Informed Consent Forms
Informed Consent Forms
USA VERSION
The ECLA 2 Glucose – Insulin –Potassium Full Scale Trial
Informed Consent (USA version)
It is a principle of medical practice that a subject who is to participate in the research investigation of a new medical treatment, device or procedure must give his or her informed consent to such participation. This consent must be based on an understanding of the nature and risks of the treatment, device or procedure. It is the responsibility of the physician to provide a subject with the information necessary to this understanding.
Explanation of the study
You are being invited to participate in this research study because it appears that you are having a heart attack. A heart attack is usually caused by a blood clot that blocks flow through the arteries that supply blood to the heart. Standard treatment for a heart attack includes aspirin, a medication (streptokinase) to dissolve the clot, thereby opening the artery and restoring blood flow to the heart, and an anticoagulant medication to thin the blood such as heparin. The purpose of this study is to evaluate an adjunctive glucose-insulin-potassium infusion and compare this with conventional approach in the treatment of myocardial infarction. Approximately 10,000 patients will be enrolled in this study throughout the world. Approximately 5,000 patients will receive GIK infusion and 5,000 will not. If you agree to participate in this study, you will receive either GIK infusion or conventional infusion through a vein (intravenously). The medication you receive will be selected by random chance (like flipping a coin). The length of time you will be on GIK infusion is planned to be for 24 hours. You will be monitored very closely during your hospitalization. Blood samples to measure glucose and potassium will be drawn throughout your hospitalization; however, this is part of routine care. No other additional blood samples are required as part of this study.
Follow-up
You will be contacted in one month and one year from today to help us to know how you are doing. Benefits You may benefit if the medication you receive is GIK infusion and it proves to be more effective or safer in the treatment of heart attacks than conventional infusion. You may, however, receive no direct benefit from being in this study, but the knowledge gained from your participation may benefit other people who have heart attacks in the future.
Risk and discomfort
Minor risk of having high or low glucose or potassium blood levels exits and exceptionally you could have inflamation at the puncture site. You will be closely monitored by the nursing staff and study physicians to identify these problems quickly, if they should occur, and allow for prompt treatment, if necessary. The effects of GIK on the unborn child are unknown. If you could possibly be pregnant you must tell your doctor immediately and not participate in this trial.
Appropriate alternative treatments
If you choose not to participate in this study, you will receive standard treatment for your heart attack.
Confidentiality
All information obtained from your participation in this study will be held strictly confidential. In addition to the health care professionals caring for you, the ECLA Coordinating Center (ECC) may review your medical records. Your identity will remain confidential if material from your medical record is used for publication or educational purposes. To facilitate follow-up in one month and again in one year, your name, address and phone number will be provided to the data center.
Research relate injuries
Immediate necessary care is available if you are injured as a direct result of your participation in this research. If you suffer any physical injury as a direct result of the drugs provided in this study, The
ECC will reimburse you for the reasonable costs of additional medical treatment, if such treatment is required, if such costs are in excess of what is paid by your insurance or other third party payer. Financial compensation for lost wages, disability, pain or discomfort is not provided. (Specify hospital) shall not provide compensation for medical expenses or any other compensation for research-related injuries. Further information about research-related injuries is available from (specify contact and phone #).
Questions about research
If you have any questions about the research or develop a research-related problem, you should contact Dr. (name) at (phone #). During non-business hours you should contact Dr. (name) at (phone #). If you have questions about your rights as a research subject, you should contact the hospital ethics committee (phone #).
Voluntary participation
Your participation in this study is voluntary. Your refusal to participate will not prejudice your future treatment or benefits here at the (hospital). You are free to discontinue participation in the study at any time without fear of penalty or loss of medical care. Your physician may also terminate your participation without your consent if you have unacceptable side effects. Any significant findings discovered during this study that may bear upon your condition or your willingness to continue participation in this study will be provided to you and your attending physician.
Costs
The regular cost of treatment for your heart attack, will be billed to you or your insurance carrier. There is no monetary (or other) form of compensation for your participation.
The ECLA 2 Glucose – Insulin –Potassium Full Scale Trial Statement of consent
I know that taking part in this study is voluntary. I may refuse to be in the study without losing any benefits I would otherwise receive. The study, as well as risks and benefits, alternatives, procedures and purpose have been explained to me. I know this study has been reviewed and approved by an ethics review committee. I have been given a chance to ask any questions that I may have and will receive a copy of this consent form. By signing this form, I have not waived any of the legal rights I otherwise would have as a patient. I authorize release of my medical records from this hospitalization to appropriately qualified representatives of ECC. In the event that I transfer to another hospital before discharge, I authorize the release of my medical records from the transfer hospital to (name of enrolling hospital) and to the study coordinating center. I understand that I may be contacted in 30 days and in 6 month to see how I am doing. For this purpose, I authorize release of my name, address and telephone number to the study data center. My identity will continue to be confidential if the data collected is used for publication or educational purposes.
__________________________ __________________
______/______/______
_____:_____
Patient Name (Print)
Signature of Patient
Date
Time
__________________________ __________________
______/______/______
_____:_____
Witness Name (print) (where required)
Signature of Witness
Date
Time
__________________________ __________________
______/______/______
_____:_____
Investigator Name (print)
Signature of Investigator
Date
Time
Informed Consent Forms
NON USA VERSION
The ECLA 2 Glucose – Insulin –Potassium Full Scale Trial Informed Consent (non USA version)
The purpose of this sheet is to provide you with information you need to decide whether to take part in a research study of GIK a new infusion for Acute Myocardial Infarction. You are being invited to participate in this research study because it appears that you are having a heart attack. A heart attack is usually caused by a blood clot that blocks flow through the arteries that supply blood to the heart. Standard treatment for a heart attack includes drugs, such as streptokinase or PTCA, to dissolve the clot, restoring blood flow to the heart, and aspirin and an anticoagulant drug (heparin) to thin the blood and prevent further clots forming. The purpose of this study is to evaluate a new Adjunctive infusion. If you decide to participate in this study you will be randomly (by chance) allocated to receive either GIK infusion or conventional infusion intravenously (through a vein). You will also receive standard treatment of aspirin, and intravenous streptokinase or PTCA. The risks and benefits of these drugs are explained below and will be discussed with you by your doctor. You will be monitored very closely during your hospitalization. You will either be given a questionnaire to complete and mail back one month from today or you will be contacted in one month. This will help us to know how you are doing. You will also be contacted at 1 year from today to see how you are doing.
Risks and Benefits
Minor risk of having high or low glucose or potassium blood levels exits and exceptionally you could have inflamation at the puncture site. You will be closely monitored by the nursing staff and study physicians to identify these problems quickly, if they should occur, and allow for prompt treatment, if necessary. The effects of GIK on the unborn child are unknown. If you could possibly be pregnant you must tell your doctor immediately. You may benefit if the medication you receive is GIK infusion and it is found to be more effective and/or safer than conventional infusion. You may, however, receive no direct benefit from being in the study, but the knowledge gained from your participation may benefit other people who have heart attacks in the future.
Alternative
If you choose not to participate in the study conventional treatment may include another infusion. Your treatment may be changed from the study plans if your doctor feels it is in your best interests to do so. If you suffer any unexpected injury or side effect directly related to participating in this study compensation may be provided by ECLA in accordance with the Clinical Trial Compensation Guidelines of the Association of the British Pharmaceutical Industry, January 1991. If you or your family wish to discuss your treatment you may contact (1) specify doctor and phone #. Please contact (2) specify study coordinator and phone # if you have other questions about the study. If you have other questions about your rights you may contact the (3) specify contact and phone # An auditor appointed by the sponsors and approved by the (4) specify IRB or Ethics Committee may review your medical file for the sole purpose of checking the accuracy of the information recorded for the study. You will not be identified by name in any reports, these reports will be used for research purposes only and stored in a locked room.
The ECLA 2 Glucose – Insulin –Potassium Full Scale Trial
Statement of consent
Principal Investigator: Dr _________________________________________________
Name of Patient or Subject: _______________________________________________
Age: ___________ years
I have heard and understood an explanation of the research project I have been invited to take part in. I have been given to read and have kept a copy of the information sheet and this consent form. I have had an opportunity to ask questions and to have them answered. I understand that I may withdraw from the project at any time and that, if I do, my medical care will not be affected in any way. I have informed Dr ______________ of any other research studies I am participating in. I have decided of my own free will to be a subject in this research. I agree to an auditor appointed by the sponsors and approved by the specify Institutional Review Board or Ethics Committee reviewing my medical file for the sole purpose of checking the accuracy of the information recorded for the study.
__________________________ __________________
______/______/______
_____:_____
Patient Name (Print)
Signature of Patient
Date
Time
__________________________ __________________
______/______/______
_____:_____
Witness Name (print) (where required)
Signature of Witness
Date
Time
__________________________ __________________
______/______/______
_____:_____
Investigator Name (print)
Signature of Investigator
Date
Time