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Does my project need prior review and approval?
All projects need an initial review by an adult sponsor which is documented on Form 1.
Studies involving human subjects need additional review and approval, first by an institutional Review Board (IRB), and then by the NHSEE Science Review Committee (SRC). The IRB can usually be set up locally at the school (see pp. 8-10 of the Rules). Once the IRB has reviewed and approved the project, it needs to be sent to the NHSEE SRC for another review before experimentation can begin.
Studies involving vertebrate animals or potentially hazardous biological agents require an additional review and approval by the NHSEEA Science Review Committee.
Hazardous chemicals, activities and devices require an additional review by a supervising adult, and a Risk Assessment Form must be completed.
Where do I send my research plan and other paperwork to get pre-approval for my project?
There are two ways to submit the research plan and other paperwork.
One is to use the Postal Service and send paperwork to the following address:
P.O. Box 5202
Manchester, NH 03108-5202
The other way is to scan the forms and send them electronically to firstname.lastname@example.org.
Who can serve as a Designated Supervisor for my project?
The Designated Supervisor may be a teacher, adult sponsor, parent, university professor or scientist who will be directly responsible for overseeing the experiment. The Designated Supervisor need not have an advanced degree, but should be thoroughly familiar with the student’s project and must be trained in the student’s area of research.
Can I continue working on my project between the NHSEE and the Intel ISEF?
Yes, as long as the active research period is no longer than 12 months in an 18-month period. And remember, that if you plan any significant changes or expansions of your research plan, be certain that you have received the proper approvals prior to starting the new phase of research.
How do I determine the “Start Date” of my project?
The start date of your project is when you begin to collect data for your experiment. The literature review and the design of your study will occur prior to your start date. The “projected” start date is the date you expect to start your project and is recorded when you complete Form 1A as you begin the review and approval process for your project. The “actual” start date is recorded when the review process is completed and the experiment begins.
If I conduct my study in a location other than school or home, do I need a Form 1C?
A Form 1C is required for experiments or equipment use on projects in research institutions, commercial or college laboratories, government or industrial settings (i.e. machine shop, manufacturer facility), and medical facilities. The form needs to be completed by the supervising scientist AFTER you have completed your work. In addition to submitting a Form 1C, you need to check the appropriate box on Student Checklist Form 1A, question 7.
How do I determine if a chemical is hazardous?
Ask your supervising adult and consult the Material Safety and Data Sheet (MSDS) for the chemical(s) you plan to use. Some MSDS sheets (e.g. Flinn), rank the degree of hazard associated with a chemical. Generally a rating more than 1 should be considered hazardous. It is possible that two or more chemicals ranked 0 or 1 when mixed can react and form a hazardous chemical.
Can I culture potentially dangerous biological agents at home?
No – collection may be done at home, but the culturing must be done at a school or a lab, given the potential risks inherent in the process.
How do I find out the biosafety level of an organism?
I am using a commercial water-test kit to test the presence of coliforms. Is this a BSL-1 or higher study?
No. This test is not considered potentially hazardous and could be done at any test site.
Should all studies using water or soil collected from the environment be considered involving potentially hazardous biological agents?
No. Even though water and soil could contain potentially pathogenic organisms, studies involving these samples are considered potentially hazardous only when the sample is cultured. The use of a coliform test kit to determine the presence of coliform bacteria does not categorize the project as one involving potentially hazardous biological agents.
Is there any agency that will certify a lab facility?
No, there is no outside certifying agency, but the facility must meet all criteria described in the “Laboratory Biosafety Manual” published by the World Health Organizationwww.who.int/csr/resources/publications/biosafety and in the”Biosafety in Microbiological and Biomedical Laboratories” published by CDC-NIH www.cdc.gov/od/ohs/biosfty/biosfty.htm
How do I know if a lab qualifies as a BSL-2 facility?
Descriptions of BSL-2 facilities are found in the World Health Organization (WHO) Manual,www.who.int/csr/resources/publications/biosafety or Biosafety in Microbiological and Biomedical Laboratories published by CDC-NIH www.cdc.gov/od/ohs/biosfty/biosfty.htm
Can I have a BSL-2 laboratory at my high school?
While there is no formal certification process, a high school lab can attain BSL2 laboratory compliance.
Self-assessment and assurance must comply with the guidelines and practices described in the “Biosafety in Microbiological and Biomedical Laboratories” published by CDC-NIH www.cdc.gov/od/ohs/biosfty/biosfty.htmand in the “Laboratory Biosafety Manual” published by WHO www.who.int/csr/resources/publications/biosafety
The essential elements of these required guidelines and practices are listed on page 23 of the Rulebook (restricted access, minimum Class 2, Type A safety cabinet, autoclave available, personal protective equipment (PPE includes lab coat, gloves, face protection) and supervised by a knowledgeable laboratory scientist. This lab should be dedicated only to the function of serving as a laboratory (i.e., not serving concurrently as a classroom and a laboratory.)
Can I order organisms from a biological supply house and be assured that they will be a BSL1?
No – both BSL1 and BSL2 organisms are available from these supply houses. Also, some BSL1 organisms have the potential to be hazardous (a PHBA), thus a risk assessment must be performed for all projects involving microbes to assure safety.
What is a blood by-product?
Blood by-products result from the separation of blood and can include red blood cells, plasma, Factor 8, etc. These products must follow the rules of Potentially Hazardous Biological Agents (PHBA), as their handling and use can require special safety precautions.
How do I get informed consent if I do a survey on the Internet?
If the IRB determines that informed consent is required, then:
a) If the participant is 18 years of age or older, the survey can contain a statement of informed consent that those taking the survey can read and check assent prior to continuing with the survey. This “check” can be considered documentation of informed consent.
b) If the participant is under 18 years of age, the parent/legal guardian must give consent by signing and returning the Human Informed Consent Form to you.
Could I use my farm animal in my science project?
Yes, farm animals may be used at a “non-regulated [research?] site”, i.e., farm or ranch. The animals can be used in non-invasive, non-intrusive, non-biomedical studies utilizing standard farming practices that do not negatively affect an animal’s health and well-being.
When is an egg embryo considered a vertebrate animal?
For pre-college science and science project purposes, this occurs in frogs when the egg hatches and becomes a tadpole; for reptiles and birds, it occurs three (3) days prior to hatching (e.g., chicken eggs at 18 days).
What is meant by “invasive” procedures?
This includes all procedures involving entry into a living body by an incision, and/or by insertion of instruments, tubes, probes, etc. Injections for the health of an animal, as directed by a veterinarian, are not considered invasive (e.g., insulin, vitamins).