University of Michigan
Consent To Be Part Of A Research Study

Information About tHIS form

You may be eligible to take part in a research study.  This form gives you important information about the study.  It describes the purpose of the study, and the risks and possible benefits of participating in the study.  

Please take time to review this information carefully.  After you have finished, you should talk to the researchers about the study and ask them any questions you have.  You may also wish to talk to others (for example, your friends, family, or other doctors) about your participation in this study.   If you decide to take part in the study, you will be asked to sign this form.  Before you sign this form, be sure you understand what the study is about, including the risks and possible benefits to you.

1.  General Information About This Study AND the RESEARCHERS

1.1  Study title: 

Molecular Markers, Health Behavior, and Comorbidities as Predictors of Tumor Recurrence, Survival, and Quality of Life in Head and Neck Cancer

1.2  Company or agency sponsoring the study: 

National Institutes of Health / National Cancer Institute  

1.3  Names, degrees, and affiliations of the researchers conducting the study: 

Sonia A. Duffy, Ph.D., R.N., University of Michigan Department of Otolaryngology, and Ann Arbor Department of Veterans Affairs Health Services Research and Development
Jeffrey E. Terrell, M.D., Department of Otolaryngology, University of Michigan 
Stephen B. Gruber, M.D., Department of Internal Medicine, University of Michigan
David L. Ronis, Ph.D., School of Nursing, University of Michigan
Nisha D’Silva, DDS, MSD, Ph.D., Oral Med/Path/Oncology, University of Michigan

2.  PURPOSE OF THis STUDY

2.1  Study purpose: 

You are being asked to participate in a research study designed to examine risk factors for patients with head and neck cancer.  The goal of this study is to determine predictors of cancer recurrence, survival, and quality of life.  Specifically, we will look at certain molecular markers (characteristics of blood, saliva and/or mucus, and tumor tissue samples) to see if they will be strong predictors of cancer recurrence, survival, and quality of life.  In addition, we will ask you about your health behaviors and any other health conditions you may be experiencing.  We want to see if these could also affect cancer recurrence, survival, and quality of life.  

3.  Information About STUDY participants (SUBJECTS)

Taking part in this study is completely voluntary.  You do not have to participate if you don't want to.  You may also leave the study at any time.  If you leave the study before it is finished, there will be no penalty to you, and you will not lose any benefits to which you are otherwise entitled.  

3.1  Who can take part in this study?

You are eligible for this study if you have been newly diagnosed with head and neck cancer.  You may be ineligible if you are 1) pregnant; 2) unable to speak English; 3) have an unstable psychiatric condition (for example suicidal); or, 4) have another type of cancer (such as skin, thyroid, ocular, ear, temporal bone, or lymphoid cancer), and do not have a squamous cell cancer of the head and neck.  

3.2  How many people (subjects) are expected to take part in this study?

This is a multi-site research study of 2500 subjects that is being conducted at the University of Michigan Medical Center, Ann Arbor VA Medical Center, and Henry Ford Hospital.  We plan to enroll 1500 subjects from the University of Michigan.

4.  information about study participation 

4.1  What will happen to me in this study?  

If you agree to participate in this study, today you will be given a survey to complete about certain health behaviors, such as smoking, alcohol use, sleep, and physical activity.  The survey will also ask about your feelings and aspects of your quality of life.  A research assistant will be available to help you if necessary.  The survey will take approximately 20 to 30 minutes to complete.  A week after you have completed this survey, we will mail you another survey about your usual diet for you to complete at home.  This additional survey will also take 20 to 30 minutes to complete.  We may contact you by telephone if we need further information from you.  You will be asked to complete the same surveys every year for the next two years, or until the study is over (whichever comes first).  If the funding of this study is extended, we may continue to mail you a yearly follow-up survey for up to 10 years to get an update on how you are doing.  

There is some new evidence that a small number of head and neck cancers may be related to Human Papilloma virus, which could be sexually transmitted.  To better understand this process, we wish to gather information about all head and neck cancer patients’ sexual history.  If you agree to answer these questions, you will be asked to complete a brief telephone questionnaire with an interviewer, which will take less than 5 minutes.  The interviewer will ask you about your sexual history.  These questions are important to ask because they may be related to the way cancer develops.  The information that you give to the interviewer will be kept confidential and will only be seen by members of the study staff.  If you are unavailable, the interviewer will leave a message and ask for you to contact them at your convenience.  The interviewer will not leave more than three messages.

Answering these sensitive questions is voluntary.  You may choose not to participate in the interview, while still completing the other parts of this study.  Please indicate below if you agree to complete the sexual history telephone interview.

 YES      NO    I am willing to complete a brief telephone interview and answer a few sexual history questions.

In order to investigate the genetics of head and neck cancer, tumor tissue, tissue from enlarged lymph nodes and adjacent normal tissue, blood specimens, and fluids such as saliva and/or nasal mucous specimens are needed for research tests to be done in our laboratories.  We will need blood, saliva and/or mucus samples from you approximately every three months for the next two years, for a total of 9 to 12 sample collections.  The blood samples will be used for research that may help doctors in the future to monitor the effectiveness of treatment and to detect recurrence before other symptoms develop.  Drawing blood will be done today and at your future regularly scheduled clinic appointments.  If you require any biopsies or surgeries, blood samples will also be taken at that time.  You will not be asked to make a separate visit to the clinic for collection of these blood samples.  A person experienced at drawing blood will take the 30 ml samples (about 2 tablespoons).  

We think that some markers might be detectable in saliva or in rare cases in nasal secretions.  You may be asked to spit into a cup to collect your saliva or the doctor may swab your nose to obtain nasal secretions.  Before collecting this mucus we will spray a mist of anesthetic into your nose.  The first sample would be collected while you are asleep in the operating room and subsequent samples would be collected each time you return to the clinic after surgery.  We will also ask you to complete a short survey every three months (usually at the time of the blood draws) for the next two years.  These short surveys will take about 5 to 10 minutes to complete and will give us an update on certain health behaviors.  

If you decide to get your treatment elsewhere and do not come back to the University of Michigan Hospital, we may ask you to have your regular health care provider draw the blood samples for our study.  There may be a charge for having blood drawn at another institution.  We will mail you a blood kit every three months for you to take with you to your next regularly scheduled doctors appointment.  You do not need to make a special appointment to do this.  Simply bring the blood kit with you whenever you have your next appointment.  The kit will include the supplies to give to your health care provider, a letter explaining that you are donating your blood for research, as well as a container and instructions on how to send the sample back to us.  The container will be sent back via Federal Express at no charge to you, and can be picked up directly from your home.

The researchers will look at your medical records and laboratory data to gather information about your condition and treatments.  If your regular treatment requires a biopsy, a small piece of tissue (less than ¼ inch in size) from the biopsy may be saved for research purposes only.  The tissue sample will be analyzed for specific genes that are thought to be important in cancer growth.  These tests are for research purposes only and will not influence your treatment.  The results from the tests will be labeled with a unique study identification number.  The file that could link the study identification number to your name will be kept secure and confidential.  The results of this genetic testing have no known treatment implications that we are aware of at this point in time.  Therefore, you will not be contacted with any results since they are purely for research purposes.  In the future, this research may help guide the treatment of head and neck cancer, but there is no expected direct benefit to you during your participation in this study.  Likewise, there are no expected commercial products (i.e. new tests or procedures) that are expected to arise from this study.  

Your blood, DNA, saliva and/or mucus, and tissue samples may be frozen, stored, and reproduced at a later date to look for other factors that may influence cancer prevention, treatment, and control.  These samples may be shared in the future with other investigators for a variety of cancer studies.  You will not be notified if the samples are reused for other research.  If your samples are shared, all information that could identify you will first be removed.  This means that people studying your samples will not know that it came from you or be able to find out that it came from you.  Your samples will only be tested for factors that are thought to be important to head and neck cancer growth.  

4.2  How much of my time will be needed to take part in this study?  

At baseline, one year and two years, it will take approximately one hour to complete the surveys (30 minutes for health survey, 30 minutes for nutrition survey).  These surveys can be mailed to your home for you to complete.  If you come in for any regularly scheduled clinic appointments, we may approach you to fill out a shortened survey (5-10 minutes) and to have your blood drawn approximately every three months.  You will not be asked to make a separate visit to the clinic for collection of these blood, saliva and/or mucus samples or surveys.  

4.3 When will my participation in the study be over? 

You will be asked to complete health surveys of different lengths, and to have your blood drawn, and donate saliva and/or mucus samples every three months for the next two years, or until the study is over (whichever comes first).  If the funding of this study is extended, we may continue to mail you a yearly follow-up survey for up to 10 years to get an update on how you are doing.

5.  information about RISKS and benefits 

5.1  What risks will I face by taking part in the study?  What will the researchers do to protect me against these risks?

The known or expected risks are:  A simple blood draw may cause discomfort and/or bruise at the site of puncture, or lightheadedness.  Less commonly, the formation of a small blood clot or swelling of the vein and surrounding area or bleeding from the puncture site may occur.  Rarely, fainting and local infection may occur.  It is possible that some of the survey questions might upset you.  However, you may choose not to answer any question that upsets you.  If at any time you feel upset by the questions asked, a trained researcher would be available to talk with you.  There is also a risk to your confidentiality.  

The researchers will try to minimize these risks by: keeping all information collected from you confidential, to the extent provided by federal, state, and local law.  All information collected about you will be labeled with a unique study identification number, which will allow the information to be linked to you.  Your name will not appear on any of the information collected for this study.  

As with any research study, there may be additional risks that are unknown or unexpected.

5.2  What happens if I get hurt, become sick, or have other problems as a result of this research?

The researchers have taken steps to minimize the risks of this study.  Even so, you may still have problems or side effects, even when the researchers are careful to avoid them. Please tell the researchers listed in Section 10 about any injuries, side effects, or other problems that you have during this study.  You should also tell your regular doctors.    
	
5.3  If I take part in this study, can I also participate in other studies?

As this study is purely observational (no treatment involved), participation in this study will not interfere with your participation in any other research studies.

5.4  How could I benefit if I take part in this study?  How could others benefit?  

You may not receive any personal benefits from being in this study.  However, the results of this study are expected to provide useful information about screening and prevention services for head and neck cancer patients.  This study could show us molecular markers and behaviors that would identify the patients at highest risk for poor health outcomes.  If we can identify those at highest risk, we can treat them earlier and more effectively.  This will lead to better outcomes and improved quality of life for those patients.

5.5  Will the researchers tell me if they learn of new information that could change my willingness to stay in this study?

Yes, the researchers will tell you if they learn of important new information that may change your willingness to stay in this study. If new information is provided to you after you have joined the study, it is possible that you may be asked to sign a new consent form that includes the new information.

6.  Other options 

6.1  If I decide not to take part in this study, what other options do I have?

Your only other option is to not participate in this study.  Your participation in this research study is entirely by your own free choice.  You may also drop out of the study at any time, after having agreed to become a subject.  

7.  ENDING THE STUDY

7.1  If I want to stop participating in the study, what should I do?

You are free to leave the study at any time.  If you leave the study before it is finished, there will be no penalty to you. You will not lose any benefits to which you may otherwise be entitled.  If you choose to tell the researchers why you are leaving the study, your reasons for leaving may be kept as part of the study record. If you decide to leave the study before it is finished, please tell one of the persons listed in Section 10 “Contact Information” (below).

7.2  Could there be any harm to me if I decide to leave the study before it is finished? 

No, you are free to leave the study at any time.  Participation in this observational study will not affect the treatment you receive from the University of Michigan Medical Center.

7.3  Could the researchers take me out of the study even if I want to continue to participate?

Yes. There are many reasons why the researchers may need to end your participation in the study.  Some examples are:

•	The researcher believes that it is not in your best interest to stay in the study.
•	You become ineligible to participate.
•	Your condition changes and you need treatment that is not allowed while you are taking part in the study.
•	You do not follow instructions from the researchers.
•	The study is suspended or canceled.

8.  Financial Information

8.1  Who will pay for the costs of the study? Will I or my health plan be billed for any costs of the study?  

All tests done for this study will be done at no cost to you.  Neither you nor your insurance company will receive any bills for tests related to this research study.  Individuals who have blood drawn at centers other than the University of Michigan may have a charge for blood draw.  You can get reimbursed for this charge by sending the researchers a copy of your receipt for the blood draw.  Any surveys or samples we ask you to mail back for this study will be postage paid and will not cost you anything.  By signing this form, you do not give up your right to seek payment if you are harmed as a result of being in this study.

8.2  Will I be paid or given anything for taking part in this study?

You will receive $10 for completing the baseline survey.  In addition, you will receive $10 for completing the same survey each year for the next two years.  You will not be compensated for the blood draws, the shorter surveys given every three months, or the additional follow-up surveys given after the first two years.  You will receive a maximum of $30 for participating in this study.

8.3  Who could profit or financially benefit from the study results?

No person or organization has a financial interest in the outcome of the study.

9.  confidentiality of subject records and authorization to release your protected health information 

The information below describes how your privacy and the confidentiality of your research records will be protected in this study.

9.1  How will the researchers protect my privacy?

We shall put the information collected about you during the study into a research record.  Your research information will be stored in a locked cabinet and will not be made a part of your regular medical record.  This research record will not show your name, but will have codes entered into it, that will allow the information to be linked to you.  However, we shall keep your research record confidential, to the extent provided by federal, state and local law.  We shall not allow anyone to see your record, other than people who have a right to see it.  You will not be identified in any reports on this study.   

9.2  What information about me could be seen by the researchers or by other people?  Why?  Who might see it?

Signing this form gives the researchers your permission to obtain, use, and share information about you for this study, and is required in order for you to take part in the study.  Information about you may be obtained from any hospital, doctor, and other health care provider involved in your care, including:
•	Hospital/doctor's office records, including test results (X-rays, blood tests, urine tests, etc.)
•	Mental health care records (except psychotherapy notes not kept with your medical records)
•	Alcohol/substance abuse treatment records
•	Your AIDS/HIV status
•	All records relating to your head and neck cancer, the treatment you have received, and your response to the treatment
•	Billing information

There are many reasons why information about you may be used or seen by the researchers or others during or after this study.  Examples include:

•	The researchers may need the information to make sure you can take part in the study.  

•	The researchers may need the information to check your test results or look for side effects.  

•	University, Food and Drug Administration (FDA), and/or other government officials may need the information to make sure that the study is done in a safe and proper manner.   

•	Study sponsors or funders, or safety monitors or committees, may need the information to: 
o	Make sure the study is done safely and properly
o	Learn more about side effects 
o	Analyze the results of the study 
 
•	Insurance companies or other organizations may need the information in order to pay your medical bills or other costs of your participation in the study.

•	The researchers may need to use the information to create a databank of information about your condition or its treatment.

•	Information about your study participation may be included in your regular UMHS medical record.

•	If you receive any payments for taking part in this study, the University of Michigan accounting department may need your name, address, social security number, payment amount, and related information for tax reporting purposes. 

•	Federal or State law may require the study team to give information to government agencies. For example, to prevent harm to you or others, or for public health reasons.

The results of this study could be published in an article, but would not include any information that would let others know who you are. 

9.3  What happens to information about me after the study is over or if I cancel my permission?

As a rule, the researchers will not continue to use or disclose information about you, but will keep it secure until it is destroyed.  Sometimes, it may be necessary for information about you to continue to be used or disclosed, even after you have left the study or the study is over.  Examples of reasons for this include:

•	To avoid losing study results that have already included your information 
•	To provide limited information for research, education, or other activities  (This information would not include your name, social security number, or anything else that could let others know who you are.) 
•	To help University and government officials make sure that the study was conducted properly

As long as your information is kept within the University of Michigan Health System, it is protected by the Health System’s privacy policies.  For more information about these policies, ask for a copy of the University of Michigan Notice of Privacy Practices.  This information is also available on the web at http://www.med.umich.edu/hipaa/npp.htm. Note that once your information has been shared with others as described under Question 9.2, it may no longer be protected by the privacy regulations of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA).  

9.4  When does my permission expire?  

Your permission expires at the end of the study, unless you cancel it sooner. You may cancel your permission at any time by writing to the researchers listed in Section 10 "Contact Information" (below).  

10.  Contact Information

10.1  Who can I contact about this study?

Please contact the researchers listed below to:

•	Obtain more information about the study
•	Ask a question about the study procedures or treatments
•	Talk about study-related costs to you or your health plan 
•	Report an illness, injury, or other problem (you may also need to tell your regular doctors)
•	Leave the study before it is finished
•	Express a concern about the study

Principal Investigator: 	Sonia A. Duffy, Ph.D., R.N.
Mailing Address:		1904 Taubman Center
				1500 E. Medical Center Drive
				Ann Arbor, MI  48109
Telephone:			(734) 845-3608

Co-Investigator:		Jeffrey E. Terrell, M.D.
Mailing Address:		1904 Taubman Center
				1500 E. Medical Center Drive
				Ann Arbor, MI  48109
Telephone:			(734) 936-7633
Pager:				(734) 936-6267

Study Coordinator:		Karen E. Fowler, MPH
Mailing Address:		Ann Arbor VA HSR&D (11H)
P.O. Box 130170
Ann Arbor, MI  48113-0170
Telephone:			(734) 845-3611

You may also express a concern about a study by contacting the Institutional Review Board listed below, or by calling the University of Michigan Compliance Help Line at 1-888-296-2481.

	University of Michigan Medical School Institutional Review Board (IRBMED)
Argus I
517 W. William
Ann Arbor, MI 48103-4943

Telephone: 734-763-4768
Fax: 734-615-1622
e-mail: irbmed@umich.edu 

If you are concerned about a possible violation of your privacy, contact the University of Michigan Health System Privacy Officer at 1-888-296-2481.

When you call or write about a concern, please provide as much information as possible, including the name of the researcher, the IRBMED number (at the top of this form), and details about the problem.  This will help University officials to look into your concern.  When reporting a concern, you do not have to give your name unless you want to.

11.  record of Information provided

11.1  What documents will be given to me?

Your signature in the next section means that you have received copies of all of the following documents:

 This "Consent to be Part of a Research Study" document.  (Note: In addition to the copy you receive, copies of this document will be stored in a separate confidential research file and may be entered into your regular University of Michigan medical record.)

12.  SIGNATURES

Research Subject:
I understand the information printed on this form.  I have discussed this study, its risks and potential benefits, and my other choices with ____________________.  My questions so far have been answered.  I understand that if I have more questions or concerns about the study or my participation as a research subject, I may contact one of the people listed in Section 10 (above).  I understand that I will receive a copy of this form at the time I sign it and later upon request.  I understand that if my ability to consent for myself changes, either I or my legal representative may be asked to re-consent prior to my continued participation in this study.

Signature of Subject: 				Date: 	

Name (Print legal name):   			                  

Patient ID:		Date of Birth: 	

Principal Investigator (or Designee):
I have given this research subject (or his/her legally authorized representative, if applicable) information about this study that I believe is accurate and complete.  The subject has indicated that he or she understands the nature of the study and the risks and benefits of participating.

Name: 		Title: 	

Signature: 		Date of Signature: