INTRODUCTION
You are invited to participate in a database regarding pain, as part of a patient centered pain research effort entitled the Stanford Pain Registry. Welcome to the Stanford Pain Registry, where doctors and patients are “working together to overcome pain.”
STANFORD PAIN REGISTRY CONSENT FORM
FOR QUESTIONS ABOUT THE STUDY, CONTACT: Martin S. Angst, MD
Associate Professor of Anesthesia, Department of Anesthesia, Stanford University School of Medicine, 300 Pasteur Drive, Stanford, CA 94305-5117, Phone (650) 498-5109.
DESCRIPTION: You are invited to participate in the Stanford Pain Registry, a research study that uses a questionnaire to gather information about painful nerve conditions. If you suffer from a painful nerve condition (neuropathic pain e.g. caused by diabetes, shingles or injury), you are invited to complete this questionnaire and thereby contribute to our ongoing effort to find solutions to chronic pain.
The Stanford Pain Registry’s questionnaire involves questions about pain such as, “How long have you had pain?” and “Does your pain keep you from sleeping at night?” In addition to questions about pain, the Stanford Pain Registry also inquires about your willingness to consider participating in future studies of pain treatments and interventions. The purpose of the Stanford Pain Registry is to build a database that allows physicians to gain a patient’s perspective on the experience of pain, and to create a pool of potential participants for future pain studies.
RISKS AND BENEFITS: The risks associated with this study are none. You will simply be asked to complete an online questionnaire that is approximately 15 minutes in length. The benefit of participating in the Stanford Pain Registry is the altruistic benefit of contributing to data collection relevant to the advancement of pain treatments and interventions. We cannot and do not guarantee or promise that you will receive any benefits from this study. Your decision whether or not to participate in this study will not affect your employment/medical care.
TIME INVOLVEMENT: Your participation in the Stanford Pain Registry will take approximately 15 minutes. The questionnaire is available on the internet and you may answer the questions from any computer that has internet access. If you do not have access to a computer, you may contact the Stanford Pain Registry by phone (650)725-8474 and we will send a paper version of the questionnaire to you. You may also request a questionnaire appointment at the Human Pain Research Lab where a member of the research team will provide you with computer access and assistance with the questionnaire as needed.
CONFIDENTIALITY: Your identity will be kept as confidential as possible as required by law. Except as required by law, you will not be identified by name, social security number, address, telephone number, or any other direct personal identifier. Your research records may be disclosed outside of Stanford, but in this case, you will be identified only by a unique code number. Information about the code will be kept in a secure location and access limited to research study personnel. The results of this research study may be presented at scientific or medical meetings or published in scientific journals. However, your identity will not be disclosed.
COSTS: There will be no cost to you for participation in this study.
PAYMENTS: There is no stipend for participation in the Stanford Pain Registry.
SUBJECT'S RIGHTS: If you have read this form and have decided to participate in this project, please understand your participation is voluntary and you have the right to withdraw your consent or discontinue participation at any time without penalty or loss of benefits to which you are otherwise entitled. You have the right to refuse to answer particular questions. Your individual privacy will be maintained in all published and written data resulting from the study.
CONTACT INFORMATION: If you have any questions, concerns or complaints about this research study, its procedures, risks and benefits, or alternative courses of treatment, you should ask the Protocol Director, Martin S. Angst, MD at (650) 498-5109. You should also contact him at any time if you feel you have been hurt by being a part of this study.
Independent Contact: If you are not satisfied with how this study is being conducted, or if you have any concerns, complaints, or general questions about the research or your rights as a participant, please contact the Stanford Institutional Review Board (IRB) to speak to someone independent of the research team at (650)-723-5244 or toll free at 1-866-680-2906. You can also write to the Stanford IRB, Stanford University, Stanford, CA 94305-5401.
Appointment Contact: If you would like assistance with completing the online questionnaire, or do not have access to a computer, you may request a questionnaire appointment at the Human Pain Research Lab where a member of the research team will provide you with computer access and assistance with the questionnaire as needed. To make or change a questionnaire appointment, please contact a member of the research team at 650-725-8474.
Alternate Contact: If you cannot reach the Protocol Director, please page the research team at (415) 607-0294.
Agreement
If you are in agreement with participation in the Stanford Pain Registry, please proceed to the questionnaire by answering yes below.
If you are not interested in participating in the Stanford Pain Registry,
please answer no below.
As stated above, you may call the Stanford Pain Registry at 650-725-8474 and request a consent and questionnaire be sent to you by mail.
Approval Date: 05/31/2009 Expiration Date: 04/30/2010