Funding

Clinical Research

Updated September 10, 2007

This sample patient consent form serves as an example to guide investigators who intend to conduct research with human subjects. The intent of the document is not to suggest required wording or format, but rather to provide categories and level of detail that are pertinent to many studies.

Observational Study Consent Form

[Clinical Center]

[Principal Investigator]

[24-Hour Contact]

If you are able, you may choose to participate in this observational study entitled, (title). The purpose of the study is to look at the relation between lifestyle factors and health, as well as quality of life. If you decide to join the study, you will be asked to complete questionnaires, have a physical exam, and provide blood samples. This study will look at the role of several health habits (for example, physical activity and diet) and exam results (such as blood pressure and body weight), as well as factors measured in the blood sample. The investigators will look at how these factors affect risks of heart disease, cancer, general health, and quality and length of life.

Purpose of the Observational Study

The main purpose of this Observational Study is to (learn more about the causes of disease in the selected population.) The clinical staff has determined that you are eligible to join this part of the study.

Reasons for the Observational Study

Examples: There are several major diseases that women may get as they get older. Breast cancer is the most commonly occurring major cancer in women. Cancers of the colon and rectum are the third most common major cancers in women. Heart disease is the most common cause of death in women age 50 to 79. If we could prevent these diseases, women could expect to live longer and healthier lives.

What Will You Be Doing?

If you decide to take part in the study, you will be followed for about n years. During this follow-up period, you will be contacted by mail each year. You will be asked to complete health update questionnaires and mail them back to the clinic. These questionnaires should take about 30 minutes to complete.

You will also receive a newsletter each year, informing you of news about the study and general information about health for women your age.

You will be invited to return to the clinic every X years. Before that visit, you will be mailed some forms, including the questionnaires to complete and bring with you to the clinic visit. At that visit, clinical staff will:

  • Review the questionnaires you completed.
  • Record the names (and possibly dosages) of medications you are taking currently.
  • Measure your pulse, blood pressure, height, weight, and the distance around your hips and waist.
  • Measure bone density in your hip and spine. This test is painless and takes about 30 minutes.
  • Give you questionnaires to complete about yourself and your lifestyle.
  • Draw about 3 tablespoons of blood for laboratory tests. For 12 hours prior to the blood test, you will not be able to exercise vigorously, eat, or drink anything except water and your regular medications. For one hour prior to the test, you will not be able to smoke.
  • Ask you to provide a urine sample (about 1 tablespoon) which will be stored for laboratory tests at a later date.

Abnormal findings of the following clinic tests will be reported to you or your doctor. Some of the blood and urine will be stored for purposes of future research studies specifically related to your disease. These studies may involve testing for the presence of genes (DNA) and investigations of blood factors (e.g., antibodies or novel inflammatory proteins) that may influence the risk of getting disease, the risk of having a severe form of the disease, and the chance of responding to treatment. These blood tests will not replace your usual medical care and results will not be available for your medical care (for example, your cholesterol will not be reported to you or your doctor). Research studies require only looking at all lab results together, and individual results will not be available.

I consent to such uses ________(pt initials)

I do not consent to such uses ________(pt initials)

Benefits and Risks

There may be no direct benefit to you for participating in this study. By taking part in this study, you may help to increase scientific knowledge about (e.g., the prevention of breast cancer.)

Blood draw
There is a small risk with the process of drawing blood. You may feel a little discomfort as the needle goes through the skin. There may be some bruising at the site where blood is drawn. Pressing hard on the spot for 1 or 2 minutes after the needle is removed will help to prevent a bruise. Very rarely, the arm may become infected. Occasionally people feel lightheaded or even faint when their blood is drawn. If you feel faint, tell the person drawing your blood and she/he will have you lie down until the feeling goes away.

Bone Density Measurement
The bone density measurement involves a small amount of radiation. Small amounts of radiation may have potential harm, but the risk is difficult to measure and is probably very small. The total radiation from the bone density measurements is less than 4% of the natural background radiation a person receives living in a typical American community for one year. It is about the same radiation as 3 coast-to-coast airline flights from the east to the west coast.

Urine Sample
Providing a urine sample involves no risk.

Costs

The tests, procedures and visits that are a part of this study will cost only your time and travel. Any test or procedure that would normally be billed to your insurance company, Medicare, or Medicaid will be billed to those sources. If you do not have sources to pay for tests and procedures, the study will pay these costs.

The study clinical center has not set aside funds to pay for any health conditions that you may develop, and will not pay for any health problems or conditions that might occur during the course of this study. These might be covered by your usual insurance, Medicare, or Medicaid. You will not be paid back for any wages lost from taking part in this study. You will not be paid for being in the study.

Confidentiality

All of your study records will be kept confidential to the extent required by law. Your personal identity will not be revealed in any publication or release of results. If a health condition is detected during this examination, you will be told about it and the information will be given to your doctor or clinic. Only staff at [name of clinical site], the Clinical Coordinating Center, FDA and the sponsor, NIH, will have access to your medical records for the purpose of study wide mailings, as well as maintaining and updating your study records. Study records will be kept indefinitely for analysis and follow-up. This study is authorized by Privacy Act 42 United States Code 241.

Right to Withdraw

Your decision to join in this study is voluntary. You may quit at any time, for any reason, without notice. We hope you will take part for the entire time of the study because we will use all of this information to draw correct conclusions. If you decide to leave the study, we hope to be able to contact you yearly to see how you are doing. If you decide to leave the study, it will not affect your regular medical care.

Voluntary Consent

If you have any questions about any aspect of the study or your rights as a volunteer, a staff member will be on hand to answer them before you sign this consent form. Additionally, if you have any questions about you rights as a participant in this study, please call (name) in the Institutional Review Board Office of [Clinical Center] at [phone number]. If you have any questions at any time, you may call: [Clinical Center name and phone number] or any of the investigators listed at the beginning of this form. Before you sign this form, please ask any questions on any part of this study that is unclear to you.

Other Information

Your joining is important to the success of this study. In order for this study to be valid, you should not join other health studies where you would be assigned at random (like the flip of a coin) to receive a medication, special test, or special treatment.

If any test suggests that a health problem needs further study, you will be sent back to your doctor or clinic, who will evaluate the need for further study. Copies of reports and hospital records of your doctor's follow-up may be requested by the institution and become part of your study record at [Clinical Center]. Whether or not you choose to join, your medical care or your medical insurance coverage will not be affected. The study does not replace your usual medical care.

If you are unable to complete the follow-up forms, the clinic staff may contact your spouse, close relative, or friend for updated information about your health. If you move, and we are not able to find you, we may try to locate you through nationally available records, such as social security.

Investigator's Statement

I have provided an explanation of the above research program. The participant was given an opportunity to discuss these procedures, including possible alternatives, and to ask any additional questions. A signed copy of the consent form has been given to the participant.

______________________________________________
Signature of Principal Investigator or Designee         Date

Participant Statement

I certify that I have read, or had read to me, and that I understand the description of the Observational Study. I have asked and received answers to all my questions about the study. I voluntarily consent to join the study. I understand that I may quit the study at any time. I understand that I may ask further questions at any time and that I will receive a copy of this signed consent form for my records. I have had an opportunity to carefully review the Informed Consent form and ask questions about it.

_____________________________________________
Signature of Participant        Date

_____________________________________________
Signature of Witness          Date