Clinical trial: NCT03821064
Section: Confidentiality
Subsections: L. Authorization To Use And Disclose (Release) Medical Information

As part of this research study, your study doctor and his/her research team will keep records of your participation in this study. The health information MUSC may use or disclose (release) for this research study includes information in your medical record, results of physical exams, medical history, lab tests or certain health information indicating or relating to your condition. Your study doctor and his/her research team will use and disclose (release) your health information to conduct this study. The health information listed above may be used by and/or disclosed (released) to the following, as applicable:  
- The sponsor of the study including its agents such as data repositories or contract research organizations monitoring the study;
- Other institutions and investigators participating in the study; - Data Safety Monitoring Boards; - Accrediting agencies; - Clinical staff not involved in the study whom may become involved if it is relevant; - Parents of minor children if less than 16 years old. Parents of children 16 years old or older require authorization from the child; or
- Health insurer or payer in order to secure payment for covered treatment; - Federal and state agencies and MUSC committees having authority over the study such as:
o The Institutional Review Board (IRB) overseeing this study; Committees  
  
with quality improvement responsibilities; Office of Human Research Protections; Food and Drug Administration; National Institutes of Health or Other governmental offices, such as a public health agency or as required by law.  
Those persons who receive your health information may not be required by Federal privacy laws (such as the Privacy Rule) to protect it and may share your information with others without your permission, if permitted by laws governing them. You do not have to sign this consent form. If you choose not to sign, it will not affect your treatment, payment or enrollment in any health plan or affect your eligibility for benefits. However, you will not be allowed to be a participant in this research study. You will be given a copy of this consent form. Your authorization will expire at the conclusion of this study or, if you are participating in a study designed for the development of a drug or device, your authorization will remain in effect until the drug or device is approved by the FDA or until the company's application to study the drug/device is withdrawn. You have the right to withdraw your agreement at any time. You can do this by giving written notice to your study doctor. If you withdraw your agreement, you will not be allowed to continue participation in this research study. However, the information that has already been collected will still be used and released as described above. You have the right to review your health information that is created during your participation in this study. After the study is completed, you may request this information. Your health information will be used or disclosed when required by law. Your health information may be shared with a public health authority that is authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury or disability and for conducting public health surveillance, investigations or interventions. No publication or public presentation about the research study will reveal your identity without another signed authorization from you. If you have questions or concerns about this Authorization or your privacy rights, please contact MUSC's Privacy Officer at (843) 792-8740. Regulations require that you be given a copy of the MUSC Notice of Privacy Practices (NPP) describing the practices of MUSC regarding your health information. One can be found at the end of this form.
Clinical trial: NCT03821064
Section: Duration of Study Involvement
Subsections: C. Duration

Participation in the study will consist of five visits, lasting 30 minutes each, over the course of approximately five months. These visits will take place at MUSC on days when you already have appointments at MUSC.
Clinical trial: NCT03821064
Section: Participant's Rights
Subsections: How To Complain About Our Privacy Practices|Person To Contact For Information About This Notice Or To Complain About Our Privacy Practices

If you think your privacy rights may have been violated, or you disagree with a decision we made about access to your PHI, you may file a complaint with the office listed in the next section of this Notice. Please be assured that you will not be penalized and there will be no retaliation for voicing a concern or filing a complaint. We are committed to the delivery of quality health care in a confidential and private environment.

If you have any questions about this Notice or any complaints about our privacy practices please call the Privacy Officer (843) 792-4037, the Privacy Hotline (800) 296-0269, or contact in writing: HIPAA Privacy Officer / 169 Ashley Avenue / MSC 332 / Charleston SC 29425. You also may send a written complaint to the Office of Civil Rights. The address will be provided at your request.
Clinical trial: NCT03821064
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: D. Risks And Discomforts

There are no physical risks to you by joining this study. However, there is the possibility you may feel uncomfortable or upset talking about your cancer. You will be encouraged to take your time when answering questions and you may refuse to answer any question at any time during this study. You may withdraw from the study at any time. There is a risk of a loss of confidentiality of your personal information as a result of participation in this study. Measures will be put in place and every effort will be made to protect the confidentiality of your private information.
Clinical trial: NCT03821064
Section: Procedures
Subsections: B. Procedures

If you agree to be in this study, the following will happen:  
1. The researchers will check your medical records to gather information about your diagnosis and treatment.  
2. You will meet with the study coordinator to fill out baseline questionnaires. 3. You will meet with a patient navigator at least three times over the course of three months (from surgical consultation to initiation of post-operative radiation therapy [PORT]). The navigator will work with you to identify and address barriers before they cause breakdowns in care from the time of surgery until PORT begins. These sessions will be audio-recorded to help ensure that the navigator thoroughly identifies and helps solve your barriers.  
4. You will meet with the study coordinator to complete questionnaires about your experience after your last visit with the patient navigator, to help us improve the process for future patients.
Clinical trial: NCT03821064
Section: Purpose of Research
Subsections: A. Purpose Of The Research

Please read this consent form carefully and take your time making your decision. As your study doctor or study staff discusses this consent form with you, please ask him/her to explain any words or information that you do not clearly understand. You are being asked to participate in this study because you are expected to have surgery and radiation for head and neck cancer. The study is sponsored by the Medical University of South Carolina and Hollings Cancer Center. The investigator in charge of this study is Evan Graboyes, MD. The study is being done at one site: the Medical University of South Carolina. Approximately 45 subjects will take part in this study.
Clinical trial: NCT03821064
Section: Voluntary Participation
Subsections: Volunteers Statement

I have been given a chance to ask questions about this research study. These questions have been answered to my satisfaction. If I have any more questions about my participation in this study or study related injury, I may contact Evan Graboyes, MD at (843)-792-0719. I may contact the Medical University of SC Patient and Family Care Liaison (843) 792-5555 concerning medical treatment. If I have any questions, problems, or concerns, desire further information or wish to offer input, I may contact the Medical University of SC Institutional Review Board for Human Research IRB Manager or the Office of Research Integrity Director at (843) 792-4148. This includes any questions about my rights as a research subject in this study. I agree to participate in this study. I have been given a copy of this form for my own records.  
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Signature of Person Obtaining Consent Date *Name of Participant
________________________________  
Signature of Participant Date Participant's Personal Representative (if applicable): ___________________________________________________ Name of Personal Representative *(Please print)* ___________________________________________________ Signature of Personal Representative Date Relationship: ___ Spouse ___ Parent ___Next of Kin ___Legal Guardian*
____ DPOA for Healthcare*
*(If you are the health care agent or guardian, please provide proof of your authority to act on behalf of the patient)