[Name of your institution]
INFORMATION PAPER
Treatment of distal radius fractures
Principal Investigator:
Your name
Your title
Investigators:
List names of all investigators
Titles
Your telephone number
Telephone numbers
Researchers’ statement
We are asking you to be in a research study. The purpose of this consent form is to give you the
information you will need to help you decide whether to be in the study or not. Please read the form
carefully. You may ask questions about the purpose of the research, what we would ask you to do, the
possible risks and benefits, your rights as a volunteer, and anything else about the research or this form
that is not clear. When we have answered all your questions, you can decide if you want to be in the
study or not. This process is called ‘informed consent.’ We will give you a copy of this form for your
records.
PURPOSE AND BENEFITS
Persons who experience a distal radius fracture may develop disability. [Provide some background
information on this injury and described outcomes from your protocol]. The goal of our research is to
quantify complications, healing, pain and activities of daily in patients 12 months after a distal radius
fracture by comparing patients who receive an injection of bone cement to strengthen the fractures site
along with the standard of care to patients who do not receive this injection but do receive the normal
standard of care. You will be randomized to receive or not to receive this injection of cement. That is,
you have a 50/50 chance to be in one group or the other.
Understanding the outcomes after this fracture may allow interventions that prevent disability
associated with it. The data from this study may change the standard of care for distal radius fractures.
It will also help us better understand these fractures and determine what patients are at greater risk of
an “unfavorable” outcome. There may be no direct benefit to you from participating in the study.
However, by participating, you may contribute to future research in this area that may ultimately
improve the quality of life of patients with an injury like yours.
PROCEDURES
If you agree to participate you will be asked to participate in 6 follow-up visits after you leave the
hospital. These visits will be scheduled at the same time as your normal follow-up visits with your
doctor. Each visit will last about 30 minutes. During these visits, your fracture healing will be
evaluated and you will also be asked to fill out questionnaires during three of these visits. These
questionnaires will ask you questions about pain, symptoms, quality of life, general health and social
functioning. You are free to refuse to answer any questions you do not wish to answer and to
terminate the completion of the questionnaires at anytime if you choose.
RISKS, STRESS, AND DISCOMFORT
[Describe any potential side effects that may occur as a result of receiving the injectable bone cement].
OTHER INFORMATION
1. You may refuse to participate and may withdraw from the study at any time.
2. Your identity and all answers to the questions asked will be strictly confidential.
3. No publication or public discussion of the results of this research will contain identifying
information of any type.
4. If you participate in this study you may be asked to participate in future studies.
5. Only the investigators of this study will have access to the data collected for the study; therefore,
your name, address, and telephone number will be retained in a secure, confidential repository.
_________________________________________________________________________________
Printed name of researcher
Signature of researcher
Date
_________________________________________________________________________________
Printed name of patient
Signature of patient
Date