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Tim Foley, Ph.D. Department of Chemistry foleyt2@scranton

Scientific Review Committee (SRC): To review and pre-approve projects involving regulated research. Tim Foley, Ph.D. Department of Chemistry foleyt2@scranton.edu. Regulated Research Requiring PRE -Approval. Human subjects Minimal risk only Informed consent required

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Tim Foley, Ph.D. Department of Chemistry foleyt2@scranton

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  1. Scientific Review Committee (SRC): To review and pre-approve projects involving regulated research Tim Foley, Ph.D. Department of Chemistry foleyt2@scranton.edu

  2. Regulated Research Requiring PRE-Approval • Human subjects • Minimal risk only • Informed consent required • Pre-approval by both Institutional Review Board (IRB) and SRC • Vertebrate animals • Observational/non-invasive studies but avoid if possible • Require certification/supervision by a veterinarian • Biological agents • Microorganisms, rDNA, fresh tissues, bodily fluids (no blood) • Must require no more than biosafety level (BSL)-1 • Controlled substances • Hazardous substances or devices

  3. Examples of BSL-1 Projects (see Intel guidelines for specifics) • Classified BSL-1 microorganisms • Unknown Microorganisms BSL-1 if • Cultured in a plastic Petri dish • Petri dish remains sealed during experiment • Some rDNA experiments BSL-1 • BSL-1 organisms • The insert DNA/vector system matters • Fresh tissue/body fluids EXCEPT for blood from non-infectious source w/ little likelihood of microorganisms present

  4. Where to Find Forms and Guidelines • Borrowed from the Intel International Science and Engineering Fair (Intel ISEF) • http://www.scisvc.org/isef/primer/index.asp • The Rules Wizard will identify the forms that are required for you project

  5. What are the Responsibilities of Students and Adults? • Student Researcher • All aspects of the research project • Adult Sponsor • Health and safety of student and any human or animal subjects • Qualified Scientist or Designated Supervisor • Required when Adult Sponsor does NOT have sufficient expertise in the research area

  6. What about Research at a Regulated Institution (university, industry)? • Supervision by a Qualified Scientist • Requires pre-approvals by the relevant institutional review boards • Institutional Review Board • Institutional Animal Care and Use Committee • Biosafety Committee

  7. Forms Required of All Projects • Checklist for Adult Sponsor (1) • Research Plan (1A) and Research Plan Attachment • Approval Form (1B) • Pre-approval signatures where applicable • SRC • Institutional review committees

  8. Project-Specific Forms • Regulated Research Institution Form (1C) • Qualified Scientist Form (2) • Designated Supervisor Form (3) • Human Subjects Form (4) • Vertebrate Animal Form (5A)- non-regulated site • Vertebrate Animal Form (5B)- regulated site • Potentially Hazardous Biological Agents Form (6A) • Human and Vertebrate Animal Tissue Form (6B)

  9. Submitting Forms to SRC • Preferred • Mail complete proposals to: Tim Foley Chemistry Dept Loyola Hall University of Scranton 800 Linden St Scranton, PA 18510 • If required to meet deadline • Fax/email Fax: 941-7510 Email: foleyt2@scranton.edu

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