Research – II

Research Forms/International
rules
Teacher: sir Darrel o.
Borja 
 “
“Wake up every day thinking you’re a fool.
For in that mindset, one strives to be come
better.”

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To learn and to enjoy
the class!

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Objective:
+ Recognize international
standard and rules in the
conduct of research

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REVIEW OF THE
PAST
DISCUSSION
Research Forms

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Are you familiar with the
International Rules
related to research
studies?
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What is/are the purpose
of these rules?
Why is there a need to
follow these rules?
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 The Purpose of
International Rules

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Let’s Familiarize with the
REGULATED RESEARCH INSTITUTION (RRI):
terms
A Regulated Research Institution within the U.S. is defined
as a professional research/teaching institution that is
regularly inspected by the USDA and is licensed to use
animals covered by the Animal Welfare Act and may also be
subject to U.S. Public Health Service Policy.

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Let’s Familiarize with the
INSTITUTIONAL REVIEW BOARD (IRB)
terms
An institutional review board, also known as an independent
ethics committee, ethical review board, or research ethics board,
is a committee that applies research ethics by reviewing the
methods proposed for research to ensure that they are ethical.

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Let’s Familiarize with the
SCIENTIFIC REVIEW COMMITTEE (SRC)
terms
A Scientific Review Committee (SRC) is a group of adults
knowledgeable about regulations concerning experimentation
especially with vertebrate animals and potentially hazardous
biological agents. The SRC must review and approve all projects
in these areas before experimentation may begin.

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Protect the right and welfare of the student researcher
Protect the rights and welfare of human participants
Protect the health and welfare of vertebrate animal
subjects ▪
Protect and promote good stewardship of the
environment

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Ensure adherence to National regulations
Ensure safe laboratory practices
Determine eligibility for competition in ISEF
(International Science and Engineering Fair)

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Human Participants
Rules

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Student researchers must complete ALL elements of the
Human Participants portion of the Research Plan/Project
Summary Instructions and the risk to human participants.
Student research involving human participants must be
reviewed and approved by an Institutional Review Board
(IRB) before any interaction (e.g., recruitment, data
collection) with human participants may begin.

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a. Projects at school, at home or in the community that is
not affiliated with a Regulated Research Institution (RRI)
must be reviewed and approved by the School IRB before
the student may begin interacting with human
participants.
b. Projects that are conducted at a Regulated Research
Institution (RRI) (e.g., university, hospital, medical
center, government lab) must have IRB approval from the
RRI.

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The student must comply with all determinations made by the
School or RRI IRB before beginning any interaction with
human participants (e.g., recruitment, data collection).

If the IRB requires a Qualified Scientist (QS), Form 2 (QSF) must

If the IRB requires a Designated Supervisor (DS), Form 3 (RAF)

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Participation in research may begin only after research
participants have voluntarily given informed consent/assent (in
some cases with parental permission).

The research study must be following all privacy laws

Students are prohibited from independently diagnosing disease,

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Student researchers may NOT publish or display information in a
report that identifies the human participants directly or any clue
that linked to them without consent.

All published instruments that are not in the public domain must
be administered, scored, and interpreted by a Qualified Scientist.
All use and distribution of the test must be in accordance with the
publisher’s requirements, including the purchase of legal copies
of the instrument.

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Studies that involve the collection of data via the use of the internet
(e.g., email, web-based surveys) are allowed, but researchers should
be aware that they can pose challenges.

After initial IRB approval, a student with any proposed changes in

After experimentation and before the competition, the Affiliated Fair

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The Research forms
This lesson focuses on the different types of
forms that a student- researcher as well as
his/her adviser must be familiar with. These
forms need to be filled in correctly before the
submission of the research paper for Science
and Engineering Fairs.

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The Research forms
1. Checklist for Adult Sponsor (1) •
 This completed form is required for ALL
projects.
 To be completed by the Adult Sponsor in
collaboration with the student researcher(s)

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The Research forms
2. Student Checklist (1A)
 This form is required for ALL projects.
It includes information about the
student, adult sponsor, title of the
project and all about the research they
will submit.

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The Research forms
Note: Research Plan/Project Summary
Instructions
A complete Research Plan/Project Summary
is required for ALL projects and must
accompany Student Checklist (1A).

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The Research forms
3. Approval Form (1B)
• A completed form is required for each student, including all
team members.
Parts:
a. To Be Completed by Student and Parent
b. To be completed by the local or affiliated fair SRC •
(Required for projects requiring prior Scientific Review
Committee /Inst. Review Board APPROVAL. Sign 2a or 2b as
appropriate.)
c. Final ISEF Affiliated Fair SRC Approval (Required for
ALL Projects)

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The Research forms
5. Regulated Research Institutional/Industrial Setting
Form (1C)
• This form must be completed AFTER
experimentation by the adult supervising the student
research conducted in a regulated research institution,
industrial setting, or any work site other than home,
school, or field.

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The Research forms
5. Regulated Research Institutional/Industrial Setting
Form (1C)
• This form must be completed AFTER
experimentation by the adult supervising the student
research conducted in a regulated research institution,
industrial setting, or any work site other than home,
school, or field.

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The Research forms
6. Qualified Scientist Form (2)
• May be required for research involving human participants,
vertebrate animals, potentially hazardous biological agents, and
hazardous substances and devices. Must be completed and signed
before the start of student experimentation.
Parts:
a. To be completed by the Qualified Scientist:
b. To be completed by the Designated Supervisor when the
Qualified Scientist cannot directly supervise

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The Research forms
7.Risk Assessment Form (3)
• Must be completed before experimentation.
Parts:
a. To be completed by the Student Researcher(s) in
collaboration with Designated Supervisor/Qualified Scientist:
b. To be completed and signed by the Designated
Supervisor (or Qualified Scientist, when applicable)

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The Research forms
8. Human Participants Form (4)
• Required for all research involving human participants not at
a Regulated Research Institution. If at a Regulated Research
Institution, use institutional approval forms for documentation
of prior review and approval. (IRB approval required before
recruitment or data collection.)

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The Research forms
9. Human Informed Consent Form
• An informed consent/assent/permission form should be
developed in consultation with the Adult Sponsor, Designated
Supervisor, or Qualified Scientist.
• This form is used to provide information to the research
participant (or parent/guardian) and to document written
informed consent, minor assent, and/or parental permission.

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The Research forms
9. Human Informed Consent Form
• When written documentation is required, the researcher
keeps the original, signed form.
• Students may use this sample form or may copy ALL
elements of it into a new document.
Note: If the form is serving to document parental permission,
a copy of any survey or questionnaire must be attached.

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The Research forms
10. Vertebrate Animal Form (5A)
• Required for all research involving vertebrate
animals that are conducted in a school/home/field
research site. (SRC Approval required before
experimentation.)

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The Research forms
10. Vertebrate Animal Form (5A)
Parts:
a. To be completed by Student Researcher
b. To be completed by Local or Affiliate Fair Scientific
Review Committee (SRC) BEFORE experimentation.
c. To be completed by Veterinarian
d. To be completed by the Designated Supervisor or Qualified
Scientist when applicable

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The Research forms
10. Vertebrate Animal Form (5A)
Parts:
a. To be completed by Student Researcher
b. To be completed by Local or Affiliate Fair Scientific
Review Committee (SRC) BEFORE experimentation.
c. To be completed by Veterinarian
d. To be completed by the Designated Supervisor or Qualified
Scientist when applicable

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The Research forms
11. Vertebrate Animal Form (5B)
• Required for all research involving vertebrate animals that
are conducted at a Regulated Research Institution.
• (IACUC approval required before experimentation. Form
must be completed and signed after experimentation.)
Parts:
a. To be completed by Qualified Scientist or Principal
Investigator

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The Research forms
11. Vertebrate Animal Form (5B)
• Required for all research involving vertebrate animals that
are conducted at a Regulated Research Institution.
• (IACUC approval required before experimentation. Form
must be completed and signed after experimentation.)
Parts:
a. To be completed by Qualified Scientist or Principal
Investigator

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The Research forms
12. Potentially Hazardous Biological Agents Risk Assessment Form
(6A)
• Required for research involving microorganisms, rDNA,
fresh/frozen tissue (including primary cell lines, human and other
primate 5 established cell lines and tissue cultures), blood, blood
products, and body fluids.
• SRC/IACUC/IBC approval required before experimentation.
Parts:
a. To be completed by the qualified scientist/designated supervisor

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The Research forms
13. Human and Vertebrate Animal Tissue Form (6B)
• Required for research involving fresh/frozen tissue (including
primary cell lines, human and other primate established cell lines and
tissue cultures), blood, blood products and body fluids.
• If the research involves living organisms, please ensure that the
proper human or animal forms are completed.
• All projects using any tissue listed above must also complete Form
6A

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The Research forms
13. Human and Vertebrate Animal Tissue Form (6B)
Parts:
a. To be completed by Student Researcher(s):
b. To be completed by the Qualified Scientist or
Designated Supervisor:

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The Research forms
14. Continuation/Research Progression Projects Form (7)
• Required for projects that are a
continuation/progression in the same field of study as a
previous project.
• This form must be accompanied by the previous year’s
abstract and Research Plan/Project Summary.

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