To facilitate reporting, there are a number of avenues available to communicate  concerns about animal care and use at North Carolina State University, or to report instances of suspected noncompliance with laws, rules, regulations, and  policies.  A whistleblower form with methods of reporting and contact information is posted: 

• In or near the entrance to animal holding, procedure, and treatment facilities
• On the NC State IACUC website: Report Animal Concerns
• To make your report completely anonymously, please go to ethicspoint.com  or call 1.844.599.8786. Please note that if you use this method to make your report, the IACUC office will not be able to contact you for an update on the outcome of our investigation because we will not have your contact information.

The USDA Animal Welfare Regulations and North Carolina law provide specific protection for employees, IACUC members, or laboratory personnel against discrimination or other reprisals for reporting violations of the Animal Welfare Act (Whistleblower protection).

Once a report has been received in the IACUC office, it is shared with the IACUC chair and University Attending Veterinarian (UAV)  as appropriate.  An initial determination for the report is assigned (Adverse event, unexpected outcome, near miss, reported concern, etc). The Chair, UAV and IACUC office will determine if further investigation and actions is required or if no further actions are required.

If warranted, the IACUC Chair promptly appoints an individual or subcommittee to conduct an evaluation of the report. Members of the subcommittee will be chosen to avoid actual or perceived conflicts of interest. The IACUC Chair may also convene an emergency meeting if immediate actions are necessary.

Investigative subcommittee actions: 

The nature of the information required to gather will vary depending on the  circumstances, but often involves: 

• Interviewing complainants (if known), any persons against whom allegations were directed, and pertinent program officials;  
• Observing the animals and their housing and experimental environment;  and  
• Reviewing any pertinent records, (e.g., animal health records, protocol, and other documents).  

The designated subcommittee representative will provide a report to the IACUC, which includes:  

• An initial report summary listing the the reported concern(s);  
• Additional information
• Corrective Actions taken
• Resolution
  • The results of interviews;  
  • The condition of animals and their housing and experimental environment;  
  • The results of records and other document reviews; 
  • Any supporting documentation such as correspondence, reports, and  animal records; 

• Conclusions regarding the substance of the concerns in relation to the requirements of the Animal Welfare Regulations, the PHS Policy, the  Guide, and institutional policies and procedures;  
• If the complaint is related to an injury or illness, a statement on the  condition of the individual(s), the circumstances related to the injury or  illness, and the prognosis; 
• Recommended action plan, if appropriate. 

The IACUC Office must notify affected individuals or other institutional or non institutional offices at this time (i.e. principal investigator, animal facility  administration, department head, associate dean and dean, as applicable).  

The IACUC Director provides a preliminary report to the Institutional Official (IO). In accordance with the Institution’s Animal Welfare Assurance Statement  if an activity is suspended by the IACUC, and if the activity is supported in any way by the Public Health Service (PHS), the IACUC, through the IO, must promptly notify the  Office of Laboratory Animal Welfare (OLAW) and any federal agency funding the  research.  If the  suspended activity involves the use of USDA-regulated species, the suspension  must also be reported to the Animal and Plant Health Inspection Service  (APHIS).  For Accredited colleges, AAALAC International may be contacted at this time, if applicable.

Upon receipt and evaluation of the report, the IACUC may: 

• Request further information,  
• Find that there was no evidence to support the concern or complaint,
• Find that the concern or complaint was not sustained, but
  • Related aspects of the animal care and use program requires further review or 
  • Other institutional programs may require review, or  
• Find that the concern or complaint was valid.  

Following the final action(s) of the IACUC, the IACUC Chair will advise the person(s) who reported the concern that the investigation of the concern has concluded. 

All individuals previously notified (i.e. principal investigator, animal  facility administration, department head, associate dean and dean, as applicable) shall also be notified of the outcome in separate correspondence in order to  maintain the reporter’s anonymity. 

For reports of non compliance, actions that may be taken by the IACUC include:

• Actions of the IACUC that may be taken to resolve non-compliance matters include:  
  • Implementing institutional actions to prevent recurrence; notifying relevant support departments impacted by the violations; 
  • Notifying the Institutional Official and University Attending Veterinarian of  its actions;  
  • Notifying funding or regulatory agencies, as required; and
  • Notifying the complainant, any persons against whom allegations were directed, and pertinent program officials (appropriate supervisory and  management staff, the public affairs office, institutional attorneys, etc.) of  the non-compliance and directives to resolve.  

• Some of the institutional actions that may be used to resolve and prevent future non-compliance and to revitalize the animal care and use compliance environment are: 
  • Suspension of animal activities
  • Require retraining in the proper use and care of animal subjects; 
  • Require other specific training aimed at preventing future incidents of protocol non-compliance;  
  • Issue letters of admonishment outlining corrective actions, including but not limited to temporary or permanent revocation of rights to use animals in research, testing or training projects;  
  • Monitoring by the IACUC (or designee) of research, testing, or training that involves the care and use of animals with specific, IACUC-mandated conditions; 
  • Recommending to the Institutional Official that additional institutional sanctions be imposed (e.g., reassignment, termination of employment).

The IACUC is empowered to suspend a project if it finds violations of the PHS Policy Assurance, or Animal Welfare Regulations.  Suspension may occur only after review of the matter at a convened meeting of a quorum of the IACUC, and with the suspension vote of a majority of the quorum present.

Further, the IACUC must inform the Institutional Official regarding the  reasons for the suspension, the actions taken and any further recommended administrative actions. The Institutional Official will take the appropriate corrective action and promptly report the action and the circumstances surrounding the suspension to the Office of Laboratory Animal Welfare (OLAW), per the conditions of NC State’s Animal Welfare Assurance Statement.  

Circumstances that must be reported to OLAW by the Institutional Official,  without delay, are: serious or continuing noncompliance with the PHS Policy;  serious deviations from the Guide for the Care and Use of Laboratory Animals (constituting violation of PHS Policy and noncompliance with our Assurance); and IACUC suspensions. 

Examples of reportable situations are in the Standard for Reporting Concerns. Adverse Events reviewed according to this guidance meeting the criteria of AAALAC reporting requirement will also be submitted promptly to AAALAC International for accredited colleges.