Roles & Responsibilities of Adults Adult Sponsor May be a: Teacher Parent University Professor Working Scientist They must have a solid background in science and should have close contact with the student during the course of the project. The Adult Sponsor is responsible for working with the student to evaluate any possible risks involved in order to ensure the health and safety of the student conducting the research and the humans or animals involved in the study. Qualified Scientist Should possess an earned doctoral/professional degree in the biological or medical sciences as it relates to the student’s area of research. Must be thoroughly familiar with the regulations that govern the student’s area of research. May be the Adult Sponsor. May be located in a different city or state as long as the student works locally with a Designated Supervisor who has been trained in the techniques the student will use. Designated Supervisor Is directly responsible for overseeing student experimentation. Does not need an advanced degree, but should be thoroughly familiar with the student’s project. Must be trained in the student’s area of research. May be the Adult Sponsor. If a student is experimenting with live vertebrate animals and they are in a situation where their behavior or habitat is influenced by humans, the Designated Supervisor must be knowledgeable about the humane care and handling of the animals. Institutional Review Board Must consist of a minimum of three members: An educator A school administrator Someone who is knowledgeable and capable of evaluating the physical and/or psychological risk involved in a given study The Parent, Adult Sponsor, Qualified Scientist and Designated Supervisor CANNOT be a member of the IRB reviewing a students’ project. For this reason, it is recommended that an IRB enlist additional members to avoid conflicts of interest. Charged with evaluating the potential physical and/or psychological risk of research involving human subjects. Federal regulations encourage local community involvement, therefore, an IRB should be established at the school level to evaluate human research projects involving its students. However, a district IRB may be used. If the research is being conducted at a federal institution (such as university, medical center, correctional facility) then that institution’s IRB must review and approve all proposed research. If an SRC, reviewing projects prior to competition, judges that the IRB’s risk assessment was inappropriate, the SRC may override the IRB’s decision and the project may fail to qualify for competition. Scientific Review Committee Must consist of a minimum of three members: A biomedical scientist (Ph.D., M.D., D.V.M., D.D.S., D.O.) An educator One other member If animal research is involved, at least one member must be familiar with proper animal care procedures. The Parent, Adult Sponsor, Qualified Scientist and Designated Supervisor CANNOT be a member of the SRC reviewing a students’ project. For this reason, it is recommended that an SRC enlist additional members to avoid conflicts of interest. Charged with reviewing projects BEFORE experimentation for the following: Evidence of literature search Evidence of proper supervision Use of accepted and appropriate research techniques Completed forms, signatures and dates showing maximum of one year duration of research and appropriate preapproval dates Evidence of search for alternatives to animal use Humane treatment of animals Compliance with rules and laws governing human and animal research Compliance with rules and laws governing human, animal research and those involving potentially hazardous biological agents Documentation of substantial expansion for continuation projects Compliance with the ISEF ethics statement Forms, Rules & Guidelines Requirements for ALL Projects All projects must have the following forms and should be completed in this order: Student Checklist (1A) completed in conjunction with the Research Plan. Research Plan MUST be TYPED and should be completed in conjunction with the Student Checklist (1A). Checklist for Adult Sponsor (1) should be done once the Student Checklist and Research Plan are near completion. Approval Form (1B) should be completed once the Student Checklist, the Research Plan and the Checklist for Adult Sponsors are all complete. An Abstract must be completed once the project is completed and all analysis and conclusions are done. A Regulated Research Institutional/Industrial Setting Form (1C) is completed AFTER experimentation is completed at a research institution or industrial setting. Requirements for Human Subject Projects The Research Plan for a project that uses Human Subjects must include the following: Subjects - Describe who will participate in the study and identify any vulnerable populations. Recruitment – Where will the subjects be found and how will they be invited to participate? Methods - What will participants be asked to do (survey, questionnaire, tests) and what is the frequency and length of time involved for each subject? Risks - What are the risks or potential discomforts (physical, psychological, time involved, social, legal, etc) to participants and how will the risks be minimized? Benefits - List any benefits to society or to individual participants. Protection of Privacy - Will any identifiable information (e.g. names, phone numbers, birth dates, email addresses) be collected? Will data be confidential or anonymous? If anonymous, describe how the data will be collected anonymously. If not anonymous, what procedures are in place for safeguarding confidentiality (where will the data be stored; who will have access to the data; and what will be done with the data at the end of the study)? Informed Consent Process - Describe how participants will be informed about the purpose of the study; what they will be asked to do; that their participation is voluntary; and they have the right to stop at any time. Informed Consent for Humans Subjects Projects Students should feel free to either use the form as it is provided by ISEF, or copy all of the following information into a new document: Purpose of the project: This is where the Student Researcher should explain as simply as possible, why they are doing the project. If you participate, you will be asked to: Include EVERYTHING the subject will be asked to do in the study. If there are different tasks for different sets of subjects, then different consent forms must be used for each set of tasks. Time required for participation: Give a good estimate for how much time the subject should expect to spend participating in the study. Risks: Remember, there is no such thing as NO RISK. If no risks are anticipated, then use the phrase “NO KNOWN RISKS.” Always keep in mind that there are emotional as well as physical risks involved in some studies. This is also where a description of how risks will be minimized should be explained. Benefits: Give any benefits to the individual participant as well as the benefit to society in general. If there are no benefits, it is perfectly all right to state that there are no benefits for participating in the study except to satisfy the curiosity of the student researcher. How confidentiality will be maintained: The best procedures are those where absolutely no identifying information is collected along with the data. Another technique is to have a numbered linked list where the data from the participant is given a number and the number is separately identified by name. This would allow the researcher to destroy the numbered list of names as soon as the need for the link is done. It is also best that the Adult Sponsor or Designated Supervisor be in charge keeping the data. Requirements for Vertebrate Animal Projects The research plan for a project that uses Vertebrate Animals must include the following: A discussion of potential alternatives to the use of vertebrate animals and detailed justification as to why vertebrate animals must be used. An explanation of the potential impact or contribution this research may have. Detailed procedures to be used, including methods used to minimize potential discomfort, distress, pain and injury to the animals during the course of experimentation and detailed chemical concentrations and drug dosages if applicable. Detailed number of animals being used, the species, strain, sex, age, etc. including justification for the number of animals planned for the research. Housing and oversight of daily care. Disposition of the animals at the termination of the study. Research Projects at Non-Regulated Sites Vertebrate Animal studies may only be conducted at a non-regulated research site (home, school, farm, ranch, field, etc.) ONLY if BOTH of the following applies: The research involves agricultural, behavioral, observational, or supplemental nutritional studies on animals AND The research involves only non-invasive and non-intrusive methods that do not negatively affect an animal’s health or well-being. All other studies using vertebrate animals must be conducted at a regulated research institution. A researcher must STOP experimentation if there is unexpected weight loss or death in the experimental subjects. The experiment can only be resumed if the cause of illness or death is not related to the experimental procedures and if appropriate steps are taken to eliminate the causal factors. If death is the result of the experimental procedure, the study must be terminated, and the study will not qualify for competition. The SRC must decide what type of supervision the project requires: A Designated Supervisor is required for all Vertebrate Animal studies and are responsible for the quality of care and handling of the animals in the project. A Veterinarian is not required for all Vertebrate Animal studies, but is recommended for experiments that involve supplemental nutrition and/or activities that would not be ordinarily encountered in the animal's daily life. A Qualified Scientist is not required for all Vertebrate Animal studies, but may be suggested by the SRC. Form 5A must be filled out by the researcher for each different type of animal being used and include the number of animals being used in the study, the housing and husbandry to be provided, and what will happen to the animals after experimentation. Research Projects at Regulated Institutes Form 5B must be filled out by the Qualified Scientist or the Principal Investigator at the regulated research institution. A copy of the regulated research institution IACUC approval letter must be attached to this form. The Qualified Scientist must describe the USDA Pain Category that the research falls under. The local SRC must also review the project to certify that the research complies with ISEF rules. This review should happen before experimentation begins. Proper euthanasia at the end of experimentation for tissue removal and/or pathological analysis is permitted. Only the Qualified Scientist or an institutional representative may perform the euthanasia. The following types of studies on vertebrate animals are prohibited: All induced toxicity studies, such as those using alcohol, acid rain, insecticide, herbicide, heavy metal, etc.; Behavioral experiments involving operant conditioning with adverse stimuli, mother/infant separation or induced helplessness; Studies of pain; and Predator/prey experiments. Requirements for Potentially Hazardous Biological Agent Projects Experimentation with potentially hazardous biological agents is prohibited in a home environment!!! Research with unknown microorganisms can be treated as a Biosafety Level-1 (BSL-1) study under the following conditions: Organism is cultured in a plastic Petri dish and sealed. Experiment involves only procedures in which the Petri dish remains sealed throughout the experiment. The sealed Petri dish is disposed of in the appropriate manner by the Designated Supervisor. If a culture is opened for identification, sub-culturing or isolation, it must be treated as a BSL-2 study and involve BSL-2 laboratory procedures and equipment. A high school lab is not typically considered a BSL-2 lab. Any study involving agents belonging to the BSL-3 or BSL-4 groups ARE NOT ALLOWED AT ALL!! BSL3 contains agents that usually cause serious disease or that can result in serious economic consequences. BSL-4 contains agents that usually produce disease that is often untreatable. Requirements for Tissue Projects The following types of tissue do not need to be treated as potentially hazardous biological agents: Plant tissue; Plant and non-primate established cell lines and tissue culture collections (the source and/or catalog number must be identified); Fresh or frozen meat, meat by-products, pasteurized milk or eggs obtained from food stores, restaurants, or packing houses; Hair; Teeth that have been sterilized to kill any blood borne pathogen that may be present; Fossilized tissue or archeological specimens; and Prepared fixed tissue slides. There are additional rules that apply to projects that involve tissues and body fluids, including blood and blood products. These types of project must ALSO complete a Human and Vertebrate Animal Tissue Form 6B. Additional Considerations for Potentially Hazardous Biological Agent Projects Established human and/or non-human primate cell lines and tissue culture collections must be treated according to the source’s BSL information and catalog numbers included in the research plan. If tissue is obtained from an animal that was sacrificed for a purpose other than the student's project, then it does not need to be considered a Vertebrate Animal project and Form 5B does not need to be completed. Documentation of the Institutional Animal Care and Use Committee (IACUC) approval for the original animal study from which the tissue was obtain is required however. If the animal was euthanized solely for the student's project, the study must be considered a Vertebrate Animal project and Form 5B must also be completed. All studies involving human or wild animal blood or blood products must be considered a BSL-2 study and involve BSL-2 laboratory procedures and equipment under the supervision of a Qualified Scientist. All studies involving domestic animals may be considered a BSL-1 study and be handled in accordance with standards and guidelines set forth in the OSHA, 29CFR, Subpart Z. Human breast milk of unknown origin, unless certified free of HIV and Hepatitis C and domestic unpasteurized animal milk must be considered BSL-2 agents. Studies of human body fluids, where the sample can be identified with a specific person, must ALSO be considered a Human Subjects project and have IRB review and informed consent. Students may use their own body fluid without review and consent. Studies involving embryonic stem cells must be conducted at a regulated research institute and reviewed and approved by the Embryonic Stem Cell Research Oversight Committee. Requirements for Projects Using Hazardous Chemicals, Activities or Devices The Risk Assessment Form 3 is a good form to have all students complete, even if it isn't necessarily required as the questions really get them to think about safety. It is important that the Designated Supervisor include ALL hazardous chemicals, activities and/or devices that will be used in the project under #1 and answer the remaining questions for each one. Be very specific and provide as much detail as possible to avoid future questions when the SRC reviews it for competition. Use the Research Plan as a guide as to what to include and make sure to include items that are used to build parts of the project as well. If firearms and/or bows and arrows are used, it is important that you include a copy of the student's and supervisor's Colorado Hunter Safety Card. Just as a scientist needs to be qualified in the area of research that a student is working in, a Designated Supervisor may need to explain their qualifications. For example, if a student were using power tools, it would be appropriate to have someone who is a carpenter by trade supervising the student, even though the parent or teacher may know how to use the tools. Being MOM or DAD is not necessarily qualification enough to supervise a project using hazardous chemicals or devices. If the student isn't going to be directly using a tool or device, but merely assisting, please indicate this under the description of safety precautions and procedures (#3). Sources of Safety Information (#5) should be done in the same manner as a reference cited list is done.