Now Published on YouTube: Dec 4, 2014 OLAW Webinar on Biomedical Research Oversight
On 12/4/14, DHHS’ Office of Laboratory Animal Welfare held a webinar on Biomedical Research Oversight. The seminar is now up on YouTube:
Key point for 2015: investigators are asked to make sure that their reports and other documents are “FOIA ready.” Essentially under the 1966 law of Freedom of Information Act (FOIA) any documentation submitted to OLAW is part of the official agency and government record. Anything you document or report to your institutional IACUC committee could be requested for under FOIA and disclosed.
Anything sent to the federal agency will be subject to public review (after documents have been “scrubbed” for privacy issues). Often OLAW does NOT inform the institution or the investigators that they have released this information as a response to a FOIA investigation or request.
Remember there are all sorts of documents that can be requested in a FOIA request, such as IACUC committee minutes, your specific IACUC protocols, medical and necropsy records and any emails involving animal care discussions.
It was noted in this OLAW webinar that often many of the FOIA requests are from groups searching just to test the state open records. Often investigators or their institutions are unaware and frequently not informed from the federal agency that information on their research projects has been released to the media or activist group.
See also OLAW’s resources page:
See below also the Dec 1, 2014 announcement from NIH on the importance of how and what you “self report” in routine documentation:
Notice of Office of Laboratory Animal Welfare Policy on Shared Animal Welfare Concerns
Notice Number: NOT-OD-15-028 Release Date: December 01, 2014
This Notice is to inform awardee institutions of the NIH Office of Laboratory Animal Welfare (OLAW) policy regarding animal welfare concerns shared by OLAW and the U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Animal Care (AC).
The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory animals (Policy, IV.F.3.) requires Assured institutions to self-report any serious or continuing noncompliance to OLAW. Institutions may also choose to share self-reports of noncompliance with AC as a demonstration of their commitment to continual animal welfare improvement, timely correction of noncompliance, and prevention of reoccurrence.
Under a Memorandum of Understanding, OLAW frequently shares self-reports of serious animal welfare concerns involving USDA regulated species with AC Animal Welfare Operations (formerly called AC Regional Offices). Serious animal welfare concerns may include unanticipated death of animal(s), and unexpected and unrelieved pain or distress to animal(s). OLAW will contact AC to share serious animal welfare concerns and issues of interest to both agencies. Institutional self-reports are shared with AC after OLAW’s investigation is completed.
AC will not cite an institution for past self-reports to OLAW if the incident:
- did not cause serious adverse effects;
- had no history of repeat noncompliance;
- was corrected in a timely manner; and
- led to effective preventative measures.
AC will cite the institution if any of the above criteria are not met.
Complaints from third parties involving previously reviewed noncompliance or any events over 3 years old will not be reexamined by AC or OLAW. This policy is in accordance with the Memorandum of Understanding that was designed to foster continual improvements in animal welfare, reduce redundancy in oversight, and reduce regulatory burden.
USDA AC has reviewed and concurs with this policy and has published consistent guidance in the November 2014 Tech Note.
Posted on January 15, 2015, in Certified Research Administrator Credentials/Exams. Bookmark the permalink. Leave a comment.