marywood.edu