Download Cheat Sheet for Reviewing Potentially Hazardous Biological Agent

Cheat Sheet for Reviewing Potentially Hazardous Biological Agent (PHBA) Projects
Research Plan:
- Must address following issues (see Research Plan Instructions for guidelines)
o Type of organism used, including source
o Risk assessment (including determination of biosafety level)
o Location of experimentation
 If the experiment was performed at home, it must be clear that no culturing
took place or that the experiment was terminated at the first signs of
growth (e.g., mold).
 If the experiment involved culturing organisms, the location of the
experimentation and the appropriate biosafety level precautions must be
outlined.
o Method of disposal: an approved method (e.g., autoclaving, disinfection with a
known and approved antimicrobial) must be specifically mentioned.
o Projects involving recombinant DNA (rDNA) should also include a description of the
genes introduced into the microbe (both the gene of interest and any antibiotic
resistance).
o Projects involving tissue (including primary cell cultures) should state that the
student had no interaction with either the animal or the human donor. Otherwise,
the project is also subject to vertebrate and human studies regulations.
- Bibliography: Must include five (Junior and Senior) or three (Elementary) references.
Form 1B – Approval Form
- Section 2: 2a OR 2b must be signed & dated.
- For 2a, confirm that the Date of Approval from local SRC was PRIOR to experimentation.
- For 2b, must also include Form 1C (Regulated Research Institution).
- Section 3: must be signed & dated (dated AFTER experimentation).
Form 2 – Must be completed if: the work involved an organism rated BSL2 or higher and/or the work
was completed at a regulated research institution.
Form 3 – Most PHBA projects will require a completed Form 3. Exceptions are LIMITED TO projects
involving: brewer’s or baker’s yeast (Saccharomyces cerevisiae) unless it is used with rDNA;
Lactobacillus, Bacillus thurgensis, nitrogen-fixing bacteria, oil-eating bacteria, and algae-eating bacteria
introduced into their natural environment (unless they are cultured); and mold growth studies that are
terminated at the first signs of mold.
PHBA-Specific Forms:
PHBA Risk Assessment Form (6A): for projects involving microorganisms, rDNA, fresh/frozen tissue,
blood, and body fluids.
- Fields 1-5 at the top must be completed.
- Qualified Scientist/Designated Supervisor box: the appropriate person (listed on Form 2)
must fill out fields 1-3 and sign.
- SRC Approval Section: must be completed BEFORE OR AFTER experimentation (check date,
and verify that it agrees with Form 1B).
o
o
If the third box in this section is checked, the appropriate approval forms from the
Research Institution must be attached.
Must be signed by the approving SRC.
Human and Vertebrate Animal Tissue Form (6B): for projects using fresh/frozen tissue, primary cell
cultures, blood, blood products, and body fluids
- Fields 1-2 must be completed.
- Field 3 must be completed if the tissue was obtained from a regulated research institution.
If so, appropriate approvals from the institution must be attached.
- The Qualified Scientist or Designated Supervisor must complete the box on the bottom.
NEW FOR 2013:
1. NCSEF: We are allowing microbiology culturing projects for ELEMENTARY students IF they
use Brewer’s/Baker’s Yeast (Saccharomyces cerevisiae) or Lactobacillus spp.
(yogurt/buttermilk cultures). ALL OTHER CULTURING RULES AND RESTRICTIONS STILL APPLY.
2. NCSEF: Elementary students can also do decomposition/composting experiments IF they do
not culture anything and IF the experiment is terminated at the first visible signs of
microbial growth (not really a new rule, but a new website clarification).
3. NCSEF: To prevent disqualification of responsibly conducted projects that would not be
disqualified at the ISEF level, we will use the definition of “culturing” used by ISEF, which
involves concerted, deliberate growth of concentrated microorganisms (does not involve
incidental growth of microorganisms in water, mud, etc.).
4. ISEF: Studies involving decomposition of vertebrate organisms (forensics studies) require a
Form 3. This is a new ISEF rule; I think we were already requiring a Form 3 for anything like
this.
5. ISEF: HUMAN and PRIMATE primary and established cell lines and tissue cultures are to be
treated as PHBAs. Thus, they now require all the forms and approvals involved (Form 3,
Form 6A, Form 6B if applicable, and IRB approval if necessary).