Animals Used In Research

1. RESPONSIBLE CONDUCT IN RESEARCH(supported in part by a grant from the National Postdoctoral Association) Animals Used In Research created January, 2009

2. Short pre-test • Presentation Objectives • NIH Comment • background • regulation, policy and Federal Assurance • animals covered by SIT Assurance • SIT institutional processes involved in animal research • timeline of events • ethical considerations • available resources • References • Faculty Presentation • Case Study and Discussion • Short post-test Presentation content RCR – Animal Research created January, 2009

3. NIH COMMENT • “There are many valid reasons for institutions to perform program oversight, institution-wide, using uniform and consistent standards for animal care and use.  Likewise, it is generally impractical to separate activities based on the source of funding.  Institutions must implement the PHS Policy for all PHS supported activities involving animals, and must ensure that any standards that might not be consistent with PHS Policy do not affect or pose risks to PHS supported activities.” • National Institutes of Health – Office of Extramural Research (1) RCR – Animal Research created January, 2009

4. BACKGROUND • As scientific knowledge increased through the centuries, so did a general sensibility toward animals. This relationship, ambiguous and often paradoxical, is not static and mirrors philosophic and societal changes… • ___ North Carolina State University, “Contemporary Science, Values and Animal Subjects in Research”(2) • “For example, when planning a surgical procedure involving a rabbit, one must decide on the type and dose of anesthetic to be used. This decision is determined by professional judgment, published recommendations and consultation with the appropriate animal experts. It is also strongly influenced by the formal rules and policies that govern the use of animals in research. On the other hand, the decision to use a rabbit in the first place has both pragmatic and moral components.” • ___ (Fuchs, in Scientific Integrity: an Introductory Text with Cases -- Francis Macrina, Editor, P. 17)(3) RCR – Animal Research created January, 2009

5. Regulation, policy and federal assurance “Animal Welfare Act” and Regulations Animal Welfare Information CenterUnited States Department of AgricultureAgricultural Research ServiceNational Agricultural Library • Ques. & Answers about Animal Welfare Act & Its Regulations for Biomedical Research Institutions • Animal Welfare Act as Amended (7 USC, 2131-2159) [Summary](4) • Public Law 89-544 - Animal Welfare Act of August 24, 1966 [Full Text, Summary • Public Law 91-579 - Animal Welfare Act Amendments of 1970 [Full Text, Summary] • Public Law 94-279 - Animal Welfare Act Amendments of 1976 [Full Text, Summary] • Public Law 99-198 - Food Security Act of 1985, Subtitle F - Animal Welfare [Full Text, Summary] • Public Law 101-624 - Food, Agriculture, Conservation, and Trade Act of 1990, Section 2503 - Protection of Pets [Full Text, Summary] RCR – Animal Research Stevens’ Institutional Policy “Animals Used in Research and Teaching” Stevens’ Federal Assurance negotiated with National Institutes of Health, Office of Laboratory Animal Welfare (NIH OLAW) – A4442-01 created January, 2009

6. animals covered by assurance(AND TYPICALLY USED AT Stevens) Rodent LIVING VERTEBRATES RCR – Animal Research Fish Amphibians created January, 2009

7. SIT Institutional processes in animal research ANY USE OF ANIMALS AT SIT REQUIRES IACUC APPROVAL RCR – Animal Research created January, 2009

8. SIT Institutional processes in animal research (cont.) ANY USE OF ANIMALS AT SIT REQUIRES IACUC APPROVAL • Protocols are rigorously scrutinized • Protocols are not transferred from one institution to another • Protocols are usually issued for a three year period – annual renewals required • “APPROVAL” on a protocol does not ensure unconditional approval when it is re-reviewed • Number of animals are strictly controlled • Numbers to be used justified in IACUC protocols • Numbers approved for purchase is compared to protocol • Numbers used for protocol is reported and inventoried • Any animals ordered, but not used, are accounted for and returned to control of IACUC • No animals are “left over” RCR – Animal Research created January, 2009

9. Timeline of events NIH, the most common federal agency to which PI’s would submit research proposals that might include animal models, typically has three submission cycles each year. The timeline shown below is offered to help with planning the preparation and submission of various required materials: RCR – Animal Research SIT IACUC review process Feb. 5 Proposal Deadline = mid January FSC Deadline Mar-Apr = protocol submitted to SIT IACUC Sep-Oct Council Review = full SIT IACUC approval submitted for JIT PROPOSAL SUBMISSION Cycle 1 Cycle2 Cycle 3 Feb 5 June 5 Oct 5 PEER REVIEW Cycle 1 Cycle 2 Cycle 3 Jun-Jul Oct-Nov Feb-Mar COUNCIL REVIEW Cycle 1 Cycle 2 Cycle 3 Sep-Oct Jan-Feb May-Jun EARLIEST FUNDING Cycle 1 Cycle 2 Cycle 3 Dec. April July PROPOSAL SUBMISSION Cycle 1 Cycle 2 Cycle 3 Feb. 5 June 5 Oct. 5 created January, 2009

10. Be aware of the need for Institutional Animal Care and Use Committee review and approval • -- required for use of all living, vertebrate animals. ‘Exempt’ is a category, it does not imply an investigator is ‘exempt’ from the application process • Be certain you know what animals are included in the categories of “…living vertebrates.” • --Fish….Amphibians….Rodents (typical animal models used at SIT). Vertebrates also include reptiles, birds, mammals, primates, marsupials, whales and dolphins and seals • Be sensitive to the number of animals proposed for use • -- minimus use….no more animals than needed • Alternative models • -- always consider whether an alternative model will suffice. See @LT Web at: http://altweb.jhsph.edu/searchaltdata.htm Ethical considerations RCR –Animal Research created January, 2009

11. Available resources • Office of Sponsored Research • Can provide assistance and direction for investigators contemplating animal research • 201.216.8762 – Barbara DeHaven, Executive Director • Institutional Animal Care and Use Committee • Questions for the IACUC may be sent to Barbara DeHaven, Executive Director of Sponsored Research. All questions and requests for assistance will be forwarded to the IACUC Chair RCR – Animal Research created January, 2009

12. National Institutes of Health – Office of Research Integrity • http://ori.dhhs.gov/ • North Carolina State University, “Contemporary Science, Values and Animal Subjects in Research” • http://ori.dhhs.gov/education/products/ncstate/index.htm • Fuchs, in Scientific Integrity: an Introductory Text with Cases -- Francis Macrina, Editor, P. 17 • Animal Welfare Act as Amended (7 USC 2131-2156) • http://www.nal.usda.gov/awic/legislat/awa.htm • “PHS Policy on Humane Care and Use of Laboratory Animals Tutorial” • -- Office of Laboratory Animal Welfare http://grants.nih.gov/grants/olaw/tutorial/index.htm • “The Ethics of Research Involving Animals” • -- Nuffield Council on Bioethics http://www.nuffieldbioethics.org/go/ourwork/animalresearch/introduction • “Laboratory Animal Training Association” http://www.latanet.com/ Reference material RCR – Animal Research created January, 2009

13. Faculty presentation Dr. Phil Leopold – University Professor RCR – Animal Research created January, 2009

14. At the beginning of January, Dr. Smith is working frantically to finish an NIH proposal in time for a June 1 submission date. She has recently had a break-through in test results from another project that could have implications for this current proposed project, but is certain a few more animals tests will yield data that would make the proposal almost sure to be funded. There are a few mice left from a previously approved (but unrelated) animal protocol. Dr. Smith is an experienced investigator and has used animals for many years while serving as a post-doc in another lab and is coming up for tenure next year Consider the following questions: CASE STUDY RCR –Animal Research created January, 2009

15. Q: Is the question as to why there are animals left in Dr. Smith’s lab from another project, one of ethics or regulation? CASE STUDY(cont.) A: Both. Separate protocols are submitted, reviewed, modified (if needed) and approved for each project. Protocols specify the number of animals to be used and those animals are accounted for at many points in the project, i.e., animals are not left over from projects to be used at a later date on un-reviewed projects. Under no circumstances can research on animals ever begin before the investigator submits a protocol and receives an unqualified approval from the IACUC. EXPLANATORY NOTE: Sometimes, research results will indicate a change in hypothesized direction. Thus, animals originally planned for use in a research design, may not be needed. Naïve animals may be turned in to the veterinarian to be held in an institutional protocol but individual investigators do NOT have animals ‘left over.’ RCR –Animal Research created January, 2009

16. Q: Dr. Smith knows that it may take 1-2 months to prepare, submit, respond to IACUC questions and concerns and ultimately receive approval. Since this will leave almost no time to actually perform the animal tests, analyze the results and include the data in the June 1 proposal is there any alternative to conducting the animal tests outside the required process? CASE STUDY(cont.) RCR –Animal Research A: The IACUC observes a posted schedule of submission and review dates; however, accommodation is extended to try and assist investigators as much as possible. created January, 2009

17. Q: What circumstances would lead an investigator to be certain that funding would result from additional test results? Is this an adequate justification for Dr. Smith’s proposed course of action? CASE STUDY(cont.) RCR –Animal Research A: The certainty of a federal award as the result of a proposal is non- existent. Previous submissions may indicate a high likelihood of funding; however, jeopardizing a scientific career based on such a possibility is a rash and unethical course of action. created January, 2009

18. Q: Are there any laws, regulations, or institutional policies that may apply to this situation? CASE STUDY(cont.) A: Any research that involves the use of animals, whether funded or unfunded, are subject to the terms and conditions of the Animal Welfare Act. Ignoring the requirements could result in the suspension of all funded research at Stevens. Additionally, the university has an institutional policy that addresses the use of animals in research, as well as a federal Assurance that is a negotiated contract that describes the use of animals at the university. RCR –Animal Research created January, 2009

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