What is the IRB looking for in an application?
The IRB is charged to protect human participants involved in research and to ensure that this research
is carried out in an ethical manner. To this end, the IRB will consider whether each proposed research
study conforms to the following standards:
1) Risks to participants are minimized.
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Risk involves the potential for physical, psychological, social, or financial harm and can
vary from minimal to significant.
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Minimal risk means that the probability and magnitude of harm or discomfort are not
greater in and of themselves than those ordinarily encountered in daily life or during the
performance of routine physical or psychological examinations or tests.
2) Risks to participants are reasonable in relation to anticipated benefits, if any, to participants,
and to the importance of the knowledge that may reasonably be expected to result from the
research.
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Evaluation of the risk/benefit ratio is the major ethical judgment that IRBs must make in
reviewing research proposals. Virtually all research involves some risk even though it may
be very slight, e.g., embarrassment over one’s performance on a task or slight discomfort
in answering personal questions about oneself. The IRB will consider the extent to which
researchers have attempted to identify the potential risks to the subject and the extent to
which those risks have been minimized as much as possible without interfering with the
validity of the research itself.
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The risk/benefit assessment is not a technical one valid under all circumstances; rather, it
is a judgment that often depends upon prevailing community standards and subjective
determinations of risk and benefit. In cases where there is the possibility of more than
minimal risk to the subject, approval will depend on the benefits of the research, the
expertise and prior experience of the researcher(s) in conducting this type of research, the
level of inducement to participate, the extent to which the subject is fully informed of the
possible risks and the availability of compensatory treatment or follow-up designed to
alleviate any negative consequences from participation.
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(For further consideration of this issue, see the third chapter of the Institutional Review
Board Guidebook published by the U. S. Department of Health and Human Services:
http://www.hhs.gov/ohrp/archive/irb/irb_chapter3.htm.)
3) Selection of participants is appropriate and reasonable, avoiding undue influence (coercion) on
individuals in seeking their involvement.
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In making this assessment, the IRB takes into account the purposes of the research and the
setting in which the research will be conducted, being particularly cognizant of the special
problems of research involving vulnerable populations, such as children, prisoners,
pregnant women, mentally disabled persons, or economically or educationally
disadvantaged persons.
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Participants, including students who are partaking in classroom experiments or faculty
scholarship, must not be induced to participate by means or in circumstances that might
affect their ability to decide freely. When course credit is offered for participating in
research, some other mechanism to earn that credit must also be made available to those
students who choose not to participate as human subjects. Rewards for participating should
be in line with the burden imposed by participating, to avoid presenting an undue influence
on a person’s ability to freely choose to participate.
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Additional safeguards should be considered to protect the rights and welfare of participants
when some or all of the participants are likely to be vulnerable to coercion or undue
influence, such as children, prisoners, pregnant women, mentally disabled persons, or
economically or educationally disadvantaged persons.
4) Informed consent is sought from each prospective participant or the participant's legally
authorized representative.
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Informed consent assures that prospective participants will understand the nature of the
research and can knowledgeably and voluntarily decide whether or not to participate.
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Investigators must not use individuals as participants unless the investigators are satisfied
that the participants, or others legally responsible for the participants’ well-being, can
fully understand the consequences of participation and can freely consent to being involved
in the study.
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Before they participate, the principal investigator must explain to individuals:
 The purpose of the research;
 The procedures to be followed;
 Any reasonably foreseeable risks or discomforts to the participant;
 Any potential benefits to the participant;
 A statement describing the extent, if any, to which confidentiality of records
identifying the subject will be maintained;
 The fact that participants are free to withdraw from the research at any time without
penalty.
 An explanation of whom to contact for answers to pertinent questions about the
research and participants’ rights.
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In general, participants are informed about the above issues through a written consent
form, and signal their agreement to be involved in the study by signing this form. The
requirement for written consent may be waived under one of the following conditions:
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The research involves no or only minimal risk;
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The consent form will be the only evidence linking the subject and the research, and the
primary risk of harm is to the subject’s privacy
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Anonymous surveys, where participants’ identity cannot reasonably be connected to the
information they provide, do not require written consent. However, the explanations of
the research procedure that are standard on a written consent form (see above) should be
included at the beginning of the survey. Consent to participate is implied when a subject
completes and returns the survey.
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Federal Law stipulates that a person must be 18 years or older in order to give legal
consent for his/her own participation in research. Subjects under the age of 18 may
participate in research only with the signature of their parent or legal guardian in addition
to their own signature. This also applies to the completion of anonymous questionnaires
since persons under 18 are not permitted legally to make the informed choice to
participate. Children should have the information about participation in the research
explained to them in language they can understand (by their parent), and, if possible, they
should also sign their consent. In some cases, children also should be given an Informed
Consent Form for them to sign that explains the study, risks, and benefits in ageappropriate language. In these circumstances, if a child does not give consent but a parent
does, the child should not be used as a subject.
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Research involving deception compromises a subject’s ability to give truly informed
consent. The IRB will consider requests to waive some of the requirements for informed
consent for research that intentionally involves deception, but only if all of the following
criteria are met:
 The research cannot be done without the deception.
 The potential value of the research outweighs any potential risks to the subject.
 The subjects are informed of the true nature of the research as soon as possible.
 The research involves no more than minimal risk (federal requirement).
5) When appropriate, there are adequate provisions to protect the participants’ privacy and to
maintain data confidentiality.
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Investigators must respect the privacy (ability to control the extent, timing, and
circumstances of sharing oneself) of their participants. In general, participant privacy is
maintained by virtue of the method used to collect information, where the method of
collection used assures that that participants’ identity can never reasonably be connected
with the information they provide. Examples: anonymous surveys or questionnaires,
substituting numerical identifiers in place of personal information.
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The research plan makes adequate provision for monitoring all data collected to ensure the
privacy of participants. Investigators must protect confidential information given to them
and must advise subjects in advance of any limits on their ability to ensure that the
information will remain confidential.
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If the data gathered by a student researcher are not anonymous, the IRB recommends that
the data be turned over to the faculty sponsor, who then becomes responsible for either
ensuring that it is destroyed or archiving it with his or her data. In cases in which a student
is planning to go on to graduate school and may want to continue the research or use the
data in future projects, he or she may request permission from the IRB to retain the data.
Permission is contingent on the student’s agreement to protect the confidentiality of the
data