SOP for Ethical Review and Approval of Preclinical Studies

Standard Operating Procedure (SOP) for Ethical Review and Approval of Preclinical Studies

1) Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the process for the ethical review and approval of preclinical studies. This SOP ensures that all preclinical studies involving animals are conducted in compliance with ethical standards, regulatory guidelines, and animal welfare laws. It provides guidance on obtaining ethical review and approval for the study protocol before commencing any animal research activities, thus safeguarding the rights of the animals used in research.

2) Scope

This SOP applies to all personnel involved in the planning and execution of preclinical studies that require ethical approval. It encompasses the process for submitting study protocols for ethical review, obtaining approval from the ethics committee or Institutional Animal Care and Use Committee (IACUC), and ensuring that the study complies with ethical standards and regulatory requirements. This SOP is relevant to study directors, researchers, ethics committee members, laboratory staff, and regulatory affairs personnel.

3) Responsibilities

Study Directors: Responsible for ensuring that the study protocol is submitted for ethical review, addressing any ethical concerns raised, and ensuring that the study complies with ethical and regulatory requirements.
Researchers: Responsible for preparing the

study protocol, providing all relevant details to the ethics committee, and addressing any concerns or modifications requested by the committee.

Ethics Committee Members: Review study protocols to assess their ethical considerations, including animal welfare, the necessity of animal use, and compliance with ethical guidelines.

Quality Assurance (QA): Ensure that the ethical approval process is documented and complies with internal standards, regulations, and guidelines.

Laboratory Staff: Responsible for adhering to the study protocol and ethical guidelines during the study, ensuring that animal welfare is maintained throughout the research process.

4) Procedure

The following steps outline the procedure for obtaining ethical review and approval for preclinical studies:

Step 1: Study Protocol Preparation
1. Prepare the study protocol, ensuring that it includes all relevant details such as study objectives, experimental design, animal model, sample size, dosing regimen, and endpoints to be assessed.
2. Include a justification for the use of animals in the study, outlining the scientific necessity and expected benefits of the research.
3. Provide detailed descriptions of the animal welfare measures that will be followed, including housing, handling, and procedures to minimize pain and distress.
Step 2: Submission of Protocol for Ethical Review
1. Submit the study protocol to the ethics committee or Institutional Animal Care and Use Committee (IACUC) for review and approval.
2. Ensure that all necessary documents, including animal welfare considerations, method of euthanasia, and any potential risks to animals, are included with the submission.
3. Ensure that the protocol addresses the 3Rs (Replacement, Reduction, and Refinement) principles of animal research to minimize the number of animals used and ensure humane treatment.
Step 3: Ethical Review Process
1. The ethics committee will review the protocol, focusing on the following key aspects:
2. If needed, the committee may request modifications to the protocol or further clarifications on animal welfare considerations.
Step 4: Ethical Approval
1. If the protocol is approved, the ethics committee will issue written approval, which must be included in the study documentation.
2. If the protocol is not approved, the ethics committee will provide feedback on the required modifications, and the study team must resubmit the protocol for further review and approval.
3. Once approval is granted, the study can proceed according to the approved protocol, with the study team ensuring adherence to the ethical guidelines throughout the study.
Step 5: Documentation and Record Keeping
1. Maintain a record of the ethical review process, including the protocol submission, the committee’s approval, and any feedback provided during the review process.
2. Ensure that all approval documentation is stored securely for future reference and regulatory audits.
3. Ensure that the ethical review and approval process is properly documented and that all required records are retained for the duration of the study and beyond.
Step 6: Ongoing Monitoring and Compliance
1. During the study, ensure ongoing monitoring to confirm that all ethical guidelines and protocols are being followed, including regular assessments of animal welfare.
2. If any significant changes to the study protocol are required during the study, submit these changes to the ethics committee for re-approval.
3. Ensure that any adverse events or unforeseen issues related to animal welfare are immediately reported to the ethics committee and addressed in accordance with ethical guidelines.

5) Documents

The following documents should be maintained during the ethical review and approval process:

Study Protocols
Ethics Committee Approval Letter
Correspondence with Ethics Committee
Documentation of Protocol Modifications
Animal Welfare Logs
Study Deviations and Justifications

6) Abbreviations

GLP: Good Laboratory Practices
IACUC: Institutional Animal Care and Use Committee
3Rs: Replacement, Reduction, and Refinement
FDA: Food and Drug Administration
QA: Quality Assurance

7) References

References to regulatory guidelines and scientific literature that support this SOP:

OECD Principles of Good Laboratory Practice (GLP)
FDA Guidelines for Ethical Review of Animal Studies
Animal Welfare Act and Regulations
International Guidelines on Ethical Use of Animals in Research

8) Version

Version 1.0: Initial version of the SOP.

9) Annexure

Ethical Review Approval Template

Study ID	Study Title	Approval Date	Ethics Committee Comments