Clinical trial: NCT05442957
Section: Confidentiality
Subsections: E. Medical Records And/Or Certificate Of Confidentiality|L. 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 then you already 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:
IRB Number: «ID»
Date Approved «ApprovalDate»

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 HEART CARE AND IN THE ARTICLES AND IN
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 chries 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:
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 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 medical information as required by military command 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.  
1. 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: NCT05442957
Section: Duration of Study Involvement
Subsections: C. Duration

Participation in the study will take 11 visits over a period of 9 months. This will consist of baseline study assessments when you enroll, 6 study intervention sessions each lasting approximately 1 hour over the course of 6 weeks, and follow-up assessments for 9 months after enrollment into the trial.
Clinical trial: NCT05442957
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: D. Risks And Discomforts There Are No Physical Risks To You By Joining This Study.

1. Interview and Rating Scales Risks: The questions that will be asked may be sensitive in nature and may make you feel uncomfortable. You may be asked personal questions that you find distressing. You may refuse to answer any question(s) that you do not wish to answer.  
2. Psychological Risks: Some of the questions the researchers ask you may be upsetting, or you may feel uncomfortable answering them. If you do not wish to answer a question, you can skip it and go to the next question.  
3. Confidentiality Risks: 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.  
4. Randomization Risk: There is a risk that randomization to the cognitive behavioral therapy or attention  
  
control intervention may cause distress. The treatment you receive may prove to be less effective or to have more side effects than the other study treatment.
Clinical trial: NCT05442957
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 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 have head and neck cancer that was treated with surgery and have expressed some body image concerns. The purpose of this study is to determine whether video telemedicine-based cognitive behavioral therapy is an effective treatment for body image concerns among head and neck cancer survivors. The study involves research. The study is sponsored by the Medical University of South Carolina (MUSC) and National Institute of Health/National Cancer Institute. The investigator in charge of this study is Evan Graboyes, MD, MPH, FACS. The study is being done at three sites: MUSC, Henry Ford Health, and Washington University School of Medicine. Approximately 226 participants will take part in the study overall, of whom approximately 75 will be recruited from MUSC. A grant from the National Cancer Institute (NCI) will sponsor this study. Portions of Evan Graboyes' and his research team's salaries will be paid by this grant.
Clinical trial: NCT05442957
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, MPH, FACS at (843) 792-0719. I may contact I may contact the MUSC Patient and Family Care Liaison at (843) 792-5555 concerning medical treatment.  
IRB Number: «ID»
Date Approved «ApprovalDate»