A Brief Summary of Guidelines for Research
UWEC Institutional Review Board for the
Protection of Human Subjects |
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| Any research
project, either funded or unfunded, originated at or supported by the University that
involves human subjects must be reviewed by the Institutional Review Board for the
Protection of Human Subject (IRB). |
| Obtaining the
informed consent of a potential human subject for participation in an experiment, survey,
interview, or demonstration is a necessary safeguard for protecting her/his well-being. |
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1. |
No respondent can
be identified in any way with the information/data provided to the researcher without
prior consent. Subjects will be advised at the beginning of the data collection procedure
that all information/data will be kept confidential, and said data will not be identified
with the subject unless she/he approves, in writing, of this disclosure. |
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2. |
At the outset of
the data collection procedure, the subject will be advised in a general way about the
purpose of the research as well as its sponsorship if a nonuniversity organization is
involved. |
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3. |
For survey
research projects, informed consent is obtained by providing a detailed explanation of the
purpose and protocol for the research project to the potential subject/respondent. The
completion of the survey instrument (i.e., questionnaire/interview schedule) shall
constitute informed consent. |
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4. |
If questionnaires
or interview schedules are used, the maximum number of follow-ups that can be reasonably
employed to improve the return rate in a given research project is subject to approval, on
a case-by-case basis, by the IRB. This limitation of follow-ups will avoid harassment and
feelings of coercion on the part of subjects. |
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5. |
No pregnant woman
my be involved as a subject in a research project unless: |
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a. |
The purpose of the research
activity is to meet the health needs of the mother, and the fetus will be placed at risk
only to the minimum extent necessary to meet such needs; or |
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b. |
The risk to the fetus is
minimal. |
Minimal Standards for Informed Consent |
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1. |
Information.
Subjects are to be given information on the purpose, procedures, possible
benefits, risks, and investigators as necessary to make informed judgments about their
participation |
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2. |
Understanding..
Investigators must take appropriate measures to assure that subjects understand the
consequences of participation in the research |
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3. |
Voluntariness.
. Subjects must be given opportunities to contemplate their decision to participate
and to give or not give their consent without coercion and with the understanding that
they may withdraw from participation at any time. |
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Definitions
of Key Terms |
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Confidentiality
means that the investigators will not make unauthorized
disclosure of identifying information and/or data that have been obtained from a
respondent. |
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Deception
in
research means that the subject/respondent, at any time of the data collection, is not
fully informed of the nature and purpose of the research in which she/he is involved so as
to prevent potentially biased reporting of data/information. |
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Human subject at risk
refers to any individual who may be exposed to the possibility of injury.
including economic, legal, physical, psychological, or social injury as a consequence of
participation as a subject in any research project or related activity that departs from
the application of those established and accepted methods necessary to meet the person's
needs or that increase the ordinary risks of daily life, including the recognized risks
inherent in a chosen occupation or field of service.
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Informed consent
means the voluntary, knowing consent of any individual or her/his legally
authorized representative, so situated as to be able to exercise free power of choice
without undue inducement or any element of force, fraud, deceit, duress, or other form of
constraint or coercion. |
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Intervention
includes both physical procedures by which data are gathered (for example,
venipuncture) and manipulations of the subject or the subject's environment that are
performed for research purposes. |
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Minimal risk
means that the risks of harm anticipated in the proposed research are not
greater, considering probability and magnitude, than those ordinarily encountered in daily
life or during the performance of routine physical or psychological examinations or tests. |
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Survey methodology
includes. but is not limited to, mail questionnaires, telephone
interviews, personal interviews, and group questionnaires that seek to collect data from
any population or sample of individuals. |
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