{"id":1247,"date":"2022-05-25T13:12:04","date_gmt":"2022-05-25T17:12:04","guid":{"rendered":"https:\/\/research.ncsu.edu\/administration\/?page_id=1247"},"modified":"2026-02-16T10:49:13","modified_gmt":"2026-02-16T15:49:13","slug":"guideline-for-blanket-protocols","status":"publish","type":"page","link":"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/iacuc\/iacuc-procedures-and-guidance\/guideline-for-blanket-protocols\/","title":{"rendered":"Standard on the Use of Blanket Protocols"},"content":{"rendered":"\n\n\n\n\n<h2 class=\"wp-block-heading\">Purpose<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Blanket protocols cover studies such as non-invasive and non-painful use of food animals for feed\/ nutrition studies, genetic studies or production activities\u00a0 in which the study design is similar but different drugs, agents or feeds may be given to the animals for evaluation.<br><br>Pharmacokinetic studies for drug evaluation (Absorption, Distribution, Metabolism, excretion) may also qualify for a blanket protocol but the protocol must be specific similar classes of PK studies with specific routes of administration not all encompassing of every route or not specific to a class of drug being tested (pharmaceutical agents must be separated by class, analgesia, antibiotics, etc.)<br>\u00a0<br>Novel experimental agents would require a separate protocol.<br><br>If details of animal use are not available at the time of initial application submission, then the application should indicate specifically what additional information will be provided as an amendment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Scope<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">All persons involved with the care and\/or use of animals in research and\/or teaching at the University including, but not limited to Principal Investigators, researchers, animal handlers, and students.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Standard<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The IACUC requires a complete description of the animal-use activity. This description includes:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>A central aim (i.e. drug class for pK studies, infectious disease category for vaccine efficacy studies, nutritional class for dietary studies, etc.)<\/li>\n\n\n\n<li>The procedures performed with\/on animals<\/li>\n\n\n\n<li>Clear and timely study endpoints, to include maximum age or duration an animal may be on the blanket protocol prior to disposition<\/li>\n\n\n\n<li>Euthanasia methods<\/li>\n\n\n\n<li>Humane endpoints&nbsp;<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">The individual experimental details will be supplied by completing an amendment to the protocol&nbsp; including the study specific details, which must be submitted and must be reviewed and approved by the IACUC before an animal activity begins.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The details of the experimental treatments: specific therapeutics\/intervention to be tested; dosages (volume and mg\/kg) and routes of administration;&nbsp;<\/li>\n\n\n\n<li>Dietary manipulations;&nbsp;<\/li>\n\n\n\n<li>Sampling methods and maximum frequencies<\/li>\n\n\n\n<li>Justification of animal numbers for the specific study based on the general&nbsp; experimental design<\/li>\n\n\n\n<li>Clear and timely study endpoints, to include maximum age or duration an animal may be on the blanket protocol prior to disposition<\/li>\n\n\n\n<li>Humane endpoints related to the experiment&nbsp;<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">For each amendment submitted, the IACUC chair decides whether the proposed changes are \u201csignificant.\u201d The decision is based on this IACUC guideline: <a href=\"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/iacuc\/iacuc-procedures-and-guidance\/review-procedures-for-significant-changes-in-an-approved-protocol\/\">Review Procedures for Significant Changes in an Approved Protocol<\/a>.<\/p>\n\n\n<div class=\"layout-one-column is-text wp-block-ncst-link-list\">\n        <ul class=\"link-list__container\">\n      \n<li class=\"ncst-component__bold-link-container wp-block-ncst-bold-link\">\n      <a \n      href=\"https:\/\/drive.google.com\/file\/d\/1LNKsG-qCDfdEJe66ITg4QI08T97LXu1p\/view?usp=sharing\"\n      class=\"ncst-component__bold-link text-link\"\n                >\n    <span class=\"text\">View standard as PDF<\/span><span class=\"arrow-indicator\"><svg class=\"wolficon wolficon-arrow-right-bold\" role=\"img\"  aria-hidden=\"true\">\n\t\t\t\n\t\t\t<use xlink:href=\"#wolficon-arrow-right-bold\">\n\t\t<\/svg><\/span>\n    <\/a>\n      <\/li>\n  \n\n    <\/ul>\n  <\/div>\n\n\n<div class=\"is-text wp-block-ncst-buttons\">\n    \n<div class=\"is-style-secondary wp-block-ncst-button\">\n      <a\n        class=\"ncst-block__button-link btn\"\n        href=\"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/iacuc\/\"\n        data-ncst-lightbox=\"false\"\n                      >\n                  <span class=\"text\">Return to IACUC Homepage<\/span><span class=\"arrow-indicator\"><svg class=\"wolficon wolficon-arrow-right-bold\" role=\"img\"  aria-hidden=\"true\">\n\t\t\t\n\t\t\t<use xlink:href=\"#wolficon-arrow-right-bold\">\n\t\t<\/svg><\/span>\n              <\/a>\n    <\/div>\n  \n\n  <\/div>\n","protected":false},"excerpt":{"rendered":"<p>Purpose Blanket protocols cover studies such as non-invasive and non-painful use of food animals for feed\/ nutrition studies, genetic studies or production activities\u00a0 in which the study design is similar&hellip;<\/p>\n","protected":false},"author":16,"featured_media":0,"parent":1180,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"source":"","ncst_custom_author":"","ncst_show_custom_author":false,"ncst_dynamicHeaderBlockName":"ncst\/default-header","ncst_dynamicHeaderData":"{\"pageIntro\":\"This standard defines\/describes\u00a0 \u201cblanket\u201d approval for animal use where procedures can be described but specific treatments and\/or animal numbers are not yet determined.\u00a0\"}","ncst_content_audit_freq":"","ncst_content_audit_date":"","ncst_content_audit_display":false,"ncst_backToTopFlag":"","footnotes":""},"tags":[],"class_list":["post-1247","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - 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