CONSENT TO PARTICIPATE IN A CLINICAL OUTCOMES DATABASE
- TITLE: Prospective registry to evaluate the effects of a rehabilitation program (SpineZone) in individuals with spine pain.
- PROTOCOL NO.:
- WIRB® Protocol #20183420
- SPONSOR: SpineZone Medical Fitness, Inc
- PRINCIPAL INVESTIGATOR:
- Name: Kamshad Raiszadeh, M.D.
- Specialty: Orthopedic Spine Surgery
- Address: 7525 Metropolitan Dr.
- Suite 306
- San Diego, CA 92108
- CONTACT PERSON: Jonathan Wu, PA-C (844) 316-7979
- PARTICIPATING SITES: SpineZone and SpineZone Online
Why are we collecting outcomes?. You are being asked to consent to your participation in a clinical outcomes research registry because you are beginning your physical therapy with SpineZone. This registry will collect data on things like your physical therapy prescription, diagnosis, co-morbidities, medical history, medications, radiographic findings and other rehabilitation-related measurements collected during your care. Outcomes data collection will not affect or alter any of your treatment. The information collected will be de-identified and no personal information will be connected to the data collected. The information will allow researchers to determine trends in care provided, with the intent of improving and optimizing future rehabilitation treatment methods, and may be shared with the community through publications and presentations. As stated above, identifiable information such as name, birth date, contact information, or any other identifying data will be removed prior to input into the database.
What is involved? During your routine visits to Spinezone, you will be asked to participate in treatment and fill out questionnaires related to your health and function, as well as any imaging studies you may have undergone in regard to the condition you are seeking treatment for. If some of your information resides with an outside referring physician or health care establishment, we would like to include information regarding your care from that institution as well. We may contact you at some later date to get more information about your health after your care. Your participation in the research will last throughout the duration of your treatment. Your data will never be used for commercial profit. No biospecimens will be collected for the outcomes database. As the data does not include any patient identifiers, you will not be notified if your data is being used; however, any publications that use the outcomes database will be available to the community through the online medical literature website called Pubmed.
What are the risks? There is the risk of a loss of confidentiality of your research-related information.
What are the alternatives? This is not a treatment study. Your alternative is to not be in this study.
Will I benefit from participating? You will receive no benefit from participating in the outcomes database, but the information may help patients in future who are treated for spine conditions.
Will I be paid? No, you will not be paid to participate in the outcomes database.
Will it cost anything to be included in the outcomes database? There is no cost to you or your insurance for the collection of the information included in the outcomes database. The normal cost of therapy will be unaffected, and will be billed to you or your insurance carrier in the same fashion as if you were undergoing therapy without the collection of data.
What are my rights?
- You can call the staff member to ask any question, concerns, or complaints about the outcomes database or if you feel you have experienced a research-related problem. The telephone number is listed at the top of this form.
- Your participation is voluntary. You can decide not to participate in the outcome database or withdraw at any time. Whatever you choose, your SpineZone therapy will NOT be affected and there will be no penalty or loss of benefits to which you are entitled.
This research is being overseen by an Institutional Review Board (“IRB”). An IRB is a group of people who perform independent review of research studies. You may talk to them at (800) 562-4789, firstname.lastname@example.org if:
- You have questions, concerns, or complaints that are not being answered by the research team.
- You are not getting answers from the research team.
- You cannot reach the research team.
- You want to talk to someone else about the research.
- You have questions about your rights as a research subject.
Your participation in this study may be stopped at any time by the study doctor or the sponsor without your consent for any reason, including: if it is in your best interest; you do not consent to continue in the study after being told of changes in the research that may affect you.
What are my responsibilities if I am included? If you participate in the outcomes database, you are expected to undergo the therapy program and complete any questionnaire, as you would absent of this collection process.
What about confidentiality? The SpineZone electronic medical record system is a secure and HIPAA compliant system and will hold all of the patient’s information. The data collected for input in the outcomes data base will be extracted by SpineZone staff, and will be stripped of patient identifiers. Your de-identified information will be stored in the database and used for research in the future. Medical records which identify you and the consent form signed by you may also be looked at and/or copied for research or regulatory purposes by monitors, auditors, the Western Institutional Review Board® (WIRB®) or regulatory authorities to the extent permitted by the applicable laws and regulations.
To participate agree during the program sign-up. I have read and understood the explanation of the SpineZone outcomes database. I understand that if I have any questions, I can contact the staff member above to have them answered to my satisfaction. I agree my de-identified information will be included in the Outcomes database. I have not been forced or made to feel obligated to take part, and understand that I can request to be removed from this registry at any time.