IRB Committee C Consent Form Template IRB File # ______
Revised 120613 Page 1 of 11
CONSENT FORM AND INFORMATION
Title of Study
STUDY TO BE CONDUCTED BY:
LOCATION:
Principal Investigator:
Study Sponsor:
Introduction
This is 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. Research studies include only participants who choose to take part. Please take your time to make your decision. You may want to discuss it with your family and friends. The information in this consent form is not meant to frighten or alarm you; it is only meant to better inform you of all possible risks or benefits of the research study.
This consent form gives you detailed facts about the research study. This information will help you decide if you would like to take part in this study. 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.
The sponsor expects to enroll (# of participants) to this research study (nationally).
Purpose of Study
You are being asked to take part in this research study because you have (type of cancer).
The purpose of this research study is to: (choose the appropriate purpose).
[Tell whether drugs are FDA approved or not; define experimental part of study.]
· (Phase II) Find out what effects (good and bad) DRUG/INTERVENTION has on your cancer.
· (Phase III) Compare the effects (good and bad) of the NEW DRUG/INTERVENTION with COMMONLY-USED DRUG/INTERVENTION on your cancer to see which is better.
This research study is being done because (choose an appropriate example, such as “currently there is no effective treatment for this type of cancer,” or “it is not known which of these commonly-used treatments is better.”
Your participation will last for (MONTHS/WEEKS, UNTIL A CERTAIN EVENT). {Where appropriate, state that the study will involve long-term / life-long follow-up}.
Consent for Specimen Storage (use if needed):
In addition to the treatment described in this consent form, the sponsor would like to store blood and tumor tissue samples for future scientific research studies. Information about storing your blood and tumor tissue will be addressed later in a separate consent form.
How the Study Works
If you choose to participate in this research study, you will have tests to find out if you meet the study requirements. The results of these tests will be used to decide whether or not you may be accepted into this study. These tests are part of the usual medical care even if you decide not to participate in the study. Some of these tests will be done more often than usual, and all of these tests are done on an outpatient basis. These tests include:
§ medical history
§ physical exam
§ blood tests (about 2 to 3 teaspoons)
(Please use the information from the model consent form provided by the sponsor to describe the treatment procedures, etc.)
{For randomized studies:}
You will be “randomized” into one of the study groups described below. Randomization means that you are put into a group by chance. It is like flipping a coin (use if only 2 choices) or drawing straws (use if more than 2 choices). The group to which you are assigned will be done by a computer. Neither you nor your doctor will choose what group you will be in. You will have an (equal, one in three, etc.) chance of being placed in any group.
{For nonrandomized and randomized studies:}
If you take part in this research study, you will have the following tests and procedures:
{List protocol procedures and their frequency. For randomized studies, list the study groups and describe the procedures applicable to each. List test procedures and procedures that are part of standard care that will occur during the study period. For blinded studies, add the following statement: “Although you and your doctor will not know which treatment you will receive, this information can be determined in the event of an emergency (this information will come from the model consent form).
Please tell your doctor if you are taking any drugs, 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 in a research study and tell them of the treatment and drugs you will be taking.
Risks and Discomforts
While on the research study, you are at risk for side effects. Your doctor will discuss these with you. The treatment used in this study may cause all, some, or none of the side effects listed. There also may be other side effects that have not been reported. Other drugs may be given to make side effects less serious and uncomfortable. Many side effects go away shortly after the treatment is stopped, but in some cases side effects can be serious, long-lasting or permanent, and could lead to death.
It is possible that receiving the study drug with your regular medications, supplements, or certain foods (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.
{List by regimen the physical and nonphysical risks of participating in the study in categories of “most common” and “less common” and “rare but serious.” Nonphysical risks may include such things as the inability to work. Do not describe risks in a narrative fashion. They should be in bullet format. Highlight or otherwise identify side effects that may be irreversible or long-term or life threatening.}
{Where allergic reaction is a potential, as in all drug studies, use the following language)
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.
{If the study is from NCI or a cooperative group that does not allow risk categories to be changed, please use the following statement:}
The risks listed above are described according to the sponsor's recommendations. Other drug information sources may indicate that these risks occur on a more or less frequent basis. Make sure to ask your study doctor about any risks that particularly concern you
Inserting an IV or Drawing Blood:
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.
Secondary cancer (use if needed):
Several chemotherapy drugs are known to increase the risk of developing a second cancer and/or leukemia (cancer of the blood). However, drugs in use today that are not currently known to cause this risk may be shown at a later time to cause the development of a secondary cancer and/or leukemia.
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 all 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, rarely, infection at the location where the needle is placed.
Studies that involve questionnaires or daily diaries:
Some of the questions regarding quality of life 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.
Reproductive Risks
(Please reference gender appropriately. The model consent form provided by the sponsor may provide additional specific information which should be included in this section)
The drugs in this research study can affect an unborn baby. If you are pregnant or nursing a baby you may not participate in this study. If you become pregnant during this study, you will be removed from the study. Both men and women taking part in this study must absolutely avoid actions that will result in pregnancy. Your doctor will discuss your options with you further. Women who think that they may have become pregnant or men who think that they may have caused a pregnancy during this study should tell their doctor right away. If you are a woman who can have children, your menstrual cycle may temporarily be irregular or may stop forever, resulting in total inability to become pregnant. If you are a man, you may be unable to father a child, now or in the future. Upon request, your doctor may discuss with you alternatives and options in this area.
PLEASE NOTE: The following language must be inserted for studies
with genetic research:
A Federal law, called the Genetic Information Nondiscrimination Act (GINA) generally makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. This law generally will protect you in the following ways:
· Health insurance companies and group health plans may not request your genetic information that we get from this research
· Health insurance companies and group health plans may not use your genetic information when making decisions regarding your eligibility or premiums.
· Employers with 15 or more employees may not use your genetic information that we get from this research when making a decision to hire, promote, or fire you or when setting the terms of your employment.
Be aware that this Federal law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance.
If the study involves data collection only (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 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.
Benefits
Participation in this research study may or may not improve your condition. It is not possible to know whether or not you will receive any personal benefit by participating in this study. The sponsor hopes the information will be of future benefit to others with your type of cancer.
Alternatives (List any alternative treatments that are applicable to this type of disease)
Instead of participating in this research study, you have these alternatives (other choices):
· no further treatment
· comfort care only
Please discuss these choices with your doctor.
New Information
Your doctor will tell you about new information that may affect your willingness to participate in this research study. Alternatives, or other choices, concerning your care will be discussed at that time. Your doctor or the sponsor can stop your participation in this study even if you are willing to continue.
(If applicable, use 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.
Cost as a Result of Study Participation
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, 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 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.
At a minimum, 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.
If drug is supplied free of charge, use the following)