Clinical trial: NCT04608773
Section: Alternatives
Subsections: Alternative **Treatments:**

You may continue to work with your clinical team for treatment options for your dry mouth, including using sprays and /or having frequent sips of water. Both of the products in the study are available over the counter.
Clinical trial: NCT04608773
Section: Confidentiality
Subsections: Privacy (Person) And Confidentiality **(Data):**

To protect your privacy, all the information and paper records pertaining to this proposed study will be stored in a locked cabinet in the School of Nursing or the Department of Otolaryngology. Any names or information that could identify you will be removed from the observational notes and survey. The identity of participants will be indicated in the surveys and on study documents by case number only. Any information about you and your participation in this research study will be handled in a confidential manner. You will not be identified by name or identifying characteristics in any publication of research results. In addition to the investigators listed on the first page of this consent form and their research staff, the following individuals may or will have access to your medical record information as well as your identifiable information related to your participation in this research study:  
- authorized officials from the University of Pittsburgh Office of Research Protections, for the purpose of monitoring the study
- authorized representatives of UPMC or affiliated health care providers may also have access to this information to provide services and address billing and operational issues.
We will share your de-identified data with the sponsor of this research, TJA Health, LLC. We may share your de-identified data with other researchers conducting similar research. We will make every attempt to protect your privacy and the confidentiality of your records. All research data will be entered into an electronic database. All data will be stored on an encrypted, password protected computer In unusual cases, the investigators may be required to release identifiable information related to your participation in this research study in response to an order from a court of law. If the investigators learn that you or someone with whom you are involved is in serious danger or potential harm, they will need to inform, as required by Pennsylvania law, the appropriate agencies.  
Page 4 of 6 This authorization is valid for an indefinite period of time and there is no expiration on the access to medical records by the study team. A description of this clinical trial will be available on http://www.clinicaltrials.gov, as required by US Law. This website will not include information that can identify you.  
At most, the website will include a summary of the results. You can search this website at any time.
Clinical trial: NCT04608773
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Study Risks:

Risks of mouth spray use:
There is a rare risk of allergic reaction to either of the sprays. Please stop using and alert the study team if you think you are having a reaction to either. Risks of washout periods: It is possible and likely that you will experience a greater amount of dry mouth symptoms during the identified "washout periods". While you will not be able to use gum, candy, lozenges or your usual mouthwashes, rinses or sprays to treat your dry mouth, you may drink unlimited amounts of water and other beverages and can even use water in spray form to help hydrate/moisten the tissues of the mouth.  
Risks of questionnaires and use of mobile app: You may become tired or distressed when completing the questionnaires associated with your participation. You can take breaks if this happens. Although every reasonable effort has been taken, confidentiality during Internet communication activities cannot be guaranteed. It is possible that additional information beyond that collected for research purposes may be captured and used by others not associated with this study. Risks of collection and storage of private health information:
It is possible that your confidentiality may be breached and your medical record information may be revealed to individuals not involved in this research. To protect your identity, research records will be coded with a random ID number. The link between your name and your research code will only be available to a select group of researchers involved in this project.  
If you believe that the research procedures have resulted in an injury to you, immediately contact the Principal Investigator who is listed on the first page of this form. Emergency medical treatment for injuries solely and directly related to your participation in this research study will be provided to you by the hospitals of UPMC.  
Page 3 of 6 Your insurance provider may be billed for the costs of this emergency treatment, but none of those costs will be charged directly to you. If your research-related injury requires medical care beyond this emergency treatment, you will be responsible for the costs of this follow-up care. At this time, there is no plan for any additional financial compensation. You do not give up any of your legal rights by signing this form.
Clinical trial: NCT04608773
Section: Voluntary Participation
Subsections: Voluntary **Participation**:|Voluntary **Consent**:|Certification Of Informed **Consent**:

Your participation in this research study is entirely voluntary. You may also withdraw your permission to allow us to use and disclose health information from your medical records by contacting the investigator listed on the first page and making the request in writing, but if you do, you will not be able to continue to participate in this study. You can decline to participate without affecting your current or future relationship with the University of Pittsburgh or UPMC.  
Your physician/clinician may be involved as an investigator in this research study.  
Before agreeing to participate, or at any time during your study participation, you may discuss your care with another doctor who is not associated with this research study. You are not under any obligation to participate in any research study offered by your physician.  
If you decide you no longer wish to participate you should contact Dr. Johnson or his research colleagues (412-647-2130). Your decision to withdraw from this study will have no effect on your current or future relationship with the University of Pittsburgh or UPMC. Any de-identified information collected prior to the date that you formally withdrew consent may continue to be used by the investigator Any recorded identifiable information will be destroyed after the required retention period.  
Page 5 of 6 The study team may decide to remove you from the study if you are unable to use the mouth sprays or complete the study assessments. You will only be paid for the initial survey if you do not complete the study.

The above information has been explained to me and all of my current questions have been answered. I understand that I am encouraged to ask questions, voice concerns or complaints about any aspect of this research study during the course of this study, and that such future questions, concerns or complaints will be answered by a qualified individual or by the investigator(s) listed on the first page of this consent document at the telephone number(s) given.  
I understand that I may always request that my questions, concerns or complaints be addressed by a listed investigator. I understand that I may contact the Human Subjects Protection Advocate of the IRB Office, University of Pittsburgh (1-866-2122668) to discuss problems, concerns, and questions; obtain information; offer input; or discuss situations that occurred during my participation. By signing this form, I consent to participate in this research study and provide my authorization to share my medical records with the research team.  
  
  
  
Print Name

I certify that I have explained the nature and purpose of this research study to the above-named individual(s), and I have discussed the potential benefits and possible risks of study participation. Any questions the individual(s) have about this study have been answered, and we will always be available to address future questions, concerns or complaints as they arise. I further certify that no research component of this protocol was begun until after this consent form was signed.