Consent to Participate in a Research Study

IRB Committees A & B Consent Form Template – Revised 081715 IRB File # Page 1 of 13 CONSENT TO PARTICIPATE IN A RESEARCH STUDY

LIST COMPLETE TITLE HERE

Study to be Conducted at: List each facility name Address City, State Zip

Sponsor Name: List sponsor name here (if applicable)

Principal Investigator: List PI name and telephone number

If your study includes children, use the following statement:

For legal guardians of minors, please note that any words referring to “you” (such as I, me, myself, you, your, yourself) also refer to “your child” throughout this consent form. Permission from you is required for your child to participate in this study.

INTRODUCTION You are being asked to participate in a research study. The Institutional Review Board of the Greenville Health System has reviewed this study for the protection of the rights of human participants in research studies, in accordance with federal and state regulations. However, before you choose to be a research participant, it is important that you read the following information and ask as many questions as necessary to be sure that you understand what your participation will involve. Your signature on this consent form will acknowledge that you received all of the following information and explanations verbally and have been given an opportunity to discuss your questions and concerns with the principal investigator or a co-investigator.

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 can search this Web site at any time.

PURPOSE You are being asked to participate in this study because …

The purpose of this study is …

The Standard of Care (SOC) for this disease, if applicable, is (what you would be receiving if not on this study - list in 6th grade lay language) If section does not apply, delete.

Include the following:

______«InstitutionName» IRB Number: «ID» Participant’s Initials Approved: «ApprovalDate» Expiration: «ExpirationDate» IRB Committees A & B Consent Form Template – Revised 081715 IRB File # Page 2 of 13

 Why the participant is being asked to be in the study;  Background information on the condition being studied;  Purpose(s) of the study;  Information about whether or not the drug/device is approved by the Food and Drug Administration (FDA), and whether the drug/device is or isn’t approved for this specific disease/condition, etc.;  Clear identification of what is investigational about the study;  Approximate number of participants involved nationally and/or internationally;  Expected duration of the participant’s participation; explain if study continues to collect information until the death of the participant.

If you are a student and the study is part of a thesis, dissertation or class project, insert this text:

The investigator is conducting this study as part of the (thesis, class project) requirements of (university, school of nursing, etc.).

If your study involves specimen storage, insert the following text and include a ‘Consent Form for Specimen Storage’:

In addition to the treatment described in this consent form, the sponsor would like to store samples of your [specify type of specimen to be stored] for future scientific research studies. Information about storing your specimens will be addressed later in a separate consent form.

PROCEDURES

 Clearly identify what is investigational about the study;  Specific identification of any research or experimental procedures, drugs, devices, etc. and whether they are approved or not approved by the FDA (display in a bullet list or Table format);  A complete description of the procedures to be followed;  How the participant will be placed into study groups;  If study is double/triple-blinded, explain steps to break the code in an emergency;  If the study involves collection of body fluids such as blood, peritoneal fluid, urine, etc., include the amount of fluid taken in teaspoons or tablespoons.

______«InstitutionName» IRB Number: «ID» Participant’s Initials Approved: «ApprovalDate» Expiration: «ExpirationDate» IRB Committees A & B Consent Form Template – Revised 081715 IRB File # Page 3 of 13 POSSIBLE RISKS Any treatment has possible side effects. The treatments and procedures used in this study may cause all, some or none of the side effects listed. There is always the risk of very uncommon or previously unknown side effects happening.

If your study involves the use of a drug or drugs, include the following:

It is possible that receiving the study drug with your regular medications, supplements, or some food (for example, grapefruit juice) may change how the study drug, your regular medications, or your regular supplements work. It is very important that you tell the study doctor about all medications or supplements you are taking during the study.

When describing complications related to cancer treatment (use if applicable):

These complications can sometimes lead to serious illness requiring hospitalization or lead to death.

 Description of any known risks;  Statement that particular treatment/device/procedure may involve risks that are unknown;  List side effects related to each drug/device/procedure involved in the study;

 If your study involves the use of a medical device, include the following:

A problem or malfunction of the device which may increase your time in surgery under anesthesia.

 If the study involves the possibility of an allergic reaction, include the following:

As with all medications, side effects may include allergic reactions. Allergic reactions may range from minor itching or rash to major reactions, which can lead to death.

 Inserting an IV or Drawing Blood (use if needed):

Inserting a needle into a vein in the arm to receive fluids and study treatment or to collect blood samples may cause pain, redness, bleeding, bruising, fainting, a clot in the accessed vein and rarely, infection at the location where the needle is placed.

______«InstitutionName» IRB Number: «ID» Participant’s Initials Approved: «ApprovalDate» Expiration: «ExpirationDate» IRB Committees A & B Consent Form Template – Revised 081715 IRB File # Page 4 of 13  Chest Catheter Placement (use if needed):

The procedure may cause pain, redness, bleeding or bruising. It is unlikely, but possible that you could develop an infection, clotting of the catheter or collapse of the lung. If you have a chest catheter placed, you will sign a separate consent form, which will describe the procedure and side effects in detail.

 Bone Marrow Aspirates and Biopsies (use if needed):

This procedure may cause some temporary pain or discomfort, redness, bleeding, bruising or possibly, infection at the location where the needle is placed.

 Studies that involve questionnaires or daily diaries (use if needed):

Some of the questions in the [specify questionnaires, diaries, etc.] are of a personal nature and may be upsetting to some participants. Your doctor and nurse will be available to discuss these questions should you have a concern or problem. You do not have to answer any questions that you do not want to answer.

 If the study utilizes drugs that may be harmful to reproductive cells, include:

You should practice an adequate method of birth control while taking part in this study. If you think that you have become pregnant or caused a pregnancy during this study, please tell your doctor immediately.

 If the study may be harmful to an unborn or nursing child, include (to the extent that the information is true):

This study may involve unknown risks to an unborn or nursing child. Women who are pregnant or nursing a child may not participate in this study. You must tell your doctor that, to the best of your knowledge, you are not now pregnant and that you do not intend to become pregnant during this study. You may be required to take a pregnancy test before you participate in this study.

 If the study involves data collection (no medical treatment) and utilizes a consent form, include the following:

There are no known medical risks related to participation in this study. The greatest risk is the possible release of your personal health information. Your study records are considered confidential, but absolute confidentiality

______«InstitutionName» IRB Number: «ID» Participant’s Initials Approved: «ApprovalDate» Expiration: «ExpirationDate» IRB Committees A & B Consent Form Template – Revised 081715 IRB File # Page 5 of 13 cannot be guaranteed. This study may result in presentations and publications, but steps will be taken to make sure you are not identified by name.

Also, please tell your doctor if you are taking any drugs, or non-prescription medications or supplements, including vitamins or herbs, other than those being used in this research study because of the risk of possible and/or serious drug interactions. Also you should tell anyone who gives you medical care that you are participating in a research study.

POSSIBLE BENEFITS It is not possible to know whether or not you may benefit from participating in this study. The treatment or procedures you receive may even be harmful. The information gained from this study may be used scientifically and may be helpful to others.

Include any benefits to the participant or others that may reasonably be expected.

ALTERNATIVE (OTHER) TREATMENTS You can still receive evaluation and treatment for your condition if you do not participate in this study. Discuss any alternative treatments with your regular doctor and/or the study doctor before you decide to participate in the study. Your decision is entirely up to you. If you decide not to participate in the study, you will not be penalized or lose any benefits and your decision will not affect your relationship with your doctor or hospital.

Standard of Care (SOC) for this disease, if applicable, – state what this is in lay language.

Insert bulleted list describing appropriate alternative procedures or courses of treatment, if any, that might be of equal or greater benefit to the participant, or those which are not experimental.

COST TO YOU FOR PARTICIPATING IN THIS STUDY

INSTRUCTIONS: The following information is provided to help you prepare this section of your consent form. Include the following information in this section:  Costs that are paid for by study funds (should be listed as bullet points), e.g., “Study funds will pay for the study drug and the MRI that is done only for research.”  Any additional costs to the participant that may result from participation in the research, including costs associated with routine care billed to health insurers  If the study is not a funded study, make sure to point out what items or

______«InstitutionName» IRB Number: «ID» Participant’s Initials Approved: «ApprovalDate» Expiration: «ExpirationDate» IRB Committees A & B Consent Form Template – Revised 081715 IRB File # Page 6 of 13 services will be charged directly to the patient or their insurance company and what items will likely not be paid by insurance, but will be the patient’s responsibility.

A common misconception among patients is that if they participate in a research study all of the costs of their care will be covered by the research sponsor. Although this is true in a few cases, the hospital is entitled to and generally will bill a subject’s health insurer for, among other things, routine care that the subject would have received had they not participated in the study. Although the amounts vary by insurer, a research subject is likely to be responsible for co-pays and deductibles associated with this routine care. It is important to make sure that patients who volunteer to participate in your research study understand their potential financial responsibility. If these or other costs billable to insurance or billable to the subject directly can be identified in advance (such as through a Medicare Coverage Analysis billing grid), it is a good idea to give the subject notice of specific items or services that may result in significant financial responsibility for the subject. If specific amounts cannot be identified in advance, you should make sure that the subject understands that they might incur some financial responsibility as a result of their participation.

If the study has funding, you must include the following language in the consent form:

“Although study funds will pay for certain study-related items and services, we may bill your health insurer for routine items and services you would have received even if you did not take part in the research. You will be responsible for payment of any deductibles and co-payments required by your insurer for this routine care or other billed care. If you have any questions about costs to you that may result from taking part in the research, please speak with the study doctors and study staff. If you are confused about what is or is not paid for in this study please discuss this with your study doctor or study staff.”

Note: You may add further language to describe specific items/services/amounts that will be the subject’s responsibility, but you may not delete any portion of the standard language.

PAYMENT FOR PARTICIPATION (if applicable)

To You: Include one of the two following statements:  You will not be paid to participate in this study.  You will be paid to participate in this study. Include a payment schedule, total amount, and any situations in which the subject would not be paid.

______«InstitutionName» IRB Number: «ID» Participant’s Initials Approved: «ApprovalDate» Expiration: «ExpirationDate» IRB Committees A & B Consent Form Template – Revised 081715 IRB File # Page 7 of 13

To Investigators: Include the following statement if the study is funded:

The investigators will be paid by the sponsor for time, effort, and oversight by the investigators and professional staff to perform procedures, tasks and accurately collect and submit data.

Include one of the following statements if the study is NOT funded:

 Neither the investigators nor professional staff will receive any special compensation above and beyond their regular salaries for time and effort to perform procedures, tasks, and accurately collect and submit data.  The investigators will not be paid above their regular salaries for conducting this study.

To Institution: (remove statement if no sponsor/no funding) The Greenville Health System (or appropriate institution) is being paid by the sponsor for staff and administrative costs associated with conducting this study.

COMPENSATION FOR INJURY AS A RESULT OF STUDY PARTICIPATION

The Greenville Health System will provide you the care needed to treat any injury, or illness, that directly results from taking part in this research study. We reserve the right to bill your insurance company or other third parties for the care you get for the injury. You may be responsible for these costs. For example, if the care is billed to your insurer, you will be responsible for the payment of any deductibles and co- payments required by your insurer or even possibly the entire cost of the service.

INSTRUCTIONS: The sponsor may request to include a statement about the injury coverage the sponsor will offer. When the sponsor requests to include such a statement, the statement may be entered below, after the institution’s commitment to provide care for the injury.

For example: “In this study, [Sponsor] may pay for medical treatment for any injury that is not paid for by your health insurer if the injury is a direct result of your taking part in the study.”

Injuries sometimes happen in research even when no one is at fault. The study sponsor, the Greenville Health System, or the investigators as part of this study have no plans to pay you or give you other compensation for an injury, should one occur. However, you are not giving up any of your legal rights by signing this form.

______«InstitutionName» IRB Number: «ID» Participant’s Initials Approved: «ApprovalDate» Expiration: «ExpirationDate» IRB Committees A & B Consent Form Template – Revised 081715 IRB File # Page 8 of 13 If you think you have been injured or have experienced a medical problem as a result of taking part in this research study, tell the person in charge of this study as soon as possible. The researcher’s name and phone number are listed in the ‘Contact for Questions’ section of this consent.

VOLUNTARY PARTICIPATION Participation in this study is completely voluntary (your choice). You may refuse to participate or withdraw from the study at any time. If you refuse to participate or withdraw from the study, you will not be penalized or lose any benefits. Your decision will not affect your relationship with your doctor or hospital.

If applicable, include a statement that the study doctor and/or sponsor may withdraw the participant from the study at any time without the participant’s permission, including a description of circumstances in which this may happen (e.g., if the participant did not follow study instructions).

If your participation in this study is stopped, your study doctor will discuss any tests or procedures that may be needed for your health and safety. You may refuse any or all of these recommended tests.

NEW INFORMATION During this study, you will be told of any important new information that may affect your willingness to participate in this study.

If applicable, also insert the following language:

A Data Safety Monitoring Board will be reviewing the data from this research from time to time throughout the study. They will notify your doctor of any new information that you need to be told about.

AUTHORIZATION TO USE AND DISCLOSE (RELEASE) MEDICAL INFORMATION As part of this research study, your study doctor and his/her research team will keep records of your participation in this study. These study records may be kept on a computer and will include all information collected during the research study, and any health information in your medical records that is related to the research study. Your study doctor and his/her research team will use and disclose (release) your health information to conduct this study. To evaluate the results of the study and for compliance with federal and state law, your health information may be examined and copied by the Food and Drug Administration (FDA), other governmental regulatory agencies, the Institutional Review Board of the Greenville Health System, the study sponsor and the sponsor’s authorized representative(s). This study may result in scientific presentations and publications, but steps will be taken to make sure you are not identified.

Under federal privacy laws, your study records cannot be used or released for research purposes unless you agree. If you sign this consent form, you are agreeing

______«InstitutionName» IRB Number: «ID» Participant’s Initials Approved: «ApprovalDate» Expiration: «ExpirationDate» IRB Committees A & B Consent Form Template – Revised 081715 IRB File # Page 9 of 13 to the use and release of your health information. If you do not agree to this use, you will not be able to participate in this study.

The right to use your health information for research purposes does not expire unless you withdraw your agreement. You have the right to withdraw your agreement at any time. You can do this by giving written notice to your study doctor. If you withdraw your agreement, you will not be allowed to continue participation in this research study. However, the information that has already been collected will still be used and released as described above. You have the right to review your health information that is created during your participation in this study. After the study is completed, you may request this information.

Once your health information has been released, federal privacy laws may no longer protect it from further release and use.

If you have any questions about the privacy of your health information please ask your study doctor.

In lieu of ‘HIPAA Authorization’ language (above) when not applicable, i.e. employee studies not involving medical information/data, include the following:

CONFIDENTIALITY Your study records are considered confidential (private), but absolute confidentiality cannot be guaranteed. Information may be kept on a computer. All records may be examined and copied by the Institutional Review Board of the Greenville Health System, and other regulatory agencies. This study may result in presentations and publications, but steps will be taken to make sure you are not identified by name.

CONTACT FOR QUESTIONS For more information concerning this study and research-related risks or injuries, or to give comments or express concerns or complaints, you may contact the principal investigator, put investigator’s name and phone number here.

You may also contact a representative of the Institutional Review Board of the Greenville Health System for information regarding your rights as a participant involved in a research study or to give comments or express concerns, complaints or offer input. You may obtain the name and number of this person by calling (864) 455-8997.

A survey about your experience with this informed consent process is located at the following website:

https://www.surveymonkey.com/s/T5C86P8

______«InstitutionName» IRB Number: «ID» Participant’s Initials Approved: «ApprovalDate» Expiration: «ExpirationDate» IRB Committees A & B Consent Form Template – Revised 081715 IRB File # Page 10 of 13 Participation in the survey is completely anonymous and voluntary and will not affect your relationship with your doctor or the Greenville Health System. If you would like to have a paper copy of this survey, please tell your study doctor.

CONSENT TO PARTICIPATE My study doctor, ______, has explained the nature and purpose of this study to me. I have been given the time and place to read and review this consent form and I choose to participate in this study. I have been given the opportunity to ask questions about this study and my questions have been answered to my satisfaction. I have been given a copy of my study doctor’s Notice of Privacy Practices. I agree that my health information may be used and disclosed (released) as described in this consent form. After I sign this consent form, I understand I will receive a copy of it for my own records. I do not give up any of my legal rights by signing this consent form.

______Printed Name of Participant

______Signature of Participant Date Time

______Signature of Witness Date Time

If your study includes children, also include the following:

______Signature of Parent/Guardian Date Time

INVESTIGATOR STATEMENT I have carefully explained to the participant the nature and purpose of the above study. The participant signing this consent form has (1) been given the time and place to read and review this consent form; (2) been given an opportunity to ask questions regarding the nature, risks and benefits of participation in this research study; and (3) appears to understand the nature and purpose of the study and the demands required of participation. The participant has signed this consent form prior to having any study-related procedures performed.

______

______«InstitutionName» IRB Number: «ID» Participant’s Initials Approved: «ApprovalDate» Expiration: «ExpirationDate» IRB Committees A & B Consent Form Template – Revised 081715 IRB File # Page 11 of 13 Signature of Investigator Date Time

Principal Investigator Phone

Co-Investigators Phone

______«InstitutionName» IRB Number: «ID» Participant’s Initials Approved: «ApprovalDate» Expiration: «ExpirationDate» IRB Committees A & B Consent Form Template – Revised 081715 IRB File # Page 12 of 13 Legally Authorized Representative (LAR)

You are being asked to enroll an individual in a research study because you are their Legally Authorized Representative (LAR). Research studies include only people who choose to take part. This document is called an informed consent form. Please read this information carefully and take your time making your decision. Ask the researcher or study staff to discuss this consent form with you. Please ask him/her to explain any words or information you do not clearly understand. We encourage you to talk with your family and friends before you decide to enroll your loved one in this research study. The nature of the study, risks, inconveniences, discomforts, and other important information about the study are listed below. Please tell the study doctor or study staff if your loved one is taking part in another research study

Consent of Legally Authorized Representative (LAR) and Authorization for the Collection, Use and Disclosure of Health Information

I give consent to have ______take part in this study [and authorize that his/her health information be disclosed/collected as outlined above]. I have received a signed copy of this form to take with me. I understand that I am being asked to serve as the LAR and give permission for the individual outlined above to participate in this IRB reviewed and approved research study. My decision is based on what I believe this individual would choose for him/herself and what I believe is now best for him/her, based on the information I have been provided. I do not have any financial conflict of interest nor am I receiving payment for this individual’s participant in the research study.

Signature of Legally Authorized Representative Date

Printed Name Legally Authorized Representative

Determination of the Person’s Ability to Give Consent

I am the study participant’s ______[Doctor, counselor, therapist, etc.]. I have examined this individual by [Insert method outlined in protocol] and have found that he/she has limited/diminished capacity and therefore is unable to give informed consent to take part in the research study and the legally authorized representative signing above is an appropriate LAR.

______Signature of Person Attesting to Limited/Diminished Autonomy of Participant Date

______

______«InstitutionName» IRB Number: «ID» Participant’s Initials Approved: «ApprovalDate» Expiration: «ExpirationDate» IRB Committees A & B Consent Form Template – Revised 081715 IRB File # Page 13 of 13 Printed Name of Person Attesting to Limited/Diminished Autonomy of Participant

Statement of Person Obtaining Informed Consent / Research Authorization

I have carefully explained to the LAR of the person taking part in the study what he or she can expect from participation, the nature of the study, and the purpose of the study. I confirm that this research subject speaks the language that was used to explain this research and is receiving an informed consent form in their primary language. The participant signing this consent form has (1) been given the time and place to read and review this consent form; (2) been given an opportunity to ask questions regarding the nature, risks and benefits of participation in this research study; and (3) appears to understand the nature and purpose of the study and the demands required of participation. This research subject has provided legally effective informed consent.

______Signature of Investigator Date Time

Principal Investigator: List PI name and telephone number

Co-Investigators: List all Co-Investigator names and telephone numbers

______«InstitutionName» IRB Number: «ID» Participant’s Initials Approved: «ApprovalDate» Expiration: «ExpirationDate»