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 > SAMPLE CONSENT FORM (Clinical) |
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1. Study Title: Heart Disease Risk Factors
2. Performance Site: X General Hospital
3. Investigators: The investigator listed below is available to answer questions about the research,
M-F, 8:00 a.m. - 4:00 p.m.
Dr. Jane Doe
578-0000
4. Purpose of the Study: The purpose of this research project is to
identify risk factors for heart disease
associated with the presence of fatty compounds
in the blood.
5. Subject Inclusion: Individuals, ages 18-50, who have suffered a
heart attack and are currently hospitalized for
treatment of this condition.
6. Number of Subjects: 125
7. Study Procedures: Each subject will have approximately 2 additional
tablespoons of blood drawn from his/her arm at the same
time blood is being drawn for tests associated with
his/her treatment for heart attack.
8. Benefits: There are no direct benefits to the subjects. However,
information gained from the study may provide early
identification of at-risk individuals to whom prevention
efforts can be directed.
9. Risks/Discomforts: There is slight discomfort and a small chance of
faintness associated with a needle stick; there
is also a slight possibility of bruising,
bleeding, and inflammation/infection at the site
of needle insertion. These risks/discomforts are
minimized by the collection of the blood by a
registered medical technologist using proper
procedure.
In any event, the collection of 2 extra tablespoons of
blood does not constitute additional risk to the subject
since blood is already being drawn for treatment, rather
than study, purposes.
10. Injury/Illness: In the unlikely event of injury or medical
illness resulting from the drawing of 2
additional tablespoons of blood, contact NAME,
TITLE, PHONE #. You will be referred for
treatment, but the expense of medical treatment
will be your responsibility. No compensation is
available in case of study-related illness or
injury.
11. Right to Refuse: Subjects may choose not to participate or to withdraw
from the study at any time with no jeopardy to their
treatment by their respective doctors or other penalty
at the present time or in the future.
12. Privacy: The LSU Institutional Review Board (which oversees
university research with human subjects) and SPONSOR
NAME (if applicable) may inspect and/or copy the study
records.
Results of the study may be published, but no names or
identifying information will be included in the
publication.
Other than as set forth above, subject identity will
remain confidential unless disclosure is legally
compelled.
13. Financial Information: There is no cost to the subjects, nor is there
any compensation for participating in the study.
14. 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 the consent form.
Subject Signature Date
The study subject has indicated to me that he/she is unable to read. I
certify that I have read this consent form to the subject and explained
that by completing the signature line above, the subject has agreed to
participate.
Signature of Reader Date
cfclinic.w5 (06/16/2001) |
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