Scientific Review Committee (SRC): To review and pre-approve projects involving regulated research Tim Foley, Ph.D.

Department of Chemistry [email protected]

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

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 infectious source w/ little likelihood of microorganisms present

EXCEPT

for blood from non-

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

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

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

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

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)

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: [email protected]