Alpha Genesis® Inc. has an extensive Ethics and Compliance Program, which is designed to ensure that all employees are aware of and comply with all legal, regulatory, contractual, and ethical requirements applicable to Alpha Genesis. AGI senior management is committed to a strong business ethics and compliance program. AGI has invested substantial resources to ensure that all AGI employees are well-trained and comply with all legal, regulatory, contractual, and ethical obligations applicable to AGI’s business. AGI’s Ethics and Compliance Program consists of three main components: 1) a Code of Ethics and Standards of Conduct Code which all employees must review and follow; 2) the Institutional Animal Care and Use Committee (IACUC), which is a semi-autonomous body composed of five voting members; and 3) Standard Operating Procedures (SOPs) to which all employees must adhere.
I. IACUC as detailed in Alpha Genesis’ Description of Institutional Animal Care and Use Program. The IACUC’s responsibilities include:
reviewing project protocols, including all protocols related to research projects, breeding projects, and all SOPs related to the care and use of animals, and recommending modifications to improve the welfare of the animals;
recommending changes to institutional policies on animal welfare and animal husbandry;
reviewing and establishing training policies; and
reporting recommendations and actions to the responsible Institutional Official.
The IACUC’s duties include the following:
The IACUC conducts an audit of AGI facilities and SOPs, at least twice each year, including assessment of compliance with all SOPs regarding the care and use of the animals in its facilities. The IACUC assists in the development of any necessary corrective action, approves the corrective action including the timetable for implementation of the corrective action, and monitors the implementation of the corrective action. The IACUC also prepares reports of the semiannual audits conducted
The IACUC is responsible for monitoring performance under AGI Code. The IACUC maintains a record of all reported allegations of possible animal abuse or other scientific misconduct, investigates all such allegations, and records the final action taken on each allegation.
The IACUC reviews and investigates all concerns relating to animal care and use in accordance with the Animal Misconduct Policy and all concerns relating to the integrity of research endeavors in accordance with the Research Misconduct Policy.
The IACUC reviews on a semiannual basis, all SOPs related to animal care and use.
AGI maintains the Assurance of Compliance with Public Health Service Policy on Humane Care and Use of Laboratory Animals with the Office of Laboratory Animal Welfare (“OLAW”), National Institutes of Health (“NIH”). Assurance of Compliance includes a detailed description of the IACUC’s responsibilities. On January 16, 2002, AGI received approval from the OLAW of its Assurance of Compliance that is valid for five years. The Institutional Official, along with the IACUC, monitors compliance with Public Health Service Policy and seeks renewal of the Assurance of Compliance, which contains data regarding procedures for protocol review and modification and other aspects of the IACUC oversight function.
II. Standard Operating Procedures: AGI requires all employees to adhere to the SOPs that are applicable to their work as a condition of employment. The SOPs clearly define the way AGI conducts its business, and include the following representative elements of the AGI program structure: care and treatment of the animals, facility maintenance, research procedures, and quality assurance. There are approximately 60 SOPs, which clearly define the way AGI’s conducts its day-to-day business. The following are representative day-to-day operations covered in the SOPs: care and treatment of the animals, facility maintenance, research procedures, and quality assurance. All directors, managers, and supervisors maintain copies of SOPs. In addition, copies are available in each building. SOPs are reviewed by the IACUC and signed off by the IACUC Institutional Official, following IACUC review and approval. The IACUC has oversight of all SOPs in use at Alpha Genesis. Employees receive training in all SOPs relevant to their job responsibilities. AGI’s extensive training program ensures that AGI will be able to provide a safe, healthy environment for both employees and animals. AGI also documents training to provide management with a tool to follow employee development, to ensure that employees have received the necessary training, and to demonstrate to outside agencies that employees are trained. All employees receive mandatory orientation and safety training during their first week of employment. Employees receive job specific training during their 90 day probationary period and at periodic intervals appropriate to the topic, but no less than annually. In addition, quarantine training is mandatory for all animal care and veterinary technicians. AGI complies with all training required by the Animal Welfare Act. This training ensures that scientists, investigators, and research technicians utilize humane methods of animal maintenance and experimentation.
III. Code of Ethics and Standards of Conduct: Each employee receives annual training in the Code during the employee’s Job Specific Training, and signs the Certificate of Acceptance of the Code of Ethics and Standards of Conduct (Code Certificate). Each new hire must meet with the Head of Human Resources for orientation, during which the Code will be reviewed and the new hire will execute the Code Certificate. Thereafter, each employee is trained in the Code as part of the employee’s annual Job Specific Training. The Code Certificate contains a representation the employee has read and understood the Code. The Code demands that AGI employees comply with the Code, all laws, regulations, and industry standards and guidelines, SOPs, and contractual provisions applicable to AGI’s business. The Code also summarizes the most important laws and guidelines that must be followed by all employees. Furthermore, the Code establishes ethical standards for Alpha Genesis’ employees to guide their conduct where laws and regulations are not clear.
IV. Implementation and Management of the Ethics and Compliance Program: The IACUC Chair serves as the Ethics Official, and works in consultation with the IACUC and Institutional Official to implement, enforce, and update the Ethics and Compliance Program. The responsibilities of the Ethics Official include: managing all aspects of the Ethics and Compliance Program and responding to reports of possible violations of the Program and questions regarding the Program. The Ethics Official reports directly to the Institutional Official. The Ethics Official maintains a file of the annual Code Certifications. AGI employees are also required to review and sign a Notification of Animal Abuse and Neglect and Reporting Deficiencies in Animal Care and Treatment. Notifications are maintained by the IACUC Chair and passed on to the Institutional Official for action. The Institutional Official may request guidance from the IACUC in investigating and resolving any issues that arise with regards to such deficiencies.