REGULATIONS AND CERTIFICATIONS FOR RESEARCH
Certain types of research require that special and designated regulations are followed. In these cases, a “Certification Statement” must be signed by the student and the sponsor, verifying that the regulations have been followed.
A. VERTEBRATE ANIMAL EXPERIMENTS
The basic aim of experiments involving vertebrate animals is to understand life’s processes. Experiments involving vertebrate animals must have clearly defined objectives requiring the use of animals to demonstrate a biological principle or answer scientific propositions. Protista and other invertebrates are preferable for most experiments involving animals. The variety of these animals and the feasibility of using large numbers make them especially suitable.
Federal, State, and VJAS regulations concerning animal research apply to ALL vertebrates under ANY conditions.
If this applies, both student and student sponsor must electronically sign the appropriate certification statement on the Reviewr platform during the paper submission.
B. HUMAN SUBJECT RESEARCH
The decision to undertake research using human subjects should rest upon valid contributions to psychological science and human welfare. The investigator must carry out investigations with respect to the research subjects’ dignity and welfare. Consent of subjects’ participation MUST be obtained anytime there is interaction with the human subjects, or anytime the environment is altered in studying the human subjects. All projects require IRB (Institutional Review Board) approval.
If the subject is under 18, parental permission must be obtained. ALL middle school and high school students, regardless of age, need a parental signature on the informed consent form. Only individuals 18 and older who are no longer high school students can sign the informed consent form without having a parental signature. The following principles describe the investigator’s ethical responsibilities:
If this applies, both student and student sponsor must electronically sign the appropriate certification statement on the Reviewr platform during the paper submission.
Notes:
C. RECOMBINANT DNA RESEARCH REGULATIONS
Recognizing the risks and benefits inherent in recombinant DNA research, VJAS has adopted a set of rules to govern student research employing these techniques. All research must be carried out in accordance with the revised NIH Guidelines for Research Involving Recombinant DNA Molecules (2011). To obtain a copy of this document, visit http://oba.od.nih.gov/oba/rac/guidelines/nih_guidelines.htm.
If this applies, both student and student sponsor must electronically sign the appropriate certification statement on the Reviewr platform during the paper submission.
D. CELL AND TISSUE RESEARCH
If this applies, both student and student sponsor must electronically sign the appropriate certification statement on the Reviewr platform during the paper submission.
E. PATHOGENIC AGENTS, TOXIC OR CONTROLLED SUBSTANCES
Each student who submits a research paper to the Junior Academy and used pathogenic agents, toxic or controlled substances in that research is required to furnish the following certification with all copies of the paper, using the “Certification Statement” found in Reviewr:
“I certify that the use of pathogenic agents, toxic or controlled substances in the experimentation and observation covered by this paper was in accordance with the rules for pathogenic agents, toxic or controlled substances contained in the latest edition of the VJAS Handbook.”
If this applies, both student and student sponsor must electronically sign the appropriate certification statement on the Reviewr platform during the paper submission.
F. MENTORED RESEARCH and/or RESEARCH CONDUCTED in a RESEARCH INSTITUTION
The writer must give credit for special assistance received from scientists or other sources on the VJAS Mentor and/or Research Facility Form. Please note that this may be a parent or close friend with expertise. This can include bench work or virtual collaboration.
Any student (whether in a traditional school setting, home-schooled, or virtual schooled) who worked in a research facility (in-person or virtual) or received help (access to data, professional guidance, etc.) from a professional other than their teacher (or instructor), must complete and submit the Mentor and/or Research Facility Form. This includes working in (or collaborating with) a laboratory or receiving help from a parent or family friend. The student downloads the Mentor/Research facility form and emails the form to their mentor. The mentor completes the form and returns the form to the student. The student then submits the form on Reviewr. The student submission will not be complete until the Mentor and/or Research Facility Form is submitted on Reviewr. If unsure if this form is required, it should be completed.
If this applies, the mentor or research facility director must complete and sign this form on Reviewr.
Each student who submits a research paper to the Junior Academy and used a mentor and/or worked in a Research Facility is required to furnish the following certification using the “Certification Statement” form on the Reviewr platform:
“This is to certify that the student worked in a research facility (in-person or virtual) or received significant help from a professional other than their teacher (or instructor)”
If this applies, both student and student sponsor must electronically sign the appropriate certification statement on the Reviewr platform during the paper submission.
- When a student does research in any of these areas, the regulations below must be followed, and both the student and sponsor must check the appropriate statements on the Certification section in Reviewr.
- The Certification Statement section must be completed for ALL types of projects.
A. VERTEBRATE ANIMAL EXPERIMENTS
The basic aim of experiments involving vertebrate animals is to understand life’s processes. Experiments involving vertebrate animals must have clearly defined objectives requiring the use of animals to demonstrate a biological principle or answer scientific propositions. Protista and other invertebrates are preferable for most experiments involving animals. The variety of these animals and the feasibility of using large numbers make them especially suitable.
Federal, State, and VJAS regulations concerning animal research apply to ALL vertebrates under ANY conditions.
- Animal experiments must be conducted with respect for life and an appreciation for humane considerations. To provide for the humane treatment of vertebrate animals, a qualified adult supervisor who has had training in the proper care of vertebrates must assume the primary responsibility for the conditions of an experiment that involves living vertebrates. If the school faculty includes no one with training in the proper care of vertebrates, the services of such a person must be obtained. ALL animals, whether laboratory, domestic, or wild must be maintained in suitable environmental conditions for that species.
- No experiments may be undertaken that involve anesthetics, drugs, thermal procedures, organisms pathogenic to vertebrates, ionizing radiation, carcinogens, or surgical procedures other than venipuncture or hypodermic injection unless the procedures are performed under the immediate supervision of a Qualified Scientist experienced in the field under investigation or a Designated Adult Supervisor in an institutional laboratory. In addition to the qualified scientist, a designated adult supervisor will be required when the research is not conducted in the qualified scientist’s laboratory. Note: This is different from the sponsor.
- The comfort of the animals used in an experiment shall be a prime concern. No experiment using live vertebrate animals shall be attempted unless the animals have been obtained from a reliable source and the following conditions can be assured: Continuous care, including weekends and vacation periods, appropriate, comfortable quarters, adequate food and water, humane treatment and gentle handling.
- Research in nutritional deficiency, ingestion, or inoculation of hazardous or reputedly toxic materials or drugs may proceed only to the point where symptoms of the deficiency or toxicity appear. Appropriate measures shall then be taken to correct the deficiency, toxicity, or drug effect if such action is feasible, or the animal(s) shall be killed by a humane method by the animal care supervisor. Students are not to euthanize animals.
- LD30 and beyond experiments are unacceptable and will not be permitted. The LD30 (lethal dose or death rate) will be calculated for the total experiment and for each subgroup in the experiment, such as the control and various experimental groups. LD30 in the total or any subgroup will not be permitted.
- Research that is designed to kill vertebrates for any reason will not be permitted. Proper euthanasia for pathological analysis is the only exception to this rule, and this is conducted by an animal care supervisor only. An animal care supervisor only must conduct this research.
- To assure proper technique, surgical procedures on vertebrates shall only be done within an academic, hospital, and clinical or institutional research facilities under direct adult supervision. This rule is intended specifically to prohibit such procedures at home.
- The student shall not be allowed to perform sacrifice unless under the supervision and in the presence of the animal care supervisor, qualified scientist, and/or the designated adult supervisor. The only exception to this rule is an emergency, which would require a humane termination of life.
- Each student who submits a research paper to the Junior Academy and uses live vertebrates in that research is required to complete the “Certification Statement” found in Reviewr:
If this applies, both student and student sponsor must electronically sign the appropriate certification statement on the Reviewr platform during the paper submission.
B. HUMAN SUBJECT RESEARCH
The decision to undertake research using human subjects should rest upon valid contributions to psychological science and human welfare. The investigator must carry out investigations with respect to the research subjects’ dignity and welfare. Consent of subjects’ participation MUST be obtained anytime there is interaction with the human subjects, or anytime the environment is altered in studying the human subjects. All projects require IRB (Institutional Review Board) approval.
If the subject is under 18, parental permission must be obtained. ALL middle school and high school students, regardless of age, need a parental signature on the informed consent form. Only individuals 18 and older who are no longer high school students can sign the informed consent form without having a parental signature. The following principles describe the investigator’s ethical responsibilities:
- IRB (institutional review board) approval (or equivalent) for all human subject projects is required.
- The rights of the participants must be protected at all times. If the study deviates from any ethical principle, the investigator must seek ethical advice and redesign the research to protect the rights of the participants.
- All individuals involved (main researcher, collaborators, etc.) in research projects dealing with human subjects are responsible for maintaining the rights of the participants involved.
- Before the commencement of the research and using language that is reasonably understandable to the participants, the investigator must inform all participants of the nature of the research and that they are free to participate or decline or withdraw from the research at any time without penalty or retribution. Such informed consent must be appropriately documented on a written Consent Form (designed by the researcher) and include:
- All negative or positive aspects of participation. “None” is not an appropriate response for negative aspects. There is always something that could impact another person in unknown ways.
- The investigator must agree to answer all of the questions posed by the participants.
- If concealment or deception is an integral feature of the design and conduct of the research, this must be explained to the participants as early as feasible. (The use of concealment or deception is only justified if no equally effective alternative procedures are available.) The investigator must honor all promises and commitments included in the agreement.
- The investigator must protect participants from present or future physical and mental discomfort, harm, and danger. This includes following proper social and physical distancing regulations imposed by local or state authorities and appropriate use and discard of PPE (personal protective equipment).
- After the data are collected, the investigator must provide the participants with an explanation of the study and remove any misconceptions that may have arisen. Where scientific or humane values justify delaying or withholding information, the investigator acquires a special responsibility to assure that there are no damaging consequences for the participants.
- Information obtained about research participants during the course of an investigation is confidential. If others may obtain access to such information, this possibility, and plans for protecting the confidentiality of participants, must be explained to the participants.
- When doing research involving only observations of the behavior of human subjects in their unmodified environment and no information is obtained that identifies individuals, consent is not required.
- Each student who submits a research paper to the Junior Academy and who used human subjects in that research is required to furnish the following certification with all copies of the paper, using the “Certification Statement” found in Reviewr:
If this applies, both student and student sponsor must electronically sign the appropriate certification statement on the Reviewr platform during the paper submission.
Notes:
- A sample of the Consent Form provided to participants and/or their parents must be included in the Materials and Methods section of the submitted VJAS Research Paper. It is satisfactory to insert an image of the informed consent form into the materials and methods. A full page for the sample informed consent form need not be used. ALL middle school and high school students, regardless of age, need a parental signature on the informed consent form. Only individuals 18 and older who are no longer high school students can sign the informed consent form without having a parental signature.
- These guidelines were adapted from the Ethical Principles of Psychologists and Code of Conduct, 1995.
C. RECOMBINANT DNA RESEARCH REGULATIONS
Recognizing the risks and benefits inherent in recombinant DNA research, VJAS has adopted a set of rules to govern student research employing these techniques. All research must be carried out in accordance with the revised NIH Guidelines for Research Involving Recombinant DNA Molecules (2011). To obtain a copy of this document, visit http://oba.od.nih.gov/oba/rac/guidelines/nih_guidelines.htm.
- All research involving recombinant DNA technology must be carried out per the revised NIH Guidelines for Research involving Recombinant DNA Molecules.
- Only research that is normally conducted in a microbiological laboratory without containment will be permitted and only when under the supervision of an appropriately Qualified Scientist. Research requiring containment is prohibited.
- Each student who submits a research paper to the Junior Academy involving recombinant DNA is required to furnish the following certification with all copies of the paper, using the “Certification Statement” found in Reviewr:
If this applies, both student and student sponsor must electronically sign the appropriate certification statement on the Reviewr platform during the paper submission.
D. CELL AND TISSUE RESEARCH
- Tissue samples such as blood, blood products, teeth, cell cultures, or body fluids of human or vertebrate animals must be obtained from an institution or biomedical scientist. Plant tissue is excluded.
- Human blood and blood products must be documented as free of AIDS and hepatitis before the student receives the tissue.
- Each student who submits a research paper to the Junior Academy which involves the use of cell or tissue research must furnish the following certification with all copies of the paper, using the “Certification Statement” found in Reviewr:
If this applies, both student and student sponsor must electronically sign the appropriate certification statement on the Reviewr platform during the paper submission.
E. PATHOGENIC AGENTS, TOXIC OR CONTROLLED SUBSTANCES
- Projects involving E-coli k-12 do not require a pathogenic organism certification statement. These projects must clearly state the complete bacteria strain in the materials and methods (E-coli k-12). Failure to do this will result in the disqualification of the project if E-coli projects: E-coli K-12 strain is not explicitly stated
- Reactions and processes that use non-toxic reactants but produce toxic products or fumes should be treated as toxic substances, and the appropriate safety precautions and certification statements are to be used.
- No research may be undertaken with pathogenic agents, toxic or controlled substances unless these procedures are performed under the direct supervision of a Qualified Scientist or Designated Adult Supervisor in an institutional laboratory. Agents obtained from unregistered sources, such as public surfaces, food, soil, etc., are to be considered potentially pathogenic and fall under these guidelines. In addition to the qualified scientist, a designated adult supervisor will be required when the research is not conducted in the qualified scientist’s laboratory.
- Please note that we automatically disqualify any projects about mold or mildew, even if an experiment is discarded at the first sight of mold growth.
Each student who submits a research paper to the Junior Academy and used pathogenic agents, toxic or controlled substances in that research is required to furnish the following certification with all copies of the paper, using the “Certification Statement” found in Reviewr:
“I certify that the use of pathogenic agents, toxic or controlled substances in the experimentation and observation covered by this paper was in accordance with the rules for pathogenic agents, toxic or controlled substances contained in the latest edition of the VJAS Handbook.”
If this applies, both student and student sponsor must electronically sign the appropriate certification statement on the Reviewr platform during the paper submission.
F. MENTORED RESEARCH and/or RESEARCH CONDUCTED in a RESEARCH INSTITUTION
The writer must give credit for special assistance received from scientists or other sources on the VJAS Mentor and/or Research Facility Form. Please note that this may be a parent or close friend with expertise. This can include bench work or virtual collaboration.
Any student (whether in a traditional school setting, home-schooled, or virtual schooled) who worked in a research facility (in-person or virtual) or received help (access to data, professional guidance, etc.) from a professional other than their teacher (or instructor), must complete and submit the Mentor and/or Research Facility Form. This includes working in (or collaborating with) a laboratory or receiving help from a parent or family friend. The student downloads the Mentor/Research facility form and emails the form to their mentor. The mentor completes the form and returns the form to the student. The student then submits the form on Reviewr. The student submission will not be complete until the Mentor and/or Research Facility Form is submitted on Reviewr. If unsure if this form is required, it should be completed.
If this applies, the mentor or research facility director must complete and sign this form on Reviewr.
Each student who submits a research paper to the Junior Academy and used a mentor and/or worked in a Research Facility is required to furnish the following certification using the “Certification Statement” form on the Reviewr platform:
“This is to certify that the student worked in a research facility (in-person or virtual) or received significant help from a professional other than their teacher (or instructor)”
If this applies, both student and student sponsor must electronically sign the appropriate certification statement on the Reviewr platform during the paper submission.