Marshall University

Huntington, WV               

                         

SUBJECT:  Reporting Policy

 

The Director, ORI will report to institutional officials and regulatory agencies when:

• The IRB determines that a problem is an unanticipated problem involving risks to participants or others

·     The IRB determines that non-compliance is serious or continuing non-compliance.

• The IRB or anyone in the organization suspends or terminates IRB approval.

 

Preparation of the Report

·        The Director, ORI drafts the report.

·        The Institutional Official approves the report.

 

 

What to Include in the Report

A. For unanticipated problems involving risks to subjects or others:

• Name of the institution (e.g., university, hospital, foundation, school, etc) conducting the research;
• Title of the research project and/or grant proposal in which the problem occurred;
• Name of the principal investigator on the protocol;
• Number of the research project assigned by the IRB and the number of any applicable federal award(s) (grant, contract, or cooperative agreement);
• A detailed description of the problem; and
• Actions the institution is taking or plans to take to address the problem (e.g., revise the protocol, suspend subject enrollment, terminate the research, revise the informed consent document, inform enrolled subjects, increase monitoring of subjects, etc.).

B. For serious or continuing noncompliance:

• Name of the institution (e.g., university, hospital, foundation, school, etc) conducting the research;
• Title of the research project and/or grant proposal in which the noncompliance occurred;
• Name of the principal investigator on the protocol;
• Number of the research project assigned by the IRB and the number of any applicable federal award(s) (grant, contract, or cooperative agreement);
• A detailed description of the noncompliance; and
• Actions the institution is taking or plans to take to address the noncompliance (e.g., educate the investigator, educate all research staff, suspend the protocol, suspend the investigator, conduct random audits of the investigator or all investigators, etc.).

C. For suspension or termination:

• Name of the institution (e.g., university, hospital, foundation, school, etc) conducting the research;
• Title of the research project and/or grant proposal that was suspended or terminated;
• Name of the principal investigator on the protocol;
• Number of the research project assigned by the IRB that was suspended or terminated and the number of any applicable federal award(s) (grant, contract, or cooperative agreement);
• A detailed description of the reason for the suspension or termination; and
• The actions the institution is taking or plans to take to address the suspension or termination (e.g., investigate alleged noncompliance, educate the investigator, educate all research staff, require monitoring of the investigator or the research project, etc.)

Distribution of the Report

The Director ORI will send copies of the approved report to:

·        The IRB by including the letter in the next agenda packet as an information item

·        The Institutional Official.

·        The following agencies: (Reporting is not required if the problem occurred at a site that was not subject to the direct oversight of the organization, or the agency has been notified of the event by other mechanisms.)

o       OHRP.

o       FDA, if the study is subject to FDA regulations.

§         For VA research: the Research and Development Coordinator will be sent a copy of the report and will then be responsible for all VA specific reporting.

o       Any “Common Rule” Federal Agency that is supporting the research.

Time Frame for Reporting Incidents

The Director, ORI will ensure that all steps of this policy will be completed within 15 days of the initiating action.  For more serious actions, the Director, ORI may expedite reporting.

 

 

 

Follow Up Responsibility:  Director, Office of Research Integrity

 

 

 

 

Revised 5-1-2007