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 > SAMPLE CONSENT FORM (Nonclinical) |
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1. Study Title: Association between Drug Usage and Migraine
Headaches: Effects of Migraine Headaches on
Attention
2. Performance Site: Louisiana State University and Agricultural and
Mechanical College
3. Investigators: The following investigators are available for
questions about this study, M-F, 8:00 a.m. - 4:30
p.m.
Dr. John Doe 578-0001
Dr. Jane Smith 578-1002
4. Purpose of the Study: The purpose of this research project is to
determine whether there is an association between
controlled drug use and migraine headaches and
whether migraine headaches alter one's ability to
concentrate.
5. Subject Inclusion: Individuals between the ages of 18 and 65 who do
not report psychological or neurological
conditions.
6. Number of subjects: 50
7. Study Procedures: The study will be conducted in two phases. In the first
phase, subjects will spend approximately 20 minutes
completing two questionnaires, one about migraine
headache symptoms; and the other, about past or current
psychological diagnoses and alcohol and drug use. In the
second phase, subjects will spend approximately two
hours completing 8 tests of attention.
8. Benefits: Subjects will be paid $10 to participate in the study.
Additionally, the study may yield valuable information
about migraine headaches.
9. Risks: The only study risk is the inadvertent release of
sensitive information found in the second
questionnaire. However, every effort will be made
to maintain the confidentiality of your study
records. Files will be kept in secure cabinets to
which only the investigator has access.
10. Right to Refuse: Subjects may choose not to participate or to withdraw
from the study at any time without penalty or loss of
any benefit to which they might otherwise be entitled.
11. Privacy: Results of the study may be published, but no names or
identifying information will be included in the
publication. Subject identity will remain confidential
unless disclosure is required by law.
12. Signatures:
The study has been discussed with me and all my questions have been
answered. I may direct additional questions regarding study specifics to
the investigators. If I have questions about subjects' rights or other
concerns, I can contact Robert C. Mathews, Institutional Review Board,
(225) 578-8692. I agree to participate in the study described above and
acknowledge the investigator's obligation to provide me with a signed copy
of this consent form.
Signature of Subject Date
cfnoncln.w5 (06/15/2001) |
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