Regulatory Affairs - IACUC Operations and Post Approval Monitoring

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Research involving vertebrate animals as defined by the Animal Welfare Act (AWA) or supported by Public Health Service (PHS) funds are legally and ethically required to adhere to policies and procedures in the “Guide for the Care and Use of Laboratory Animals” 8th Edition. Washington DC National Academy Press. Local oversight of the use of laboratory animals is the responsibility of the Institution’s Animal Care and Use Committee (IACUC).

For small biotech firms or institutions that are initiating research involving animals, constituting a properly functioning IACUC can be most efficiently accomplished by bringing in outside experts like the Kelly Group to assist in navigating the process and establishing compliant policies and processes. 

Every organization constantly seek ways to streamline costs and utilize resources effectively. For small organizations involved in animal research, outsourcing the Institutional Animal Care and Use Committee to a firm like the Kelly Group can provide significant savings.

All ICAUC must comply with PHS and USDA the review and approval of the use of animals in research. The federal regulations provide standards that define the structure and composition of the IACUC and the policies and procedures to be followed. The composition of the IACUC requires a minimum of five members. The members must have the expertise and experience to conduct reviews and apply the federal regulations. The committee should also have diversity of race, gender, culture and sensitivity. At least one member must be a non-scientist and one member must not be affiliated with the institution.

Organizations with a limited number of studies to review face unique challenges. The composition of the IACUC must be maintained as described above. Ongoing training of the committee should be provided as part of best practice. The timeline of completion can also be a challenge. If an online system is not used, recordkeeping becomes more complicated with opportunities for errors and delays. Bringing together the committee members for full reviews may not be easy if the reviewers have other obligations in the organization. Busy clinicians, educators, and evaluators may be unable to complete the reviews in a timely manner.

Outsourcing provides benefits for small and large organizations involved in research. A primary benefit is the removal of internal politics from the review. Another benefit is the elimination of unnecessary delays. Outsourcing can also assist with an accurate tracking and recordkeeping system of research studies reviews.

Every organization has room to improve, including IACUCs. Process Improvement is the proactive task of identifying, analyzing and improving upon existing committee processes within an organization to optimize workflow for administrators, committee members, Principle Investigators and to introduce industry accepted best practices.

Process improvements are most successful when they involve a systematic approach following change management methodology. Process Improvement for IACUCs should be an ongoing practice and should always be followed up with the analysis of tangible areas of improvement. When implemented successfully, the results can be measured in the enhancement of protocol quality, investigator satisfaction, customer loyalty, increased productivity, efficiency and lower overall cost. 

COMPLIANCE AUDITS

A compliance audit is a comprehensive review of an organization’s adherence to regulatory guidelines and internal policies and procedures. Small-businesses and research institutions have the same level of responsibility for complying with the Animal Welfare Act (AWA) and PHS policy as large pharmaceutical firms and universities and often lack the internal resources necessary to insure regulatory compliance.

The objective of an external compliance audit is to provide an unbiased assessment of the overall effectiveness of an organization’s compliance practices and protocols. A compliance audit also uncovers intentional or unintentional weaknesses or deficiencies in an organization’s s program for the humane care and use of animals. Evolving standards of care and technical advancements can sometimes cause compliance programs to be weak or unintentionally deficient. 

While examining an organization’s program for the human care and use of animals, a compliance audit must determine whether the program is complaint with regulations promulgated in the AWA, PHS policy and the Guide (Guide for the Care and Use of Laboratory Animals, 8th ed. Washington DC National Academy Press) and very importantly if the day-to-day operations are consistent with the organization’s program description.

A final audit report from the Kelly Group will in addition to a written effectiveness assessment, include suggestions and recommendations for how your organization can improve your animal care and use program. To assist your organization in making program improvements we will most often fully describe each weakness or deficiency, including possible reasons for its occurrence and potential consequences or ramifications in addition to program improvement recommendations.

POST APPROVAL MONITORING

Post Approval Monitoring (PAM) is a program that monitors research projects (Animal Study Protocols) to confirm that the research is being conducted as approved by the organization’s IACUC, thus ensuring compliance with federal regulations and guidelines for the use of animals in research. Other goals of a PAM program are to ensure the well-being of the subject animals, provide assistance to investigators preparing for audits and to serve as a compliance resource for the organization’s management team. 

PAM can result in several outcomes that either confirm compliance with IACUC approved research or serve as opportunities to improve and organization’s research efforts. These include but aren’t limited to:

1. All procedures and processes follow the approved Animal Study Protocol.
2. The observed efforts demonstrated minor deficiencies and suggestions for improvement are noted.
3. Significant deficiencies between the approved Animal Study Protocol and the observed efforts exist. Under these circumstances the review will result in an immediate report to the organization’s IACUC.

Outsourcing your PAM program to the Kelly Group can provide several benefits:

• It provides an unbiased review eliminating any real or perceived conflicts of interest.
• Your review will be conducted by an expert using a standardized transparent system that is adapted to your organization.
• Our monitoring efforts can be implemented when required as quickly as required.
• It is a cost effective alternative to hiring and training your own auditor.

An excellent review of the benefits of a robust PAM program can be found in a white paper by Simon Selwood Ph.D.

 A number of conferences, courses and on line material available to train IACUC committee members. IACUC 101 , PRIMER, and SCAW  are all excellent training conferences that can be supplemented by a battery of  online resources assembled by the American Association for Laboratory Animal Science (ALAAS) and the Office of Laboratory Animal Welfare (OLAW).

Alternatively, the Kelly Group can provide training for your IACUC at your location, on your timeline using a custom syllabus that reflects your organization’s specific issues and requirements.