Human Subjects
Review Tutorial
Why do human subjects project
need to be reviewed so carefully?
On July 12, 1974, the National Research Act
was signed into law, there-by creating the
National Commission for the Protection of
Human Subjects of Biomedical and
Behavioral Research.
The Commission was charged with
identifying the basic ethical principles that
should underlie the conduct of biomedical
and behavioral research involving human
subjects and to develop guidelines which
should be followed to assure that such
research is conducted in accordance with
those principles.
Thus the Belmont Report was created.
What is the Belmont Report?
The Belmont Report consists of three
principles, or general prescriptive
judgments, that are relevant to research
involving human subjects. They are stated
at a level of generalization that should assist
scientists, subjects, reviewers and interested
citizens to understand the ethical issues
inherent in research involving human
subjects
What are the three basic ethical
principles?
1. Respect for Person
 Individuals
should be treated as autonomous agents.
 Persons with diminished autonomy are entitled to
protection.
These include, but are not limited to pregnant women,
mentally disabled persons, economically or educationally
disadvantaged persons, individuals with diseases such as
cancer, asthma, diabetes, cardiac disorders, psychiatric
disorders, dyslexia, AIDS, etc., children/minors, and
prisoners.
What are the three basic ethical
principles?
2. Beneficence
Do
not harm.
Maximize possible benefits and minimize possible harms.
One should not injure one person regardless of the benefits
that might come to others. It must be decided when it is
justifiable to seek certain benefits despite the risks
involved, and when the benefits should be forgone because
of the risks.
What are the three basic ethical
principles?
3. Justice
The
selection of research subjects needs to be scrutinized
in order to determine whether some classes are being
systematically selected simply because of their easy
availability, their compromised position, or their
manipulability, rather than for reasons directly related to the
problem being studied.
Research should not unduly involve persons from groups
unlikely to be among the beneficiaries of subsequent
applications of the research.
What is an Institutional Review
Board (IRB)?
An IRB is a committee that must evaluate the potential
physical and/or psychological risk of research involving
human subjects.
All proposed human research must be reviewed and
approved by an IRB BEFORE experimentation begins.
This includes any surveys or questionnaires to be used in a
project.
What are the IRB membership
requirements?
Federal regulations REQUIRE local community
involvement, therefore, an IRB should be established at the
school level to evaluate human research projects.
An IRB must consist of a minimum of three members:
a) A science teacher
b) A school administrator
c) Someone who is knowledgeable and capable of
evaluating the physical and/or psychological risk involved in
a given study: A medical doctor, physician’s assistant,
registered nurse, a psychiatrist, psychologist, or licensed
social worker.
What are some tips for a
successful IRB?
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The Adult Sponsor, parents, Qualified Scientist and
Designated Supervisor of a project MUST NOT be a
member of the IRB reviewing that project.
Have two science teachers as members of the IRB to
avoid a conflict of interest if one of them is the Adult
Sponsor of a project needing review.
Include a medical person to review medical human
subjects projects and a behavioral specialist to review
psychology human subjects projects.
Ask for help of the state SRC or international SRC if
there are questions about how to advise a student.
Who has jurisdiction?
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If the project includes subjects limited to where the
researcher goes to school or lives, then the local
(school) IRB should be reviewing a project.
If the researcher is working at a university or other
regulated institution, then the initial approval must come
from that institution’s IRB and the local IRB is
responsible must ensure the research is appropriate for
that age of student and that all ISEF rules are followed.
If the project includes subjects from places such as other
schools, universities, or nursing homes, then those
facilities have the right and obligation to review the
project as well.
What exactly is human subject
research?
A human subject is a living individual about whom a
researcher, conducing research obtains:
(1) Data through intervention or interaction with the
individual
OR
(2) Identifiable private information.
Research is a systematic investigation designed to develop
or contribute to generalizable knowledge.
Quiz – Is it human subject
research?
A researcher is conducting a study testing the
reflex capabilities of different groups of
athletes.
Hit Enter to see the answer.
Yes – the researcher is collecting data through direct
interaction with people. Any project where subjects
participate in physical activities (physical exertion, ingestion
of any substance or any medical procedure) are considered
human subjects projects.
Quiz – Is it human subject
research?
A researcher is having people test a newly
engineered device that replaces the traditional
computer mouse.
Hit Enter to see the answer.
No – product testing of engineering projects are not
considered human subject projects, although if a student
wishes to restrict the subject population to one of the at-risk
groups, it would be best to have IRB approval.
Quiz – Is it human subject
research?
A researcher is using a survey to collect the
opinions of fellow students on different types of
music.
Hit Enter to see the answer.
Yes – research that involves psychological, educational
and/or opinion studies using such tools as surveys,
questionnaires and tests are human subjects projects.
Quiz – Is it human subject
research?
A researcher conducts a study observing
whether or not cars come to a complete stop at
certain intersections.
Hit Enter to see the answer.
No – behavioral studies of unrestricted, public settings in
which all of the following apply (1) The researcher has no
interaction with the individuals being observed; (2) the
researcher does not manipulate the environment is any
way and (3) the researcher does not record any personally
identifiable data, are not human subjects projects.
Quiz – Is it human subject
research?
A researcher is conducting a study in which
he/she is the subject of the study.
Hit Enter to see the answer.
Yes – all studies where the researcher is the subject of the
research is considered human subjects projects.
Quiz – Is it human subject
research?
A researcher is conducting a study on people’s
responses to a person greeting them outside of
a store while holding a puppy, holding a balloon
and then holding nothing.
Hit Enter to see the answer.
Yes – behavioral observations that either (1) involve any
interaction with the observed individual(s) or where the
researcher has modified the environment, (2) that occur in
a non public or restricted access setting, or (3) involve the
recording of personally identifiable information are
considered human subjects projects.
Quiz – Is it human subject
research?
A researcher is doing a statistical analysis of
crime statistics in different types of cities.
Hit Enter to see the answer.
No – data/record review studies in which the data are taken
from pre-existing data sets that are publicly available or
published are not considered human subjects projects.
Quiz – Is it human subject
research?
A researcher is conducting a study on the
correlation between GPA and extra-curricular
activities.
Hit Enter to see the answer.
Yes – data/record review projects that include identifiable
data are considered human subjects projects.
Quiz – Is it human subject
research?
A researcher is looking at de-identified x-rays of
head injuries obtained from a doctor’s office.
Hit Enter to see the answer.
No – studies where the student receives the data in an
anonymous format is not considered a human subjects
project as long as the student also receives a certification
from the doctor that they are in compliance with all privacy
and HIPAA laws and they have been properly de-identified.
What are the risks that should be
considered during the review?
Many kinds of possible harms and benefits need to be
taken into account:
Psychological harm or benefit
Physical harm or benefit
Legal harm or benefit
Social harm or benefit
Economic harm or benefit
Risks and benefits of research may affect the individual
subjects, the families of the individual subjects and society
(or special groups of subjects in society) at large .
What criteria should an IRB use in
reviewing research proposals?
Risks to subjects are minimized (1) by using
procedures which are consistent with sound
research design and which do not
unnecessarily expose subjects to risk, and
(2) whenever appropriate, by using
procedures already being performed on the
subjects for diagnostic or treatment
purposes.
What criteria should an IRB use in
reviewing research proposals?
Risks to subjects are reasonable in relation
to anticipated benefits, if any, to subjects,
and the importance of the knowledge that
may reasonably be expected to result.
What criteria should an IRB use in
reviewing research proposals?
Selection of subjects is equitable. In making
this assessment, the IRB should take into
account the purposes of the research and
the setting in which the research will be
conducted and should be particularly
cognizant of the special problems of
research involving vulnerable populations.
What criteria should an IRB use in
reviewing research proposals?
Informed consent will be sought from each
prospective subject or the subject’s legally
authorized representative (guardian).
What criteria should an IRB use in
reviewing research proposals?
When appropriate, the research plan makes
adequate provision for monitoring the data
collected to ensure the safety of subjects.
What criteria should an IRB use in
reviewing research proposals?
When appropriate, there are adequate
provisions to protect the privacy of subjects
and to maintain the confidentiality of data.
What kind of determination can the
IRB make of a research project?
Minimal
Risk where informed consent is recommended,
but not required. The IRB must provide a justification for
this waiver if the subjects are under 18 years of age.
Minimal Risk where informed consent is required.
More than minimal risk where informed consent and a
Qualified Scientist are required.
Rejection of proposed research.
Whenever possible, the IRB should review the research
plan with a critical eye that not only assesses risk, but also
the soundness of the research and provide guidance to the
student in making his/her research the best it can be.
What does No More Than Minimal
Risk mean?
No more than minimal risk exists when the
probability and magnitude of harm or
discomfort anticipated in the research are
not greater (in and of themselves) than
those ordinarily encountered in DAILY LIFE
or during performance of routine physical or
psychological examinations or tests.
Quiz – Is it more than minimal risk?
A researcher is testing resting pulses before
and after running four laps around a ¼ mile
track using both trained and untrained runners.
Hit Enter to see the answer.
Yes – exercise other than that ordinarily encountered in
daily life by a subject (in this case, the untrained runners) is
more than minimal risk.
Quiz – Is it more than minimal risk?
A researcher is testing the affects chewing
gum, eating breath mints, or using mouth wash
have on the accuracy of a breathalyzer testing
device.
Hit Enter to see the answer.
Yes – ingesting any substance or exposure to any
potentially hazardous material is more than minimal risk.
Quiz – Is it more than minimal risk?
A researcher is conducting a survey of
classmates that includes questions asking
about divorce, depression, anxiety and suicide.
Hit Enter to see the answer.
Yes – answering questions related to person experiences
such as sexual, physical or child abuse, divorce and/or
psychological well being MUST be considered more than
minimal risk..
Quiz – Is it more than minimal risk?
A researcher is testing subject’s reactions
to a particularly violent video game.
Hit Enter to see the answer.
Yes – exposing subjects to stimuli or experimental
conditions that could potentially result in emotional stress
MUST be considered more than minimal risk.
Quiz – Is it more than minimal risk?
A researcher comparing different
ethnicities’ fingerprint patterns.
Hit Enter to see the answer.
Yes – any activity that could potentially result in negative
consequences for the subject due to invasion of privacy or
breech of confidentiality should be considered more than
minimal risk.
How can risks be minimized?
Consider using adults rather than
children/minors in any human subjects
project being proposed.
How can risks be minimized?
Always allow subjects to withdraw from the
research at any time.
How can risks be minimized?
Collect the data anonymously or develop
data collection procedures that make it
impossible to link any identifying information
with an individual’s responses or data.
Anonymity - no way to identify participant
Confidentiality – methods and limitations in protecting the
identity of participants and their data (link lists or coding
schemes)
What is Informed Consent?
The process of obtaining informed consent
provides information to the subject about the
risks and benefits associated with
participating in the research study and
allows the subject to make an educated
decision about whether or not to participate.
What is Informed Consent?
Describe the purpose of the study as clearly
as possible.
For Example:
The purpose of this study is to identify and map sulfate
concentrations in water and forage samples.
What is Informed Consent?
List ALL of the research procedures in which
the subject will be involved. If there are
different procedures for different groups of
people, then SEPARTE consent forms need
to be completed for each group.
For Example:
A survey regarding sulfate toxicity in cattle will be given to
those land owners who are cattle producers.
What is Informed Consent?
Include the duration of the subject’s
involvement.
For Example:
The survey should only take 15 to 20 minutes to complete.
What is Informed Consent?
Describe and assess any potential risk or
discomfort, and, if any, potential personal
benefits that may be reasonably expected by
participating in the research. If there are none,
use the following statements:
No known risks.
No personal benefits to the subject.
For Example:
There are no known risks to the subjects by participating in
this study – potential benefits include receiving information
from the sulfate analysis done on the water and forage
from their land.
What is Informed Consent?
Describe the procedures that will be used to
minimize risk, to obtain informed consent
and/or assent and to maintain confidentiality.
For Example:
All landowners will receive a detailed project overview, a
copy of the survey, a map and a release form. All
properties will be identified by a code and not by the land
owner’s name. All landowners will be allowed to withdraw
their participation at any time during the research.
What is Informed Consent?
If documented informed consent is not
required, subjects must give their
consent/assent to participate in the study.
The procedure for obtaining consent/assent
should be included in the research plan.
Quiz – Is documented informed
consent necessary?
A researcher is working with a teacher to see
what effects different testing strategies have on
student’s scores.
Hit Enter to see the answer.
No – research involving normal educational practices does
not require documented informed consent. The researcher
should send a note home to parents informing them of the
research that their children will be taking part of in an effort
to increase test scores.
Quiz – Is documented informed
consent necessary?
A researcher is observing different intersections
in town and documenting whether cars are
coming to a complete stop. Information about
the car and driver are not collected.
Hit Enter to see the answer.
No – research on behavior or characteristics of individuals
where the researcher does NOT manipulate the subjects’
behavior does not require documented informed consent.
Quiz – Is documented informed
consent necessary?
A researcher is looking at the memory
capabilities of girls and boys at different grade
levels using pictures and words.
Hit Enter to see the answer.
No – surveys and questionnaires that involve perception,
cognition or game theory and do not involve gathering
person information, invasion of privacy or potential for
emotional distress (what are the pictures and words being
used?) do not require documented informed consent.
Quiz – Is documented informed
consent necessary?
A researcher is looking at the best angle to use
when shooting free throws, using basketball
team players as subjects.
Hit Enter to see the answer.
No – studies involving physical activity where the
probability and magnitude of harm or discomfort anticipated
in the research are not greater than those ordinarily
encountered in daily life or during performance of routine
physical activities do not require documented informed
consent.
What if . . . ?
The researcher doesn’t want the subjects to
see the survey prior to completing it, but
parental/guardian consent is needed?
A copy of the consent form and a sealed copy of the
survey/questionnaire can be sent home to parents with
instructions not to divulge the survey contents to the
subjects. Always offer the subjects the opportunity to not
have their survey included in the study even after they have
completed it.