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recruiting OBGYNs for interview studyFrom: Andrea Kalfoglou (akalfoglou@jhu.edu)Tue Jul 29 09:16:03 2003
Dear OB/GYN, I would like to invite you to participate in a research project being conducted by the Genetics and Public Policy Center at Johns Hopkins University. We would like to interview practicing OB/GYNs over the telephone to learn more about their opinions and experience related to reproductive genetics. People who are interviewed will be paid $50 for an hour and a half of their time. People are eligible to participate if they are U.S. residents, fluent in English, and are a practicing OB/GYN who delivered at least 30 babies last year. The findings from this research will be used to help the Genetics and Public Policy Center create educational materials and policy options related to genetic tests and technologies. This research project is funded by The Pew Charitable Trusts. More information about the Center and its research activities can be found at http://www.DNApolicy.org. If you choose to participate, your interview will be tape recorded and transcribed. Your name and all personal references that might be used to identify you will be erased from the transcript of what you said. Your responses will be combined with the responses of other participants in a summary report and research publications. You would be among 65 other people interviewed as a part of this study; however, as few as 15 primary care providers will participate. This study has been reviewed and approved by the Johns Hopkins Institutional Review Board (IRB). The disclosure statement is pasted below. If you would like more information about participating in this study, call toll-free 1-866-501-1019 between the hours of 9 am and 5 pm Eastern Daylight Time. We will take the first callers who meet the eligibility criteria, so please call soon. When you call, please identify yourself as an OB/GYN. A staff member from the company that is conducting the interviews, Abt Associates, will talk with you about the study, ask you some questions to see if you qualify to participate, and schedule the interview. Your participation in this study is voluntary. If you agree to participate, you may choose to withdraw at any time, for any reason. Thank you for giving this your consideration. Sincerely, Kathy Hudson, Ph.D. Principal Investigator Interview Disclosure Statement Johns Hopkins University Genetics and Public Policy Center’s Study on Reproductive Genetics PURPOSE OF RESEARCH STUDY: This research study is sponsored by the Genetics and Public Policy Center at the Johns Hopkins University with funding from the Pew Charitable Trusts. Abt Associates Inc. is the company that is doing the interviews along with Johns Hopkins University and five researchers from other universities. The purpose of this study is to learn about people’s attitudes about genetic tests related to having children. About 65 people will be in this study by being interviewed, with as few as 5 people with similar experiences as you. The information we collect will be used to help the Genetics and Public Policy Center make educational materials and policy options. The findings will appear in medical and policy journals so that others may benefit from what we learn. People over the age of 18, who can speak English, and who can understand and answer these questions may join the study. We are also interested in interviewing people who have more experience with genetic tests. PROCEDURES: If you agree to join this research study, you will be interviewed over the telephone for about 1˝ hours. You will be asked to answer questions about your awareness, attitudes, and beliefs about genetic tests and related medical procedures. The discussion will be audio taped and other researchers may listen in. We would like to keep your contact information for two years in case we want to ask you some more questions. This will include your name, phone number, address, and e-mail address. RISKS/DISCOMFORTS: We do not think there is any major risk to you if you are interviewed. The main risk to you is the chance that some of the questions we ask might upset you. The questions might be especially upsetting if you or a family member has a genetic disease or if you have had experience with these genetic tests and medical procedures. Examples of topics that might upset you include the difficult decisions some people must make about genetic testing and medical procedures, such as tests done before or during pregnancy. You do not have to answer any questions you do not wish to answer. If you reach the point where you do not wish to keep talking about these issues, please tell the study staff. You may quit the study at any time. (see Withdrawal Procedures below). There is a small risk of loss of confidentiality. This risk will be minimized by destroying the audiotape after it is transcribed, and by removing names and all other personal identifying information from the transcript of the tape. (See Privacy Information section on page 2 for further details.) If you would like to talk more with a counselor, you can get referral to a counselor near you from the American Psychological Association by calling the toll-free number (800) 964-2000. The referral is free, but you would have to pay for the counseling yourself. If you would like more information about genetic testing and genetics and genetic disease, you can call the Genetics and Rare Diseases Information Center at the toll-free number (888)205-2311. JOINING OF YOUR OWN FREE WILL AND ALTERNATIVES TO PARTICIPATION (Volunteering for the study): Your participation in this study is voluntary. You do not have to join this or any research study. If you do join, and later change your mind, you may quit at any time. If you refuse to join or quit early from the study, you will not be punished or lose any benefits to which you have a right. Your care at any Johns Hopkins Institution or at any organization that may have helped us recruit you will not change. COSTS/COMPENSATION: You will receive $50 for being interviewed. We will mail you a check after the interview. WITHDRAWAL PROCEDURES: You may quit from the study at any time. You do not have to answer any questions you do not want to answer. If you want to quit, please notify the study staff right away. You will still get paid for the interview. If you quit the study, it will not change the future care you get at any Johns Hopkins Institutions or at any organization that may have helped us recruit you. PRIVACY INFORMATION: We will take a number of steps to keep any personal information about you confidential to the fullest extent possible by law. First, we will only use first names during our discussion. Second, all of the researchers in this study promise to keep the information you provide confidential. Third, computers used to process the data will require a password. Fourth, when we transcribe these tapes, we will erase any personal information you provide, such as the school you attended, your relative’s names, or the city you live in. Other information you have given us, such as your age, sex, and race will be matched to what you say today, but not to your name. Finally, the audiotape, your contact information, and any matches between your personal information and transcripts of the interview will be destroyed within two years after the study is over. Also, people doing the research and others in charge of making sure that the research is done correctly may review the audiotape or your interview. This might include people from any Johns Hopkins Institutions, Abt Associates (and others doing work on the project like transcribers), The Office for Human Research Protections, or the five researchers from other universities that are part of the research team. All of these people are also required to keep your identity confidential. The information that identifies you will not be given out to people who are not working on the study, unless you give permission. QUESTIONS YOU MAY HAVE ABOUT THE RESEARCH STUDY: This disclosure statement explains the research study. Please read it carefully. Ask questions about anything you do not understand. If you do not have questions now, you may ask later. If you have questions about the research study, you may ask the interviewer from Abt Associates or you can call the principal investigator from Johns Hopkins, Dr. Kathy Hudson at (202) 663-5971 (not a toll-free telephone number). QUESTIONS ABOUT YOUR RIGHTS AS A RESEARCH SUBJECT: If you have any questions about your rights as a subject in a research project, you should call the Johns Hopkins Medicine (JHM) Institutional Review Board (IRB) East Baltimore Offices (JHM-IRB 1-4) at (410) 955-3008, or the JHM-IRB Bayview Office (JHM-IRB 5) at (410) 550-1853 to get help or advice. These are not toll-free telephone numbers.
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