[vc_row][vc_column][vc_column_text]CONSENT FOR EGCG LONGITUDINAL QUESTIONNAIRE PARTICIPATION
- Why is this longitudinal questionnaire being conducted?
The purpose of this longitudinal questionnaire is to gather information from individuals who have been diagnosed with idiopathic pulmonary fibrosis (IPF) or pulmonary fibrosis (PF) and who are currently taking a green tea extract supplement (EGCG) to aid in the treatment of their PF/IPF. Gathering the information requested in this longitudinal questionnaire will allow BioNews and its partners to obtain a better understanding of this supplement and potentially enable BioNews and its partners to provide its readers more relevant editorial content to the larger IPF and PF patient communities.
- What will I have to do?
If you agree to participate in this longitudinal questionnaire, you will have the opportunity to complete an online longitudinal questionnaire. The longitudinal questionnaire includes questions about your diagnosis, medical history, prognosis, treatments and supplements such as green tea extract, and other background information. It should take you about 10 minutes to complete.
After you complete the longitudinal questionnaire, we may contact you with follow-up questions based on your answers and your willingness to provide your contact information to further understand the patient experience. We may also request that you participate in additional longitudinal questionnaires, which, like this longitudinal questionnaire, will also be completely voluntary.
- Am I required to participate in this longitudinal questionnaire?
No. Your participation in this longitudinal questionnaire is completely optional. Whether or not you participate in this longitudinal questionnaire is completely up to you. Even if you start the longitudinal questionnaire, you may stop participating at any time up until you submit the longitudinal questionnaire.
- Am I required to take green tea extract or any particular treatment?
Nothing about this longitudinal questionnaire requires or compels you to take or ingest a green tea extract or any other treatment or supplement. Although to participate in this longitudinal questionnaire as an experimental participant, you must be already taking a green tea extract to aid in the treatment of your PF/IPF, nothing in this longitudinal questionnaire or otherwise requires you to continue taking the supplement. To participate as a control participant, you must not already be taking a green tea extract to aid in the treatment of your PF/IPF. Just as you are not required to participate in this longitudinal questionnaire, you are not required to take a green tea extract or any other form of treatment whatsoever. It is not the suggestion of BioNews to start or stop taking any green tea extract in order to participate in this longitudinal questionnaire either as an experimental or control participant.
BioNews does not provide medical advice, diagnosis, or treatment to anyone. BioNews does not advocate for or against taking green tea extracts or any other type of treatment for PF/IPF or any disease or condition. BioNews shall not be responsible or liable for any injuries, results, or damage that result from an individual’s decision to take or not take any particular treatment, including but not limited to a green tea extract.
- If I decide to participate in this longitudinal questionnaire, am I guaranteed to be included as a participant?
No. Although you will complete the first part of the longitudinal questionnaire, depending on the information you provide you may not be eligible to complete the remainder of the longitudinal questionnaire.
If you are not already taking a green tea extract to aid in the treatment of your PF/IPF prior to starting this longitudinal questionnaire, you will not be eligible to participate in this longitudinal questionnaire as an experimental participant.
- Who will have access to my personal information?
Your medical information and any other personal information you enter into the website during your participation in the longitudinal questionnaire may be reviewed, analyzed, and/or aggregated by BioNews and/or a third party company. Please review BioNews’ privacy statement, which identifies who may have access to your personal information if you consent to participate in the longitudinal questionnaire. BioNews employees and personnel who analyze longitudinal questionnaire results will have access to your medical and other personal information you provide in response to longitudinal questionnaire questions, as well as your name and contact information in the event you provide it.
Once collected by BioNews, your medical information and other personal information provided in the longitudinal questionnaire may be shared with third parties, such as pharmaceutical companies, medical device companies, and government agencies. However, in the event BioNews shares such information with third parties, your individual health information will only be shared with third parties upon your express consent to share such information with third parties. Should the generic medical information you provide in response to longitudinal questionnaire questions be published, it would not be associated with your name or likeness.
BioNews may use your name and contact information (limited to e-mail or phone number and city/state) to communicate with you regarding the longitudinal questionnaire or other BioNews offerings and opportunities.
- Will any of my personal information be used for research?
Possibly. If you are eligible to complete the entire longitudinal questionnaire, BioNews may share certain details of your medical information and data with external research partners outside of BioNews. It is possible, even likely, that BioNews will share your longitudinal questionnaire answers and personal information with third parties for the purposes of conducting clinical trials and research. These third parties may include pharmaceutical companies, device manufacturers, research organizations, and government agencies.
However, BioNews will not share any of your personal individualized information of any kind with any third party unless you specifically consent to BioNews providing that personal information to third parties for clinical trial recruiting purposes.
- Are there any benefits to me from participating in this longitudinal questionnaire?
We do not expect you to benefit personally from participating in this longitudinal questionnaire. Your participation may lead to new discoveries about PF/IPF, including potential treatments and cures. BioNews strives to enhance public and professional understanding of rare diseases to improve the prognosis for those who have them. We hope that the knowledge we gain from your (and others’) participation in this longitudinal questionnaire will benefit others, including you, in the future. In addition, by participating in the longitudinal questionnaire you may learn more about BioNews’ research findings.
- Are there any risks to me from participating in this longitudinal questionnaire?
Even though BioNews makes every effort to safeguard all information collected from its longitudinal questionnaires with highly sophisticated encrypted HIPAA-compliant devices and services, there are potential risks to you from participating in this longitudinal questionnaire. They may include the possibility that someone without authorization may steal or access your longitudinal questionnaire or personal information. Such a data breach could lead to the release of that information to the public. Furthermore, although the analyzed results of longitudinal questionnaires conducted by BioNews will be summarized and will not include your personal information, the possibility exists, though highly unlikely, that a third party that has your medical information or data in its possession could compare the longitudinal questionnaire results to the information it has and determine your identity.
Some longitudinal questionnaire questions may make you or your family members uncomfortable. You may find some of the questions to be sensitive or distressing to you based on your condition or experiences.
There may also be risks to your participation in this longitudinal questionnaire that BioNews cannot currently foresee.
- Who can answer my questions about this longitudinal questionnaire?
If you have questions or concerns about this longitudinal questionnaire, or have experienced a research-related problem or injury, please send an e-mail to the following address:
STATEMENT OF CONSENT
I have read this form in its entirety. I have been given the chance to ask questions about this form and the longitudinal questionnaire and have my questions answered. If I have more questions, I have been informed of who to contact. By clicking the ”NEXT” button below, I agree to participate in this longitudinal questionnaire. I can print or save a copy of this consent information for future reference. If I do not want to participate in this study, I can close my internet browser.
SPECIFIC INFORMATION FOR SECOND CONSENT FOR THIRD PARTIES
CONSENT TO USE AND DISCLOSE INFORMATION TO
THIRD PARTIES FOR RESEARCH PURPOSES
If you agree by clicking “YES” below, the results of this longitudinal questionnaire as well as your personal information provided will be shared with third parties for the purposes of research, including clinical trials, which may include pharmaceutical companies, medical device companies, and government agencies. By clicking “YES” below, you are giving your permission for BioNews for (a) BioNews, and (b) any third parties with which BioNews shares your information, including persons or companies working for BioNews or with those third parties, to use and share your longitudinal questionnaire answers and personal information as described below:
- These are the types of information that may be used and shared for research purposes:
- Your name, e-mail address, phone number, city, and state;
- All information provided in response to longitudinal questionnaire questions.
- BioNews and third parties to which your information is provided may:
- Receive, use and share your information to conduct research trials and as required by law;
- Share your information with representatives of government agencies, review boards and others who watch over the safety and effectiveness of medical products and/or the conduct of research;
- Use and share your information for internal reference, for comparison with other data, to help design subsequent trials, and in papers submitted to United States and foreign regulatory agencies regarding later-developed products.
- Please note that:
- Neither your name nor your identity will be disclosed in any article that may be published about a clinical trial or otherwise;
- Once all personal information has been removed from your trial records, the remaining information in the trial records may be used and shared freely;
- You do not have to sign this consent form, but if you do not, you will not be able to have your information used in this trial;
- You may change your mind and withdraw this Authorization at any time by writing to: [email protected]
If you withdraw this Authorization, your information that has already been shared may continue to be used and shared to maintain the integrity of the research.
This Authorization does not have an expiration date as it relates to future submissions to regulatory agencies.