Baby Loss Surveys
AN AGREEMENT TO BE IN A RESEARCH STUDY
INFORMED CONSENT DOCUMENT
Sponsor: Donna Murphy, BLD, LPTA
City and State: Cincinnati, OH
Protocol Number and Title: 417; Discerning Needs in Pregnancy Loss through Surveys
Study Doctor: Donna Murphy, BLD, LPTA
Address of Study Site(s): Heaven's Gain
6359 Daleview Road
Cincinnati, OH 45247
24-Hour Telephone Number: (513) 607-6083
You are invited to take part in this research study. This form tells you why this research study is being conducted, what will happen in the research study, possible risks and benefits to you, your choices, and other important information. If there is anything that you do not understand, please ask questions by: Calling a study coordinator at (513) 607-6083 or by email heavensgain@fuse.net Then you can decide if you want to join this study or not.
WHY ARE WE INVITING YOU TO PARTICIPATE IN THIS STUDY?
You are being invited to participate in this research study because you have experienced a pregnancy loss by miscarriage, still birth, or early infant death. We need information about your pregnancy and delivery to learn more about differences in experiences that will help to identify what practices are working well, what practices may be discouraged, and to welcome new tools that may help others in the future. We hope to have a wide variety of participants, who have experienced loss from decades ago to recent losses. We plan to chart trends over time and the benefits or possible trauma related to these trends. We encourage you to invite your friends to participate in this study as well.
DO YOU HAVE TO BE IN THIS STUDY?
You can decide whether to take part in this study or not. You are free to say yes or no. Even if you join this study, you do not have to stay in it. You may stop at any time.
WHY IS THIS RESEARCH STUDY BEING DONE?
The information collected in this study will be analyzed to determine which practices are helpful in dealing with pregnancy loss, which practices are not helpful in dealing with pregnancy loss, and ideas on which practices may be beneficial to implement in dealing with pregnancy loss.
WHAT WILL HAPPEN IF YOU TAKE PART IN THE STUDY?
Your participation in this study only requires answering the questions of an online questionnaire. There is an opportunity to expand on your answer if you wish on most questions in the comment section. The entire questionnaire should take you no more than 40 minutes to complete but, may take longer If you choose to comment in the comment sections. If you prefer, you may request a copy of the study questionnaire to print out and complete on paper and mail to the study coordinator for inclusion in the study database by sending an email to heavensgain@fuse.net.
WHO IS ELIGIBLE TO PARTICIPATE IN THE STUDY?
Mothers and Fathers of angels (parents who have experienced a loss during pregnancy or shortly after birth) are eligible to participate in the study. There are additional surveys for family and friends, health care workers, ministers, and funeral directors.
WHAT WILL HAPPEN WITH THE DATA COLLECTED IN THIS STUDY?
The information collected in this study will be analyzed to determine which practices are helpful in dealing with pregnancy loss, which practices are not helpful in dealing with pregnancy loss, and ideas on which practices may be beneficial to implement in the future. We hope to show trends that show improvement in meeting the needs of families experiencing loss better now verses the past few decades.
If you withdraw from the study, no new data about you will be collected for study purposes. All data that have already been collected for study purposes will be shared with the study sponsor.
WILL THE INFORMATION YOU PROVIDE BE KEPT CONFIDENTIAL?
Yes, the information you provide in this study will not include any identifying information such as your name and address. Once submitted it will not be possible to determine who submitted the data.
The following people will have access to your study records:
- Study Doctor
- Sponsor Company or Research Institution
- Salus IRB
- The Department of Health and Human Services (DHHS)
- Other State or Federal Regulatory Agencies
Salus IRB has approved this study and this informed consent document. Salus IRB is a committee of scientific and non-scientific individuals who review, require modifications to, and approve or disapprove research studies by following the federal laws. This group is also required by the federal regulations to provide periodic review of ongoing research studies.
CAN YOU STOP BEING IN THE STUDY?
You can stop the survey at any point. We do appreciate you finishing the survey so we can accumulate a variety of information that can hopefully be beneficial to families in the future.
WHAT RISKS OR PROBLEMS CAN I EXPECT FROM THE STUDY?
You may feel that some of the questions we ask are stressful or upsetting. You may skip any questions you do not wish to answer or you may exit the study at any time. If you would like help with emotions related to this study, you may call trained grief counselors at First Candle at 1-800-221-7437.
ARE THERE ANY BENEFITS TO TAKING PART IN THE STUDY?
You may not personally benefit by taking part in this survey although the data received may help families in the future who are dealing with pregnancy loss.
ARE THERE ANY COSTS TO BEING IN THE STUDY?
No, there is no cost to you to participate in this study.
WILL YOU BE PAID TO BE IN THE STUDY?
No, there is no payment offered to participate in this study.
WHOM TO CONTACT?
You may contact the study doctor or study staff at the phone number listed on the first page of this consent document:
- for answers to questions, concerns, or complaints about this research study,
- to report a research related injury, or
- for information about study procedures.
If you need medical attention please go to the nearest emergency room.
You may contact Salus IRB if you:
- would like to speak with someone unrelated to the research,
- have questions, concerns, or complaints regarding the research study, or
- have questions about your rights as a research participant.
Salus IRB
2111 West Braker Lane, Suite 400
Austin, TX 78758
Phone: 855-300-0815 between 8:00 AM and 5:00 PM Central Time
Email: salus@salusirb.com
If you would like additional information about your rights, research in general, or IRBs, you may visitwww.salusirb.com.
WILL YOU BE GIVEN NEW INFORMATION ABOUT THE STUDY?
Once the study is completed, we will be happy to share a summary of the results when they are published. You may request results of the study at heavensgain@fuse.net
HOW LONG WILL YOU KEEP THE INFORMATION FROM THIS STUDY?
The information in this study will be kept for a minimum of 10 years. In the future it may be found to be useful for comparison purposes should the study be again conducted after a period of time to determine if any improved outcomes have been achieved.
LEGAL RIGHTS
You do not lose any legal rights by signing this consent document.
CONSENT TO PARTICIPATE IN THE STUDY
By clicking on I agree, I confirm the following:
I have been provided the consent document.
In the consent document, the study’s purpose, procedures, risks and possible benefits have been explained to me.
I agree to let the study team use the information gathered for this study.
I agree that my answers and comments made may be used for educational purposes.
I voluntarily agree to participate in this research study.
I have been told that I can stop at any time.
Thank you for your participation.
The Study Team
Print a signed and dated copy of this informed consent document to keep.
FOR Salus IRB USE ONLY
Initial draft mys: 04Sep15