Reporting
Research-related Accidents and Illnesses and Violations of the NIH Guidelines
The NIH (National Institutes of Health) Guidelines for Research Involving Recombinant DNA Molecules require submission of a report to the NIH of “any significant problems, violations of the Guidelines, or any significant research-related accidents and illnesses.” The Guidelines also require reporting to state and local authorities any research-related accident or illnesses that may be hazardous to public health.
The Principal Investigator is responsible for immediately notifying the Biosafety Officer of any event that might require such notification. The Institutional Biosafety Committee (IBC) will conduct a review, determine the applicability of the requirements, and file a report with the NIH as appropriate.
It is important that all such incidents be reported to the Biosafety Officer as soon as possible to ensure expeditious review and timely regulatory reporting.
Reporting Process
The IBC protocol for reporting any significant problems or violations of the NIH Guidelines or any significant research-related accidents or illnesses follows the steps indicated below:
- The Principal Investigator reports in writing to the Biological Safety Officer.
- The Biosafety Officer reports the incident to the IBC Chairperson and Director of Research Integrity and Assurance.
- The Biosafety Officer investigates the reported incident and reports to the IBC Chairperson.
- The IBC Chairperson makes the report to the NIH on behalf of the IBC and the University.
- The Biosafety Officer contacts local health officials in the event that the incident may affect public health.
- The IBC Chair reviews the incident with the IBC at the next regularly convened meeting or sooner, depending upon the nature of the incident.
Contact Information:
Jacqueline Wagner
Environmental Health and Biological Safety Officer
Phone: (609) 258-1427
E-mail: jw6@princeton.edu
Report a Concern
Faculty, staff and students who work with recombinant DNA and biosafety agents on behalf of the University assume responsibility for conducting their duties within the law and in keeping with Princeton’s highest ethical standards. In keeping with this responsibility, each individual who works with materials covered under the University’s biosafety program must:
- Understand and follow principles of conduct in the comportment of their University obligations,
- Ensure that they and the staff who report to them are aware of and operate in compliance with applicable laws and policies, and
- Report incidents of non-compliance or concerns.
Direct concerns or observations of inappropriate laboratory biosafety must be reported in order for the institution to fulfill its responsibility to review and fully investigate all potentially inappropriate activity reported by a member of the public or an individual within the institution. If you have a concern, please raise it to the University in any of the following ways:
Raise your concern directly with the person involved. Because some procedures used in the course of biosafety work may be unfamiliar to the observer, it may be helpful to speak directly with the person involved in the activity to clarify the situation. If you choose not to speak about the concern directly with that person, for any reason, you are still encouraged to pursue your concern within the University.
Raise your concern with a supervisor. Supervisors, managers or a chairperson in your department can provide you with guidance regarding your concern. Concerns may also be raised to the Biosafety Officer or University Veterinarian.
Bring your concern to the IBC. The IBC has the responsibility to review and fully investigate all inappropriate, neglectful, or non-compliant activities involving the use of biological materials. You may submit a confidential report directly to the committee by phone at 609-258-3105, email IBC@princeton.edu, or by mail to Princeton University IBC, P.O. Box 36, Princeton, NJ 08544-0036.
SUBMIT A REPORT TO THE PRINCETON UNIVERSITY HOTLINE. If all avenues have been exhausted and you have not received a sufficient response or if you would like to remain anonymous, submit a report online or via telephone at 1-866-478-9804.
