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Questions and Answers

Which of the following committees is responsible for the oversight of projects involving human participants?

  • Institutional Biosafety Committee (IBC)
  • Institutional Animal Care and Use Committee (IACUC)
  • Institutional Review Board (IRB) (correct)
  • Embryonic Stem Cell Research Oversight Committee (ESCRO)

Independent laboratories meet the requirements for oversight as per the regulations for Regulated Research Institutions.

False (B)

What must projects conducted at a Regulated Research Institution obtain for approval?

IRB approval

The _____ Review Committee is the final arbiter of the qualification of students to participate in ISEF.

<p>ISEF Scientific</p> Signup and view all the answers

Match the following safety protocols with their corresponding BSL levels:

<p>BSL-1 = Basic laboratory practices, no special precautions required. BSL-2 = Limited access and biohazard warning signs necessary. BSL-3 = Controlled access and respirators may be required. BSL-4 = Complete isolation, specialized facilities required.</p> Signup and view all the answers

Which of the following is NOT a component of ethical considerations in RDNA studies?

<p>Maximizing financial gain from research (C)</p> Signup and view all the answers

The ISEF Scientific Review Committee reviews research plans after the competition starts.

<p>False (B)</p> Signup and view all the answers

What form should independent laboratories complete for documentation regarding adult supervision and conditions of research?

<p>Regulated Research Institution/Industrial Setting Form 1C</p> Signup and view all the answers

What is a key requirement for research involving potentially hazardous biological agents?

<p>BSL-2 containment with documented IBC review is required (A)</p> Signup and view all the answers

Research involving substances with unknown effects can proceed without supervision.

<p>False (B)</p> Signup and view all the answers

What steps must be taken if clinical distress is observed during a research project?

<p>The project must be suspended and measures taken to correct the deficiency or drug effect.</p> Signup and view all the answers

A laboratory conducting research with potentially hazardous biological agents must have at least __________ containment.

<p>BSL-2</p> Signup and view all the answers

Match the following documents with their requirements:

<p>Checklist for Adult Sponsor = Required for initial project approval Qualified Scientist Form = Needed for guidance and compliance PHBA Risk Assessment Form = Mandatory for studies involving body fluids Vertebrate Animal Form = Required for research involving vertebrate animals</p> Signup and view all the answers

Which is NOT a required form for conducting research involving vertebrate animals?

<p>Risk Management Plan (7A) (A)</p> Signup and view all the answers

All research projects involving human tissues require a PHBA Risk Assessment Form.

<p>True (A)</p> Signup and view all the answers

If distress is observed during an experiment involving drugs or nutritional deficiencies, the project must be __________.

<p>suspended</p> Signup and view all the answers

Who may not serve on the SRC or IRB reviewing a student's project to avoid conflict of interest?

<p>The student's Adult Sponsor or relative (C)</p> Signup and view all the answers

A Direct Supervisor must have an advanced degree in science.

<p>False (B)</p> Signup and view all the answers

What is the main responsibility of a Direct Supervisor in a student research project?

<p>To provide direct supervision and ensure compliance with necessary documentation.</p> Signup and view all the answers

The __________ must ensure proper care when a student's project involves vertebrate animals.

<p>Adult Sponsor</p> Signup and view all the answers

Match the following roles with their responsibilities:

<p>Adult Sponsor = Provides general support and oversight Direct Supervisor = Directly supervises experimentation SRC = Examines projects for compliance IRB = Reviews human subject research</p> Signup and view all the answers

Which form must the Direct Supervisor complete if applicable?

<p>Qualified Scientist Form (2) (A)</p> Signup and view all the answers

The use of accepted and appropriate research techniques is not a responsibility of the Direct Supervisor.

<p>False (B)</p> Signup and view all the answers

Name one requirement for the Direct Supervisor when the research involves potentially hazardous biological agents.

<p>To ensure compliance with rules and laws governing animal and human research.</p> Signup and view all the answers

The Scientific Review Committee (SRC) examines evidence of proper __________.

<p>supervision</p> Signup and view all the answers

Which of the following is a part of the responsibilities of the Direct Supervisor?

<p>Reviewing the Risk Assessment Form when needed (C)</p> Signup and view all the answers

Flashcards

Direct Supervisor Qualifications

Doesn't require an advanced degree but must be knowledgeable in the student's research area, familiar with procedures and materials, and agree to needed training.

Direct Supervisor (DS)

The person directly overseeing a student's research project, providing guidance and supervision.

Direct Supervisor Responsibilities

Directly supervising experimentation, completing required documentation (e.g., Qualified Scientist Form), reviewing and completing risk assessments.

Conflict of Interest (COI)

A situation where a person's personal interests could influence their judgment or decision-making regarding a research project. This should be avoided when reviewing research.

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Adult Sponsor Eligibility

Teachers, parents, professors, and other professionals specializing in science CAN act as an adult sponsor, BUT not a relative, qualified scientist, or direct supervisor. It's to prevent conflict of interest.

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Scientific Review Committee (SRC)

A committee that evaluates research projects to ensure adherence to guidelines and safety procedures (e.g., proper supervision, use of approved techniques).

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Vertebrate Animal Research

Research involving vertebrate animals, must be approved by SRC and involve humane care and handling knowledge.

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Research Project Review

Projects must pass various reviews (SRC, IRB, etc.) to ensure ethical adherence to applicable rules regarding human or animal subjects, and appropriate research techniques.

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Nutritional Deficiency Research

Research on nutritional deficiencies is allowed until signs of distress are observed. If distress is seen, the research must be stopped, and measures taken to correct the issue. Only resume it after correction.

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Regulated Research Institution (RRI)

A research institution (like a university, hospital, or government lab) that is required to have specific oversight committees for certain types of research.

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Institutional Animal Care and Use Committee (IACUC)

A committee that reviews and approves animal research projects in regulated research institutions.

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Unknown Drug Effect Research

Research on substances or drugs of unknown effect is allowed but must stop if distress arises. The deficiency or reaction must be corrected before resuming research.

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Required Forms (Adult Sponsor)

Adult sponsors need to fill out a checklist, and students need their own checklists, as well as a research plan, a project summary, and an approval form.

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Animal Care and Use Committee (ACUC)

A committee similar to IACUC; ensures ethical animal care.

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Regulated Research Institution Form

A form required for research done at institutions that are regulated.

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Animal Ethics Committee

An ethical review board for animal research similar to IACUC and ACUC.

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Institutional Review Board (IRB)

A committee that reviews and approves human subject research in RRI settings.

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Qualified Scientist Form

A form required for research projects needing qualified scientific input or oversight.

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Human Subjects Participant Program (HSPP)

Program for managing human research participants, often part of review processes in regulated research settings.

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Vertebrate Animal Form

A form essential for studies utilizing vertebrate animals; follows institutional guidelines.

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PHBA Risk Assessment Form

Required for studies involving potentially hazardous biological agents (PHBA).

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Institutional Biosafety Committee (IBC)

Committee reviewing research involving biohazards, biological safety in research settings.

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Human and Animal Tissue Form

Mandatory for projects involving human or animal tissue and body fluids.

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Embryonic Stem Cell Research Oversight Committee (ESCRO)

Oversight committee specifically for embryonic stem cell research in regulated research settings.

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Potentially Hazardous Biological Agents (PHBA)

Microorganisms (bacteria, viruses, etc.), recombinant DNA, or animal/human tissues/fluids requiring specific safety protocols.

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Safety Review Committee

Oversight committee for all research projects that ensures the safety of the research environment.

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ISEF Scientific Review Committee(ISEF SRC)

Committee reviewing science fair projects for eligibility, qualification, and review prior to competition.

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Independent/Private Laboratories

Labs that are not considered part of a Regulated Research Institution, following different oversight procedures.

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Study Notes

ISEF International Rules

  • The Regeneron International Science and Engineering Fair (ISEF) is a program of Society for Science.
  • ISEF rules cover guidelines for science and engineering fairs, specifically for the 2024-2025 events.
  • Rules cover general requirements for all projects, roles and responsibilities, human participants, vertebrate animals, potentially hazardous biological agents, hazardous chemicals, activities, or devices, and engineering inventions projects.
  • These guidelines cover ethics, eligibility, project limitations, project continuation/progression, team projects, and the appropriate submission of all forms.

Table of Contents

  • Includes sections on general requirements, roles and responsibilities, human participants rules, vertebrate animal rules, potentially hazardous biological agents rules, hazardous chemicals/activities/devices, and engineering and invention projects.

ISEF Rules Wizard

  • An interactive tool to guide students in preparing their intended project and in listing required forms.

ISEF Rules FAQs

  • Frequently Asked Questions are available for questions about the rules.
  • Students are encouraged to use this resource to ask and answer questions.

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Related Documents

ISEF Rules 2024-2025 PDF

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