1. Participant Informed Consent
Title of Study: Study of Naturopathic Approaches to UC
Principal Investigator: Joshua Goldenberg, ND, FABNG
Co-Investigator: Mark Davis, ND, FABNG
Study Staff: Claudia Bustamante, ND, FABNG; Jennie Cheung ND; Ilana Gurevich, ND, FABNG; Natalie Scheeler, ND, FABNG; Katie Stage, ND, FABNG; Megan Taylor, ND
Study Sponsor: Gastroenterology Association of Naturopathic Physicians.
The Helfgott Research Institute is conducting a research study called, "Prospective Observational Study of Naturopathic Approaches to UC". This study is sponsored by the Gastroenterology Association of Naturopathic Physicians.
2. What is the study about?
The purpose of this study is to look at naturopathic care for individuals with ulcerative colitis (UC). This study will include 50 participants. You have been identified as a potential participant for this study because you have come to a naturopathic doctor for care of your UC.
3. How long will I be in the study?
If you choose to join the study, your participation will last for 6 months.
4. What will happen in the study?
If you decide to participate in this study, we will ask you to complete a series of surveys related to your experiences with UC and the care you receive for it. We will ask you to complete these surveys through an online study tool called REDCap. These surveys will take place after your first visit, at 1 month, at 3 months, and at 6 months. We will ask you for your email address or for permission to send you a message through your patient portal if you decide to participate in this study so that we can email you a REDCap link for the 1-month, 3-month, and 6-month surveys. We estimate that these should take 15-30 minutes to finish on each occasion-your answers will remain confidential and secure and will in no way influence the medical care you receive at the clinic. Details about your treatment prescriptions will be taken from your patient chart after completion of the study. Throughout this time, you will continue to see your naturopathic care team at the clinic. Your medical care is completely separate from your participation in this study. Your medical care will be determined by your naturopathic doctor.
If you are eligible and wish to join the study, you must sign this consent form. If you do not sign the consent form you cannot join the study.
You may take your time reviewing this consent form. If you have any questions about the study or your participation in it, before signing this consent form, please contact the principal investigator, Joshua Goldenberg either by email or phone (jgoldenberg@nunm.edu, 503-552-1882).
After signing this consent form electronically, you will have the option of downloading a PDF copy for your records. You may also request a copy of your signed consent form and we will mail it to you.
5. What if I have questions?
You may contact Joshua Goldenberg at 503-552-1882 or by email (jgoldenberg@nunm.edu) if you have questions about the study. He is in charge of the study.
6. Do I have to be in the study?
You decide if you want to be in the study. Deciding not to take part will not affect your relationship with your medical provider or NUNM. You may also get a second opinion from another doctor not involved in the study.
This study is completely voluntary, meaning whether or not you participate is up to you. You can leave the study at any time and you do not have to give a reason. Leaving the study will not affect your relationship with your medical provider or NUNM.
The study investigators may ask you to leave the study if it is in your best interest. The study investigator may ask you to leave the study if you do not follow the study rules.
7. What if I don't want to be in the study?
You can choose not to be in the study and you do not have to give a reason. You can choose to continue care for your UC and not be involved with this study. Your health care will not be influenced in any way by your participation or lack of participation in this study.
8. Are there any costs?
There are no costs to participate in this study. However, you are responsible for the payment of your medical care, as well as all future medical care costs, while participating in this study.
9. Will I be paid for being in the study?
You will be compensated $25 per survey (up to $100).
10. Are there any risks?
There is always a small risk of a breach of confidentiality to your personal health information. However, these risks have been addressed and minimized as much as is possible. These risks include filling out online surveys, as well as giving access to your electronic health record so that we can gather data about your treatment plan.
You will be told about any new information that may affect your willingness to participate in the study.
There could be risks that we are unaware of at the time of the study.
If you experience any side effects while in the study, contact your doctor as soon as possible. If you experience a medical emergency while in the study, please call the Emergency Department at 9-1-1.
11. What if I feel I've been hurt by taking part in the study?
If you feel you have been injured or harmed by taking part in this study, please contact Joshua Goldenberg at (503) 552-1882. If you feel you were harmed while taking part in this study, you may be treated at NUNM. However, NUNM does not offer to pay the cost of this treatment.
If you feel your rights have been violated or you have been harmed by this study, please contact the NUNM Institutional Review Board Chair, Dr. Andrew Erlandsen, at (503) 552-1794.
12. Are there any benefits?
There are no direct benefits from being in this study. However, your participation will help us learn more about the naturopathic treatment of UC.
13. Your privacy is important
The Health Insurance Portability and Accountability Act (HIPAA) is a federal law to protect your privacy. Protecting your privacy is very important to us.
During this study, we will ask about your (past and current) medical history and your experience as a patient, with online surveys. We will also access your electronic health chart to collect data about the treatment you received. This information will be used to determine your eligibility for the study, as well as provide data for the study. Your personal health information will be kept private and only authorized study staff will have access to this information. We will use a study number instead of your name for all surveys.
The principal investigator, Joshua Goldenberg, will link your study number with your name at the end of the study so that we can collect data about your treatment from your electronic health chart. In this process, he may see your name, dates related to you and your care (including birthdate, admission date, discharge date, and exact age), email address, medical record number, and city and state. Other authorized study personnel may also see this information, but they will not be able to link this information to your survey answers.
All paper forms will be kept in a locked, secure office. All electronic data will be stored on password-protected computers. Your name will not be used in any publications or presentations about this study.
By signing this consent form you are stating that we can use your health information in the ways mentioned above for this study. You are not waiving any of your legal rights by signing this form.
You have the right to take away your permission to use your health information as part of the study. In order to do this you must send a written request to:
Joshua Goldenberg
Helfgott Research Institute
2220 SW 1st Ave.
Portland, OR 97201
Once your letter is received, no additional information about you will be collected from you for this study. Any data that was collected before we received your letter will continue to be used for the study. Taking away your permission to use your health information will not affect your relationship with NUNM.
We are collecting only the personal health information that we need for the specific purpose of this study. Your personal health information cannot be used for additional research purposes.
NUNM may be required to provide copies of your personal information to Federal or other government agencies as required by law. It may also be required to provide copies to the Institutional Review Board (IRB) or other groups that monitor the safety and welfare of study participants.
If your personal health information is disclosed by this authorization to an individual or agency not covered by laws that prohibit re-disclosure, your personal health information may not remain confidential. However, Oregon law does not allow re-disclosure of HIV/AIDS information, mental health information, genetic information, and drug/alcohol diagnosis, treatment, or referral information.
Your permission to use your identifiable health information (your HIPAA authorization) will expire when the study is complete.
14. Signatures
By signing this consent form it means the following:
• I know my rights have not been waived by signing.
• I have had all of my questions answered and I know whom to ask if I have more questions.
• I have read this form and understand it.
• I want to join the study.
• I know I can leave the study at any time and do not have to give a reason.
***Required: A signed and dated copy of this consent form will be provided to the participants the day they are consented. (ICH [2016] Section 4.8.11)***
Thank you for participating in our research study!