|Policy & Guidance|
|Compliance & Oversight|
|Research Involving Human Subjects|
|Office of Laboratory Animal Welfare (OLAW)|
|Animals in Research|
|Peer Review Policies & Practices|
|Guidance for Reviewers|
|Intellectual Property Policy|
|Acknowledging NIH Funding|
|Invention Reporting (iEdison)|
|NIH Public Access|
|Date||News Flash Description|
|November 29, 2001||OLAW and APHIS Suggestions to Bring Electronic Protocol System into Compliance|
|November 20, 2001||7th National Symposium on Biosafety in Atlanta in January|
|November 8, 2001||February Conference on Mouse Transgenics in Houston, Texas|
|October 29, 2001||January IACUC 101 Training Session Offered in Hawaii|
|October 29, 2001||December 10-11 Workshop on IACUC Education and Animal Well-Being|
|September 24, 2001||OLAW and APHIS Comment on Lab Animal Column Regarding IACUC Minutes and Use of Audiotapes|
|September 24, 2001||NC ARENA IACUC 101 Rescheduled|
|August 23, 2001||September California Compliance Conference|
|August 10, 2001||October IACUC 101 Training Session Offered in Connecticut|
|June 22, 2001||OLAW and APHIS Comment on Lab Animal Column Regarding IACUC Approval of Protocols|
|May 7, 2001||IACUC 101 Session Cosponsored by Purdue University August 13|
|May 1, 2001||ILAR Workshop on Regulation of Laboratory Animals|
|April 25, 2001||June Workshop on IACUCs Presented in NYC|
|April 25, 2001||September IACUC 101 Training Session Offered in North Carolina - SOLD OUT!|
|April 4, 2001||AVMA Issues Revised Euthanasia Report|
|March 20, 2001||OLAW and APHIS Comment on Innovative Protocol System|
|March 13, 2001||April IACUC Training Opportunity in Seattle|
|February 14, 2001||Clarification of Training Requirement under PHS Policy on Instruction in the Responsible Conduct of Research|
|February 12, 2001||Guidance Regarding Administrative IACUC Issues (alternate IACUC members, IACUC review at collaborating institutions) and Regulatory Burden|
|January 29, 2001||IACUC 101, ARENA and PRIM&R Meetings in San Diego|
|January 10, 2001||NIH Issues Reminder of Need for IACUC Approval Prior to Peer Review|
|January 5, 2001||Pain and Distress Workshop Proceedings Available|
News Flash Items
OLAW and APHIS Suggestions to Bring Electronic Protocol System into CompliancePosted November 29, 2001
The Director of OLAW and Acting Deputy Administrator of APHIS Animal Care have published a letter to the Editor in the November 2001 issue of Contemporary Topics, responding to the September 2001 Contemporary Topics article, "A Novel Interactive Electronic Protocol System" by Lewis et al (40:14-16). The letter suggests relatively minor modifications of the described system that could be made to make it fully compliant with PHS Policy on Humane Care and Use of Laboratory Animals and/or the Animal Welfare Act Regulations, and with previously published guidance on the subject (see Lab Animal letter to the editor March 2001, http://www.labanimal.com/letters/garnett.html ). The text of the letter to the Editor is posted at: http://grants.nih.gov/grants/olaw/references/elec_protocol_sys.htm.
7th National Symposium on Biosafety in Atlanta in JanuaryPosted November 20, 2001
The Office of Laboratory Animal Welfare/NIH (OLAW) and the Centers for Disease Control and Prevention (CDC) will co-sponsor the 7th National Symposium on Biosafety, entitled, "Managing Risk in Animal Care and Use," in Atlanta, Georgia, on January 26-30, 2002. Additional co-sponsorship commitments have been received from the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC), the American Association for Laboratory Animal Science (AALAS), the American College of Laboratory Animal Medicine (ACLAM), the Animal and Plant Health Inspection Service/USDA (APHIS), the American Society of Laboratory Animal Practitioners (ASLAP), the Institute for Laboratory Animal Research/NRC/NAS (ILAR), the Lab Animal Magazine, Scientists Center for Animal Welfare (SCAW), the University of Georgia, the Agricultural Research Service/USDA, the Yerkes Primate Research Center, and others. This education program will focus on managing hazards in the animal facility, animal facility design, safeguarding the U.S. against foreign animal diseases, and working with genetically modified animals. The conference agenda and a registration form are available at the contractor's website: http://www.eagleson.org/home.htm .
February Conference on Mouse Transgenics in Houston, TexasPosted November 8, 2001
The Baylor College of Medicine (BCM) will present Co-Conferences: "Care and Characterization of Genetically Engineered Mice" and "Comparative Pathology in Functional Genomics," on February 12-16, 2002, at Cullen Auditorium, BCM, in Houston, TX. The C.L. Davis Foundation for the Advancement of Veterinary and Comparative Pathology of BCM has received sponsorship commitments from the University of Texas Health Science Center at Houston, the University of Texas MD Anderson Cancer Center, and the Office of Laboratory Animal Welfare/NIH. The interactive format will include lectures, demonstrations, case presentations, and poster presentations. Attendees are invited to present a Poster or a 15-minute Case Report on an interesting case involving a mutant animal model or potential model.
Conference agenda and a registration form is available at: http://www.afip.org/CLDavis/CLDavis.meetings.htm#transgenics
January IACUC 101 Training Session Offered in HawaiiPosted October 29, 2001
On January 23, 2002, the Applied Research Ethics National Association (ARENA) in conjunction with the University of Hawaii at Manoa, the NIH Office of Laboratory Animal Welfare (OLAW), and Qualiti Laboratories will present ARENA IACUC 101. IACUC 101 is a full day didactic and interactive course. Participants will receive an extensive Resources Manual plus other valuable reference materials and information. The session will be held in Honolulu, Hawaii, on January 23, 2002. Announcement and registration information are posted at: http://grants.nih.gov/grants/olaw/Hawaii.htm.
December 10-11 Workshop on IACUC Education and Animal Well-BeingPosted October 29, 2001
The Scientists Center for Animal Welfare (SCAW) Winter Conference - Advancing IACUC Education and Research Animal Well-Being - will be held December 10-11, 2001, in San Antonio, Texas, and cosponsored by the University of Texas Health Science Center at San Antonio and the NIH Office of Laboratory Animal Welfare (OLAW). The SCAW workshop will include topics such as alternatives literature searches, regulatory burden, USDA coverage of rats, mice and birds, new refinement technologies, the effect of international standards, and psychological well-being of nonhuman primates. There will be a reception the evening of December 10 for participants. Conference agenda and a registration form are available at the SCAW website: http://scaw.com/conference.htm .
OLAW and APHIS Comment on Lab Animal Column Regarding IACUC Minutes and Use of AudiotapesPosted September 24, 2001
The September 2001 Lab Animal Protocol Review column (30(8):21-23), "Did an Audiotape Squirrel Away the Minutes?" addresses the PHS Policy and USDA animal welfare regulatory requirement for IACUC minutes, particularly with regard to Committee deliberations. The OLAW Director and APHIS, Animal Care Deputy Administrator provide clarification and guidance of this requirement, and comment on the use of audiotape in lieu of a written summary. The column is posted at: http://grants.nih.gov/grants/olaw/references/laba01v30n8.htm.
NC ARENA IACUC 101 RescheduledPosted September 24, 2001
The canceled September 13, 2001 ARENA IACUC 101 course has been rescheduled for Tuesday, November 27, 2001. It will take place as originally planned at the Sheraton Imperial Hotel & Convention Center, Research Triangle Park, NC 27709.
PREVIOUSLY REGISTERED INDIVIDUALS - FIRST PRIORITY will be given to those individuals who were registered for the September 13 program. Those individuals must contact Kathryn Byrd at 919-513-6421 or Samantha Hartford at 919-513-6259 by October 1 to confirm their place. On October 2 the course will be open to individuals not previously registered. If unable to attend the November 27 program, please contact Kathryn Byrd or Samantha Hartford so they may begin the process of reimbursement.
Participants must make their own hotel reservations by November 5 in order to obtain the discount rate ($102 single/double with 11% sales tax). The conference hotel is the Sheraton Imperial Hotel & Convention Center, P.O. Box 13099, Research Triangle Park, NC 27709, phone 919-941-5050.
NEW REGISTRANTS - On Tuesday, October 2, the November 27, 2001 course will open to general registration. Interested individuals are welcome to contact Kathryn Byrd at 919-513-6421 or Samantha Hartford at 919-513-6259 before October 2 to be placed on a waiting list. The wait list will be handled in the order that requests are received. Registration forms are available upon request via e-mail from Mary Lou James: email@example.com.
September California Compliance ConferencePosted August 23, 2001
The Office of Laboratory Animal Welfare, along with the USDA Animal and Plant Health Inspection Service, is pleased to co-sponsor the California Society for Biomedical Research September 14 Conference Compliance: The Right Stuff. The Conference will focus on compliance with PHS Policy and related USDA and AAALAC requirements, and will address responsible conduct of research, fostering an institutional culture of compliance, and related topics. The University of California, Davis will host the meeting at the Walter A. Buehler Alumni and Visitors Center. To register go to the Conference web site at http://www.ca-biomed.org/news.html, and scroll down to find a link to the registration form in PDF format. For additional information contact Allison Chilcott at 916-558-1515.
October IACUC 101 Training Session Offered in ConnecticutPosted August 10, 2001
On October 16, 2001, the Applied Research Ethics National Association (ARENA) in conjunction with Yale University, the NIH Office of Laboratory Animal Welfare (OLAW), Southern New England AAALAS, Bayer - Pharmaceutical Division, Bristol-Myers Squibb, Boehringer Ingelheim Pharmaceuticals, Inc., and Pfizer will present ARENA IACUC 101. IACUC 101 is a full day didactic and interactive course. Participants will receive an extensive Resources Manual plus other valuable reference materials and information. The session will be held in New Haven, CT on October 16, 2001. Announcement and registration information are posted at: IACUC 101 - Yale University.
OLAW and APHIS Comment on Lab Animal Column Regarding IACUC Approval of ProtocolsPosted June 22, 2001
The June 2001 Lab Animal Protocol Review column (30(6):18-20) entitled "Is Ad Hoc Approval Enough?" discusses veterinary and IACUC responsibilities and authority for approving anesthetic and analgesic regimens, and approval mechanisms when substantive information necessitating deliberation or IACUC judgment is required. The Director of OLAW and Deputy Administrator of APHIS, Animal Care (AC) provide their comments on the issues raised in the column. The column is posted at: http://grants.nih.gov/grants/olaw/references/laba01v30n6.htm
IACUC 101 Session Cosponsored by Purdue University August 13Posted May 7, 2001
On August 13, 2001, the Applied Research Ethics National Association (ARENA) in conjunction with the Purdue University - West Lafayette, Indiana and the NIH Office of Laboratory Animal Welfare (OLAW) will present ARENA IACUC 101. IACUC 101 is a full day didactic and interactive course. Participants will receive an extensive Resources Manual plus other valuable reference materials and information. The session will be held in West Lafayette, IN on August 13, 2001. Announcement and registration information are posed at: IACUC 101 - Purdue University.
ILAR Workshop on Regulation of Laboratory AnimalsPosted May 1, 2001
The Institute for Laboratory Animal Research (ILAR), National Research Council, National Academy of Sciences will hold a workshop May 21-22, 2001, in the National Academy of Sciences Auditorium, Washington, D.C., as part of a series of ILAR Workshops on Regulatory Issues in Animal Care and Use.
The purpose of this workshop is to determine whether ILAR should conduct a study to make recommendations on consolidating regulations of laboratory animals. Speakers will address current regulations as well as proposed new regulations under the Animal Welfare Act, and highlight current practices for laboratory animal care. Other presentations will focus on possible alternative oversight schemes, animal welfare considerations and legislative issues. The workshop will close with a panel discussion of whether ILAR should conduct a study on evaluation of duplication of regulations, and whether ILAR should make recommendations to achieve a more efficient, less duplicative approach to regulation of laboratory animals that will ensure the best science inextricably linked to the best animal welfare.
June Workshop on IACUCs Presented in NYCPosted April 25, 2001
Columbia University College of Physicians and Surgeons and OLAW will present a workshop entitled Institutional Animal Care and Use Committee 2001: A Research Odyssey, on June 21 and 22, 2001, in New York, New York. The workshop is designed to provide institutional officials, IACUC representatives (chairs, members, administrators and non-affiliates), veterinarians, animal facility supervisors and technicians, principal investigators, postdoctoral students, graduate students, and laboratory technicians with a forum to learn about changes in Federal regulations and to discuss and evaluate effective strategies to enhance performance standards for the humane care and use of animals in research. The workshop web site is: http://cpmcnet.columbia.edu/dept/cme/AnimalCare-2001/Olaw.html
September IACUC 101 Training Session Offered in North Carolina - SOLD OUT!Posted April 25, 2001
On September 13, 2001, the Applied Research Ethics National Association (ARENA) in conjunction with NC State University, the NIH Office of Laboratory Animal Welfare (OLAW), GlaxoSmithKline, Piedmont Research Center, Inc., and CIIT Centers for Health Research, will present ARENA IACUC 101. ARENA IACUC 101 is a full day didactic and interactive course. Participants will receive an extensive Resources Manual plus other valuable reference materials. The session will be held in Research Triangle Park, North Carolina. Announcement and registration information are posted at: ARENA IACUC 101 Training Session Offered in North Carolina.
AVMA Issues Revised Euthanasia ReportPosted April 4, 2001
The 2000 Report of the American Veterinary Medical Association (AVMA) Panel on Euthanasia was issued March 1, 2001 in the Journal of the AVMA (Vol. 219, No. 5). Since the PHS Policy on Humane Care and Use of Laboratory Animals requires IACUCs to use the recommendations of the AVMA Panel on Euthanasia, OLAW has issued a notice in the NIH Guide for Grants and Contracts regarding implementation of the new report.
The NIH Guide notice is posted at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-029.html
The AVMA Panel Report is posted at: http://www.avma.org/issues/animal_welfare/euthanasia.pdf (PDF)
OLAW and APHIS Comment on Innovative Protocol SystemPosted March 20, 2001
The Director of OLAW and Deputy Administrator of APHIS, Animal Care (AC), have written a letter to the Editor of Lab Animal regarding a recent article "An Innovative IACUC Protocol System" (30(2):32-35). While recognizing many positive elements in the system, and that there are circumstances under which the PHS Policy on Humane Care and Use of Laboratory Animals and/or the Animal Welfare Act regulations do not apply, both OLAW and AC find elements of the system to be noncompliant with the federal requirements for protocol review. Because many readers of Lab Animal are subject to these federal requirements, clarification of these inconsistencies is essential. The text of the letter to the Editor is posted at: http://www.labanimal.com/letters/garnett.html
April IACUC Training Opportunity in SeattlePosted March 13, 2001
The Washington Association for Biomedical Research (WABR), the University of Washington, and OLAW are pleased to offer a one-day training opportunity for IACUC members and affiliates on April 17, 2001, in Seattle, Washington. The workshop will include a thorough overview of the functions of an IACUC and the rules, regulations and policies necessary for compliance with federal mandates. It will also include a forum on pain and distress in laboratory animals, and opportunities to meet with colleagues from other statewide organizations. Additional information is available from the WABR website at: http://www.wabr.org/IACUCworkshop.htm, or by contacting Laura at 206-956-3640 or firstname.lastname@example.org.
Clarification of Training Requirement under PHS Policy on Instruction in the Responsible Conduct of ResearchPosted February 14, 2001
The HHS Office of Research Integrity issued the PHS Policy on Instruction in the Responsible Conduct of Research (RCR) in December, 2000 (see http://ori.dhhs.gov/). The RCR Policy includes nine core instructional areas, including one describing research involving animals (#7), as significant in conducting responsible research and ensuring integrity of the research record. OLAW has received a number of inquiries about the RCR Policy relative to the training requirements of the PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy).
If an institution already has as approved Animal Welfare Assurance with OLAW, no additional steps are needed to satisfy the core instructional area of research involving animals in the RCR Policy. Institutions with approved Animal Welfare Assurances have demonstrated compliance with the PHS Policy, as determined by OLAW, and will therefore be in full compliance with the research involving animals core instructional area of the RCR policy. This information appears in Frequently Asked Question #14 on the ORI RCR Policy web site cited above.
Guidance Regarding Administrative IACUC Issues (alternate IACUC members, IACUC review at collaborating institutions) and Regulatory BurdenPosted February 2, 2001
The Office of Laboratory Animal Welfare issued guidance today regarding the use of alternate Institutional Animal Care and Use Committee (IACUC) members, and reminding institutions that there is no federal requirement for duplicate protocol or program review. The notice also cites a Department of Defense Shelf Life Extension Program now recognized by OLAW and USDA, and announces a renewed Memorandum of Understanding (MOU) Concerning Laboratory Animal Welfare with the USDA, FDA, and NIH.
The notice, published in the NIH Guide for Grants and Contracts as Notice OD-01-017, is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-017.html.
IACUC 101, ARENA and PRIM&R Meetings in San DiegoPosted January 29, 2001
On March 24, 2001, the Applied Research Ethics National Association (ARENA), in conjunction with the NIH Office of Laboratory Animal Welfare (OLAW) and the University of California, San Diego (UCSD), will present IACUC 101 http://www.primr.org/iacuc101.html. This one day course is designed to educate those who have responsibility within their institution's animal care program, and will cover the steps necessary for compliance.
On March 25, ARENA will hold its 2001 IACUC Meeting http://www.primr.org/iacucrole.html which will focus on practical solutions for IACUCs as they maintain the balance between assuring animal welfare and facilitating valuable research, testing and teaching.
The 2001 IACUC Conference http://www.primr.org/advscience.html of Public Responsibility in Medicine and Research (PRIM&R), cosponsored by OLAW, AAALAC International, and UCSD, will be held March 26-27. This annual meeting will address innovative ways to manage the balancing act required of IACUCs, attending veterinarians and veterinary staff, institutional administrators, researchers, and those in policy-making positions.
There is one on-line registration (Click Here) that may be used for any of the three meetings. All meetings will all be held at the Paradise Point Resort in San Diego, California.
NIH Issues Reminder of Need for IACUC Approval Prior to Peer ReviewPosted January 10, 2001:
The NIH has published a notice in the NIH Guide for Grants and Contracts to remind the community that there is no change in the NIH policy for submission of IACUC approval when animal studies are involved. IACUC approval is still required of all such applications either when the application is submitted, or within 60 days thereafter; otherwise, the application cannot be peer reviewed. The entire notice, OD-01-008, may be read at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-008.html.
Pain and Distress Workshop Proceedings AvailablePosted January 5, 2001:
Proceedings from an NIH-supported ILAR (Institute for Laboratory Animal Research) workshop held June 22, 2000, on the Definition of Pain and Distress and Reporting Requirements for Laboratory Animals are now available. The proceedings may be read online or ordered from the following website: http://www.nap.edu/catalog/10035.html .
The workshop addressed the existing and proposed USDA requirements for reporting pain and distress in laboratory animals, including several proposed categorization schemes, and USDA's proposed definition of "distress." Workshop participants were also asked to comment upon whether the information contained in the 1992 ILAR report, Recognition and Alleviation of Pain and Distress in Laboratory Animals, is still useful to investigators in assisting them to comply with regulations. The speakers provided perspectives based on their individual expertise in the areas of science of pain and distress, animal welfare policy, protocol review, and/or as representatives of relevant organizations or institutions.
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