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A Study of an Experimental Diagnostic Test


A company, IVD, Inc., is working on a new test to diagnose diseaseria. Diseaseria is a disorder of the stomach that can cause swelling, redness and discomfort that may result in severe nausea and/or headaches with fever and stomach pain. If left untreated, diseaseria can be fatal. Diseaseria has few symptoms so finding a test to help diagnose it is important. The experimental part of the test is (…how the lab equipment analyzes the sample rather than the procedure).


If you agree to be in the study you will be a research subject. You would be agreeing to do two things.

1. You will have one small tube of blood drawn from an arm vein.

2. Some information about your health will be collected.

When IVD Inc. is finished with the samples they will be destroyed.


Drawing blood can be uncomfortable, can cause a bruise or, rarely, an infection.  In order to make sure research is valid, the FDA and the company has the right to randomly audit records but not to take any information that may identify you.


There will be no benefit to you. The knowledge from the study might help to make a better test used to diagnose diseaseria.  Your sample and information will be added to other samples and used by scientists.  If the company makes money as a result of their research, you will not share in the profits, if any.


The alternative to participating is choosing not to take part.  You may refuse.


There is no cost to you to take part. You will be paid $xx.xx at the end of your visit. Even if IVD makes lots of money, you will not share in any of the profits.


 If you have any questions about anything involving this study, you should talk to:

Drs. …at xxx-xxx-xxxx

Additional contact information

If you have questions about your rights as a research subject, or if you have complaints that you do not want to talk to the doctor about you may call Ethical & Independent Review Services E&I) at (800) 472-3241, email them at This e-mail address is being protected from spambots. You need JavaScript enabled to view it



You have the right to refuse to take part in this study. Once in the study, you have the right to withdraw at any time, however, you will not be able to get your sample back as it will no longer be identifiable. If you refuse or withdraw there will be no penalty to you.



If you agree to be in this study, please sign this form.


Signature                     Printed Name                         Date


If you are a minor, a parent or guardian must sign.


Signature                     Printed Name                         Date


Person who explained the study must sign.


Signature                     Printed Name                         Date





CF 7/1/09 – Version 2.x

Last Updated ( Friday, 07 April 2017 09:41 )