University at Buffalo
Consent to participate in a research study


Title of the Study
  Internet use by patients with implantable defibrillators.

 
Introductory Statement

It is a principle of medical ethics that the human subject participants of a research protocol be informed of the purpose and benefits of the project; the research methods to be used; the potential risks or hazards of participation and the right to ask for further information at any time during the research procedure.  You have the right to know whether medical treatment or compensation is available for physical injuries occurred as a result of participation in the project. Your choice to participate is a voluntary one, and you are free to withdraw from the research project at any time. Your signature at the end of this consent form will indicate that the principal investigator, or his/her agent, has answered all your questions and that you voluntarily consent to participate in this investigation.


Researcher

This study is being done by Suzanne Dickerson DNS RN, a nurse researcher at University at Buffalo, School of Nursing.

 
Sources of Funding

None


Site of the Study

Researcher’s password protected web site.


Eligibility

Persons with an implantable defibrillator who use the Internet for support.


Purpose

The purpose of this study is to find out how individuals, use the Internet (bulletin board, live chat or email) for support. I would like to learn about how and why you use these mediums. I hope in the future to be able to suggest uses of Internet to support people in your situation.

 
Procedure

I would like to communicate with you by virtual online discussion group. You will be given a user name and password to enter the secure site.  You will be asked to describe experiences of how and why you use the Internet.  In the discussion group you will answer the questions on a discussion list with others with ICD, like yourself who regularly use the Internet.  You can post answers for other's reactions and discuss issues for a two week time frame.  You will be asked to answer a few questions about your situation.  You may be emailed by the investigator to clarify or expand on your stories.  If you are under 18 years of age, you should obtain permission to participate from your parent or guardian by having them read this consent and email the investigator permission to join in the study.

 
Risk/Benefits

I do not think you will find any question upsetting, however, you do not have to answer any questions you choose not to.  I hope that by learning about the experience people have using the Internet, we may be better able to help others.  If you decide to join the study you are free to drop out from the study at any time without harm.


New Findings

You will be told of any new information or new risks that may be found during the study that may cause you to change your mind about joining the study.


Costs

There are no costs to you associated with this study.


Confidentiality

The information related to you will be treated in strict confidence to the extent provided by law. Your identity will be coded and will not be associated with any published results. Your code number and identity will be kept in a locked file of the principal investigator. Your names will not be included with any communication record. We will not tell others who you are.  When we give results of the study at a meeting, teaching a class or in a paper your name will not be used.  Any facts you gave us will be reported so that your identity will be unknown.


Potential Secondary Analysis

In coding interviews, our team codes those sections that are directly related to the experiences of ICD patients.  We may notice that other valuable information about what is meaningful to people with an ICD may be present through out the interviews even though  not directly in response to our original interview questions.  If we conduct a secondary analysis of the same interviews, we would as your permission to do this analysis on your interview.

 
The following statement is required for all research studies, “Routinely the University at Buffalo, State University of New York, its agents, or its employees do not compensate for or provide free medical care for human subjects/participants in the event that any injury results from participation in a human research project.  In the unlikely event that you become ill or injured as a direct result of participating in this study, you understand that you may receive medical care, but it will not be free of charge even if the injury is a direct result of your participation.”


By returning an email to the researcher, I indicate that I have read and understand the following:

  1. If I have any questions about this research I can email or call the researcher Dr. Dickerson at email sdickers@buffalo.edu or (716) 829-3254 from Monday through Friday from 8am to 4:30pm or I can write to her at:
  2.           Dr. Suzanne Dickerson
              914 Kimball Tower
              3435 Main Street
              Buffalo, New York 14214.
  3. If I have questions about my rights as a research subject, I may call the Chairperson of the Human Subjects review committee. The chairperson may be reached at (716) 829-2752 or by writing to:
  4.           Human Subject review committee
              186 Farber Hall
              Buffalo NY 14214.
  5. I can choose to be part of this study or not. Even if I choose to be part of this study, I can withdraw from this study at any time by calling, writing or emailing the researcher.
  6. Whether I join this study or not my medical care will not be affected in any way.
  7. I know I can ask questions about this study at any time.
  8. I understand I will not receive payment for being in this study.
  9. I have read the entire contents. I have been told about what will happen in the study and what I am supposed to do.  All my questions have been answered about the study to this point.
  10. I give my consent freely to take part in this study based on the facts given to me as noted in this form.
  11. Your consent will be indicated by your return of a statement indicating consent by email or mail.

Email Dr. Dickerson (sdickers@buffalo.edu) to confirm that you have read this page and consent to the study.

Copy and paste the following into the email message, or print and return via mail to Dr. Dickerson at the address listed above.  After we receive your email consent, we will send a reply giving you your user name, password, and URL to the web site for the virtual focus group.

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I consent to participate in the ICD internet study.

Name:
Birthdate:
Gender:
Years of education:
Hours per week usage of the Internet:
How long have you been using the Internet?
When did you receive your ICD?
Number of firings?
What other supports do you have?

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Back to Desription of the Study

Last update: August 2002
Comments, Questions? E-mail: sdickers@buffalo.edu