Investigation, reporting, and program improvement

TY - JOUR

T1 - Investigation, reporting, and program improvement

AU - Jackson, Todd A.

N1 - Funding Information: The Institutional Animal Care and Use down to identify what could prevent similar determine whether a clarification needs to Committee (IACUC) should rapidly occurrences in the future. be published. conduct an investigation to gather Once it becomes clear that Public Health Based on the results of the investigation, complete information about what happened. Service-funded animal activities have taken the IACUC and IO should identify any Questions that need to be answered place without IACUC approval, the Office programmatic changes appropriate to include: What species was involved and is for Laboratory Animal Welfare (OLAW) prevent problems like this from reoccurring. that species regulated by the United States must be notified promptly. According to Does a PAM program need to be Department of Agriculture (USDA)? What NOT-OD-13-044, “it is appropriate to implemented or improved? Is the training was the funding source for the research and submit a preliminary report prior to the program adequate to ensure all research did it involve funding from the National completion of a full investigation and team members know their responsibility Institutes of Health or the National Science implementation of a corrective plan”. to conduct animal procedures as described Foundation? How many animals were Institutions must also provide a final in IACUC-approved protocols? Do some involved? What procedures were performed report including a detailed explanation individuals need refresher training? Do on the animals and by whom? Were those of the circumstances and actions taken. animal procurement and protocol transfer same species, people, and procedures The final report must be signed by the procedures involve a method of verifying approved under another related protocol? Institutional Official (IO) and submitted IACUC approval? Do grant application Were the animals housed in a centralized either via email in PDF format or by fax. processes include a method to verify animal facility or an investigator-managed, If the project involved a USDA-regulated grant congruency with IACUC-approved satellite facility and what prevented species, the IACUC and IO should review procedures? The IACUC and IO should husbandry, veterinary, and post-approval USDA’s December 2017 Technical Note implement changes as needed to prevent monitoring (PAM) staff from noticing titled “Incentives for Identifying, Reporting, a repeat of the noncompliance while that unapproved procedures were taking Correcting, and Preventing Noncompliance minimizing additional regulatory or training place? Were the animals from an in-house with the Animal Welfare Act” for advice burden on the faculty and staff. ❐ production colony or purchased from an on reporting to USDA. Finally, most external vendor without first verifying animal-related research articles include that an IACUC-approved protocol was in a statement about IACUC approval. place? Had all members of the research Assuming that occurred in this scenario, team been trained about requirements Katayama should contact the journal to for prior IACUC approval? It is critical inform them that the project had not to learn where and how the system broke been IACUC-approved and let the journal

PY - 2018/3/1

Y1 - 2018/3/1

UR - http://www.scopus.com/inward/record.url?scp=85042544892&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85042544892&partnerID=8YFLogxK

U2 - 10.1038/s41684-018-0005-z

DO - 10.1038/s41684-018-0005-z

M3 - Comment/debate

C2 - 29483690

AN - SCOPUS:85042544892

VL - 47

SP - 53

JO - Lab Animal

JF - Lab Animal

SN - 0093-7355

IS - 3

ER -