SRDI NOCICEPTION STUDY CONSENT FORM
Study Title: Study on Stimulation of Nociceptors in the Peripheral Nervous System (Pain)
Why have you been asked to participate in this research study?
You have been asked to participate in this research study because you have specially selected by our random generator. The SRDI has reviewed your medical information and has determined that you may be eligible for this study.
How long will you be in the study and what will happen during the study?
1. We will review your medical chart to acquire data about your present nociceptor functioning and other medical problems you may have.
2. You will be subjected to a series of tests that will stimulate the A-delta and C nerve fibres in your peripheral nervous system in order to assess acute and chronic pain.
3. You will be in this study for 3 years or until such a time you expire during the course of this research study. Should this happen, your body will be immediately donated to Science for the benefit of other research studies.
4. In addition, you will be asked to complete a questionnaire after each test. This will help us see how well you are doing in response to the stimulation and if you are having any side-effects such as affected ability to respire, degree of vision and/or mobility (fine and gross motor skills).
5. All test subjects will be rewarded with cake.
6. The cake is a lie.
What are the risks and discomforts of the research study?
There are foreseeable risks associated with participation in this research. There will be great discomfort.
These include but are not limited to increased blood pressure and heart rate, angioedema (swelling of face, hands or feet, eyes, lips, tongue, difficulty in swallowing or breathing), slow heart rate, dizziness, low blood pressure, heart block, tiredness, depression, headache, nausea, diarrhea, sleep disturbances, worsening of asthma (wheezing and shortness of breath), bruising, infection, excess bleeding, clotting, fainting, skin irritation, myocardial infarction, cerebrovascular accidents, mental retardation, premature ejaculation, internal haemorrhaging, gonaherpasyphilaids, higher mortgage rate, low oil pressure, erections lasting more than 4 hours, nausea, vomiting, water weight gain, lower back pain, receding hairline, eczema, seporiasoriasis, itching, chafing clothing, liver spots, blood clots, ringworm, excessive body odor, uneven tire wear, pyorrhea, gonorrhea, diarrhea, halitosis, scoliosis, loss of bladder control, hammertoe, the shanks, low sperm count, warped floors, cluttered drawers, hunchback, heart attack, low resale value on your home, feline leukemia, athlete's foot, head lice, clubfoot, MS, MD, VD, fleas, anxiety, sleeplessness, drowsiness, poor gas mileage, tooth decay, parvo, warts, unibrow, lazy eye, fruit flies, chest pains, clogged drains, hemorrhoids, dry heaving, sexual dysfunction and anal seepage.
If you become pregnant there may be risks to you or to the baby which we do not currently know about or could predict. The tests may cause injury and even death to the developing fetus. There is no way to guarantee that the study will not have a harmful effect on a developing baby (embryo, fetus, or infant).
Will it cost you anything to be in this study?
There are no additional costs associated with participating in this research. Tests required for the will be provided to you free of charge. You will be responsible for all other costs related to your medical care such as hospitalization, surgery, drugs, laboratory tests, diagnostic procedures and physician fees (see next section for injuries during the study). You will not receive reimbursement or compensation.
What happens if you believe you are injured during this study?
Immediate necessary medical care is available at the SRDI in the event that you are injured as a result of your participation in this research study. However, there is no commitment by SRDI, Kurotsuchi Mayuri or other SRDI physicians to provide monetary compensation or free medical care to you in the event of a study-related injury.
Are there benefits to taking part in the research study?
There is unlikely to be any direct benefit to you from participating in this research. However, the results of this study will be beneficial to the SRDI because it will improve our ability to perform, understand the effects of nociceptor stimulation and interpret the measurements of nociception.
Who do you call if you have questions about this study?
If you have questions about this study, you should contact Kurotsuchi Mayuri.
If you have questions or want more information about the SRDI or about being in a study, you may visit the SRDI and make your inquiries there.
If you have questions concerning your rights as a subject in this study, you should contact the SRDI also.
If you have any questions concerning the study, drug side effects, or to report a research related injury, you should contact the SRDI as well.
CONFIDENTIALITY
We will not use your name or other personal information for this research, mostly because you are just a number to us. We protect the identities of our subjects by assigning them a unique ID number and sometimes a few letters from the first and last name in place of their name.
Information acquired cannot be given to anyone unaffiliated with the SRDI. Information that is collected during this study will be stored in a separate research file available only to the research personnel conducting this study. These personnel are responsible for maintaining the confidentiality and security of these records.
Information gathered during this study may be inspected and verified by staff representatives SRDI. Medical records for this study will be treated as confidential by the SRDI. The results of this study may be published for all the subjects as a group.
ALTERNATIVES
Participation in this research is compulsory. If you choose to participate, you cannot withdraw at any time.
CONSENT
"The purpose of this study, procedures to be followed, risks and benefits have been explained to me. I have been allowed to ask the questions and my questions have been answered to my satisfaction. I have been told whom to contact if I have additional questions. I have read this consent form and agree to be in this study. I have been told that I will be given a signed copy of this consent form."
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Signature of Subject Date