The purpose of this SOP is to outline the steps for evaluating and investigating a report of noncompliance or concern for animal welfare in a live, vertebrate animal research study or educational activity.
General Information
Researchers conducting research, training or educational activities with live, vertebrate animals are required to conduct the activity in a humane, ethical and responsible manner, in accordance with the methods and procedures approved by the UNCW Institutional Animal Care and Use Committee (IACUC). Failing to follow the approved methods and procedures is a violation of UNCW IACUC policy.
Scope
The SOP pertains to all live, vertebrate animal research, teaching and training activities conducted by UNCW faculty, staff and students, or external researchers collaborating with UNCW faculty, staff or students on research approved by the UNCW IACUC.
Applicable Definitions
Allegation of Noncompliance – an unproven assertion of noncompliance.
Attending Veterinarian (AV) – the AV has direct program authority and responsibility for the Institution’s animal care and use program including access to all animals. The AV reports to the IACUC chair and directly to the institutional official (IO) if any violations of the AWA are discovered.
Continuing Noncompliance – repeated instances of noncompliance by the same investigator. “Repeated instances” can mean a noncompliant activity occurring multiple times within the same study, or a noncompliant activity occurring once in multiple studies. Such repetition if unaddressed may affect the humane care and use of live, vertebrate animals.
Institutional Official (IO) – the individual who bears ultimate responsibility for the Animal Welfare Assurance Program and is responsible for resource planning and ensuring alignment of program goals with the university’s mission.
Minor Noncompliance – noncompliance that does not increase risk to animals, such as an administrative inconsistency from the methods and procedures approved by the IACUC. Examples of minor noncompliance include but are not limited to:
Failing to submit annual review information within a reasonable time following the due date.
Failure to notify the IACUC when appropriately trained personnel were added to the research team;
Using a location not listed on the approved protocol for approved activities.
Noncompliance – failure to comply with federal regulations, state laws, or UNCW policies or SOPs related to the humane care and use of live, vertebrate animals, and/or the requirements or determinations of the IACUC, or provisions of the approved research, education or training study.
Principal Investigator (PI) – the member of a research team who is ultimately responsible for the project. The PI may not be a student. If a student is the primary researcher on a project, the student’s faculty advisor may serve as the PI.
Research Misconduct – fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. It does not include honest error or differences of opinion. Noncompliance of IACUC policies and/or SOPs generally does not constitute research misconduct.
Serious Noncompliance – instances of noncompliance that pose an actual or potential increased risk to the wellbeing of live, vertebrate animals or UNCW research team members working on animal research. Examples of serious noncompliance include but are not limited to:
Conducting research, education or training activities involving live, vertebrate animals without UNCW IACUC review and approval;
Continuing use of animals after study approval has lapsed;
Changing the PI of the study without IACUC approval;
Allowing untrained or inappropriately trained individuals to work with animals;
Not providing anesthetics or analgesics as required by the approved protocol;
Performing unapproved surgical procedures;
Using an unapproved euthanasia method;
Other major deviations from approved methods and procedures that may place animals or research team members at risk; and/or
A combination of continuing and/or minor incidents of noncompliance or concerns of inhumane treatment of animals.
Whistleblower – a person who informs on an individual or an organization engaged in an unethical or illegal activity.
General Procedures
Retaliation and/or discrimination against any individual who acts as a whistleblower by reporting a concern regarding animal welfare is strictly prohibited and actionable. Retaliation and/or discrimination may result in a disciplinary action up to and including dismissal from employment or expulsion from the university, in accordance with procedures established by university policies.
Any individual who identifies a concern regarding animal welfare or who identifies a possible incident of noncompliance should report the matter to IACUC staff, the IACUC chair, or the IO. The Research Integrity Office (RIO) also maintains a reporting system on its website to accept anonymous complaints or concerns.
The recipient of the concern, if not the RIO director, will notify the RIO director of the concern at the earliest opportunity.
If the IACUC chair has a conflicting interest in the matter, the RIO director will ask the IO to designate an IACUC member without a conflicting interest to oversee the IACUC’s response to the concern.
If the report is made by a complainant whose identity is known, and the complainant wishes to maintain confidentiality of his/her identity, the RIO director will not divulge the complainant’s name unless it is ultimately found that the complainant provided inaccurate information in bad faith. If so, the RIO director will share the complainant’s identity to appropriate authorities such as the IO and/or General Counsel’s office for possible disciplinary or legal action.
At the conclusion of the review or investigation, the RIO director will communicate the IACUC’s findings to the reporting individual, if their identity is known.
Within one day of being notified of the concern, the IACUC chair or designee will determine the appropriate initial response based on whether the concern:
Places animal welfare or safety at risk If the concern describes conditions that threaten animal welfare, the IACUC chair or designee will immediately:
Notify the AV and request a site visit. If the site visit reveals a deviation from regulation, policy or protocol that poses a serious threat to animal welfare, the IACUC chair/designee and/or AV have authority to temporarily halt research activities until the full committee convenes to determine appropriate action.
Notify the IO
Places staff safety at risk:
If the concern describes conditions that create unsafe conditions for research team members, the IACUC chair or designee will immediately:
Notify the UNCW Environmental Health & Safety office and request a site visit.
Notify the IO
Involves research misconduct
If the concern describes research misconduct, the IACUC chair/designee will advise the RIO director to refer the matter to appropriate institutional officials in accordance with UNCW’s Research Misconduct policy.
Involves noncompliance with IACUC policy that does not impact animal welfare.
Upon determining the appropriate initial response, the chair/designee will instruct IACUC staff to send an inquiry to the PI of the study on behalf of the chair/designee to notify the PI that a concern regarding animal welfare and/or possible noncompliance has been identified, and instruct the PI to respond to the concern within two days.
IACUC staff will retain a copy of the notification in electronic format.
IACUC staff will place the concern on the next regularly scheduled convened IACUC meeting for evaluation and will provide the committee with a summary of the concern and the PI’s response. If the PI fails to respond, IACUC staff will advise the committee of the PI’s failure to respond.
If necessary, based on the nature of the concern, the IACUC chair may call a special meeting to review the matter.
Only a quorum of convened IACUC members may determine if a concern or complaint warrants a full investigation.
Minor Noncompliance
When the IACUC determines that a concern or complaint constitutes an incidence of minor noncompliance, the IACUC may direct the chair/designee, a subcommittee, or IACUC staff to instruct the PI to develop a corrective action plan to address the problem, establish the due date of the corrective action plan, and who will review it to determine if it is acceptable.
Serious Noncompliance
If the IACUC determines that an incident of noncompliance is serious, or if the IACUC finds a significant number or repeated minor infractions the IACUC can vote to require any of the following actions or combination of actions:
Take no action – When the IACUC votes to take no action, the PI, his/her immediate supervisor, and the IO will be notified in writing. IACUC staff will file a report in electronic format.
Open an in-depth investigation - When the IACUC votes to open an in-depth investigation, the IACUC will designate two or more members of the committee who do not have conflicting interests in the study and are not in the role of chair/designee to conduct the investigation under the coordination of the RIO director.
Suspend the protocol – When the IACUC votes to suspend the protocol, the RIO director will notify the PI, his/her immediate supervisor, and the IO in writing on behalf of the IACUC of the date the suspension must commence. When a protocol is suspended, no new animals can be collected. The researcher may also be required to safely return animals to the collection location if collected from the field, or if possible, transfer animals to another approved study conducted by a researcher not involved with the incident of noncompliance. The IACUC may instruct the PI to provide the IACUC with a plan to phase out the use of animals, which must be accepted by the IACUC, and must contact the IACUC when all animals have been phased out. The study may resume only when the IACUC votes to lift the suspension of the protocol.
Terminate the protocol – When the IACUC votes to terminate the protocol, the RIO director will notify the PI, the PI’s immediate supervisor, and the IO in writing on behalf of the IACUC of the date the termination must commence. When a protocol is terminated, all research activities related to the protocol must cease. The IACUC may direct the PI as to how to terminate the protocol. Typically, the PI may not collect new animals and must submit a plan to the IACUC describing how existing animals will be cared for until they are able to be transferred to other approved studies conducted by researchers not involved in the incident of noncompliance, safely returned to the collection site if collected from the field, or other humane method of ceasing use of the animals. The study may not resume until the IACUC votes to lift the termination of the protocol or to allow some parts of the study to continue.
Prevent the researcher/PI from conducting research at UNCW - In extreme cases, the IACUC may decide to no longer permit a researcher to conduct research at UNCW. When the IACUC votes to prevent a researcher from conducting research, the RIO director notifies the PI, the PI’s immediate supervisor, and the IO in writing on behalf of the IACUC. When the IACUC votes to prevent a researcher from conducting research at UNCW, all relevant research activities must cease.
In addition to or in lieu of the above-mentioned actions, the IACUC can vote to require the researcher to complete additional training in the humane care and use of animals, require more frequent than annual review of protocols, place a researcher on temporary probation from conducting animal research, require the researcher to destroy data already collected, or take any similar disciplinary action appropriate to the magnitude of the noncompliance.
The IACUC or IO may take any of the above actions when it is determined a research protocol is not being conducted according to federal or local regulations or UNCW policies and procedures, has deviated from its approved protocol, or raises concerns about the risks to animals or research team members.
Procedures for Conducting an In-Depth Investigation
When the IACUC determines that an in-depth investigation is required to obtain detailed information regarding the conduct of a live, vertebrate animal study, the investigation team may:
Conduct interviews of knowledgeable sources, including but not limited to the principal investigator (PI), research team members, and animal housing staff;
Request from the PI a written response to questions;
Observe the methods and processes used; and
Collect and review any related documentation, including but not limited to correspondence, feeding and husbandry logs, or other study materials.
The investigation team shall ensure that the investigation is conducted in a timely manner, is thorough, and the procedures used are limited to those that are deemed reasonable and necessary in order to produce relevant, reliable and sufficient detail that will enable the IACUC chair/designee or full board to determine further actions needed, if any.
They should establish and communicate deadlines for interviews, responses, and document collection, and make available extensions for good cause.
Upon conclusion of the investigation, the investigation team shall prepare a written report to the IACUC detailing the investigation process, the investigation findings, and the investigative team’s recommendations for further actions to be taken, which may include, but are not limited to:
Require no further action;
Accept and approve a proposed corrective action plan provided by the PI or the Institution;
Require that the PI modify the protocol to minimize risk, such as modifying the feeding or husbandry procedures or revising other methods and procedures;
Require the interval at which continuing review is conducted to be modified to less than one year as appropriate to the degree of risk;
Require observation of the research;
Require submission of status reports on a defined set schedule to the IACUC;
Require additional education and training for the PI and/or other research team members;
Require that random audits be performed of studies conducted by the PI to ensure study procedures are followed as approved by the IACUC;
Replace the PI of the study with an experienced animal researcher with a clean research compliance record, selected by the IACUC;
Issue a letter of reprimand to the PI and/or other research team member(s) and copying as appropriate the department chair, faculty advisor (if noncompliant individual was a student), dean, provost, institutional official, or other administrator;
Require the PI to destroy or decommission data collected by noncompliant methods or during a lapse in IACUC approval;
Refer the PI or all of the research team to another University entity (i.e., IO, Sponsored Programs and Research Compliance, Institutional Risk Management, Human Resources);
Refer the matter to the appropriate UNCW office(s) that handle(s) research misconduct and/or whistleblowing activities;
Suspend any or all components of the research (i.e., new animal collection, specific experiments, and data analysis) until a corrective action plan can be developed and implemented or until additional review can occur;
Terminate the research; and/or
Revoke the privilege of the PI and/or members of the research team to conduct live, vertebrate animal research or education activities.
The IACUC will review the investigation report at the next scheduled full board meeting and will consider the recommendations made by the investigation team. If the investigation is completed in-between regularly scheduled IACUC meetings, the IACUC may decide if an additional meeting should be scheduled to consider the recommendations.
The IACUC chair/designee will issue a final determination letter to the PI to convey the final decisions of the board. The letter shall also describe the PI’s appeal rights.
Appeals and Reporting Procedures
Appeal
The PI may appeal any action by the IACUC in writing to the IO within 10 business days of receiving notification of the decision. The IACUC’s decision will stand until the appeal can be properly evaluated. The IO’s decision is final. The only grounds for requesting an appeal are if the researcher believes that the IACUC’s decision is due to inadequate, or inaccurate information, or noncompliance with university policy, state law or federal regulation. Mere disagreement with the IACUC’s decision does not constitute grounds for an appeal.
The RIO director will report the IO’s decision to the IACUC at the next scheduled meeting and will record the decision in the meeting minutes.
Reporting to Federal Agencies
As required by applicable law, regulation or UNCW policies, the IO shall report, in writing, the finding of serious or continuing noncompliance and the action(s) taken by UNCW to address such noncompliance to regulatory agencies, the study sponsor, and UNCW officials as appropriate.
In accordance with UNCW’s Assurance to the Office of Laboratory Animal Welfare (OLAW), Part VI.B., the IACUC must report to OLAW when the following occurs on animal research supported by a Public Health Service agency or the National Science Foundation:
Any serious or continuing noncompliance with the PHS Policy
Any serious deviations from the provisions of the Guide
Any suspension of an activity by the IACUC.