Reporting of Protocol Deviations and Unanticipated Problems

Reporting of Protocol Deviations and Unanticipated Problems

Standard Operating Procedures

Animal Ethics Committee, Faculty of Health Sciences, University of Cape Town

Reporting of protocol deviations, unanticipated problems and welfare violations in animal research

1. Policy

In line with international ethics and regulatory requirements, the Faculty of Health Sciences Animal Ethics Committee (FHS AEC) must have a standard operating procedure which defines the reporting of all animal welfare violations, protocol violations and any unanticipated problems that may arise during animal experimental work.

For definitions of protocol violations and unanticipated problems, see the attached appendix.

In addition, the following incidents must also be reported:

1) Any shortcoming in the Animal Unit’s programme of animal care and occupational health and safety that jeopardises the health and well-being of University staff and students.

2) Any non-compliance with operating policies of the University, Animal Unit and Animal Ethics Committee.

3) Any action that may compromise or harm the academic programme in the Faculty of Health Sciences or its Animal Unit or harm the reputation of the University.

2. Responsibility

Reporting is the responsibility and duty of all members of the University. Failure to report an incident may be construed as an irresponsible act and may have negative consequences for any persons involved with such an omission.

3. Purpose

This document provides a formal means of reporting animal welfare incidents, protocol violations and unanticipated problems related to animal research procedures, treatments, and the care and well-being of research animals, so they may be investigated and corrected.

4. Anonymity in reporting and immunity from reprisals

Any person who wishes to report an incident must complete the Animal Incident Report Form (see pg 5) and available at http://www.health.uct.ac.za/research/animalethics and include his or her name and contact details. Note that names will not be divulged in any correspondence or meeting, if anonymity is requested.

All University staff and students are protected against reprisals arising from good faith reporting of incidents.

5. Reporting an incident

The information recorded in the Animal Incident Report Form (see pg 5) and available at http://www.health.uct.ac.za/research/animalethics should be derived from personal observation.

The report must be submitted preferably within 24 hours of the incident being observed. In instances where immediate intervention is required, the Animal Unit Manager and his Deputy must be contacted immediately and informed of the matter. If they are not available inform the Unit Director.

The written report must be submitted by hard copy, e-mail or fax to the Secretary, FHS Animal Ethics Committee, or fax: 021 406 6411

Contact details:

Animal Unit Director: Dr Bert Mohr ( 021 404 7752

Animal Unit Manager: Mr Hiram Arendse ()

Tel: 021 4066763; Cell: 073 0871762

Animal Unit Secretary: or Fax: 021 4066226 or Tel: 021 4047752).

Animal Ethics Committee Chair: Prof G Louw ()

Tel: 021 4066302; Fax: 021 4487226

Information submitted in the report may be used as evidence in any subsequent formal enquiry into the matter.

6. Examples of instances that may give rise to reporting

Observed deficiencies relating to:

Housing, environment and location of animals;

Cage and room sanitation and hygiene standards;

Caging, feeding, watering and environmental enrichment;

Animal care, monitoring of well-being;

Record keeping;

Invasive surgery, anaesthesia, analgesia and euthanasia;

Post-operative care;

Transport, handling and restraint.

Veterinary care;

Performance and competency of Animal Unit staff, researchers and co-workers;

Potential harm from biohazards, noxious substances, ionizing radiation, chemicals, animal aggression;

Violations of Animal Unit facility procedures and access controls.

(NOTE: This list is not exhaustive, but provides some indicators for reporting incidents. For further examples, see the appendix.)

7. Response to report submitted

Upon receipt of the report by the Animal Unit Manager / Director of the Animal Unit, a decision must be taken whether immediate action is needed. The Chair of the AEC must be notified as soon as possible thereafter.

A report as to the immediate action taken must be submitted by the AU Manager / Director to the Chair of the AEC as soon as possible.

The Chair must, within seven (7) days, acknowledge receipt of the complaint to the complainant and notify AEC members that a complaint has been received. The Chair must also bring the report of the AU Manager to the attention of the AEC and a decision must be taken whether a further formal inquiry is necessary.

The Chair of the FHS AEC, together with Director and Manager of the Unit will decide whether a formal inquiry is indicated. The Chair of the FHS AEC must report to the SAEC if a formal inquiry is required and the action taken at its next meeting.

If the deviation is minor and has no impact on the study or welfare of participants, no further action is necessary, except that the minor deviation is noted. It is the responsibility of the PI to report the matter in the next report.

Repeat minor violations and deviations will not be tolerated. Anyone who incurs three (3) or more minor transgressions may be suspended from doing animal research, pending a full investigation.

8. Formal inquiry

Where the need for a formal inquiry arises, the Chair must call for reports regarding the allegations from the Principal Investigator, the Animal Unit Manager, Animal Unit Director, the Head of the Research Unit, group or centre, and the Head of Department.

9. Composition of formal inquiry panel

1. A panel of 3-5 persons, ordinarily members of the FHS AEC, but which may include other persons if deemed necessary must investigate the complaint.

2. In the case where special expertise might be needed to deal with technical aspects of the substance of the complaint, then such expertise should be sought without compromising the independence of the panel.

10. Appointment of formal inquiry panel

The panel must be appointed by the Chair of the FHS AEC who must also draw up timelines for the submission of documentation, for the investigation of the matter and for delivery of the panel’s decision. The panel will select a chairperson.

11. Powers of formal enquiry panel

1.  The panel is empowered

·  to request further information if needed;

·  to interview parties;

·  to uphold the complaint and order the experimentation to cease immediately until such conditions as may be imposed are fulfilled; or

·  to dismiss the complaint.

2.  The Chair of the panel must inform the FHS AEC, the complainant, the PI and the head of department of the decision reached.

3.  For audit purposes, sufficient detail of the complaint, the action taken and the reasoning in reaching the decision must form part of the minutes of the next FHS AEC meeting.

4.  If the investigative panel is unable to reach a decision, the matter must be referred to the full FHS AEC committee (which must call a special meeting if necessary) to deal with the matter.

5.  If the full FHS AEC is unable to reach a decision, the matter must be referred to the SAEC.

12. Appeal procedure

1.  A complainant or PI or other interested person who is not satisfied with the outcome of the process may appeal in writing to the Chair of SAEC, stating the reasons for the appeal.

2.  If the matter has already been referred to the Chair of SAEC and that committee has reached a decision, that decision is final and can only be taken on review to a Deputy Vice Chancellor nominated by the Vice Chancellor in the case of a procedural irregularity.

3.  The procedure for appeals is set out in a separate document: SAEC Appeal SOP.

ANIMAL INCIDENT REPORT FORM:

Form to be completed for the reporting of any unanticipated problem or protocol deviation or violation of animal welfare that occurred during animal experiments.

Description of the incident.
Please provide a factual description of the incident below:
Date and time of incident:
Place of incident:
Nature of the incident:
Names of any person associated with the incident:
Describe how the incident came to your attention.
Any other information you wish to share:
Give details of whom the incident was reported to and the date and time of reporting:
If more space is required for reporting, please add additional pages to accommodate the details.

(FOR OFFICIAL USE)

PROTOCOL INFORMATION:
Incident Reference Number:
FHS AEC REF Protocol Number:
Date received:
Principal Investigator:
Department:
Date of incident:
Time of Incident:
Location of Incident:
Date and time Animal Unit Manager / Director informed:
Date and time AEC Chairperson informed:
CLASSIFICATION:
Animal welfare violation:
Protocol deviation:
Unanticipated problem:

FINDINGS OF INITIAL INVESTIGATION: FOR OFFICE USE

NO VIOLATION
MINOR VIOLATION
MAJOR VIOLATION

FOR OFFICE USE – to be completed by the Chair of the FHS AEC

Was any immediate corrective action taken?
By whom was the corrective action taken?
Were you (Chair: FHS AEC) satisfied with the corrective action taken?
What dereliction of duty, if any, may have caused the incident?
How in your opinion should future incidents of this nature be avoided?

Incident investigated, reviewed and resolved.

Date:

Signature and designation:

Report submitted to sponsor YES / NO

Report submitted to PI YES / NO

Report submitted to SAEC YES / NO

Person reporting:

Details of person/s reporting incident. (This section must be filled in. If you wish to remain anonymous, please indicate this below and your details on this page will not be divulged in any further inquiry which the Faculty of Health Sciences may institute on this matter).

Name/s:
Telephone number/s:
E-mail addresses:
Signature:
I / we wish to remain anonymous in reporting this incident to the Animal Ethics Committee and the Senate Animal Ethics Committee:
Yes / No (please circle)

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2 July 2010