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U.S. Department of Health and Human Services
Indian Health Manual

Part 3, Chapter 7: Manual Appendix D

Sample Informed Consent Form

Name & Address of Institution
Investigator
Telephone Number

I understand that my physician recommends that I receive______________________, an investigational new drug for treatment of my disease.  The reason for this recommendation is that no other effective medicines or methods of management are available; that other approved drugs have failed; or that I am unable to tolerate other approved drugs, because of toxic reactions, etc.  (The investigator must indicate appropriate reason or reasons.)

________________________is a drug available at this time only for investigational use.  Previous experience in animals and human beings has been favorable, but there is no assurance that the results will always be favorable in human disease.  Toxic effects that have appeared include _______________________________________.  As with all investigational and approved drugs other side-effects, including long term side-effects, may emerge with increased experience.

I understand that I am free to withdraw my consent and stop my participation in this treatment, and that this action would not affect my receiving the best care and alternate treatments available in this facility.

I have had adequate time to consider my decision and have had my questions about the purpose of this medication and possible side-effects or harm answered fully to my satisfaction.

I understand that in the event of injury or harm established as resulting from use of the investigational drug, appropriate medical care may be provided by the Indian Health Service.  Neither the IHS nor the Federal Government has provisions for financial compensation in the event of such injury.

I agree to participate in this project as described.

Date:____________________

Patient's Signature:______________________________________________

Witness:_______________________________________________________

I have explained the above to the patient and believe that he/she understands.

Date:___________________

Phsician's Signature:_____________________________________________