Research Informed Consent
Title of Study: AN INTERNET-BASED STUDY FOR PEOPLE WITH
DIABETES
Principal Investigator (PI): Alison
Radcliffe
Psychology
Department
313-577-2773 email: diabetes_research@wayne.edu
Purpose
You are being asked to be in a research study of coping with diabetes
because you stated that you have Type I diabetes. This study is being conducted
at
Study Procedures
If you agree to take part in this research study, you will be asked to complete questionnaires related to your health and mood several times over the next several months, as well as complete a writing exercise. During the first session you will be asked to complete a number of questionnaires over the internet, this will require about 1 hour. After this session you will be assigned to a study condition randomly (like flipping a coin). Some people will be asked to complete their writing at the beginning of the study, others will be asked to complete their writing at the end of the study. You will be asked to return to the website to complete these additional questionnaires one and three months after you are assigned to your study condition.
When you are asked to complete your writing assignment, you will be told your writing topic. You may be asked to write about personal experiences or about daily events. Again, which topic you are assigned will be determined randomly (like flipping a coin). You will be asked to complete your first writing exercise when you are told your writing topic. Next, you will be asked to write 3 more times over the next 2 weeks on your assigned topic. You can write at a private location of your choosing where there is an internet-access computer. Each writing session should last for 20 minutes, and before and after each writing session, you will rate your mood. The webpage on which you will be writing is secure, and you will be given an ID and password so that only you and our team can read what you write. Also, you may get feedback from a writing guide after each session, but whether or not you do will be determined randomly.
You will return to the webpage 1 month and again 3 months after your start writing to complete several health questionnaires, and each of these sessions will take about 30 to 60 minutes each. In addition, you will be asked to maintain a simple record on the website for one week after each assessment time point to record daily your glucose ratings. You will simply be asked to record the glucose ratings you would normally take each day.
Benefits
As a participant in this research study, your health and mood,
may be improved by participating in this study; however, you might not experience any benefits. Information from this study may benefit other
people now or in the future.
Risks
We expect the risks of your participating in this study to be minimal and unlikely. However, you may experience a negative mood while writing about certain topics. Although the website is secure, there is a risk of the loss of confidentiality of your writings or other information. If at any time during the study there is a concern that child abuse or elder abuse has possibly occurred, or that you have a reportable communicable disease (certain sexually transmitted diseases and/or HIV), then this information must be released to the appropriate authorities. There may also be risks involved in taking part in this study that are not known to researchers at this time.
Study Costs
Participation in this study will be of no cost to you.
Compensation
For taking part in this research study, you will be eligible to be paid
for your time and inconvenience. At the time of randomization you will be
entered into a lottery with other participants for one of twenty $100 prizes to
compensation for your time. Your odds of winning are approximately one in ten.
Confidentiality
All information collected about you during the course of this study will
be kept confidential to the extent permitted by law. You will be identified in
the research records by a code name or number. Information that identifies you
personally will not be released without your written permission. However, the
study sponsor, the Human Investigation Committee (HIC) at Wayne State
University, or federal agencies with appropriate regulatory oversight [e.g.,
Food and Drug Administration (FDA), Office for Human Research Protections
(OHRP), Office of Civil Rights (OCR), etc.) may review your records.
When the results of this research are published or discussed in
conferences, no information will be included that would reveal your identity
Voluntary Participation/Withdrawal
Taking part in this study is voluntary.
You have the right to choose not to take part in this study. If you
decide to take part in the study you can later change your mind and withdraw
from the study. You are free to only answer questions that you want to
answer. You are free to withdraw from
participation in this study at any time.
Your decisions will not change any present or future relationship with
The PI may stop your participation in this study without your consent. The
PI will make the decision and let you know if it is not possible for you to
continue. The decision that is made is to protect your health and safety, or
because you did not follow the instructions to take part in the study. While
taking part in this study you will be told of any important new findings that
may change your willingness to continue to take part in the research.
Questions
If you have any questions about this study now or in the future, you may
contact Alison Radcliffe or one of her research team members at the following
phone number 313-577-2773. If you have
questions or concerns about your rights as a research participant, the Chair of
the Human Investigation Committee can be contacted at (313) 577-1628. If you
are unable to contact the research staff, or if you want to talk to someone
other than the research staff, you may also call (313) 577-1628 to ask
questions or voice concerns or complaints.
Consent to Participate in a Research Study
By clicking on the “I agree and wish to begin the study” like below you are agreeing to participate in this study.
If you have questions about the study please either call the principal investigator, Alison Radcliffe, at 313-577-2773 or send an email to diabetes_research@wayne.edu
I agree to all the terms above and wish to participate in this study