Information sheet for waived documentation of consent
IRB# 00026276
TITLE: National Nursing Survey of Parental Holding Practices in NICUs in the United States
PRINCIPAL INVESTIGATOR: Brian Scottoline, MD, PhD. [(503) 494-2186]
CO-INVESTIGATORS: Emily Garavatti, MD [(503) 494-2634] Taralyn Calder, MSN, RN, RNC-NIC [(503) 494-8122]
WHY IS THIS STUDY BEING DONE?:
You have been invited to be in this research study because you are a member in the Vermont Oxford Network or the National Association of Neonatal Nurses. . The purpose of this study is to explore parental holding practices in neonatal intensive care units (NICUs) across the United States and territories.
Data collected from you in this study will not be used and/or shared for future research.
WHAT PROCEDURES ARE INVOLVED IN THIS STUDY?:
The following study should take approximately 5 minutes of your time. The survey will ask about your role and experience working in the NICU, and about parental holding practices in your unit. No identifying information will be collected, and your response will be anonymous.
If you have any questions, concerns, or complaints regarding this study now or in the future, or if you think you may have been injured or harmed by the study, contact Brian Scottoline at (503) 494-2186.
WHO WILL SEE MY PERSONAL INFORMATION?
No personal identifying information will be collected.
WHAT RISKS CAN I EXPECT FROM TAKING PART IN THIS STUDY?:
Although we have made every effort to protect your identity, there is a minimal risk of loss of confidentiality.
WHAT ARE THE BENEFITS OF TAKING PART IN THIS STUDY?:
You will not benefit from being in this study. However, by serving as a subject, you may help us learn how to benefit patients in the future.
WHAT ARE THE ALTERNATIVES TO TAKING PART IN THIS STUDY?:
You may choose not to be in this study.
WILL I RECEIVE RESULTS FROM THIS STUDY?
The results of this research will not be made available to you because the research is still in an early phase and the reliability of the results is unknown.
WHO WILL SEE MY PERSONAL INFORMATION?:
In this study we are not receiving any identifiable information about you so there is little chance of breach of confidentiality.
WILL ANY OF MY INFORMATION OR SAMPLES FROM THIS STUDY BE USED FOR ANY COMMERCIAL PROFIT? Information about you or obtained from you in this research may be used for commercial purposes, such as making a discovery that could, in the future, be patented or licensed to a company, which could result in a possible financial benefit to that company, OHSU, and its researchers. There are no plans to pay you if this happens. You will not have any property rights or ownership or financial interest in or arising from products or data that may result from your participation in this study. Further, you will have no responsibility or liability for any use that may be made of your samples or information.
WHERE CAN I GET MORE INFORMATION?:
This research is being overseen by an Institutional Review Board (“IRB”). You may talk to the IRB at (503) 494-7887 or irb@ohsu.edu if:
• Your questions, concerns, or complaints are not being answered by the research team.
• You want to talk to someone besides the research team.
• You have questions about your rights as a research subject.
• You want to get more information or provide input about this research.
You may also submit a report to the OHSU Integrity Hotline online at https://secure.ethicspoint.com/domain/media/en/gui/18915/index.html or by calling toll-free (877) 733-8313 (anonymous and available 24 hours a day, 7 days a week).
DO I HAVE TO TAKE PART IN THIS STUDY?
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.
The participation of OHSU students or employees in OHSU research is completely voluntary and you are free to choose not to serve as a research subject in this protocol for any reason. If you do elect to participate in this study, you may withdraw from the study at any time without affecting your relationship with OHSU, the investigator, the investigator’s department, or your grade in any course. If you would like to report a concern with regard to participation of OHSU students or employees in OHSU research, please call the OHSU Integrity Hotline at 1-877-733-8313 (toll free and anonymous).
HOW DO I TELL YOU IF I WANT TO TAKE PART IN THIS STUDY?
Please complete the following survey if you consent to participation in the study. If you would not like to participate in the study, please close the browser.