RESEARCH CONSENT FORM
STUDY OF REPRODUCTIVE HEALTH
Title of Project: Feasibility of an Internet-Based Study of Time-to-Pregnancy (Female Participants)
Principal Investigator: Lauren A. Wise, Sc.D.
This research study is being carried out by investigators at Boston University to evaluate factors related to fertility and pregnancy. Women who agree to participate in the study will be asked to fill out a series of Internet-based questionnaires every two months for a period of approximately one year. You are being asked to participate in this research study because you are female, between the ages of 21 and 45, are attempting to become pregnant, and are currently living with your male partner.
The purpose of the study is to determine what factors might affect a couple's fertility. Among the volunteers for this study who become pregnant, we will also be looking at what factors could increase risk for miscarriage, preterm birth, low birth weight, and adverse child health outcomes. In addition, we will be assessing whether it is feasible to use the Internet for medical research studies.
What Happens In This Research Study
You are one of approximately 20,000 women being asked to participate in this study. If you agree to participate, we will ask you to fill out a comprehensive baseline questionnaire on your lifestyle and medical history. This first questionnaire should take about 30-35 minutes to fill out. In the first questionnaire, we will ask you to provide your full name, residential address, and date of birth so that we can link your questionnaire data with birth registry and newborn screening data from your state or province, if available. For example, Massachusetts (MA) residents will have their data linked with the MA Department of Public Health birth registry to obtain additional birth outcome data, such as infant birth weight and gestational age.
Ten days after the first questionnaire, we will ask you to complete a dietary questionnaire (30-40 minutes) about your typical diet in the previous year. Thirty days after the first questionnaire, we will invite you to complete an optional supplemental questionnaire about stress and social support.
Every two months after the baseline questionnaire, we will also ask you to complete a short follow-up questionnaire (10-15 minutes) that will include questions about lifestyle and health issues that may have changed during the previous two months. We will ask you to complete a maximum of 6 of these short questionnaires over a one-year period. We will send you an email reminder with a link to the study website to remind you when it is time to fill out these follow-up questionnaires.
Finally, if you become pregnant, we will ask you to fill out a questionnaire in early pregnancy (up to 14 weeks of gestation), a questionnaire in late pregnancy (at about 32 weeks of gestation), and a final questionnaire in the postpartum period (6 months after delivery). These short questionnaires (10-15 minutes) will ask about any changes to your lifestyle or health during pregnancy and postpartum. The postpartum questionnaire will ask about your child's health.
After enrollment, you will be asked whether you would like to invite your male partner to participate. If you agree, he will be asked to complete one short questionnaire (10-15 minutes) about his lifestyle and medical history and a dietary questionnaire (30-40 minutes) 10 days later.
Based on your responses to selected questions, we might ask whether you would be willing to release your or your future child's medical records so that we can obtain further details about selected health outcomes.
You may skip any questions that you do not wish to answer, and you may also withdraw entirely from the study at any time. All data that you provide will be available to Boston University investigators and may be analyzed in their investigation of whether these factors influence fertility or pregnancy outcomes. Your data will not be shared with your male partner.
Risks and Discomforts
You may find that some of the questions asked on the questionnaires make you feel uncomfortable or bring back unpleasant memories. Some questions can also lead to emotional discomfort. If you feel emotional distress as a result of your participation in the study, you are encouraged to discuss this with your health care provider. Depending on your responses to certain questions, you may be called by telephone and/or sent an email with a list of resources.
As with any data collection, there is a very small risk of breach of confidentiality; however, we employ many safeguards to keep the data confidential using up-to-date technology. The data that you provide on the study website will be encrypted (a process of coding data to make it unreadable by outside parties, such as is done when using a credit card on the internet) to eliminate the possibility that an outsider can gain access to the information. Data that you supply will be identified by number only, and will be stored in computer files protected by a series of passwords known only to staff working on the study. All analyses will be conducted using coded data without any names or other personal identifiers.
There may be unknown risks or 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 the study.
You will receive no direct benefit from your participation in this study. However, your participation may help the investigators identify factors that promote conception or interventions that could increase the chances of successful pregnancy. The study may also identify factors related to miscarriage, preterm birth, and low birth weight that could help prevent these conditions. We will inform you about study results by posting information on the study website (http://presto.bu.edu), after the findings have been published.
Your alternative is not to participate in the study.
Subject Costs and Payments
There are no costs to you for participating in this study. You will not be paid to participate in this study. However, a random sample of the enrolled female participants will be selected to receive a free premium subscription to Kindara (value: $50/year), a software program that allows women to chart their menstrual cycles and record their fertility signs online (by computer or smart phone). Only new Kindara members are eligible for this promotion. If you complete the dietary questionnaire, you will: 1) receive a report summarizing your intake of macro- and micro-nutrients such as the percent of calories from fat, protein, and carbohydrate, and folate, calcium, and iron intake; and 2) be entered into a lottery to win a $100 gift card to the grocery store of your choice (1 out of every 500 participants will be randomly selected to win). If you become pregnant and you successfully complete your late pregnancy questionnaire, you will be given a coupon for 10% off your purchase at Magic Beans (www.mbeans.com), a baby gear store. If your male partner completes his baseline questionnaire, you and your male partner will be entered into a lottery to win a free i-pad mini ($379 value). One in every 250 couples in which the male partner completes his questionnaire will be randomly selected to receive a free i-pad mini. Finally, if you complete all of the required follow-up questionnaires, you will be entered into a lottery to win a $200 gift card (1 out of every 500 women will be randomly selected to win).
A random sample of female participants will be offered Clearblue RAPID DETECTION home pregnancy tests by mail at no cost to them. These tests have been donated to PRESTO by Clearblue for the purposes of 1) providing an incentive to our participants, 2) providing our participants with a reliable way to detect their pregnancies (e.g., 1-2 days after a missed period), and 3) comparing participation rates between those randomized to receive the pregnancy tests with those not randomized. Only de-identified data (i.e., data without any identifying information that can be linked back to you) will be shared with investigators at Clearblue. A letter will be sent to selected participants inviting them to receive the tests (yes vs. no) and asking them to confirm their mailing address.
This study is covered by a Certificate of Confidentiality (CoC) from the National Institutes of Health. All studies funded by the National Institutes of Health that involve identifiable information are covered by a CoC. The CoC provides how we can share research information. Because we have a CoC, we cannot give out research information that may identify you to anyone that is not involved in the research except as we describe below. Even if someone tries to get your information in connection with a legal proceeding, we cannot give it to them. The CoC does not prevent you from sharing your own research information.
If you agree to be in the study and sign this form, we will share information that may show your identity with the following groups of people:
When we share research data, there still may be a small chance that someone could figure out that the information is about you. Such sharing includes:
- People who do the research or help oversee the research, including safety monitoring.
- People from federal and state agencies who audit or review the research, as required by law. Such agencies may include the U.S. Department of Health and Human Services, Food and Drug Administration, National Institutes of Health, and Massachusetts Department of Public Health.
- Any people who you give us separate permission to share your information.
- Publishing results in a medical book or journal.
- Adding results to a Federal government database.
- Using research data in future studies, done by us or by other scientists.
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. You may print a copy of this consent form for your records.
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 take part in the study and then change your mind, you can withdraw from the research at any time. Your decision to participate is completely up to you and will not affect your being able to get health care at Boston University or payment for your health care. It will not affect your enrollment in any health plan or the benefits you can get.
If there are any new findings during the study that may affect whether you want to continue to take part, you will be told about them as soon as possible. The investigators may decide to discontinue your participation without your permission because they may decide that staying in the study will be bad for you or the sponsor may stop the study.
Whom to Contact With Questions about Research and Subjects' Rights
To obtain further information about your rights as a participant, you may also call 617-358-5372 or email email@example.com. You will be talking to someone at the Boston Medical Center and Boston University Medical Campus Institutional Review Board (IRB). The IRB is a group that helps monitor research. You should call or email the IRB if you want to find out about your rights as a research subject. You should also call or email if you want to talk to someone who is not part of the study about your questions, concerns, or problems.
You may also contact the Study's Principal Investigator, Dr. Lauren A. Wise, if you have any questions about research or your rights as a research subject. She may be reached by e-mail (firstname.lastname@example.org) or by phone at 617-358-3424.
By clicking "I agree to participate in this study" (below), you are indicating that you have read this consent form (or have had it read to you), that your questions have been answered to your satisfaction, and that you voluntarily agree to participate in this research study.