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