Informed Consent
Title: Experiences of Obese African American Women as they have Utilized Healthcare Services: Influence of the Experiences on Utilization of Preventive Healthcare Services Principal Investigator: Margaret Moloney, RN, PhD, ANP
Student Investigator: Winsome Stephenson, RN, MS, PhD (c)
Introduction/Purpose:
You are invited to take part in a research study. The purpose of this study is to learn more about the experiences of obese African American women as they have used healthcare services. We hope to understand how their experiences determine their use of healthcare screens for breast and cervical cancers. You are invited to take part because you arean African American woman who is overweight. A total of 15 women will be recruited for this study. We expect that this study will take about 10 months. Participation in the study should take no more than a total of 2 hours.
Procedures:
If you decide to take part, you will be asked to sign a consent form before you start the study. Ms. Stephenson, the student researcher, will conduct an interview with you at the location that was agreed upon when you first spoke with her. You will have contact with only one researcher. The interview will take place sometime during the months of June-November. The purpose of this interview is to hear your thoughts about the experiences you have had when you have sought healthcare. You may be asked to do a second interview. The second interview is to clarify any information from your first interview. This second interview will be within one month of the first. Both interviews will be at a time and place that is agreed upon by both you and the researcher. Both interviews will be tape-recorded and will last about 45-60 minutes each. After the tape-recorded interview, you will be asked to answer four questions. The first question asks whether you have health insurance.
The second question asks about your marital status. The third question asks for your employment. The fourth question asks about the highest level of schooling that you had. For your time in the study, you will receive a $20.00 gift certificate.
Risks:
In this study, you will most likely not have any more risks than you would in a normal day of life. However, it is possible that talking about negative experiences you may have had because of your weight may cause you to become upset. If being in this study causes you distress, Winsome Stephenson will talk with you about finding a counselor. However, Georgia State University does not have funds set aside to pay for such care or to provide you with compensation if you should need care.
Benefits:
Being in this study may notbenefit you personally. Overall, we hope to gain information about the experiences that larger African American women have when they use healthcare services. We also hope to determine if these experiences cause the women to delay
healthcare for screens that would find breast and cervical cancers. This information may help us to plan interventions that will help larger African American women to seek timely screens for these cancers. We also hope to prevent the many deaths from breast and cervical cancers that are seen in larger women.
Voluntary Participation and Withdrawal:
Participation in this research study is voluntary. You do not have to be in this study. If you decide to be in the study and change your mind, you have the right to drop out at any time. You may chose not to answer an interview question at any time. Whatever you decide, you will not be penalized in any way for the decision you make.
Confidentiality:
We will keep your records private to the extent allowed by law. We will use a number code or pseudonym rather than your name on all study records. Only Winsome
Stephenson and Dr. Moloney will have access to the information you provide.
Information may also be shared with those who make sure the study is done correctly (Georgia State University Institutional Board, Mercer University Institutional Review Board, the Office for Human Research protection and/or the Food and Drug
Administration [FDA]). The information you give us will be stored in a locked file. We will use a code key to identify which files are yours. This code key will be kept in a separate locked file, away from the data. The code key will be destroyed one year after the study is ended. Someone who does not know your identity will transcribe your
interview tapes. The typed transcripts will have no information that might identify you. The audio-tapes will be stored in a locked file cabinet in the student researcher‘s home. These tapes will be destroyed one year after the study has ended. Your name and other facts that might point to you will not appear when we present this study or publish its results. The findings will be summarized and published in group form. You will not be identified personally.
Contact Persons:
Call Dr. Margaret Moloney at (404) 413-1170, email [email protected] or Winsome Stephenson at (678) 468-9556, email [email protected], if you have questions about this study. If you have questions or concerns about your rights as a participant in this research study, you may contact Susan Vogtner in the Office of Research Integrity at Georgia State University at 404-413-3513 or [email protected] or Ms. Ava Chambliss-Richardson in the office of Research Compliance at Mercer University at 478- 301-4101.
Copy of Consent Form to Participant:
We will give you a copy of this consent form to keep.
If you are willing to volunteer for this research and be tape-recorded, please sign below.
I give my consent to participate in this study
I DO NOT give my consent to participate in this study.
Participant‘s First Name:_______________ Last Name:___________ Date:_________
Participant‘s Signature___________________
Please complete your telephone contact information below, so that we can reach you. _______________________________
Preferred telephone Number (s)
____________________________ __________ Student Principal Investigator Date
Appendix D Recruitment Flyer
Appendix D