Consent to Participate in a Research Study
H-26119 - THE USE OF NARRATIVES IN IRRITABLE BOWEL SYNDROME
(IBS)
Background
Writing narratives has been shown to improve patient's management of symptoms and wellness in various chronic conditions. This research study is being done to gain more knowledge about the management of irritable bowel syndrome (IBS). Your participation is voluntary and you may refuse to participate, or may withdraw from the study at any time and for any reason without affecting your future care at this institution.
Purpose
The objective of this project is to test the feasibility and effects of writing narratives on the management of irritable bowel syndrome.
What Happens In This Research Study
You will be one of approximately 200 subjects to be asked to participate in this study.
All of the research in this study will take place online and will be overseen by Boston University Medical Center.
You have been asked to participate in this study because you may have a history of Irritable Bowel Syndrome and are between the ages of 18-75. This research study consists of writing for 30 minutes each day for a total of 4 days, along with completing questionnaires. The 30 minute writings will be on a particular topic which we will give to you. Please note that you must have access to the internet and be able to write narratives for four consecutive days to take part in this study. Unfortunately, if you cannot make this time commitment or do not have regular internet access you will not be able to participate in the study. Also if you enroll in the study and are not able to write for 4 consecutive days, you will not be able to continue with the study.
You will complete questionnaires 4 times during this study.
- Before you write 4 consecutive days
- After you write for 4 consecutive days
- Approximately 1 month after you complete the writing phase (i.e. 4 consecutive days of writing) of the study
- Approximately 3 months after you complete the writing phase of the study
The questionnaires you complete will be used to learn information about your IBS symptoms. Each set of questionnaires takes approximately 25 minutes to complete.
If you agree to participate in the study and do not complete the online questionnaires within 1 week, the research coordinator will re-contact you. The study coordinator will send you a reminder card via email or call you. If at any point in time, you no longer wish to participate in the study, please notify the research coordinator at 617-638-6579 or at ibs.study@bmc.org. After we receive your message, we will not contact you again.
YOUR PARTICIPATION IS VOLUNTARY
Your decision to participate in this study is up to you and voluntary. The care you receive at Boston Medical Center will not be changed if you decide to participate or to not participate in this research study.
To participate in this study you must pass our screening questions. Please note that we will be keeping information we obtain from your screening questionnaire regardless of whether you are eligible or ineligible for the study. This information will include demographic information such as your age, gender, and years of education. Your name and identity will not be kept on file. Instead your data will be anonymous and be identified by a number.
CONSENT TO ALLOW USE OF NARRATIVES:
We are now asking you for permission to document or maybe even quote your narrative, or parts of it, for educational purposes (i.e. teaching, conferences, etc.) and publications (scientific papers, journals, books, etc.). We will not use your name when using your narrative. Instead, all narratives will be identified with ID numbers to maintain confidentiality
We will keep any narrative as long as it might be useful to us.
We are also asking you for permission to keep your narrative writing on file for additional data analysis in the future if it is needed. If you agree, we will use the narratives for data analyses conducted in the future.
Please remember that we will not use your name when using your narrative. Instead, narratives will be identified with ID numbers to maintain confidentiality
Your participation is completely up to you. You do not have to agree to let us use your narrative. Your decision will not affect your being able to obtain care at BMC or your being in the study. (Please check the choice that applies.)
Yes, you may use my narrative as described above.
No, you may not used my narrative as described above.
FUTURE STUDIES:
Are you interested in receiving information regarding future IBS related studies? (Please check the choice that applies.)
I am interested in receiving information regarding future IBS related studies.
I am NOT interested in receiving information regarding future IBS related studies.
Risks and Discomforts
This study involves no health risks. No subjects will be identified in any report or publication about this study. There is a risk of loss of confidentiality. Although every effort will be made to keep research records private, there may be times when federal or state law requires the disclosure of such records, including personal information.
There may be unknown risks/discomforts involved. Study staff will update you in a timely way on any new information that may affect your health, welfare, or decision to stay in this study.
Potential Benefits
You will receive no direct benefit from your participation in this study. However, your participation may help the investigators learn about the effects of writing on the management of Irritable Bowel Syndrome.
Alternatives
The following alternative procedures or treatments are available if you choose not to participate in this study: An alternative to participating in the study would be to write on your own and get information about IBS management from the internet or the library.
Subject Costs and Payments
There are no costs to you for participating in this research study. You will be paid $25 to participate in this research study. Once we receive your completed narratives and your 1 and 3 month questionnaires, you will be mailed a check. You will receive payments (the check will be sent to you in the mail) in installments after you complete each section of the study. The order is as follows:
1) Writing Phase (2 questionnaire sets and 4 narratives) = $5.
2) One Month Follow up = $10
3) Three Month Follow up = $10
Confidentiality
Information from this study and from your completed questionnaires may be reviewed and photocopied by the Food and Drug Administration (FDA) and/or state and federal regulatory agencies such as the Office of Human Research Protection as applicable, and the Institutional Review Board of Boston University Medical Center. Information from this study and from your completed questionnaires may be used for research purposes and may be published; however, your name will not be used in any publications.
Subject's Rights
By consenting to participate in this study you do not waive any of your legal rights. Giving consent means that you have heard or read the information about this study and that you agree to participate.
If at any time you withdraw from this study you will not suffer any penalty or lose any benefits to which you are entitled.
You may obtain further information about your rights as a research subject by calling the Office of the Institutional Review Board of Boston University Medical Center at 617-638-7207.
The investigator or a member of the research team will try to answer all of your questions. If you have questions or concerns at any time, or if you need to report an injury while participating in this research, contact us at (617) 638-6579 at any time.
Right to Refuse or Withdraw
Taking part in this study is voluntary. You have the right to refuse to take part in this study. If you decide to be in the study and then change your mind, you can withdraw from the research. Your participation is completely up to you. Your decision will not affect your ability to get health care at this institution or payment for your health care. It will not affect your enrollment in any health plan or benefits you can get.
If you choose to take part, you have the right to stop at any time. If there are any new findings during the study that may effect whether you want to continue to take part, you will be told about them as soon as possible.
The investigator may decide to discontinue your participation without your permission because he/she may decide that staying in the study will be bad for you, or the sponsor may stop the study.
