Report a Concern

Faculty, staff and students who conduct research 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 must:

Understand and follow the institutional 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 accordance with applicable laws and policies, and
Report incidents of non-compliance or concerns.

Direct concerns or observations of inappropriate conduct 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 situations can be misinterpreted, it may be helpful to speak directly with the person involved in the activity to clarify the situation. If you choose not 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 DIRECTLY WITH A SUPERVISOR. Supervisors, managers or a chairperson in your department can provide you with guidance regarding your concern.
BRING YOUR CONCERN TO THE OFFICE OF RESEARCH INTEGRITY AND ASSURANCE. The Office of Research Integrity and Assurance will bring any and all concerns to the appropriate committees. The IACUC, IRB, IBC and Conflict of Interest in Research committees are responsible for reviewing and fully investigating all inappropriate, neglectful, or non-compliant activities involving the conduct of research. You may submit a confidential report directly to RIA by phone at 609-258-3321, email [email protected], or by mail to Princeton University, Research Integrity, and Assurance, P.O. Box 36, Princeton, NJ 08544-0036.

Reporting Animal Concerns

Report a Concern

Faculty, staff and students who work with animals 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 animals or within an animal facility 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 animal care or treatment 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 animal research can be misinterpreted, 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 University Veterinarian.

BRING YOUR CONCERN TO THE IACUC. The IACUC has the responsibility to review and fully investigate all inappropriate, neglectful, or non-compliant activities involving the care or treatment of animals. You may submit a confidential report directly to the committee by phone at 609-258-3105, email [email protected], or by mail to Princeton University IACUC, 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.

Reporting Human Subject Concerns

Adverse Events, Unanticipated Problems and Protocol Deviations

Faculty, staff and students who conduct human subject research 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 on human research studies 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 conduct or significant variance from an approved protocol 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 the following way:

The most common event that occur are considered unanticipated problems or protocol deviations that take place during the course of a research project involving human research should be reported to the IRB promptly. In addition to consultation with the IRB administrators, a form recording the pertinent information about the unanticipated event or deviation should be submitted to the IRB within 10 days of the event.

Unanticipated problem involving risks to subjects or others (including, researchers, technicians, bystanders, the public, etc.) include any incident, experience, or outcome that meets all of the following criteria:

unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
related or possibly related to a subject’s participation in the research; and
suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) related to the research than was previously known or recognized.

Events Requiring Prompt Reporting to the IRB

The following events may represent unanticipated problems involving risks to subjects or others and thus should be promptly reported:

Adverse events or injuries that are serious, unexpected, and related
Adverse device effects that are unanticipated
Breaches of confidentiality involving risks
New information indicating an unexpected change in risks or potential benefits (e.g., literature/scientific reports or other published findings)
Unapproved changes made to the research to eliminate an apparent immediate hazard to a subject
Subject complaints indicating an unanticipated risk, or complaints that cannot be resolved by the research staff
Protocol deviations, violations, or other accidental or unintentional changes to the protocol or procedures involving risks or with the potential to recur
Events requiring prompt reporting according to the protocol, sponsor, or funding agency. Investigator’s brochure updates/revisions to safety information (excluding routine updates), if applicable
Data and Safety Monitoring Board (DSMB) reports, interim analyses, or other oversight committee/monitoring reports which alters the risk/benefit profile
Other problem or finding (e.g., loss of study data or forms, a subject becomes a prisoner while participating in research, etc.) that an investigator or research staff member believes could influence the safe conduct of the research

IRB Review

These events may be reviewed using expedited review procedures or at a fully convened IRB meeting. A determination will be made by the full committee regarding whether the event is an unanticipated problem involving risks to subjects or others and if further action is necessary.

IRB Action(s) will be based on the nature of the event, degree to which research participants are placed at risk, occurrence or prevalence of previous problems, etc. The IRB will also consider the rights and welfare of participants when making these determinations.

Possible IRB Actions may include the following:

Request a correction action plan from the investigator
Require modification of the information disclosed during the consent process
Require modification of the protocol
Verification that participant selection is appropriate and observation of the actual informed consent
An increase in data and safety monitoring of the research activity
Request a directed audit of targeted areas of concern
Request a status report after each participant receives intervention, if applicable
Modify the continuing review cycle (from 12 months to 6 or 3 months)
Request additional Investigator and study staff education
Notify current subjects, if the information about the noncompliance might affect their willingness to continue participation
Require current participants to re-consent to participation
Suspend the study or;
Terminate the study

Report a Concern

BRING YOUR CONCERN TO THE IRB. The IRB has the responsibility to review and fully investigate all events that may have or non-compliant activities involving human research studies. You may submit a confidential report directly to the committee by phone at 609-258-0865, email [email protected], or by mail to Princeton University IRB, Research Integrity and Assurance, Princeton, NJ 08544-0036.

Events that do not involve human subjects research:

Reporting Biohazard Concerns

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 must notify the Biological Safety Officer. Notifications should be made the day that the event occurred.
The Biosafety Officer reports the incident to the IBC Chairperson (Chair) and Research Integrity and Assurance (RIA).
The Biosafety Officer investigates the reported incident and creates an incident summary.
The Biosafety Officer sill send the incident summary via email to the NIH on behalf of the IBC and the University, and copies the IBC Chair and the Director of RIA.
Depending on the incident, the BSO will prepare an incident report and send the report to the NIH within 30 days of the incident.
The Biosafety Officer contacts local health officials in the event that the incident may affect public health.
The Biosafety Officer will present the incident to the IBC at the next regularly convened meeting or sooner, depending upon the nature of the incident.

CONTACT INFORMATION: Jacqueline Wagner, Biosafety Officer. Phone: (609) 258-5294; E-mail: [email protected]

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.

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 [email protected], or by mail to Princeton University IBC, P.O. Box 36, Princeton, NJ 08544-0036.

Reporting Conflict of Interest Concerns

Report a concern

BRING YOUR CONCERN TO THE CONFLICT OF INTEREST IN RESEARCH REVIEW PANEL. The review panel has the responsibility to review and fully investigate all inappropriate, neglectful, or non-compliant activities involving conflicts of interest in Research. You may submit a confidential report directly to the committee by phone at 609-258-3105, email [email protected], or by mail to Princeton University Conflict of Interest in Research, 87 Prospect Ave, 3rd Floor, Princeton, NJ 08544.

Hotline

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 call 1-866-478-9804