Office of Research and Sponsored Programs:<br /> Failure to Report: Deviation or Violation
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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
University Policies
- Academic Freedom
- Additional Contracted Work Policy for Faculty Members
- Animal Subjects in Research and Teaching
- Conflict of Interest in Research
- Controlled Substances in Research
- Doctoral Equivalency
- Educational Training in Animal Research
- Educational Training in Human Participants Protection for Investigators
- Educational Training in Human Participants Protection for IRB Members and IRB Administrative Personnel
- Educational Training in Responsible Conduct of Research
- Employee Training
- Institutional Review of Research Involving Human Participants
- Professional Leave of Absence
- Research Misconduct
- Whistleblower Policy
Funding Policies
- Direct and Indirect Costs
- Equipment Purchase Policy
- Grant Submission Policy
- Multiple Submissions
- Salary Savings from Sponsored Projects
Procedure Guidelines and Schedules
- Application Types
- Failure to Report: Deviation or Violation
- Failure to Report: Status Report
- Grants, Contracts and Cooperative Agreements
- Guidelines for Student Research Activities
- IACUC Procedures
- Sponsored Programs Guidelines & Procedures
Office of Research and Sponsored Programs | Keith J. O'Neill Center for Healthy Families, Room 214 | (570) 340-6088 | research@marywood.edu