CONSENT TO TAKE PART IN A RESEARCH STUDY

Title

Principal Investigator:

Sub-Investigators:

Purpose

This is a research study. Research studies involve only those who choose to take part. This consent form may contain words that you do not understand. Please ask the study doctor or the research staff to explain any words or information that you do not clearly understand. Before you decide to take part in this study, you need to understand why the research is being done, what it will involve, any risks to you, and what is expected of you. Whether or not you choose to take part, your doctor will discuss the standard of care (usual) treatments you can receive. If you choose to take part, you must sign this form before you can be enrolled in the study. This process is known as informed consent. You may take home an unsigned copy of this consent form to think about or discuss with family or friends before making your decision. (**Take out for EP studies – frequently patients are not given opportunity to take consents home – procedures are usually decided at bedside)

You are being asked to take part in this research study …

The purpose of this research study is……………

For Oncology Cooperative studies only, where a specimen consent is required:

Before you may begin this study, you will also be asked (in a separate consent form) if samples of your blood and tissue (a piece of the tumor already removed during your surgery or a biopsy) can be kept for future research testing. Although you will not have access to the results of these tests, the tests may help future patients. (For some studies, also include: If your cancer comes back, you will be asked to allow the collection of another blood sample.) You do not have to allow your blood or tissue to be kept for future testing in order to be in this study.

This research study is being sponsored by ______. [ALSO ENTER FINANCIAL INFORMATION HERE, IF THERE IS FUNDING BY A SPONSOR OR BY ANOTHER SOURCE.].

This research study will be performed at one or more Baptist Healthcare System, Inc. facilities. These facilities are:

  1. Baptist Health Lexingtonin Lexington, Kentucky; and/or
  2. Baptist Health Corbin in Corbin, Kentucky; and/or
  3. Baptist Health Richmond in Richmond, Kentucky; and/or
  4. Baptist Physicians Lexington, Inc. in Lexington, Kentucky.

In this consent document, the facilities listed above will be referred to as Baptist.

A total of approximately _____patients are expected to enroll in this clinical study at approximately ______research institutes. A total of approximately _____patients are expected to enroll in this research at Baptist.

The research procedures will be conducted at Baptist. The research study will last approximately [ENTER AMOUNT OF TIME].

Procedure(s)

If you agree to take part in this research study, the following procedures will be performed. To help you understand which parts of the procedure are parts of the research study, these steps are in italics. In other words, the steps presented in italics are additional to steps that usually would be performed before, during, and after your normal treatment for ______.

Text that may be appropriate for some consents:

  • Other tests that the doctor might feel are needed to fully learn about your disease and to see if you can take part in this study.

Risks/Discomforts

All drug treatments have the potential to cause side effects.

Possible side effects from having blood samples taken include faintness, inflammation (swelling) of the vein, pain, bruising or bleeding where the needle is inserted into your skin. There is also a slight chance of infection. The necessary safety measures to reduce the chances of these risks will be taken.

The following may be appropriate for some consent forms:

It is possible that other medications, over the counter drugs or herbal products that you are taking may interfere with your treatment during this study or may result in harm to you when combined with the study treatment. You must inform the study doctor or research staff of any such products that you are taking.

You should carefully follow the doctor’s directions for taking this study drug. You should not give the study drug to other people and should keep it out of the reach of small children.

There is always a chance that any medical treatment can harm you, and the investigational treatment in this study is no different. In addition to the risks listed above, you may experience a previously unknown risk or side effect.

Risks for Women/Men of Childbearing Potential

The effects of ……. on the growth and development of an unborn baby are not known. Birth defects, including physical deformities, mental retardation, premature birth or other problems are known risks of some [drugs or procedures]. If you are a sexually-active female of child bearing potential, you must have a negative pregnancy test prior to participation in this study and you must agree to take precautions to avoid the possibility of a pregnancy because it is not known how this drug, treatment, device will affect an unborn child. You will not be permitted to enter this study if you are pregnant, plan to become pregnant during the research study, or if you are breast-feeding. Women of childbearing potential must use an effective method of birth control during the course of the study. Effective methods of contraception include birth control pills, intra-uterine contraceptive devices (IUD), contraceptive patch, vaginal ring,birth control shot, non-prescription and prescription barrier methods,or implanted contraceptives. If you are a sexually active male, you must use an effective method of birth control during the course of the study. The effective method of birth control for men consists of properly used condoms with a spermicide. Even when you use birth control, there is the chance you or your partner could become pregnant anyway. If you suspect that you or your partner are pregnant or are concerned that you or your partner may have become pregnant, you are asked to notify your doctor that is listed on the first page of this consent form.

New Findings

You will be informed of any important new findings that may affect your health, welfare or willingness to continue in this study.

Benefits

There are no medical benefits that can be guaranteed to you for your taking part in this research study. Your willingness to take part, however, may help doctors better understand and/or treat others who have your condition. Information gained from this study may benefit others. No guarantees have been made to you as to the results of this research study.

Alternatives

You may choose not to take part in this study. You may also choose to receive no treatment for your condition at this time. Choosing not to take part in this research study will not affect the present or future care you receive from your doctor. If you do not wish to take part in this study, the other choices may include______. [DESCRIBE OTHER OPTIONS THAT MAY BE AVAILABLE.]

Patient Costs/Payment

(Add any information about known additional costs to the subject that may result from participation in the research.)

[You or your insurance company will be billed for the cost of being in the hospital and for all treatment you have while in the hospital. You or your insurance company will also be billed for the follow-up office visits after ______.] Many of the tests, procedures, and exams you will receive are believed to be part of good medical care and may or may not be covered by your insurance company (or other 3rd party providers such as Medicaid or Medicare). (Sponsor) will provide (blank) at no cost to you for this study. If your insurance company does not pay for your care you will be responsible for the cost of the medical care related to your condition including but not limited to: lab tests, co-payments, doctors’ fees, hospitalization and procedures, and medications.

You will not receive any compensation (payment) for taking part in this study. (Note: Remove and add appropriate text if a stipend will be paid to the patient)

Illness/Injury Resulting from the Research Study

In the event an injury or illness occurs as a direct result from taking part in this researchstudy, no form of compensation (i.e. payment) is available from Baptist. Medical treatment of the illness or injury will be available to assist your recovery at your own expense, or at the expense of your insurance company, which may or may not provide coverage. If you have questions, you should contact your insurance company. If you experience a side effect or injury, and if emergency medical treatment is required, you should contact your doctor listed on the first page of this consent form.

If you are injured as a result of taking part in this study, no other arrangements will be made for financial payments or other forms of compensation (such as lost wages, lost time or discomfort) which may be related to such injuries.

Withdrawal from the Research Study

Your decision to take part in this study is voluntary. You are free to withdraw at any time. A decision to withdraw or not to take part in the study will not affect the quality of medical care that you receive. Your decision will not result in any penalty or loss of benefits to which you are otherwise entitled and will not affect your future medical care.

Even though you have given your consent, your doctor has the right to take you out of the study should it be decided that continuing to take part in thisstudy would be harmful to you in any way. The study sponsor may need to withdraw you from the study. This may occur if you are not able to follow the directions given to you, if it is found that your being in the study is more risk than benefit to you, or if it is decided to stop the study early for a variety of scientific reasons. If you withdraw voluntarily or if you are withdrawn by your doctor, you may be asked to cooperate in having lab tests and exams that your doctor thinks are necessary for your safety. If you withdraw from the study, any data collected between the time of your enrollment and withdrawal from the study will be retained and used for purposes of the study analysis.

Confidentiality

Taking part in this study may result in a loss of privacy, since persons other than thestudy doctor(s) might view your study / medical records.

Records kept for this study that identify you will be kept confidential (private) as required by law. Your records may be inspected by:

  • Government agencies such as the U.S. Food and Drug Administration (FDA), the U.S. Department of Health and Human Services (DHHS), (list other agencies that may be applicable)
  • Authorized representatives of the study sponsor (the sponsor’s staff that has permission to review this information), including agents and/or contractors (other persons/companies hired by the sponsor to help with the study),
  • The central laboratory for the study (if one is used to perform tests), and
  • The Baptist Health Lexington Institutional Review Board (IRB) (a formal panel of people whoinitially review and continue to monitor all research studies and registries as required by FDA and DHHS regulations).

They may inspect or review study / medicalrecords about you, but will keep these records private as required by law.

Also, parts of your medical records that contain information important to this study may be copied and sent to a central locationfor medical review. When this happens, your records will be assigned a number, and your name or other means of identifying you will be removed.

If the proposed clinical trial involves FDA regulated drugs, biologics, or medical devices, the following paragraph must be included in the consent document:

A description of this clinical trial will be available on 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.

Whenever possible, information about you sent to the sponsor of this study, a lab or other organization involved with this study will not include your name, social security number or other means of identifying you. Instead, a code number assigned to your records will be used to keep your identity private. You will not be identified by name in any reports or presentations of data obtained from this study.

AUTHORIZATION TO USE AND DISCLOSE HEALTH INFORMATION FOR RESEARCH PURPOSES

Introduction

Federal regulations give you certain rights related to your health information. This includes the right to know who will be able to get the information and why they may be able to get it. The Investigators must get your authorization (permission) to use or give out any health information that might identify you.

This form may contain words that you do not understand. Please ask the Investigators or research staff to explain any words or information that you do not understand. You may take home an unsigned copy of this authorization form to think about or discuss with family or friends before making your decision.

By signing this Authorization, you agree to permit Baptistand its staff, and other health care providers (together “Providers”), and (Investigator Name) and his [Co-Investigators or Sub-Investigators] [associates], and the research staff (together “Researchers”), to use and disclose health information about you, including health information in your medical records to conduct this clinical study, as described below.

1.The health information that may be used and disclosed includes:

  • All information collected during the research described in the Informed Consent Form for the (Protocol Name) study.
  • Health information in your medical records that is important and related to the research. This may include information from your medical history used to find out whether you meet the requirements to take part in this study, information obtained during the study including information about your response to any study treatments you receive, information about physical exams, blood and urine tests, x-rays, and other tests and procedures that may be performed, and other information related to your taking part in this study.

2.The Providers may disclose health information in your medical records:

  • To the Researchers and to the Sponsor (Sponsor Name).
  • The Office for Human Research Protections in the U.S. Department of Health and Human Services.

3.The Researchers may:

  • Use and share your health information among themselves and with other researchers involved with the research; and
  • Disclose your health information to the Sponsor.

4.The Sponsor may:

  • Use and share your health information to conduct the clinical research and to confirm the research results as described in the Informed Consent; and
  • Remove from your health information the information that could be used to identify you.
  1. The Providers, Researchers and Sponsor may:
  • Disclose your health information as required by law and to representatives of government organizations, review boards (such as the Food and Drug Administration [FDA] or similar government agencies in other countries, and the Baptist Health Lexington Institutional Review Board), and other persons who are required to watch over the safety and effectiveness of medical products (drugs and devices), treatments and how the research is conducted.
  1. Once information that could be used to identify you has been removed:
  • The information that remains is no longer subject to this Authorization and may be used and disclosed by the Researchers and Sponsors as permitted by law, including other research purposes.

7.Once your health information has been disclosed to a third party:

  • It may be subject to further disclosure by recipients, and federal privacy laws may no longer protect it from further disclosure
  • The Researchers and the Sponsor agree to protect your health information by using and disclosing it only as permitted by you in this Authorization and the Informed Consent form
  • No publication about the research will reveal your identity without your specific written permission
  • These limitations to protect information about you continue even if you revoke (take back) this Authorization.

8.Please note that:

  • You do not have to sign this Authorization, but if you do not, you will not be allowed to take part in the research.
  • You may change your mind and revoke (take back) this authorization at any time. However, if you revoke this Authorization, you will no longer be allowed to take part in the research study. Also, even if you revoke this Authorization, the information already obtained by the Researchers and Sponsor may be used and disclosed as permitted by this Authorization and the Informed Consent. To revoke this Authorization, you must do so in writing by sending a letter to Baptist Health Lexington’sClinical Research Center at 1740 Nicholasville Road, Lexington, KY 40503.If you have a complaint or concerns about the privacy of your health information, you may also write to the Baptist Health Lexington’sPrivacy Officer at the same address.
  • While the research is in progress, you will not be allowed to see your health information that is created or collected during the research. After the research is finished, however, you may see this information as described in Baptist’s Notice of Information practices.

9.This Authorization does not have an expiration (ending) date.