Sample Informed Consent Format

Study No.: «ID» Emory University IRB Document Approved On: «ApproveDate» IRB use only Project Approval Expires On: «ExpireDate»

Emory University Consent to be a Research Subject

Title:

Principal Investigator:

Sponsor:

Investigator-Sponsor:

Study-Supporter:

If you are the legal guardian of a child who is being asked to participate, the term “you” used in this consent refers to your child

Introduction You are being asked to be in a medical research study. This form is designed to tell you everything you need to think about before you decide to consent (agree) to be in the study or not to be in the study. It is entirely your choice. If you decide to take part, you can change your mind later on and withdraw from the research study. The decision to join or not join the research study will not cause you to lose any medical benefits. If you decide not to take part in this study, your doctor will continue to treat you.

Before making your decision:  Please carefully read this form or have it read to you  Please listen to the study doctor or study staff explain the study to you  Please ask questions about anything that is not clear

You can take a copy of this consent form, to keep. Feel free to take your time thinking about whether you would like to participate. You may wish to discuss your decision with family or friends. Do not sign this consent form unless you have had a chance to ask questions and get answers that make sense to you. By signing this form you will not give up any legal rights.

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. law. This Web site will not include information that can identify you. At most the Web site will include a summary of the results. You may search this Web site at any time.

Study Overview The purpose of this study is to…

Procedures

Risks and Discomforts There may be side effects from the study drug or procedures that are not known at this time. The most common risks and discomforts expected in this study are:

The less common risks and discomforts expected in this study are: Page 1 of 8 Version Date: MM/DD/YYYY IRB Form 09052013 Study No.: «ID» Emory University IRB Document Approved On: «ApproveDate» IRB use only Project Approval Expires On: «ExpireDate»

Rare but possible risks include:

If you are a woman: to protect against possible side effects of the study drug, women who are pregnant or nursing a child may not take part in this study. If you become pregnant, there may be risks to you, the embryo, or fetus. These risks are not yet known. If you are a woman of childbearing ability, you and the study doctor must agree on a method of birth control to use throughout the study. If you think that you have gotten pregnant during the study, you must tell the study doctor immediately. Pregnant women will be taken out of the study.

If you are a man: the effect of the study drug on sperm is not known. To protect against possible side effects, if you are a man you should not get a sexual partner pregnant while taking the study drug and for ______days/weeks/months after the last dose. You and the study doctor should agree on a method of birth control to use throughout the study.

If you will be taking the study drug home, keep it out of the reach of children or anyone else who may not be able to read or understand the label. Do not let anyone else take the study drug besides you.

New Information It is possible that the researchers will learn something new during the study about the risks of being in it. If this happens, they will tell you about it. Then you can decide if you want to continue to be in this study or not. You may be asked to sign a new consent form that includes the new information if you decide to stay in the study.

Benefits This study is not designed to benefit you directly. Your [condition] may improve while you are in this study but it may not, and it may even get worse. This study is designed to learn more about…. The study results may be used to help others in the future.

Compensation You will not be offered payment for being in this study.

OR SOMETHING LIKE

You will be get $____ for each completed study visit. If you do not finish the study, you will be paid for the visits you have completed. You will receive $____ total, if you complete all study visits.

Other Treatment Outside this Study If you decide not to enter this study, there is care available to you outside of this research. [List the major standard care options and/or possibility of other studies] The study doctor will discuss these with you. You do not have to be in this study to be treated for [condition].

Confidentiality Certain offices and people other than the researchers may look at your medical charts and study records. Government agencies and Emory employees overseeing proper study conduct may look at your study records. These include the Food and Drug Administration, the Office for Human Research Protections, Emory offices that are part of the Human Research Protection Program, and those that are involved in administration and billing. Study sponsors and people or companies they use to carry out the study may also look at your study records. Emory will keep any research records Page 2 of 8 Version Date: MM/DD/YYYY IRB Form 09052013 Study No.: «ID» Emory University IRB Document Approved On: «ApproveDate» IRB use only Project Approval Expires On: «ExpireDate» we create private to the extent we are required to do so by law. A study number rather than your name will be used on study records wherever possible. Your name and other facts that might point to you will not appear when we present this study or publish its results.

Study records can be opened by court order. They may also be produced in response to a subpoena or a request for production of documents.

There is a Certificate of Confidentiality for this Study:

We will do everything we can to keep others from learning about your participation in the research. To further help protect your privacy, the investigators have obtained a Confidentiality Certificate.

What the Certificate of Confidentiality protects: The National Institutes of Health has given this study a Certificate of Confidentiality. Emory would rely on it to not give out study information that identifies you. For example, if Emory received a subpoena for study records that identify you, we would say no. The Certificate gives Emory legal backup to say no. It covers information about you that could harm your image or finances. It also covers information about you that could harm your chances at a job or getting insurance.

What the Certificate of Confidentiality does not protect: The Certificate does not prevent you or someone other than you from disclosing your information. The Certificate does not prevent Emory from making the following disclosures of information about you:  Information to state public health offices about certain infectious diseases  Information to law officials if child abuse has taken place  Information Emory gives to prevent immediate harm to you or others  Information Emory gives to the study sponsor as part of the research

Research Information Will/Will Not Go Into the Medical Record: If you are or have been an Emory Healthcare patient, you have an Emory Healthcare medical record. If you are not and have never been an Emory Healthcare patient, you do not have one. Please note that an Emory Healthcare medical record will be created if you have any services or procedures done by an Emory provider or facility for this study. Copies of the consent form and HIPAA patient form that you sign will/will not be placed in your Emory Healthcare medical record.

Emory Healthcare may create study information about you that can help Emory Healthcare take care of you. For example, the results of study tests or procedures. These study results will/will not be placed in your Emory Healthcare medical record. Anyone who has access to your medical record will be able to have access to all the study information placed there. The confidentiality of the study information in your medical record will be protected by laws like the HIPAA Privacy Rule. On the other hand, some state and federal laws and rules may not protect the research information from disclosure.

We will take reasonable steps to keep a copy of the consent and HIPAA authorization forms that you sign out of our medical records system. If we are not successful in keeping these forms out, in spite of our efforts, we will take steps to remove them. If they cannot be removed, we will take steps to limit access to them.

Emory does not control results from tests and procedures done at other places, so these results would not be placed in your Emory Healthcare medical record. They will not likely be available to Emory Healthcare to help take care of you. Emory also does not have control over any other medical records that you may have with other healthcare providers. Emory will not send any test or procedure results from the study to these providers. If you decide to be in this study, it is up to you to let them know. Page 3 of 8 Version Date: MM/DD/YYYY IRB Form 09052013 Study No.: «ID» Emory University IRB Document Approved On: «ApproveDate» IRB use only Project Approval Expires On: «ExpireDate»

The researchers will review the results of certain study tests and procedures only for the research. The researchers will not be looking at the results of these tests and procedures to make decisions about your personal health or treatment. For this study, those things include:

In Case of Injury

OPTION 1: The sponsor may choose not to pay for Subject Injury Costs for any subject, no matter if the subject is insured, or how he/she is insured.

If you get ill or injured from being in the study, Emory would help you to get medical treatment. Emory and the sponsor have not, however, set aside any money to pay you or to pay for this medical treatment. The only exception is if it is proved that your injury or illness is directly caused by the negligence of an Emory or sponsor employee. “Negligence” is the failure to follow a standard duty of care.

If you become ill or injured from being in this trial, your insurer will be billed for your treatment costs. If you do not have insurance, or if your insurer does not pay, then you will have to pay these costs.

If you believe you have become ill or injured from this research, you should contact Dr. __ at telephone number ___. You should also let any health care provider who treats you know that you are in a research study.

OPTION 2: The sponsor may choose to pay for Subject Injury Costs for all subjects, no matter if the subject is insured, or how he/she is insured.

If you get ill or injured from being in the study, Emory would help you get medical treatment. You should let the study doctor know right away that you are ill or injured. If you believe you have become ill or injured from this study, you should contact Dr. __ at telephone number ___. You should also let any health care provider who treats you know that you are in a research study.

If you get ill or injured as the direct result of being in this study, the sponsor will pay the costs for your medical treatment of the illness or injury if it:

(a) is not a medical condition that you had before you started the study; (b) is not the result of the natural progress of your disease or condition; (c) is not caused by your failure to follow the study plan; and (d) is not proved to be directly caused by the negligence of an Emory or sponsor employee. “Negligence” is the failure to follow a standard duty of care.

Your insurance will be billed for any costs of medical treatment for your injury or illness that the sponsor does not pay. Your insurer may be told that you are in a research study. If you do not have insurance, or if your insurance does not pay, then you will have to pay these costs.

Emory has not set aside any money to pay you or to pay for your treatment if you get ill or injured from being in the study. The only exception to this policy is if it is proved that your injury or illness is directly caused by the negligence of an Emory or sponsor employee.

Page 4 of 8 Version Date: MM/DD/YYYY IRB Form 09052013 Study No.: «ID» Emory University IRB Document Approved On: «ApproveDate» IRB use only Project Approval Expires On: «ExpireDate»

OPTION 3: The sponsor may choose to pay for Subject Injury Costs for uninsured subjects or subjects with Medicare/Medicaid and to pay any part of Subject Injury Costs for privately insured subjects that are not covered and/or paid by their private insurance.

If you get ill or injured from being in the study, Emory would help you get medical treatment. You should let the study doctor know right away that you are ill or injured. If you believe you have become ill or injured from this research, you should contact Dr. __ at telephone number ___. You should also let any health care provider who treats you know that you are in a research study.

If you get ill or injured as the direct result of being in this study, then, depending on what insurance you may have, the sponsor may pay for some or all of the costs for your medical treatment of the illness or injury if it:

(a) is not a medical condition that you had before you started the study; (b) is not the result of the natural progress of your disease or condition; (c) is not caused by your failure to follow the study plan; and (d) is not proved to be directly caused by the negligence of an Emory employee. “Negligence” is the failure to follow a standard duty of care.

If your case meets all four of these requirements and you are uninsured or have Medicare or Medicaid, then the sponsor will pay all of the costs of your medical treatment for the illness or injury.

If your case meets all four of these requirements and you have private insurance, Emory will look at the claims for these costs to see if they can be sent to your insurer for payment. Your insurer may be told that you are in a research study and given information about your treatment.

You will have to pay for any costs that the sponsor or your insurer does not pay. The sponsor will pay for any of the costs that are not paid by your insurance provider. The sponsor will not pay for costs like co-payments that your insurer says you have to pay.

Costs OPTION 1: There are no costs, research or standard of care related, associated with the study.

There will be no costs to you for participating in this study, other than basic expenses like transportation. You will not be charged for any of the research activities.

OPTION 2: The sponsor will pay for certain items or services associated with the study. The study sponsor will pay for certain items and services that you may receive if you take part in this study.

You will have to pay for the items or services for which the study sponsor does not pay. The sponsor will not pay for your regular medical care. If you have insurance, Emory will submit claims to your insurance for items and services that the sponsor does not cover. Emory will send in only those claims for items and services that it reasonably believes your insurance will pay and that the sponsor has not paid.

Page 5 of 8 Version Date: MM/DD/YYYY IRB Form 09052013 Study No.: «ID» Emory University IRB Document Approved On: «ApproveDate» IRB use only Project Approval Expires On: «ExpireDate»

The actual amount that you have to pay depends on whether or not you have health insurance and whether or not that insurance will pay for any research study costs. Generally, insurance companies will not pay for items and services that are required just for a research study. Some insurance companies will not pay for regular medical treatment or treatment for complications if you are in a study. How much you will have to pay for any co-payments, deductibles or co-insurance depends on your plan. Emory and the sponsor will not pay for these costs.

It is a good idea to contact your insurance provider and tell them you want to be in this research study. Ask them what they will pay for and what they will not pay for. You can also ask the study team for help in figuring out what you will have to pay.

If you do not have insurance, Emory will review your case as part of its program for low-income patient care. The standard policies of that program will apply. The program will figure out if you have to pay any costs for taking part in the study and what those costs will be.

OPTION 3: The sponsor will not pay for any items or services associated with the study. The study sponsor does not plan to pay for any items or services that you may receive if you take part in this study.

You will have to pay for the items or services that are part of this study. The sponsor will not pay for your regular medical care. If you have insurance, Emory will submit claims to your insurance for items and services that are part of this study. Emory will send in only those claims for items and services that it reasonably believes your insurance will pay and that the sponsor has not paid.

Withdrawal from the Study You have the right to leave a study at any time without penalty. For your safety, however, you should consider the study doctor’s advice about how to go off the study treatment. If you leave the study before the final planned study visit, the researchers may ask you to have some of the final steps done.

The researchers and sponsor also have the right to stop your participation in this study without your consent if:  They believe it is in your best interest;  You were to object to any future changes that may be made in the study plan;  [reasons specific to this study]  or for any other reason.

Contact Information Contact [study contact person(s)] at [telephone number(s)]: Page 6 of 8 Version Date: MM/DD/YYYY IRB Form 09052013 Study No.: «ID» Emory University IRB Document Approved On: «ApproveDate» IRB use only Project Approval Expires On: «ExpireDate»

 if you have any questions about this study or your part in it,  if you feel you have had a research-related injury or a bad reaction to the study drug, or  if you have questions, concerns or complaints about the research

Contact the Emory Institutional Review Board at 404-712-0720 or 877-503-9797 or [email protected]:  if you have questions about your rights as a research participant.  if you have questions, concerns or complaints about the research.  You may also let the IRB know about your experience as a research participant through our Research Participant Survey at http://www.surveymonkey.com/s/6ZDMW75.

Page 7 of 8 Version Date: MM/DD/YYYY IRB Form 09052013 Study No.: «ID» Emory University IRB Document Approved On: «ApproveDate» IRB use only Project Approval Expires On: «ExpireDate»

Consent Please print your name and sign below if you agree to be in this study. By signing this consent form, you will not give up any of your legal rights. We will give you a copy of the signed consent to keep.

Name of Subject

Signature of Subject Date Time

Signature of Person Conducting Informed Consent Discussion Date Time

______Name of Person Conducting Informed Consent Discussion

Signature of Legally Authorized Representative Date Time with authority for research decisions

Authority of Legally Authorized Representative or Relationship to Subject

Signature of Assent for 17 year old Subject Date Time

Page 8 of 8 Version Date: MM/DD/YYYY IRB Form 09052013