Sample Consent Form

This sample consent form does not cover all situations. It was written for an investigational drug study, but it can be easily adapted for other situations.

Please number the pages of this form. Include a footer that identifies the version date. Remember to update the version date if you revise the consent form.

If your study has more than one consent form, clearly label each form by number or by population, e.g., "consent form #2" or "consent form for subjects with diabetes."

_______________________________________________________________________________

Researchers: [Insert names, academic/staff positions, departmental/division affiliations, telephone numbers, and email addresses (optional) of principal researchers and study staff.]

24-Hour Emergency Telephone Number: [Include this information for studies involving more than minimal risk of harm. Provide the contact person’s name or position. Make sure the person/people listed know about the study and its risks.]

Include the following introductory section:

"We are asking you to be in a research study. The purpose of this consent form is to give you the information you will need to help you decide whether to be in the study or not. Please read this form carefully. You may ask questions about the purpose of the research, what we will ask you to do, the possible risks and benefits, your rights as a volunteer, and anything else about the research or this form that is not clear. When we have answered all of your questions, you can decide if you want to be in the study or not. This process is called "informed consent." We will give you a copy of this form for your records. "The consent form may contain words that you do not understand. Please ask the researcher or the study staff to explain any words or information that you do not clearly understand. You may take home an unsigned copy of this consent form to think about or discuss with family or friends before making your decision."

Purpose of the Study

Provide a brief (two or three-sentence) background and explain the purpose of activity. Clearly state that the project involves research. For drug or device studies, state that an investigational drug or device will be used. Use the generic name for the drug, followed by the trade name in parentheses.   For studies involving drugs, state how many people will participate in the study. Use lay language.

"The purpose of this research is to see whether Drug A (generic name followed by trade name in parentheses): For Phase I Studies: a) "...is safe for use in human beings. Drug A has been shown to be safe in animals, but it has not yet been tested in humans" or, b) "...can be safely given to patients with Disease X. There have been no previous human studies of Drug A; however, laboratory research (research in test tubes or animals) suggests that Drug A can act against Disease X. Only persons with Disease X can be in this study." For Phase II Studies: "...is an effective treatment for Disease X and to learn about the side effects of Drug A." For Phase III Studies: "...is a safe and effective treatment for Disease X." (If randomized), "We will compare Drug A with the standard treatment for Disease X.”

"In this study we: For Phase I Studies: a) "...want to study how Drug A is metabolized (broken down) in the body, to measure the amount of Drug A in the blood, and to see how long it stays in the body" or, b) "...want to give several different doses of Drug A to learn the effects (good and bad) of each dose" or, c) "...want to learn what dose of the drug is safe for humans and how often the drug should be given," or d) "...want to see if Drug A is safe and has activity against Disease X in humans. Drug A is an experimental (drug/device). The U.S. Food and Drug Administration (FDA) allows Drug A to be used only in research with a limited number of people. About 100 people will take part in this study. You will be one of 10 people at the University of Washington." For Phase II Studies: (If randomized) "...will compare Drug A with Drug B, which is the standard treatment for Disease X. Drug A is an experimental (drug/device). The U.S. Food and Drug Administration (FDA) allows Drug A to be used only in research with a limited number of people. About 200 people will take part in this study. You will be one of 12 people at the University of Washington." For Phase III Studies: a) "...will compare Drug A with Drug B, which is the standard treatment for Disease X" or, b) " ...will compare Drug A with placebo (an inactive substance that contains no medicine). Drug A is an experimental (drug/device). The U.S. Food and Drug Administration (FDA) allows Drug A to be used only in research. About 400 people will take part in this study. You will be one of 50 people at the University of Washington."

Procedures

Describe the tests and procedures to be performed for study purposes and the schedule by which they will be administered. Include the time commitment for each, the total amount of time involved, and how long the study will last. State who will perform the procedures, e.g., "by a person trained to draw blood." If it is necessary to discuss standard care procedures in the context of the consent form, clearly indicate which procedures are performed only for research purposes and which procedures are part of standard care. All information about procedures that would influence the subject’s decision to participate should be included, e.g., if pregnancy testing, HIV testing, or a urine drug screen will be done, the consent form should so state. Use lay language.

If drugs are involved, describe the route of administration and the dosage.

If tissues or other specimens are to be taken, so state. If specimens will be stored for future use, add a sentence stating that subjects will be asked to sign a separate consent form for this purpose. Depending on your study, use either the consent form for specimens that are identifiable (Consent Form Sample Template - Identifiable Specimens) or the consent form for specimens that are non-identifiable (Cosent Form Sample Template - Non-Identifiable, De-Linked, Anonymized Specimens).

If blood is to be drawn, specify the amount in lay terms, e.g. teaspoons.

If questionnaires or interviews are involved, include examples of the most personal and sensitive questions. Include a statement that individuals are free not to answer any question or item.

If identifiable recordings - such as photographs, audio, or visual recordings - will be made, so state. If you will keep the recordings, explain that subjects will be given an opportunity to review the recordings and to delete any portions.

If procedures will be done at other sites, so state.

If health information will be extracted from the medical record or from other confidential sources, so state. Describe the information to be extracted and the purpose for its use in this research. Be sure to state that all health information collected during this study will become "study data."

“We will record information from your medical record about the diagnosis and treatment of your breast cancer. This health information and all health information that we collect during the study will be kept as study data.”

State how long you will need access to medical records.

“Signing this consent form allows us to look at your medical records for [insert length of time].”

If available, include a Flow Sheet or chart of study procedures, refer to it in this section and attach a copy to the Consent Form. Such charts are usually very helpful to subjects. (Researchers may need to edit the charts, using lay language and explanations of medical terms or abbreviations that appear on sponsors’ charts.)

For a Phase I Study (pharmacokinetic study with healthy volunteers, done in the Clinical Research Center (CRC)): "If you agree to be in this study, we will ask you to do the following things: First, we will do a screening evaluation. The purpose of the screening evaluation is to find out if you are eligible to be in the rest of the study. You will need to come to the CRC on the 7th floor of the University of Washington Hospital for the screening procedures. "At screening, we will do a physical examination. We will ask about your medical history, including your past and present illnesses. We will ask about all medicines that you are currently taking. We will also ask you about any current alcohol or drug abuse. If you currently abuse drugs or alcohol, you will not be eligible to be in this study. Then we will do a urinalysis, and we will draw some blood (about 3 teaspoons) for testing in the laboratory. These tests include____, ____,____. If you are a female of childbearing potential, we will do a pregnancy test (a blood test). If you are pregnant, you will not be eligible to be in this study. You will also have a blood test to find out whether you have been infected with HIV (the virus that causes AIDS). For the HIV testing, we will ask you to sign a separate consent form. If you are infected with HIV, you will not be eligible to be in this study. We will obtain the blood for all of these tests through a single needle puncture of a vein. The total amount of blood to be drawn for these screening tests is ______. The blood will be drawn by a trained person. "If the results of the screening tests show that you are eligible to continue with this study, we will ask you to come back to the CRC for a visit that will last 12-14 hours. You will need to be at the CRC at 7:00 in the morning, after not having eaten since midnight the night before. We will take a saliva sample (about one teaspoonful) and a blood sample from a vein in your arm (also about one teaspoonful). One hour later (at about 8:00 a.m.) we will give you a single (state size) dose of Drug A, dissolved in apple juice. You will not be allowed to eat until 4 hours after you take Drug A. At ___, ____, ____, ____, ____, ____, and ____ hours after you take Drug A, we will take more 1-teaspoon saliva samples. At ____, ____, ____, ____, ____, ____, and ____ hours after you take Drug A, we will take more 1-teaspoon blood samples. If you choose, a catheter (a small plastic tube) will be placed in a vein on your arm or hand so that we will not need to do a separate needle stick for each blood sample. We will then give you lunch, and you can go home. When you go home, we will give you two containers so that you can collect all of your urine and return the containers to us on the following two mornings. Each morning when you return the urine containers to the CRC, we will take a blood sample and a saliva sample. In total, we will take ___ teaspoons of blood and ___ teaspoons of saliva."

For a Phase II or Phase III Study (double blind, controlled design): "If you agree to be in this study, we will ask you to do the following things: First, we will do a screening evaluation. The purpose of the screening evaluation is to find out if you are eligible to be in the rest of the study. The screening evaluation period will be two weeks. We will begin the screening evaluation by doing a physical examination, including a chest x-ray and an electrocardiogram (ECG) to measure your heart rhythms. For the ECG, we will tape (#) electrodes (small discs) to your chest and make recordings of your heart. The ECG will take about (#) minutes. We will review your medical chart from the office or clinic where you have been treated. We will collect some blood (# teaspoons) and some urine to test in the laboratory. Some of the blood taken for laboratory tests will be used to test for HIV (the virus that causes AIDS). For the HIV testing, we will ask you to sign a separate consent form. If you are female, we will ask you if you are pregnant, and we will do a urine or blood test for pregnancy. We’ll ask you to fill out a questionnaire about your moods and feelings. Examples of the most personal questions are: ____________. You may refuse to answer any questions. This entire visit will take about two hours. "During the two-week screening period, we’ll ask you to keep a diary of your symptoms. Keeping the diary will take about five minutes daily. During the two-week screening period, you should continue to take your regular medicine. "If the screening evaluation (physical examination and test results) show that you are eligible to continue with the study, we will randomly assign you to Group 1 or Group 2. This means that you will have a 50/50 chance (like flipping a coin) of being in either group. One of the groups will receive Drug A, and the other group will receive Drug B. Neither you nor the researchers will know which treatment you will receive, although the researchers can find out in an emergency. "We will give you the study tablets at the next visit (Study Visit #1). You will take the tablets [# mg of Drug A or # mg of Drug B] by mouth three times a day, every six hours, for ___ weeks. We will ask you to continue keeping the diary of symptoms. "Every week for the next nine weeks we want you to come back to this clinic for a checkup. At each Study Visit, we will do a brief physical examination, and we will ask you how you have felt. We will measure your blood pressure. We will take two teaspoons of blood and a urine sample. Throughout the study, we will ask you to continue with the diary of symptoms. "Twice during the study (at Study Visits 5 and 10) you will have a Magnetic Resonance Imaging (MRI) exam. For the MRI exam, you will need to lie quietly for about one hour, during which time you will hear a loud banging noise. You may feel warm during this procedure. "At Study Visit 10, we will ask you to fill out the same questionnaire about your moods and feelings. As before, you may refuse to answer any questions. "One month later we will ask you to come the clinic for a follow-up visit brief physical examination, measure your blood pressure and how have been feeling. "Participation in the study will take a total of about____ hours over a period of _____ weeks. "All study procedures will be done at (state location)."

Risks, Stress, or Discomfort

Describe risks, stress, or discomfort associated with any procedure being performed for study purposes or on a schedule determined by study participation. Do not state that there are no risks or that risks "should be" minimal. For treatment studies, explain that subjects' condition may not get better or may become worse while participating in the study. Use lay language. Sample risk descriptions of procedures commonly encountered in clinical trials include:

Arterial puncture risks: "Putting a needle in your artery may cause the blood flow to stop and may cause tissue damage."

ECG/EEG risks: "The glue used to keep the electrodes in place during the ECG may irritate your skin and cause redness."

MRI risks: If you plan to use sedatives and/or contrast agents, include associated risks. "Because the MRI machine acts like a large magnet, it could move objects containing iron in the MRI room during your examination, which could possibly harm you. We will take precautions to prevent this from happening. Loose metal objects, like pocket knives or key chains, are not allowed in the MRI room. If you have a piece of metal in your body, such as a fragment in your eye, aneurysm clips, ear implants, spinal nerve stimulators, or a pacemaker, you will not be allowed into the MRI room and cannot have an MRI." "Having an MRI may mean some added discomfort for you. In particular, you may be bothered by feelings of claustrophobia (a "closed-in" feeling) and by the loud banging noise during the test. Temporary hearing loss has been reported from this loud noise. This is why we will ask you to wear earplugs. At times during the test, you may be asked not to swallow for a while, which can be uncomfortable. Because the risks to a fetus from MRI are unknown, pregnant women must not participate in this study."

Placebo risks: "If you are in the group that receives placebo, your condition will go without active treatment for ____ weeks."

Questionnaire risks: "Some of the questions on the questionnaires may be embarrassing to you. You may refuse to answer any of the questions."

Radiation risks: Please see sample radiation risk statements.

Randomization risks: "You will be randomly assigned to receive Drug A or Drug B. The treatment you receive may prove to be less effective or to have more side effects than the other study treatment(s) or other available treatment(s)."

Venipuncture risks: For single blood draws: "Having blood drawn may cause some pain. A bruise may form where the needle enters the vein. Drawing blood may cause some people to faint." For indwelling catheters, add: "Very rarely, the catheter may cause an infection."

Vision testing risks: "The drugs used to test your eyes will cause blurred vision for several hours. Some people are allergic to these drugs."

Describe possible side effects associated with any medications that you will administer for study purposes (this includes comparator drugs), e.g., eye drops, sedatives, contrast agents. In deciding which side effects to list, aim for a balance between likelihood of harm and magnitude of harm. Describe first the most commonly experienced side effects, then list in descending order those that are less likely to occur. List rare side effects only if catastrophic. Use lay language. Include the sentence:

"As with any drug, there may be side effects, including the risk of death, that we do not know about. There may also be unanticipated or unexpected risks, including long-term risks that may not be known until later, and sometimes not for many years after the study is over."

If patients may experience exacerbation of symptoms by removal of usual medications or assignment to placebo, so describe. For appropriate studies, describe the possibility of drug interactions. Use lay language.

Drug risks: "The risks from Drug A include nausea, headache, and dizziness. Drug A also caused anemia (low blood count) in some people. Four weeks after the treatment, blood counts were back to normal. Very rarely, Drug A may cause abnormal heart rhythms. The risks from Drug B include nausea and headache. If either drug causes problems for you, we will treat you and stop giving the drug to you. As with any drug, there may be side effects, including the risk of death, that we do not know about. We will tell you if we learn any new information about Drug A or Drug B that might make you change your mind about being in this study." Drug interactions: It is important that you tell your study doctor about any drugs that you are using, including over-the-counter drugs. The combination of drugs you are already taking, plus the study drug(s), may put strain on your kidneys or liver. Your study doctor will monitor you to find out if this is happening.

Provide directions or specify whom to contact in the event that an adverse event occurs.

Where appropriate, state that the study procedures may involve risks to the subject (or to the embryo or fetus, if the subject were pregnant) which are not currently foreseeable. Remember that there can be pregnancy-related risks for men as well as for women. Consider drug half-life when telling subjects how long after the study to avoid conception. Use lay language.

Pregnancy risks: "We don’t know what the effects of Drug A might be on a developing fetus. If you are a woman of childbearing potential, we will test you to make sure you are not pregnant. You or your sexual partner must not get pregnant while in this study. You or your sexual partner must use a reliable method of birth control for at least ___ months before the study, while you are participating in the study, and for ___ months after you stop taking Drug A (this is because Drug A may stay in your blood for up to ___ months after you stop taking it). Reliable methods of birth control include birth control pills, intrauterine device (IUD), implanted contraceptive (such as Norplant), vasectomy, tubal ligation, or diaphragm and condom."

If tests (such as screening tests) for reportable diseases are done for study purposes that are not required for standard care, so state, and explain the meaning of "reportable disease." If the results of tests done for study purposes only (not required for standard care) will be put in subjects’ medical records and if those test results might compromise subjects’ ability to obtain insurance or employment, so state. Use lay language.

Confidentiality risks: "If the test results show that you have (reportable disease), we are required by law to report your name and your positive test results to the Seattle-King County Health Department."

If this is a treatment study, explain:

"Your condition may not get better or may become worse while you are in this study."

If the study drug is taken home, explain:

"Only you can take the study drug. It must be kept out of the reach of children and persons who may not be able to read or understand the label."

Alternatives to Taking Part in this Study

Describe alternative procedures/treatment, including standard treatment, when available. Be sure not to imply that participation in the research is the only way to obtain medical care and attention. Use lay language.

“There are other treatments for your condition. These include (LIST MAJOR DRUGS AND/OR THERAPIES). The researcher will discuss these with you. You can be treated for Disease/Condition X even if you do not take part in this study. You can also receive treatment for your symptoms only. You may choose to have no treatment at all.” (IF STUDY DRUG IS AN APPROVED DRUG), "There are alternatives to being in this study. The alternatives include treatment with Drug B (without having to have the tests done only for this study), any of the other known treatments for Disease X, treatment of your symptoms only, or no treatment at all."

Benefits of the Study

Describe reasonably expected benefits to the subjects and/or to society. Include only those benefits which are unique to study participation. If there are no benefits, so state. Use lay language.

For Phase I Studies: "There will be no direct benefit to you from being in this study. However, we hope that the results of this study will help in the treatment of future patients with Disease X." For Phase II or III Studies: "You may benefit from the study if you receive a treatment that proves to be effective. We cannot guarantee that there will be any benefit to you. We hope that the results of this study will help us learn which treatments for Disease X are safest and work best." If subjects may be assigned to a placebo group: "If you receive placebo (no active medication), you will not benefit from being in this study." or "If you receive placebo (no active medication), it is unlikely that you will benefit from being in this study."

Medical Record Information

Insert this section only if your research involves procedures, tests, or other services that will be provided through a UW Medicine clinical facility. UW Medicine clinical facilities include: UWMC, UW clinics, Harborview, and Seattle Cancer Care Alliance.

We are required by Federal regulations and UW Medicine policy to put information about your participation in this research into your UW Medicine medical record. If you do not have a UW Medicine medical record, one will be created for you even if your only connection with UW Medicine is as a research subject. The information in your UW Medicine medical record will include: •  Name of the study [ insert AAA account name, when available ] •  Name of the group or company paying for the research [ insert sponsor's name here ] •  The number assigned to this study by the group or company •  The name of the researcher •  The name of the study coordinator •  Contact phone number for the study •  Contact email address for the study •  Emergency phone number for the study •  Expected start and end dates for your time in the study •  Whether there are healthy volunteers in the research Information about your research procedures and test results may also be put in your medical record. This will include: [insert list] People who have access to your medical record may be able to find out that you are in this study. They will also be able to see test results or procedures that are put in your medical record. In the future, if you give permission to any person or group (such as an insurance company or employer), to look in your medical record, they could receive this research information. If you have already given permission to anyone (such as your health insurance company) to look at your medical record, they will receive this research information if they ask for a copy of your medical record. [Insert the two sentences below ONLY if all of the following statements are true: 1) Procedures are being billed to subjects and/or their health insurer; 2) The insurance for at least some of the subjects is something other than Medicare or Medicai; 3) You or the subjects are not obtaining pre-authorization from the subject's health insurer.] Though very unlikely, this could have some effect on what procedures your health insurance company (but not Medicaid or Medicare) is willing to pay for while you are in the research. If this infrequent situation happens, we may be able to help by giving you some information to share with your health insurance company.

Other Information

To comply with federal regulations, include the following statement:

"Being in this study is voluntary. You may choose not to be in this study, and you may withdraw from the study at any time without penalty or loss of benefits to which you are otherwise entitled."

State whether study data will be confidential (linked to identifiers) or anonymous (no links). To comply with Federal privacy regulations, state who, or what agencies, will have access to or may use or disclose identifiable data. For more information about the definitions of "confidential" and "anonymous," consult the Human Subjects Division Web site.

“In addition to the researchers, the following may have access to study data which may include identifiable health information from your medical records: University of Washington (UW) Human Subjects Review Committee (the board that oversees research at the UW); UW Medicine’s compliance and quality improvement groups; (INSERT NAME OF STUDY SPONSOR), the sponsor of this study; (IF APPROPRIATE) Researchers from other institutions that are taking part in this research; (IF APPROPRIATE) Federal agencies such as the Department of Health and Human Services or the United States Food and Drug Administration, and similar agencies from foreign countries; e.g., "The U.S. Food and Drug Administration (FDA) reserves the right to review study data that may contain identifying information;" Agencies that accredit hospitals at the University; Data and safety monitoring boards that are responsible for the safety of research subjects; Your health insurer; other health care providers who become involved in your care; (IF PAYING SUBJECTS BY CHECK) Budget and finance employees of the University of Washington; (INSERT OTHER PEOPLE OR GROUPS WHO MAY ACCESS, USE, OR DISCLOSE PERSONAL HEALTH INFORMATION FOR STUDY PURPOSES).” "Although we will make every effort to keep your information confidential, no system for protecting your confidentiality can be completely secure. It is possible that unauthorized persons might discover that you are in this study, or might obtain information about you. University and government offices sometimes review studies such as this one to make sure they are being done safely and legally. If a review of this study takes place, your records may be examined. The reviewers will protect your privacy. The study records will not be used to put you at legal risk of harm."

Explain provisions for maintaining confidentiality. State how long you will need to retain study data linked to identifiers. If study data and/or the research consent form will be added to the medical record, so state. Explain how subjects’ screening tests will be handled if they are not eligible for the study.

“The study data about you will be numbered and linked to your name.  We will keep a master list for __________years (or indefinitely).” “(IF APPROPRIATE) “We will put a copy of this consent form in your medical record. We will also put copies of test and exam results from this study into your medical record if the results are important for your medical care.” “The results of your screening tests may show that you are not eligible to continue in the study. If this happens, we will keep your screening information for ________years and then we will destroy the information.”

If you intend to conduct this study under the terms of a Federal Certificate of Confidentiality, add the following language:

“ We have obtained a Certificate of Confidentiality from the Federal government. A Certificate of Confidentiality protects your privacy by allowing us to refuse to disclose your name or other identifying information to anyone outside this research project. In the unlikely event of an audit by our funding agency, we may have to reveal your name, but only to the agency’s authorized personnel.”

Explain whether subjects will be responsible for costs related to study procedures. Depending upon the circumstances of the study, one of the following statements may be appropriate:

"We will not charge you for any of the study treatments or procedures. Company C, the manufacturer of Drug A, will cover the costs of Drug A and Drug B, the administration of the study drugs, and all tests and clinic visits associated with this study." Or "We will bill your insurance company for the routine clinic visits, and all standard laboratory tests, e.g., routine blood counts, and blood chemistry tests. Drug A and Drug B will be provided free of charge and you will not be billed for tests or clinic visits required only for purposes of research, e.g., extra blood tests, x-rays, or MRI exams. Because this treatment is experimental, your insurance company may refuse to pay for costs related to this treatment. In this case you may be financially responsible."

Include information about who will pay for treatment of subject injuries.

"If you think you have a physical injury or illness related to this study, contact the study staff right away. The study staff will treat you or refer you for treatment." For industry-sponsored studies: "The sponsor of the study, Company C, will pay for the treatment of injury or illness caused by the study drug or design." For studies in which the UW Compensation Plan applies (non-industry sponsor, investigator-initiated): "The UW will pay up to $10,000 to treat injury or illness caused by the study." For studies in which injuries may result from an underlying condition or from standard care: "We will bill you and your insurer for treatment of problems that result from your [INSERT NAME OF DISEASE] or from standard care." For all studies in which injury or illness is possible, state: "You will not lose your legal right to seek payment if you sign this form."

Include specific information when subjects will receive an inducement, e.g., money, free services, for participating in the study. If subjects will receive an inducement, remember to include the mandatory information about use of their Social Security numbers (see below).

"We will not pay you for being in this study." Or "In return for your time, effort, and travel expenses, we will pay you $10 for coming to each clinic visit -- for a total of $120 if you complete the whole study (the screening visit, the 10 Study Visits, and the follow-up visit). If you do not complete the study, we will pay you $10 for each visit you do complete. We will mail a check to you about ____ weeks after your participation in the study has ended. For tax purposes only, we must report your Social Security number to the University of Washington."

Describe anticipated circumstances under which the researcher would terminate the subject’s participation without regard to the subject’s consent. If appropriate, describe the consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation.

"We may withdraw you from this study without your consent if we believe it is in your best interest or if you are unable to follow study procedures."

Depending on your specific study, the following may be appropriate:

New findings: "Any significant new developments during the course of this research that might change your decision to be in this study will be reported to you. You may be asked to sign a revised consent form if this happens." Source of funding: "[DRUG COMPANY OR OTHER FUNDOR] is paying the study team and/or the University of Washington to do this study."

Subject’s Statement

Include this paragraph as written below:

This study has been explained to me. I volunteer to take part in this research. I have had a chance to ask questions. If I have questions later about the research, I can ask one of the researchers listed above. If I have questions about my rights as a research subject, I can call the Human Subjects Division at (206) 543-0098. [If relevant, add: I give the permission to the researchers to use my medical records as described in this consent form.] I will receive a signed and dated copy of this consent form.

________________________________________		_________________
Subject's Signature		Date
________________________________________
Printed Name of Subject

Copies to: Subject, Researcher’s file, Medical record (if applicable)