Clinical trial: NCT04552587
Section: Confidentiality
Subsections: E. Medical Records And/Or Certificate Of Confidentiality|I. **Data Sharing**|J. **Authorization To Use And Disclose (Release) Medical Information**|Notice Of Privacy Practices Musc Organized Health Care Arrangement (Ohca)

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. 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.

Information about you (including your identifiable private information and/or any identifiable biospecimens) may have all of your identifiers removed and used for future research studies or distributed to other researchers for future research without additional informed consent from you or your legally authorized representative.

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:
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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.

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.  
UNDERSTANDING YOUR PROTECTED HEALTH INFORMATION (PHI)
The Medical University of South Carolina and its affiliates (including but not limited to the Medical University Hospital Authority, MUSC Physicians, MUSC Physicians Primary Care, MUSC Health Partners, MUSC Health Alliance, MUSC Strategic Ventures, LLC, and MUSC Strategic Ventures
(MSV) Health, Inc.) 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."  We collect, receive, or share 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.  
OUR PLEDGE REGARDING YOUR HEALTH INFORMATION MUSC is committed to protecting the privacy of health information we create and obtain about you.  This Notice tells you about the ways in which we may use and disclose health information about you.  It also describes your rights and certain obligations we have regarding the use and disclosure of your health information.  We are required by law to: (i) make sure your health information is protected, (ii) give you this Notice describing our legal duties and privacy practices with respect to your health information, and (iii) follow the terms of the Notice that is currently in effect. HOW WE MAY USE AND RELEASE YOUR PROTECTED HEALTH INFORMATION (PHI) –
The following uses do NOT require your authorization, except where required by SC law:
A
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 insurance company.  
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. Business Associates. Your medical information could be disclosed to people or companies outside our Health System who provide services. These companies typically are required to sign special confidentiality agreements before accessing your information.  They are also subject to fines by the federal government if they use/disclosure your information in a way that is not allowed by law.  
5. For public health activities.  We report to public health authorities, as required by law, information regarding births, deaths, various diseases, reactions to medications and medical products.  
6. 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 are suspected.  
7. 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.  
8. Judicial and administrative proceedings. Your PHI may be released in response to a subpoena or court order.  
9. Law enforcement or national security purposes. Your PHI may be released as part of an investigation by law enforcement or for continuum of care when in the custody of law enforcement.  
10. Military and Veterans. If you are a member of the U.S. or foreign armed forces, we may release your modical information as required by military cmmand authorities.  
1. Uses and disclosures about patients who have died.  We may provide medical information to coroners, medical examiners and funeral directors so they may carry out their duties.  
12. 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 13. Research. We may use and disclosure your medical information for research purposes.  Most research projects are subject to Institutional Review Board.  
(IRB) approval. The law allows some research to be done using your medical information without requiring your written approval.  
14. 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 such harm 15. For workers compensation purposes. We may release your PHI to comply with workers compensation laws.  
16. Marketing. We may send you information on the latest treatment, support groups, reunions, and other resources affecting your health. 17. 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. 18. Appointment reminders and health-related benefits and services. We may contact you with a reminder that you have an appointment. 19. Disaster Relief Efforts . We may disclose your medical information to an entity assisting in disaster relief efforts so that your family can be notified about your condition.  
Note:  incidental uses and disclosures of PHI sometimes occur and are not considered to be a violation of your rights.  Incidental uses or disclosures are by-products of otherwise permitted uses or disclosures which are limited in nature and cannot be reasonably prevented.  
B. You may object to the following uses of PHI:
1. Inpatient hospital directories.  Unless you tell us not to, we may include your name, location, general condition and religious affiliation in our patient directory so your family, friends and clergy can visit you and know how you are doing.
Clinical trial: NCT04552587
Section: Duration of Study Involvement
Subsections: C. Duration

Participation in the study will take place over approximately 8 weeks. Participation will consist of an initial 30-minute survey to be completed online, by mail, or over the phone, a one-time 30-45-minute session scheduled in person or virtually at a time that is convenient for you, and a 10-15-minute survey 6 weeks after your session.
Clinical trial: NCT04552587
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: D. Risks And Discomforts

There are no physical risks to you by joining this study. Other possible risks:
1. There is the possibility you may feel uncomfortable or upset talking about cancer. You will be encouraged to take your time when answering questions and you may refuse to answer any question at any time during the study.  
2. You may be asked to provide information you consider confidential or private during study interviews or because study staff will review your medical record.  
3. There is the potential for a loss of confidentiality.
Clinical trial: NCT04552587
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 staff discusses this consent form with you, please ask him/her to explain any words or information that you do not clearly understand. The purpose of this research study is to test a nutritional support program for head and neck cancer patients and their primary caregivers after treatment. This program includes a care plan and mobile support system to help patients and their caregivers prepare for and cope with nutritional challenges after treatment. You are being asked to participate in this study either because you are completing your treatment for head and neck cancer in the next several weeks or you have completed treatment for head and neck cancer within the last 3 months. The investigator in charge of this study is Katherine Regan Sterba, PhD. This study will involve approximately 30 pairs of volunteers and the study is being done at the Medical University of South Carolina.  
  
If you agree to be in this study, the following will happen:
A. You will be asked to identify the person who is your main caregiver. For example, this may be someone you have depended on when dealing with your cancer or someone who provides emotional or practical support to you when you need help. We will invite both you and your main caregiver to enroll in this study.  
B. We will ask you to complete an initial survey that will take around 30 minutes. This survey can be completed online, by mail or over the phone and includes questions about your health, your healthcare, your needs, and your demographics.  
C. We will ask you and your caregiver to participate in either option 1 or 2 below:
1. A 30-45-minute, in-person clinic session with a nurse at the Hollings Cancer Center, where you will receive and review a personalized care plan and the nurse will make any referrals for services needed and encourage you to use the resources and attend any appointments made.  
2. A 30-45 virtual session either using a secure online platform or telephone. You will review a personalized care plan and the nurse will make any referrals for services needed and encourage you to use the resources and attend any appointments made.  
D. Six weeks after your in-person or virtual session, you will be asked to participate in a 10-15 minute survey online, by mail, or over the telephone, by mail or online. We will ask you about your current needs and your opinions about the clinic session and the care plan you received.  
E. Your medical chart will be reviewed to collect information about your overall health status and your cancer diagnosis and treatment.
Clinical trial: NCT04552587
Section: Voluntary Participation
Subsections: K. Student Participation|L. Employee Participation

Your participation or discontinuance will not constitute an element of your academic performance, nor will it be a part of your academic record at this Institution.

Your participation or discontinuance will not constitute an element of your job performance or evaluation, nor will it be a part of your personnel record at this Institution.  
IRB Number: Pro00066211 Date Approved 9/2/2020