Human Biological Materials definition

Human Biological Materials means material from a human being including but not limited to Deoxyribonucleic Acid (DNA), Ribonucleic Acid (RNA), blastomeres, polar bodies, cultured cells, embryos, gametes, progenitor stem cells, tissues and growth factors and any modifications or derivatives thereof Human Research Ethics Committee (Medical) University of the Witwatersrand, Johannesburg (HREC): means the Human Research Ethics Committee (Medical) of the University of the Witwatersrand, Johannesburg which is registered with the South African National Health Research Ethics Council, whose purpose is to review and, where the proposals meet the ethical standards of the committee, approve all health research protocols4 Intellectual Property Rights: means statutory and other proprietary rights resulting from creations of the human mind such as copyright, patents, scientific works, discoveries and trademarks Informed Consent: Materials means an on-going information sharing process which allows a Donor to consent to participate and determine whether and how their Materials will be utilised in the Project, as approved by the HREC from time to time means Human Biological Materials and Data Parties: means the Provider and the Recipient in this Agreement Project: means the health research project for which the Materials will be used hereunder Research Results: means all products of the research, whether tangible or intangible Secondary Use: means use of the Materials for health research purposes other than the uses determined in the approved protocol. Secondary uses must be approved by the HREC5 Signature Date: means the effective date subject to clause 7
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Human Biological Materials means human tissues, organs, blood, plasma, serum, DNA, RNA, proteins, cells, skin, hair, nail clippings, urine, saliva and other body fluids, embryos, fetuses, fetal tissues, reproductive materials and stem cells.
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Human Biological Materials means material from a human being, including but not limited to Deoxyribonucleic Acid (DNA), Ribonucleic Acid (RNA), blastomeres, polar bodies, cultured cells, embryos, gametes, progenitor stem cells, tissues and growth factors and any modifications or derivatives thereof;
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Examples of Human Biological Materials in a sentence

  • Compliance with the recommendations of the NIH Office of Human Subject Research Medical Administrative Series (MAS) #MO1-2 entitled “Procurement and Use of Human Biological Materials for Research,” and any other federal or state requirements.

  • Research Involving Human Biological Materials: Ethical Issues and Policy Guidance.

  • The SOP does not cover detailed safety procedures for handling Human Biological Materials (HBMs) or hazardous chemicals and it is recommended that personnel follow institutional safety guidelines.

  • The Regulation of the Transborder Transfer of Human Biological Materials for Clinical Trials: A Case Study of Kenya.

  • Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity (NBAC 1998), Ethical Issues in Human Stem Cell Research (NBAC 1999a), Research Involving Human Biological Materials: Ethical Issues and Policy Guidance (NBAC 1999b), and Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries (NBAC 2001).

  • The Material Transfer Agreement (MTA) of Human Biological Materials, 2018,[4] and the National Department of Health ethics guidelines, 2015,[5] do have some provisions for the transfer of data.The GDPR and POPIA will change the abovementioned infor-mation.

  • Compliance with the recommendations of the NIH Office of Human Subject Research Medical Administrative Series (MAS) #M01-2 entitled “Procurement and Use of Human Biological Materials for Research,” and any other applicable federal or state requirements pertaining; to the procurement and use of human biological material for research.

  • Co-enrollment in A5128, “Plan for Obtaining Informed Consent to Use Stored Human Biological Materials (HBM) for Currently Unspecified Analyses,” does not require permission from the 1077HS protocol chairs.

  • These samples may also be called “anonymous.” See GUIDANCE: IRB Review of Research using Human Biological Materials (HRP-087).

  • These samples may also be called “anonymized.” See GUIDANCE: IRB Review of Research using Human Biological Materials (HRP-087).


More Definitions of Human Biological Materials

Human Biological Materials means ‘material from a human being, including DNA, RNA, blastomeres, polar bodies, cultured cells, embryos, gametes, progenitor stem cells, small tissue biopsies and growth factors from the same’ (Regulation 177 GG 35099 2 March 2012); blood and blood products are also included (Regulation 180 GG 35099 2 March 2012).
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Human Biological Materials means Material from a human being including but not limited to Deoxyribonucleic Acid (DNA), Ribonucleic Acid (RNA), blastomeres, polar bodies, cultured cells, embryos, gametes, progenitor stem cells, tissues and growth factors and any modifications or derivatives thereof;
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Human Biological Materials means any fluid, tissue or other material obtained from a human subject and derivatives thereof that contain patient identifiable material. Such derivatives include, but are not limited to, genomic DNA and cells populations derived from such tissues or fluids.
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Human Biological Materials means material from a human being including but not limited to Deoxyribonucleic Acid (DNA), Ribonucleic Acid (RNA), blastomeres, polar bodies, cultured cells, embryos, gametes, progenitor stem cells, tissues and growth factors and any modifications or derivatives thereof Research Ethics Committee: Intellectual Property Rights: means a Research Ethics Committee (REC) which is registered with Committee the South African National Health Research Ethics Council; means statutory and other proprietary rights resulting from creation of the human mind such as copyright, patents, scientific works, discoveries and trademarks; Informed consent: means a formal agreement that a Donor (with legal capacity to do so) signs to give permission for donation of Materials, after being informed about the project and includes an on -going information sharing process which allows a Donor to consent to participate and determine whether and how their Materials will be utilised in the Project, as approved by the REC from time to time; Materials: means Human Biological Materials and Data;
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Human Biological Materials shall have the meaning set forth in Section 4.6.
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Related to Human Biological Materials

  • Biological Materials means certain tangible biological materials that are necessary for the effective exercise of the Patent Rights, which materials are described on Exhibit A, as well as tangible materials that are routinely produced through use of the original materials, including, for example, any progeny derived from a cell line, monoclonal antibodies produced by hybridoma cells, DNA or RNA replicated from isolated DNA or RNA, recombinant proteins produced through use of isolated DNA or RNA, and substances routinely purified from a source material included in the original materials (such as recombinant proteins isolated from a cell extract or supernatant by non-proprietary affinity purification methods). These Biological Materials shall be listed on Exhibit A, which will be periodically amended to include any additional Biological Materials that Medical School may furnish to Company.

  • Biological Material means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system;

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • Manufacturing Know-How means all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.

  • Contractor Materials means Materials owned or developed prior to the provision of the Work, or developed by Contractor independently from the provision of the Work and without use of the JBE Materials or Confidential Information.

  • Manufacturing Technology means any and all patents, patent applications, know-how, and all intellectual property rights associated therewith that are owned or controlled by Licensor, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno-associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Biological agent shall mean any pathogenic (disease producing) micro-organism(s) and/or biologically produced toxin(s) (including genetically modified organisms and chemically synthesized toxins) which cause illness and/or death in humans, animals or plants.

  • Supplier Materials has the meaning given in clause 8.1(h).

  • Study Materials means all the materials and information created for the Study, or required to be submitted to the Sponsor including all data, results, Biological Samples, Case Report Forms (or their equivalent) in whatever form held, conclusions, discoveries, inventions, know-how and the like, whether patentable or not, relating to the Study, which are discovered or developed as a result of the Study, but excluding the Institution’s ordinary patient records.

  • Active Pharmaceutical Ingredient or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”), tenofovir disoproxil fumarate (“TDF”), elvitegravir (“EVG”), and cobicistat (“COBI”).

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • Program Materials means the documents and information provided by the Program Administrator specifying the qualifying EEMs, technology requirements, costs and other Program requirements, which include, without limitation, program guidelines and requirements, application forms and approval letters.

  • Controlled technical information means technical information with military or space application that is subject to controls on the access, use, reproduction, modification, performance, display, release, disclosure, or dissemination. Controlled technical information would meet the criteria, if disseminated, for distribution statements B through F using the criteria set forth in DoD Instruction 5230.24, Distribution Statements on Technical Documents. The term does not include information that is lawfully publicly available without restrictions.

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.

  • Licensed Technology means the Licensed Patents and the Licensed Know-How.

  • IP Materials has the meaning given to it in clause E8.1 (Intellectual Property Rights).

  • Therapeutic school means a residential group living facility:

  • SAP Materials means any materials (including statistical reports) provided, developed or made available by SAP (independently or with Customer’s cooperation) in the course of performance under the Agreement, including in the delivery of any support or Professional Services to Customer. SAP Materials do not include the Customer Data, Customer Confidential Information or the Cloud Service. SAP Materials may also be referred to in the Agreement as “Cloud Materials”.

  • Product Technology means the Product Know-How and Product Patents.

  • Promotional Materials means all sales representative training materials and all written, printed, graphic, electronic, audio or video matter, including, without limitation, journal advertisements, sales visual aids, formulary binders, reprints, direct mail, direct-to-consumer advertising, internet postings and sites and broadcast advertisements intended for use or used by either Party or its Affiliates or sublicensees in connection with any promotion of a Product.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Confidential Materials means all tangible materials containing Confidential Information, including without limitation written or printed documents and computer disks or tapes, whether machine or user readable.

  • Regulatory Materials means regulatory applications, submissions, notifications, registrations, Marketing Authorizations or other written materials, correspondence, submissions made to or with a Regulatory Authority that are necessary or reasonably desirable in order to Develop, Manufacture or Commercialize the Licensed Products in the Field in a particular country.

  • Developed Materials means Materials created, made, or developed by Contractor or Subcontractors, either solely or jointly with the Judicial Branch Entities or JBE Contractors, in the course of providing the Work under this Agreement, and all Intellectual Property Rights therein and thereto, including, without limitation, (i) all work-in-process, data or information, (ii) all modifications, enhancements and derivative works made to Contractor Materials, and (iii) all Deliverables; provided, however, that Developed Materials do not include Contractor Materials.

  • Licensed Compounds means: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).

  • Customer Materials any materials, data, information, software, equipment or other resources owned by or licensed to You and made available to Us pursuant to facilitating Your use of the Services, including Customer Data.