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 .
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May be a:
They must have a solid background in science and should have close contact with the student during the course of the project.
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.
A school administrator
Someone who is knowledgeable and capable of evaluating the physical and/or psychological risk involved in a given study
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.Institutional Review Board
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.
A biomedical scientist (Ph.D., M.D., D.V.M., D.D.S., D.O.)
One other member
If animal research is involved, at least one member must be familiar with proper animal care procedures.
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 statementScientific Review Committee
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.
All projects must have the following forms and should be completed in this order:
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.
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.
The research plan for a project that uses Vertebrate Animals must include the following:
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:
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:
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.
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:
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:
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!! BSL-3 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.
The following types of tissue do not need to be treated as potentially hazardous biological agents:
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.