Scientists: Responsible for conducting experiments and research with full ethical compliance, ensuring that animal and human studies are carried out in accordance with ethical guidelines and that informed consent is obtained when necessary.

Ethical Review Committees (IRB/IACUC): Responsible for reviewing and approving all research proposals involving human or animal subjects to ensure that they meet ethical, legal, and regulatory standards. They assess the potential risks and benefits of the proposed studies.

Regulatory Affairs: Ensures that all research complies with relevant regulatory guidelines, including Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and other applicable national and international standards.

Quality Assurance (QA): Ensures that all ethical standards are met during the research process, including compliance with data integrity and reporting requirements.

4) Procedure

The following steps outline the detailed procedure for ensuring ethical considerations in drug discovery research:

1. Step 1: Ethical Approval for Research
   1. Ensure that all drug discovery research projects that involve human or animal subjects are reviewed and approved by the relevant ethical review boards (e.g., IRB for human studies, IACUC for animal studies).
   2. Submit detailed research protocols, including experimental designs, informed consent forms, and safety procedures, for ethical review and approval. Ensure that these protocols demonstrate compliance with ethical standards and regulatory requirements.
   3. Obtain written approval from the ethical review committees before beginning any research that involves human participants or animals.
2. Step 2: Informed Consent for Human Studies
   1. Ensure that informed consent is obtained from all human research participants. Provide them with clear and comprehensive information about the study, its purpose, procedures, potential risks, and benefits.
   2. Ensure that participants understand their right to withdraw from the study at any time without penalty and that their participation is voluntary.
   3. Document the informed consent process thoroughly, including obtaining signatures from participants and maintaining records of the consent forms.
   4. Ensure that consent forms are written in a language that is easily understandable by the participants, avoiding medical jargon.
3. Step 3: Animal Welfare in Research
   1. Ensure that all animal studies are conducted in accordance with ethical guidelines, including the 3Rs (Replacement, Reduction, Refinement). Minimize animal suffering by using alternative methods where possible, reducing the number of animals used, and refining experimental procedures to minimize pain or distress.
   2. Ensure that animals are housed in appropriate environments that meet their physical and psychological needs, and that they receive proper care, including appropriate veterinary supervision.
   3. Submit animal research protocols to the Institutional Animal Care and Use Committee (IACUC) for review and approval, ensuring compliance with relevant animal welfare laws and guidelines.
4. Step 4: Data Integrity and Scientific Honesty
   1. Ensure that all data collected during drug discovery research is accurate, reliable, and free from falsification or manipulation. Maintain rigorous standards for data collection, analysis, and reporting.
   2. Ensure that all research findings are transparently documented and published in peer-reviewed journals. Avoid plagiarism by properly citing sources and acknowledging contributions from collaborators.
   3. Document all deviations from the approved protocols, including any adverse events or unexpected outcomes, and report these promptly to the relevant regulatory authorities and ethical review committees.
5. Step 5: Confidentiality and Privacy
   1. Ensure that the confidentiality and privacy of research participants, patient data, and intellectual property are maintained throughout the drug discovery process.
   2. Ensure that all personal data obtained during human studies is securely stored and protected according to applicable data protection regulations (e.g., GDPR, HIPAA).
   3. Ensure that any sensitive information, including proprietary scientific data, is handled securely and shared only with authorized individuals or organizations in accordance with confidentiality agreements.
6. Step 6: Compliance with Regulatory Guidelines
   1. Ensure that all drug discovery research adheres to relevant regulatory guidelines, such as Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and other international or national standards that apply to human and animal studies.
   2. Regularly review and update research protocols and practices to ensure compliance with changes in regulations or ethical guidelines. Conduct audits to verify compliance with regulatory requirements.
   3. Work closely with regulatory bodies, including the FDA and EMA, to ensure that the drug discovery process is aligned with regulatory expectations and that all necessary approvals are obtained for clinical trials and drug development.
7. Step 7: Reporting and Addressing Ethical Issues
   1. Ensure that any ethical issues, including violations of informed consent, animal welfare concerns, or data integrity issues, are promptly reported to the appropriate authorities and handled according to internal protocols.
   2. Ensure that the project team is trained in ethical decision-making and is equipped to identify and address ethical challenges during the drug discovery process.
   3. Maintain documentation of all ethical issues and resolutions, and use these instances to improve ethical standards and practices for future projects.

5) Abbreviations

• IRB: Institutional Review Board
• IACUC: Institutional Animal Care and Use Committee
• GCP: Good Clinical Practices
• GLP: Good Laboratory Practices
• HIPAA: Health Insurance Portability and Accountability Act
• GDPR: General Data Protection Regulation

6) Documents

The following documents should be maintained throughout the ethical review and research process:

1. Ethical Approval Documentation (IRB/IACUC)
2. Informed Consent Forms
3. Animal Welfare Protocols
4. Data Integrity and Reporting Records
5. Regulatory Compliance Documentation

7) Reference

References to regulatory guidelines and ethical standards that support this SOP:

• FDA Good Clinical Practice (GCP) Guidelines
• ICH Guidelines for Clinical Trials
• World Health Organization (WHO) Ethical Standards in Medical Research

8) SOP Version

Version 1.0