Mary Jackson Pitts, Ph.D.
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Mary Jackson Pitts, Ph.D.
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OUTLINE
FOR INFORMED CONSENT STATEMENTS As
specified in the guidelines, each study requires an Informed Consent Statement
(which is read and signed by a subject), an Informational Sheet (which is read
by the subject), or verbal instructions (which are read to the subject). The
following points should be used to construct such statements, sheets, or
instructions.
I. PURPOSE OF THE STUDY.
Briefly describe the reason the research project is being conducted.
II. REQUIREMENT FOR
PARTICIPATION. Describe what
subjects will be asked to do if they decide to participate (i.e., procedures to
be followed, length of participation, etc.). III. POTENTIAL
RISK. Fully describe any potential
harm or discomfort subjects could experience and the likelihood such negative
effects will occur. When necessary,
state that unexpected risks may occur and/or any risks of voluntarily
withdrawing from the study. Describe
any compensation or treatment available if harm should occur.
IV. POTENTIAL BENEFITS.
Describe any potential benefits subjects could gain from participation
(including monetary payments, extra course credit, etc.).
V. ALTERNATIVE TREATMENTS.
Describe any alternative therapies available and the potential risks and
benefits of these therapies.
VI. WITHDRAWAL OF TREATMENT.
Describe the circumstances under which treatment may be withdrawn without
the subjects' consent. VII. VOLUNTARY
CONSENT. Indicate that
participation is voluntary and that there will be no penalty for refusal to
participate. Also indicate that the
subject can withdraw consent at any time. When
interview or questionnaire data are being collected, indicate that subjects can
refuse to answer individual items on the survey. VIII.
CONFIDENTIALITY. Indicate
that all data collected will be kept confidential.
When responses are anonymous, indicate this to the subjects. IX. QUESTIONS. Inform subjects that they can ask any questions they have about the research. Give the name of the person(s) to be contacted, and this person's address and/or telephone number. Include the investigator's name, address, and telephone number that the subject may use to ask questions and report any study related problems. Include the Office of Research, Library 101, P.O. Box 2760, State University, AR 72467, or Julie Linnstaedter, Office of Research, 870-972-2447 or the IRB office, 870-972-2694
X. SIGNATURE.
Studies using information sheets or verbal instructions do not require
signed informed consent--assent is implied by the subjects' participation.
When subjects are provided with a formal informed consent statement, have
subjects sign a statement that they have read and understand the informed
consent information. _________________________________________________________________
Note.
Parts III, IV, V, and VI may be omitted when they do not apply to the
research project. A waiver of
confidentiality can be included with Part VIII when approved by the IRB. |