Clinical trial: NCT04098458
Section: Confidentiality
Subsections: E. Medical Records And/Or Certificate Of **Confidentiality**|L. **Authorization To Use And Disclose (Release) Medical** Information|Notice Of Privacy Practices|How To Complain About Our Privacy Practices

This research is covered by a Certificate of Confidentiality from the Federal government. This means that the researchers may not disclose information or biospecimens that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, nor can the information or biospecimens be used as evidence, unless you have consented to this disclosure. Information or biospecimens protected by this Certificate cannot be disclosed to anyone else who is not connected with the research except if you have consented to the disclosure, including for your medical treatment; or if it is used for other scientific research, as allowed by federal regulations protecting research subjects.  
  
3 of 11 A Certificate of Confidentiality does not prevent you from voluntarily releasing information about yourself or your involvement in this research. If you are an MUSC patient you have an MUSC medical record. If you have never been an MUSC patient, a MUSC medical record will be created for the purposes of this study. Results of research tests or procedures will be included in your MUSC medical record. All information within your medical record can be viewed by individuals authorized to access the record. We will make every effort to keep confidential all research information in the medical record that identify you to the extent allowed by law; however, there is the possibility that your research information will be disclosed. The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, state, or local law. Examples of required disclosure include: child abuse and neglect, or harm to self or others Finally, a Certificate may not be used to withhold information from the Federal government needed for auditing or evaluating Federally funded projects or information needed by the FDA

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.

MUSC Organized Health Care Arrangement
(OHCA)
THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW
YOU CAN GET ACCESSS TO THIS INFORMATION. PLEASE REVIEW IT CAREFULLY.  
The Medical University of South Carolina and its affiliates (including but not limited to the Medical University Hospital Authority, MUSC Physicians, and MUSC Physicians Primary Care) participate in a clinically integrated health care setting. As a result of this clinical integration, these organizations function as an Organized Health Care Arrangement (OHCA) as defined by the Health Insurance Portability and Accountability Act (HIPAA). For purposes of this notice, the members of the MUSC OHCA are collectively referred to in this document as "MUSC." W**e collect or receive this information about your past, present or future health** condition to provide health care to you, to receive payment for this health care, or **to operate the hospital**
and/or clinics.  
HOW WE MAY USE AND RELEASE YOUR PROTECTED HEALTH INFORMATION (PHI) A. The following uses do NOT require your authorization, except where required by SC **law:** 1. **For treatment.** Your PHI may be discussed by caregivers to determine your plan of care. For example, the physicians, nurses, medical students and other health care personnel may share PHI in order to coordinate the services you may need.  
2. **To obtain payment**. We may use and disclose PHI to obtain payment for our services from you, an insurance company or a third party. For example, we may use the information to send a claim to your insurancecompany. 3. **For health care operations.** We may use and disclose PHI for hospital and/or clinic operations. For example, we may use the information to review our treatment and services and to evaluate the performance of our staff in caring for you.  
4. **For public health activities.** We report to public health authorities, as required by law, information regarding births, deaths, various diseases, reactions to medications and medicalproducts. 5. **Victims of abuse, neglect, domestic violence.** Your PHI may be released, as required by law, to the South Carolina Department of Social Services when cases of abuse and neglect aresuspected. 6. **Health oversight activities.** We will release information for federal or state audits, civil, administrative or criminal investigations, inspections, licensure or disciplinary actions, as required by law. 7. Judicial and administrative **proceedings.** Your PHI may be released in response to a subpoena or courtorder. 8. **Law enforcement or national security purposes.** Your PHI may be released as part of an investigation by law enforcement. 9. **Uses and disclosures about patients who have died.** We provide coroners, medical examiners and funeral directors necessary information related to an individual'sdeath.  
10. **For purposes of organ donation.** As required by law, we will notify organ procurement organizations to assist them in organ, eye or tissue donation and transplants. 11. **Research.** We may use your PHI if the Institutional Review Board (IRB) for research reviews, approves and establishes safeguards to ensure privacy. 12. **To avoid harm.** In order to avoid a serious threat to the health or safety of a person or the public, we may release limited information to law enforcement personnel or persons able to prevent or lessen suchharm.  
13. For workers compensation **purposes.** We may release your PHI to comply with workers compensation laws.  
14. **Marketing.** We may send you information on the latest treatment, support groups and other resources affecting your health. 15. **Fundraising activities.** We may use your PHI to communicate with you to raise funds to support health care services and educational programs we provide to the community. You have the right to opt out of receiving fundraising communications with each solicitation.  
16. **Appointment reminders and health-related benefits and services.** We may contact you with a reminder that you have an appointment.  
B. **You may object to the following uses ofPHI:**
1. **Hospital directories.** Unless you object, we may include your name, location, general condition and religious affiliation in our patient directory for use by clergy and visitors who ask for you by name. 2. **Information shared with family, friends or others.** Unless you object, we may release your PHI to a family member, friend, or other person involved with your care or the payment for your care. 3. **Health plan.** You have the right to request that we not disclose certain PHI to your health plan forhealth services or items when you pay for those services or items infull.  
C. Your prior written authorization is required (to release your PHI) in the following **situations:**
You may revoke your authorization by submitting a written notice to the privacy contact identified below. If we have a written authorization to release your PHI, it may occur before we receive your revocation 1. Any uses or disclosures beyond treatment, payment or healthcare operations and not specified in parts A & B
above.  
2. Psychotherapy notes.  
3. Any circumstance where we seek to sell yourinformation.  
WHAT RIGHTS YOU HAVE REGARDING YOUR PHI
Although your health record is the physical property of MUSC, the information belongs to you, and you have the following rights with respect to your PHI:
A. **The Right to Request Limits on How We Use and Release Your PHI.** You have the right to ask that we limit how we use and release your PHI. We will consider your request, but we are not always legally required to accept it. If we accept your request, we will put any limits in writing and abide by them except in emergency situations. Your request must be in writing and state (1) the information you want to limit; (2) whether you want to limitour

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.
Clinical trial: NCT04098458
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: NCT04098458
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: NCT04098458
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). The navigator will work with you to identify and address barriers before they cause breakdowns in care from the time of surgery until postoperative radiation therapy 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: NCT04098458
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 purpose of this study is to evaluate the feasibility and acceptability of a new patient navigation intervention to decrease delays starting radiation therapy after surgery for white and AfricanAmerican head and neck cancer patients. The study involves research. 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 15 subjects will take part in this study. A grant from the National Institute of Health (NIH) will sponsor this study. Portions of Evan Graboyes' and his research team's salaries will be paid by this grant.
Clinical trial: NCT04098458
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. 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)* *(If you are the health care agent or guardian, please provide proof of your authority *to act on* behalf of the patient)  
| Signature of Personal Representative   | Date   |        |             |                 |
|----------------------------------------|--------|--------|-------------|-----------------|
| Relationship:                          | Spouse | Parent | Next of Kin | Legal Guardian* |
| DPOA for Healthcare*                   |        |        |             |                 |