Marquette University Agreement of Consent For Research Participants
Randomized Comparison of Two Internet-Based Natural Family Planning Methods
Richard J. Fehring, PhD, RN and Mary Schneider, MSN, FNP Marquette University,
College of Nursing
1.
Invitation to Participate
You and your partner have been invited to participate in this research study. Before you agree to participate, it is important that you and your partner read and understand the following information. Participation is completely voluntary. Please ask questions about anything you or your partner do not understand before deciding whether or not to participate. Please note that to be eligible to participate in this study you need to be sexually active, be in a committed relationship with one partner, and intend not to become pregnant for one full year. If you switch your sexual partner at any time during this study you will no longer be eligible for the study and are asked to inform the researchers of your change of status.
2.
Purpose
The purpose of this research study is to compare the effectiveness of two natural family planning (NFP) methods that are provided over the internet by the Marquette University Institute for Natural Family Planning. One of the NFP methods is the use of a hand held electronic hormonal fertility monitor. The other method involves the self-observation of cervical mucus to track fertility. Both of the methods will involve placing information about your fertility into an online charting system that automatically displays the days of fertility and infertility. If you agree to participate in this study you will be one of approximately 600 participants (plus their male partners) in this research study.
3.
Fertility Monitor Method
If you are assigned to the fertility monitor group you will be provided a small hand held electronic fertility monitor that measures two hormones in the urine. Use of the monitor requires turning on the monitor every morning to find out your fertility status and to determine whether a test will be required. When a test is needed, you will be asked to place a test strip (similar to a pregnancy test strip) under your first morning urine stream for 3 seconds and then to clip the test strip onto the monitor where it will be read. Within 5 minutes the monitor will tell you your fertility status: low, high, or peak fertility. You will be asked to use a test strip approximately 10 times per menstrual cycle. We ask you to place the information from the monitor onto an online charting system on a daily basis along with information about your menses (i.e., your period) and your intercourse patterns. The online charting system will automatically tell you when you are fertile or not.
4.
Cervical Mucus Monitoring Method
If you are assigned to the cervical mucus monitoring group, you will also be provided with a fertility monitor, but only at the completion of the study. Cervical mucus monitoring requires external observation of cervical vaginal fluids on a daily basis. This means checking for vaginal fluids at the time you go to the bathroom and before bedtime. Checking for vaginal fluids become part of your personal hygiene and takes only a few minutes a day. Based on your daily observations you will know if you have low, high, or peak type fertile mucus. You will be asked to record your observations on an online fertility charting system on a daily basis along with information about your menses (i.e., period) and your intercourse patterns. The online charting system will automatically tell you when you are fertile or not.
5.
Procedures
If you agree to participate you will be asked to complete a short online registration form, after which you will be automatically assigned to use either the fertility monitor or the cervical mucus method of NFP. (Please note that the online system will automatically assign you to either the fertility monitor or the cervical mucus monitoring group -- you will not have the choice as to which group that you are placed in). If you are assigned to the fertility monitor group a ClearBlue Easy Fertility monitor will be mailed to you within 2 weeks. You will be asked to watch a short online podcast of how to use these two methods and to read a short one page instruction. You will then be asked to monitor your fertility on a daily basis and to record your fertility information on the online automatic charting system for one year. You and your partner will also be asked to complete (online) a short ten item satisfaction survey at 1, 3, 6, and 12 months of use and to indicate your intention and strength of intention for avoiding pregnancy on the online charting system before each menstrual cycle. If you should become pregnant while participating in this study you will also be asked to complete a short online pregnancy evaluation and to verify the pregnancy with a pregnancy test provided by us. The charting system will only be visible to the Marquette researchers and professional nurse NFP teachers involved with this study. Your name will not be on the charting system, but rather you will be automatically assigned a pass word and code number when you agree to participate in this study.
6.
Duration
Your participation will consist of providing information about your fertility on a daily basis for 12 months. Your daily fertility observations and charting should take you 5 minutes or less. You will also be asked to provide your (and your partner's) intention for avoiding pregnancy and strength of intention before each menstrual cycle of charting. This will take about 30 seconds or less before each menstrual cycle. Finally, you (and your partner) will also be asked to complete a short 10 item satisfaction survey after 1, 3, 6, and 12 months of use. The 10 item satisfaction survey takes about 5 minutes or less to complete.
7.
Risks
You should know that there is a small risk of achieving an unintended pregnancy (i.e., 2-3% or less) if you follow the instructions and are consistent in your charting. If you are not consistent in observing and charting your fertility signs your chances of achieving an untended pregnancy is about 10-14%. This rate compares with an 8% unintended pregnancy rate among women who do not use the birth control pill consistently. If you do become pregnant, you will automatically be asked to complete the online pregnancy evaluation form and to consult with the professional nurse NFP teacher through e-mail. Please note that you will most likely become pregnant if you have intercourse during the fertile phase as indicated by the electronic fertility charting system or by the self-observation of cervical mucus.
8.
Benefits
The benefit of participating in this online effectiveness study of two methods of NFP through the Marquette NFP web site is that you will have free use of the electronic charting system, the discussion rooms, and advice from the professional NFP teachers, physicians, and bioethicist. After this study is completed the web site will only be accessed by a paid subscription. Another benefit of participating in this study is the information it provides about monitoring and interpreting fertility. You will also have the satisfaction that you will be contributing to the development of NFP methods and helping health professionals and users of NFP know which methods are the most effective and most easy to use.
9.
Confidentiality
All information you reveal in this study will be kept confidential. All your data and fertility charts will be assigned an arbitrary code number rather than using your name or other information that could identify you as an individual. When the results of the study are published, you will not be identified by name. The data downloaded from the Web site will not have any of your personal identification. Your personal information will be destroyed by deleting the online electronic files 3 years after the completion of the study. Electronic files of the data from the study without any identifying information about the participants will be retained indefinitely for future research purposes. Your research records may be inspected by the Marquette University Institutional Review Board or its designees, The US Department of Health and Human Services and its Office of Public Health and Science and Office of Population Affairs, and (as allowable by law) state and federal agencies. The host server for the online NFP Web site is password protected and has a high level of security. The host server is a national corporation that hosts thousands of web sites and was selected by the Marquette University Information Technology Office as a secure host server.
10.
Compensation
All female participants in this study will receive a free $200 ClearBlue Easy Fertility Monitor with a beginning supply of test strips. However, the participants in the cervical mucus monitoring group will not receive the monitor until they have completed the 12 months of charting. If the participants do not complete the 12 months of the study or become pregnant intentionally, they will not receive a free monitor. If a participant becomes pregnant un-intentionally and followed the rules of the method, they will still receive a free monitor. All participants will receive a $10 gift certificate for each completed menstrual cycle of data up to 13 menstrual cycles or 12 months of charting, i.e., a potential of up to $130.00. Gift cards will be sent when the participant completes the study.
11.
Extra Costs To Participate
Subjects in the fertility monitoring group will be expected to obtain test strips after the initial supply runs out. The test strips will run approximately $18-20 per menstrual cycle.
12.
Injury or Illness
Marquette University will not provide medical treatment or financial compensation if you should become pregnant during the duration of this research project. This does not waive any of your legal rights nor release any claim you might have based on negligence.
13.
Voluntary Nature of Participation
Participating in this study is completely voluntary and you may withdraw from the study and stop participating at any time without penalty or loss of benefits to which you are otherwise entitled.
The data that you have generated up until the time that you withdraw from the study will be included in the study's data set unless you prefer it not be included. If you do not wish it to be included it will be electronically deleted. If the data is deleted you will not be compensated for those menstrual cycles with a gift card. If you are in the monitor group and withdraw from the study, we will ask that you return the fertility monitor at your own expense.
14.
Contact Information
If you have any questions about this research project, you can contact either the principal investigator Dr. Richard J. Fehring, PhD, RN at (414-288-3838 or richard.fehring@marquette.edu) or the co-investigator Mary Schneider, MSN, FNP at (414-288-3854 or mary.schneider@marquette.edu). If you have questions or concerns about your rights as a research participant, you can contact Marquette University's Office of Research Compliance at (414) 288-7570.
ONLINE CONSENT:
I have read the online consent form and decided that I will participate in the project described. Its general purposes, the particulars of involvement, and possible risks and inconveniences have been explained to my satisfaction. My consent is indicated by clicking on the "YES" option below.
I consent to participating in this effectiveness study of two methods of natural family planning through this online NFP Web site:
YES - Female Response
YES - Male Response
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