Institutional Review Board (IRB)
Ethics and Informed Consent
Marygrove College
Resources:
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Marygrove College IRB Documents
http://research.uthscsa.edu/ocr/Privacy and
Confidentiality in Human Research.pdf
http://www.gifted.uconn.edu/siegle/research/Ethics
/ethics.htm
Overview
Introduction: Ethics and Classroom
Research
 Definitions
 3 Basic Ethical Principles

◦ Respect for Persons
◦ Beneficence
◦ Justice
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Summary
Introduction:
Ethics and Classroom Research

Why are we learning this?
◦ It is important to the future of education that
teachers act as researchers and add to the
knowledge base of educational research.
◦ Researchers are bound by ethics.
◦ Researchers connected to an organization that
collects federal funds must have a way to review
research for ethical considerations.
◦ Some Marygrove students receive federal student
aid.
◦ Therefore, Marygrove MAT - Teacher as Researcher
students must learn about research ethics and
conform to federal guidelines.
Definitions: Code of Ethics
Researchers are bound by a code of ethics that
includes the following protections for subjects:
1. Protected from physical or psychological
harm (including loss of dignity, loss of
autonomy, and loss of self-esteem)
2. Protection of privacy and confidentiality
3. Protection against unjustifiable deception
4. The subject must give voluntary informed
consent to participate in research.
Parents/Guardians must give consent for
minors to participate. Minors over age 7
must also give their consent to participate.
Definitions: Research

Research is a systematic investigation (this might
range from applying scientific methodology
involving independent and dependent variables to
an ethnographic study of a community).
o It includes research development, testing, and
evaluation (this also includes pilot studies,
feasibility studies, and other preliminary
studies).
o It is designed to develop or contribute to
generalizable knowledge (an essential
consideration is whether it is the intention of
the investigator to contribute to generalizable
knowledge).
Definitions: Human Subjects

Living individual(s) about or from whom an
investigator conducting research obtains:
◦ Data through intervention or interaction (does not
need to be face-to-face, could be via email or a
participant observation) with the individual or
◦ Identifiable private information – (a) information
about behaviors that occur in a context where the
individual can reasonably expect that no
observations or recording is taking place, or (b)
information that is provided for a specific purpose
and for which the individual can reasonably expect
will not be made public.
Definitions:
Privacy and Confidentiality
Privacy relates to a person. Examples include: where a
person goes, what a person does, who a person is with. The
research proposal should outline strategies to protect
privacy, including how the investigator will gather data about
the participants.
 Confidentiality relates to information/data about an
individual. This is the agreement between the researcher and
the participant about how the participant’s identifiable
private information will be handled, stored, and published.
This means storing raw data in a secure place, not publishing
data in which subjects are identified by name, encrypting or
password protecting documents and computers.

Definitions:
Voluntary Informed Consent

Voluntary informed consent means that
the person involved:
◦ Has legal capacity to give consent
◦ Is able to exercise free power of choice (no
fraud, force, deceit, duress, etc.)
◦ Has enough knowledge and comprehension
of the research to make an enlightened
decision
Definitions: Risk
Risk is the chance that something bad
might happen as a result of participating in
the research.
 Risk can be physical, mental, or emotional.
 Risk for those under 18 or in special
populations is almost always greater than
for most adults.

3 Basic Ethical Principles

Respect for Persons
◦ Voluntary Consent
◦ Privacy/Extra Protection

Beneficence
◦ Risk
◦ Confidentiality
◦ Monitor Data for Safety

Justice
◦ Subject Selection Equality, Vulnerable
Populations, Populations of Convenience
Respect for Persons:
Informed Consent

Policy Concerning INFORMED CONSENT
 In
accordance with Federal regulations, College policy on research
involving human subjects requires the use of “informed consent” forms,
which must be signed by the subject or the legally authorized
representative of the subject.
 The
IRB Behavioral Sciences Board is charged with the task of reviewing
these forms in advance. Therefore, each request for the approval of a
research project should be accompanied by a FINAL COPY of a consent
form prepared for that project.
 Only
persons whose consent has been obtained in the manner indicated
can be used as research subjects. All signed consent forms must be
retained by the investigator for a minimum of three years. Only IRB
approved consent forms may be used.
 If
changes are made to a previously approved consent form, please
notify the IRB administrative office. You must have your new consent
document reviewed and approved before it may be used for your
subjects (see the Informed Consent document for more details).
Respect for Persons:
Privacy

Privacy Policy – Either no identifying information is
recorded to link a person with the data, or if
identification is possible, no questions are being asked
or information being collected that could reasonably
harm the individual’s reputation, employability, financial
standing, or place them at risk for criminal or civil
liability.

Invasion of Privacy – This can occur if personal
information is accessed or collected without the subject’s
knowledge or consent. The subject’s participation may be
revealed without their knowledge (e.g., email
communications with a subject about recovering from sexual
assault might be read by family members).
Respect for Persons:
Additional Protection


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The regulations also set forth requirements for obtaining
permission by parents and guardians and, except under certain
circumstances, assent by the children themselves.
When the child is a ward of the state, the appointment of an
advocate is required under some circumstances.
The regulations exempt from coverage most social, economic, and
educational research in which the only involvement of children
as subjects will be in one or more of the following categories:
 Research conducted in established or commonly accepted educational
settings, involving normal educational practices
 Research involving the observation of public behavior
 Research involving the use of educational tests
 Research involving the collection or study of existing data, documents,
records, or specimens
Beneficence:
Risk

Risk in an experiment must be minimized.
◦ Minimized risk means that the chance and amount of
harm or discomfort anticipated in the research are no
greater than what would be encountered in regular,
daily life.



Risks in physical science, like medicine, are often
easy to see.
Risks in social and behavioral science research,
like that in teacher-research or action research,
are often more elusive and less predictable.
Be especially careful about your communications,
which can cause unintended risks.
Beneficence:
Reasonable Risk to Benefits


Risks to participants must be reasonable in relation to
the anticipated benefits, if any, to the participants and to
society and the importance of the knowledge that may
reasonably be expected from the study.
Risks, even when unavoidable, can be reduced or
managed. If there are precautions, safeguards, and
alternatives that can be incorporated into the research
activity to reduce the probability of harm or limit its
severity or duration, the IRB will require these changes
before approving the study.
Beneficence:
Risk & Pre-existing Data Sources
Using pre-existing data sources reduces
risk to subjects
 Identification of subjects can be done by
assigning a number to each
 Examples of pre-existing data sources
might include number of office referrals
or test grades

Beneficence:
Maintain Confidentiality



Confidentiality – Researchers must guarantee that information
related to subjects is kept confidential as described in their
Informed Consent document.
Breach of Confidentiality – The primary source of risk in the
social and behavioral sciences is that information obtained by
researchers could harm subjects if disclosed outside the research
setting.
Requirements – Researchers must maintain and destroy records
as stipulated in the federal records.
◦ Every principal investigator is required by federal regulations to
maintain records of all correspondence relating to the use of human
subjects in research.
◦ These records must be maintained for at least three years after the
close of the study.
◦ After that time, records can be destroyed in such a manner as to
continue to protect the identity of subjects (e.g., shredding documents
that identify participants).
Beneficence:
Monitor Data for Subject Safety
As you collect data during your research
project, pay attention to the effect of the
study on the participants.
 For example, suppose you are doing a
study in which you try to reduce bullying.
If the intervention you try actually makes
the bullying worse, you should stop
immediately and consult your mentor.

Justice
Equal Subject Selection – this means
making sure that if you are selecting only
some of your students for the
intervention, you select those students in
a way that has nothing to do with race,
gender, age, etc.
 A good way to select students equally is a
random selection method (like every
third student on a list).

Justice (continued)

Avoid exploitation of vulnerable
populations or populations of
convenience.
◦ Vulnerable populations include those in
prison, those with special needs, those who
are ill, etc.
◦ Populations of convenience are groups
selected because they are handy rather than
representative of the total population.
◦ Use appropriate selection techniques to
decide who will and who will not be asked to
participate in the research.
Summary
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As part of the Teacher as Researcher course and
the Capstone B project, you will file an
Institutional Review Board (IRB) Application.
In filling out the application, you will address the
basic principles of Respect for Persons,
Beneficence, and Justice.
You will submit your IRB Application to your
mentor, who will begin the approval process.
Once your application has been approved, you
will be able to begin collecting data.
You must maintain private and confidential
records of your research.