Rules and Guidelines

1. Rules and Guidelines

2. ScienceMONTGOMERY Rules that differ from ISEF Rules • A signed Informed parental consent Form is required for every Human Subject under 18 years of age. Use Form 4 (p. 36). An adult must be present to supervise all work with human subjects. • ScienceMONTGOMERY uses Categories that are different than ISEF and Team Projects are judged in the categories with the Individual projects. ScienceMONTGOMERY Overview on the website lists the categories. • Your Abstract may be submitted in your own format; the Abstract Form in the Rules Wizard, online, is a guide, not a requirement for ScienceMONTGOMERY. (The ISEF signature page is not required and your Abstract will not be “Embossed” as “Official” by ScienceMONTGOMERY) Post the Abstract on the display board. We suggest you also leave ten copies on the table in front of your display for Judges’ use. • Form 1C Regulated Research Institutional/Industrial Setting must be submitted if appropriate, but must NOT be displayed with your Project. • Submit a printout of your registration page with appropriate signatures.

3. Adult Roles and Responsibilities: Oversee the student’s project • Adult Sponsor-oversees student’s project • Qualified Scientist-Professional degree related to research involving procedures/materials regulated by law • Designated Supervisor-when no QS to supervise projects using hazardous chemicals, activities or devices • Required for all human subjects projects • AS, and DS or QS can be one person, with the highest level of credentials required by the project. • IRB • SRC

4. IRB (Institutional Review Board) • Must review human subject studies before experimentation begins. • Membership • science teacher • school administrator • someone knowledgeable about evaluating risk: MD, PA, RN, psychiatrist, psychologist, licensed social worker. IRB may be set up by a school or individual, or sent to ScienceMONTGOMERY before Dec. 1, for review. (No one on the IRB may be part of the student’s project.)

5. SRC (Scientific Review Committee) • Must review Vertebrate & Potentially hazardous biological agents projects before experimentation begins • SM SRC reviews all projects just prior to competition • Membership • biomedical scientist (Ph.D., M.D., D.V.M., D.D.S., D.O.) • science teacher • one other member SRC may be set up by a school or individual or submitted to ScienceMONTGOMERY before Dec. 1, for review. No one on the SRC may be part of a student’s project.

6. Safety First at ScienceMONTGOMERY • 4 categories require extra safety precautions: • Human Subjects-must be approved before work is begun • Vertebrate Animals- “ “ “ • Potentially Dangerous Biological Agents- “ • Hazardous Chemicals, Activities or Devices

7. Human Subjects • Human Subjects studies • Intervention or interaction with subjects and/or • Identifiable private information • NotHuman Subjects studies • Review of publicly available data • Observations at unrestricted public settings

8. Risk activities (more than minimal risk) requires extra caution & supervision • Exercise • Ingestion • Emotional stress – survey, stimuli • Invasion of privacy • Breech of confidentiality

9. Written Informed consent is required • Most human subjects projects • When more than minimal risk • If IRB determines that potentially there could be emotional stress • When subjects belong to risk group • All work done with subjects under the age of 18 requires written parental permission.

10. Vertebrate Animals(more than just a backbone!)

11. What is a vertebrate animal at ScienceMONTGOMERY? • Live, nonhuman vertebrate mammalian embryos or fetus • Bird and reptile eggs within 3 days of hatching • All other nonhuman vertebrates at hatching or birth

12. Prohibited vertebrate studies • Any treatment with a tendency to be hazardous to health • Behavioral experiments with • Operant conditioning with aversive stimuli • Mother/infant separation • Induced/learned helplessness • Studies of pain • Predator/prey experiments

13. Studies at Regulated Research Institutions • Must be approved by committee(s) that approve all other vertebrate studies at the institution. Turn in copies of approvals to ScienceMONTGOMERY. • Experimentation must also follow ISEF guidelines and adhere to restrictions regarding pain (for pre-college students).

14. Potentially Hazardous Biological Agentsrequire a risk assessment • Microorganisms (including bacteria, viruses, fungi, mold, etc.) • Recombinant DNA technologies • Human or animal fresh tissues, blood or body fluids

15. Risk Assessment • Defines potential level of harm, injury or disease to plants, animals or humans • Involves • Assignment of bio. agent to a risk-of-containing-infectious-agents group • Determination of level of containment and biosafety precautions • Assessment of expertise of adult(s) to supervise

16. All Studies Involving Potentially Hazardous Biological Agents • Must have prior approval by SRC/Institution • All studies are prohibited in a homeenvironment-this includes mold and bacteria • Studies intended to produce or genetically engineer bacteria with multiple antibiotic resistance are prohibited • Bakers yeast, brewers yeast and most protists and archaebacteria are exempt

17. Unknown microorganisms • School site is OK if: • Organisms cultured in plastic petri dish or petrifilm which remains sealed throughout experiment • Culture dish is disposed of in appropriate manner • Special lab required if petri dish is ever opened-school may qualify

18. Not included as potentially hazardous biological agents. • Plant tissues • Established cell and tissue cultures (purchased) • Meat and meat by-products – grocery stores, restaurants, packing houses • Hair • Sterilized teeth • Fossilized tissue/archeological specimens • Prepared fixed tissue slides

19. Hazardous Chemicals, Activities or Devices require supervision • Chemicals- • Equipment- • DEA-Controlled Substances- • Prescription Drugs- • Alcohol and Tobacco- • Firearms and Explosives- • Radiation-