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– 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 EXCEPT for blood from non-infectious source w/ little likelihood of microorganisms present

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 FoleyChemistry DeptLoyola HallUniversity of Scranton800 Linden StScranton, PA 18510

• If required to meet deadline– Fax/email

Fax: 941-7510Email: foleyt2@scranton.edu