344ATemplate.doc W8BNMSWD&6YmBIN ࡱ> PRO@ +jbjbqq |e$ lth(   ,I iZ     H 4H H H  8H X6 H H 2 H H  CONSENT TO BE A RESEARCH SUBJECT Title There is no rule that the full incomprehensible title must be used. The title should be in lay language. Put the protocol ID in the footer. Being in a study is different from being a patient. As a patient, the doctors focus is on you. As a subject, the investigator must also follow the rules of the study. Those rules and your individual needs may come into conflict. In the event of a conflict, the study doctors first responsibility is for your safety and welfare. This consent form describes the research study and your role as a participant. Please read this form carefully. Do not hesitate to ask anything about the information provided; it should stimulate your questions. The doctor or nurse will describe the study and answer your questions. INFORMATION YOU NEED ABOUT THIS STUDY A. BACKGROUND AND PURPOSE This section is introductory. It sets the stage. It should give some idea about why the study is being done and the "research" objectives. After reading this section, the procedures and goals should make sense. The purpose is to answer some question; it is not to assist or treat an individual. This section should have no personal pronouns. It is also possible to include explanations of the test article or of the history of the development. REMEMBER, a picture or diagram is worth 1000 words!!! This section can end with an invitation. Why is this person being invited to this event? B. PROCEDURES This section should provide a simple overview of the experience of being a subject as compared to the experience of being a patient. Anything that is experimental or investigational should be noted as such. Chronological explanations help. Calendars, pictures and charts help. The schema (translated into lay procedures) is nice. Ancillary procedures such as male and female contraception requirements should be mentioned as should abstinence from drugs (licit or illicit), caffeine or sex. C. POSSIBLE RISKS OR DISCOMFORTS This section should include an explanation of what a potential subject needs to know to make an "informed" decision. The regulation requires reasonably foreseeable risks but a reasonable person might want more. It should include serious risks and their frequency (common, rare, etc.) and common events and their magnitude. Words such as common and rare might have different meanings to subjects. If there is concern about pregnancy, the potential harm should be noted. Subjects may be concerned with legal, emotional financial and logistical harms as well. Confidentiality: The risk of loss of privacy and financial harms should be discussed. No absolute promises or guarantees of confidentiality may ever be made unless the investigator is willing to go to jail to protect his or her sources. Reference to the HIPAA authorization can be made here to say that there is more information on the topic of privacy. Information about injury is required IF there is more than minimal risk. There must be "an explanation as to whether any compensation and as to whether any medical treatments are available " and if so, "what they consist of or where further information may be obtained." Many subjects wish to know the net effect rather than who is isnt responsible. D. POSSIBLE BENEFITS Realistic benefits or outcomes to individuals should be stated. Financial compensation is not a benefit and should be mentioned below. Realistic benefits to future patients, to society, or to the company may be mentioned. E. FINANCIAL CONSIDERATIONS Costs: Subjects should have a clear idea of the magnitude of their financial responsibility. They should know if it will cost them more to participate, if they will be paid and if their insurance might be altered. Conflicts: This is the place to mention that the investigator is being paid. Compensation: Payment belongs here. The time and manner of payment should be clear. F. ALTERNATIVES To make a choice one must have options. What are the choices and their relative risks and benefits? Is the same procedure available without being a subject? G. QUESTIONS Subjects should know where to get answers or help. The first person to ask should be the investigator. The IRB is a fall back to call if there is an issue with the investigator. Type of questionRolePersonContactAbout the study, procedures risks, benefits, alternatives and rights Talking about subject rights is the PIs responsibility. InvestigatorDr. ChapeauPhone (ext)About changing the appointment or parking or further discussionCoordinatorF. FedoraPhone (ext)About long term effects Sponsor (company)Caps, Inc.PhoneAbout issues you dont think you can discuss with the investigator The IRB should be available as a last resort if issues cannot be resolved peacefully.Institutional Review BoardIRC1-800-472-3241 info@irb-irc.com H. RIGHTS Both subjects and investigators have some rights. Subject rights: Participation should be voluntary. You should not feel compelled to agree. You should be told about the study and your questions should be answered to your satisfaction. You should have all the information you wish. Keep asking questions. If you refuse, there should be no penalty If you agree and wish to withdraw, you may. You should tell the investigator in case there is any safety issue. In California, a Bill of Rights should be attached. Investigator rights: It is the investigators right to accept or not accept participants. Occasionally studies must be stopped or individuals dropped from a study. Investigators can do this. GIVING CONSENT THE SUBJECT If you agree to participate and if your questions have been answered, you may sign the form. You will be given a copy of this form to keep and to refer to as needed. (In California) You will also receive a copy of the California Experimental Subjects Bill of Rights. Reference to HIPAA Authorization can be made here.   SignaturePrinted nameDate THE PERSON EXPLAINING THE INFORMATION IRC asks that the person discussing the issues with the participant take responsibility for co-signing. I explained this information. I am co-signing this form to demonstrate joint responsibility in the effort to inform this person.   SignaturePrinted nameDate THE FOLLOWING CAN BE ADDED BUT ONLY IF APPROPRIATE TO THE PROTOCOL ASSENT OF A MINOR - Although minors may not have the legal right to sign an agreement, they may have definite opinions. Minors who have the ability to read at about the 6th grade or more are being asked to read this form and to decide for themselves. PERMISSION OF A PARENT OR GUARDIAN As minors cant legally consent, the agreement of a custodial parent or guardian is also required in order to participate. If the minor has agreed and if you give your permission, he or she can be enrolled.   SignaturePrinted nameDate Relationship to subject PERMISSION / CONSENT OF LEGALLY AUTHORIZED GUARDIAN This section should be included only if the IRB is being asked to allow proxy consent. If the potential subject is someone who cannot decide independently, that person cannot give complete consent. As the legally authorized person, you are being asked to give your permission. The person who is to be enrolled must be included in the discussion to the extent that it is possible and, if that person refuses, that refusal should normally be honored. If you agree, you are giving your permission on behalf of the subject to enroll him or her into this study.   SignaturePrinted nameDate Relationship to subject CALIFORNIA EXPERIMENTAL SUBJECT'S BILL OF RIGHTS The rights below are set out by the California legislature in 1978 as the rights of every person asked to be in a research study. This page should accompany a information/consent form giving information about the proposed study. As an "experimental" or "research" subject you have the following rights: 1. To be told what the study is trying to find out. 2. To be told what will happen to you and whether any of the procedures, drugs, or devices is different from what would be used in standard practice. 3. To be told about the frequent and/or important risks, side effects, or discomforts of the research drugs, devices, or procedures. 4. To be told if you can expect any benefit from participating and, if so, what the benefit might be. 5. To be told the other choices you have and how they compare to being in the study. 6. To be allowed to ask any questions concerning the study both before agreeing to be involved and during the course of the study. 7. To be told what sort of medical treatment is available if any complications arise. 8. To refuse to participate at all or to change your mind about participation after the study is started. This decision will not affect your right to receive the care you would receive if you were not in the study. 9. To receive a copy of the signed and dated consent form. 10. To be free of pressure when considering whether you wish to agree to be in the study. If you have questions you should ask the researcher or research assistant. You may contact Independent Review Consulting, which is concerned with protection of subjects. You may reach the IRC office during business hours. 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