Recently, OLAW (NIH/DHHS) signed a Memorandum of Understanding (MOU) with the Offices of Research Oversight and Research and Development of the VA regarding laboratory animal welfare. The purpose of these types of high-level agreements is many fold, but primarily to state a common set of goals and guidelines. The goal in this case was a “common interest in the care and welfare of laboratory animals used in research and testing”. The intents as described are:
- particularly in the areas of education and compliance;
- avoid duplication of effort in achieving standards for the care and use of laboratory animals, thereby reducing regulatory burden on the VA and VA-affiliated institutions; and
- promote harmonization among VA sponsored activities and between VA institutions and other Public Health Service (PHS) Assured institutions.
This recent example of a MOU illustrates that it is important to formalize the conduct of research between two institutions. With the rise of external compliance boards (IRBs and IBCs) and interinstitutional collaborations, there needs to be documented evidence of the responsibilities of each party. The VA commonly uses these MOUs when investigators hold joint appointments at the VA and elsewhere.
Regarding the division of labor and accountability of each institution, here are some decisions that need to be considered when proposing a sharing of research responsibilities (IACUC-based examples, but pertinent to research compliance review):
- Veterinary care (obtaining animals, husbandry and care, incident response, following Guide/PHS/USDA regulations, liability, staffing, vet availability)
- Protocol Review (IACUC of record, scientific review, knowledge of performance sites, review of amendments and annual reviews)
- Reporting requirements (USDA reports on animal/procedure use, notification of incidents whether related to the protocol in question, semi-annual inspection findings)
- Financial (F&A fund disbursement, billing rates, account reconciliation, credit for effort)
In addition, the Guide (p.15) has this to say about working with others:
Interinstitutional collaboration has the potential to create ambiguities about responsibility for animal care and use. In cases of such collaboration involving animal use (beyond animal transport), the participating institutions should have a formal written understanding (e.g., a contract, memorandum of understanding, or agreement) that addresses the responsibility for offsite animal care and use, animal ownership, and IACUC review and oversight (AAALAC 2003). In addition, IACUCs from the participating institutions may choose to review protocols for the work being conducted.
Needless to say, appropriate legal review of these documents is required!