McMaster University Research Ethics Board (MREB)



PARTICIPANT INFORMATION AND CONSENT FORMDetermining The Optimal Finger For Hypertension and Preeclampsia Assessment Using Pulse Oximeter CollectionPrincipal Investigator: Dr. Kenneth I. Lim (MD, FRCSC), Associate ProfessorDepartment of Obstetrics and Gynaecology, Division of Maternal Fetal Medicine, UBC Phone: 604–875–3174Co-Investigators: Dr. Mohamed Elgendi (BSc, ME, PhD), Post-Doctoral FellowDepartment of Obstetrics and Gynaecology, Division of Maternal Fetal Medicine, UBC Phone: 604–875–2723Dr. Rabab Ward (BSc, ME, PhD, FRSC, FIEEE, FCAE, FEIC),ProfessorDepartment of Electrical and Computer EngineeringPhone: 604–822–9428Dr. Judy Needham (BSc, MSc, PhD)Research Program Manager Dept. of Obstetrics & GynaecologyFaculty of Medicine, UBCPhone: 604–875–2979?Dr. Jayson Potts (MD, FRCPC, MEng)Division of General Internal MedicineFaculty of Medicine, UBCPhone: 604–875–2424 x 6438For non-emergency contact numbers:If you have any questions or desire further information about this study before or during participation, or if you experience any adverse effects, you can contact Dr. Kenneth I Lim, Principal Investigator, at 604–875–2665. For emergencies only: In case of pregnancy related emergencies or concerns, please contact your most responsible caregiver, midwife, family doctor or obstetrician gynecologist.INVITATIONYou are being invited to participate in a research study because you are pregnant and you may qualify for this study. In order to decide whether or not you want to participate, you should understand what is involved and the potential risks and benefits. This form gives detailed information about the research study, which will be discussed with you. Once you understand the study, you will be asked to sign this form if you wish to participate. Please take your time to make your decision. YOUR PARTICIPATION IS VOLUNTARYYour participation is voluntary. You have the right to refuse to participate in this study. If you decide to participate, you may still choose to withdraw from the study at any time without any negative consequences to the medical care, education, or other services to which you are entitled or are presently receiving. Before you decide, it is important for you to understand what the research involves. This consent form will tell you about the study, why the research is being done, what will happen to you during the study and the possible benefits, risks and discomforts. WHO IS CONDUCTING THE STUDY?This study is being conducted by researchers from the University of British Columbia. The study is not receiving funds from an external agency or sponsor.BACKGROUNDOxygen levels in pregnant women are measured using a non-invasive and safe machine called the pulse oximeter. The oxygen level is measured by placing a probe on a woman’s finger for one minute, and the information collected through this method is used for patient monitoring and diagnosis of pregnancy-related complications. This research study is being done because, at present, there are no guidelines outlining the best finger to use for measuring the oxygen saturation in the blood in pregnant women. It might be that different fingers of the hand provide different quality of information, and it is important to identify which finger provides the highest quality of information so that clinicians can make more accurate diagnoses. We will also be looking at the signal pattern to see if it is predictive of pregnancy outcomes. A total of 200 women will be recruited from BC Women’s hospital for this study and pregnant women with and without hypertension will be included. The technology for this study (pulse oximetry) has been in use for many years and no ill effects are known. It is routinely used in pregnant patients currently. This device differs from those only in how it transmits information to a device/computer. Data from the pulse oximeter will be stored on a secured, encrypted server with password protection. Only the investigators involved in this study will have access to this data.In addition, we will be using electrocardiogram information to monitor your heart rate and time the signals. This is also a widely used technology with no ill effects, and also being used commonly in pregnant patients. WHAT IS THE PURPOSE OF THE STUDY?The purpose of this study is to determine the optimal finger to use for oxygen saturation measurement. In the future, this might help doctors to more accurately diagnose and monitor complications related to pregnancy. WHO CAN PARTICIPATE IN THIS STUDY?For this study, we will recruit women who have no hypertension and those who have hypertension developed during pregnancy. These women will be compared in the data analysis, and will also be looked at according to how many weeks gestation they are. You may be able to participate in this study if:You are pregnant at 20 – 40 weeks gestationYou are 20 years of age or olderYou have a singleton pregnancyYou are delivering at BC Women’s HospitalWHO CANNOT PARTICIPATE IN THIS STUDY?You cannot participate in this study if:You have skin diseaseYou have significant obstetrical or medical complications such as connective tissue disease You use prescribed medication (except hypertension medication)You have prior significant injury to arms (fracture, burn, trauma, surgeryYou smoke tobacco or marijuanaYou use illegal drugsYou have renal diseaseYou have connective tissue diseaseYou had a major organ transplantYou had or have cancerYour baby has a major malformationYour baby has a genetic syndromeYou have other significant obstetrical or medical complicationsAppointment Exclusion CriteriaIf you chose to participate, before the scheduled appointment you must not: Drink caffeinated beverages within 6 hours before data collectionPerform a vigorous exercise that significantly increased your heartrate (e.g., running, swimming) within 1 hour before data collectionHave artificial nails (e.g., gel, acrylic, shellac)Have Henna on your fingertipsWHAT DOES THE STUDY INVOLVE?If you volunteer to participate in this study, we will ask you to:Attend one study session at BC Women’s Hospital to have your pulse oximeter reading taken. In total the session will take a maximum of 60 minutes. This visit can be done in conjunction with, before or after, any other visit you may have at BCWH.We will ask some general questions about your medical history and measure your blood pressure from both arms. After this, we will collect the pulse oximeter readings by placing probes on the finger tips; a probe is a small clasp (like a wide hair clip) that does not hurt when put onto your finger tip. Signals generated from the blood flow from the fingers will be recorded at the same time for quick measurement. During this test we will also collect electrocardiogram (ECG) signals that will be used during the analysis as a reference to help determine which finger gives the highest quality of information. The ECG will be collected from near your shoulder and the ECG electrodes will need to be placed directly on the skin in this area. Basic demographic and health information (e.g. age, date of diagnosis of hypertension, etc.) necessary for this study and basic contact information (method of contact for follow up if needed) will be collected from you during this study. Pregnancy outcome data will be obtained from your medical chart and your baby’s medical chart once your consent is given and your Medical Record Number (MRN) and your baby’s MRN will be collected in order to collect this information.WHAT ARE THE POSSIBLE HARMS AND DISCOMFORTS?There are no known harms or discomforts to participating in the study. The study is non-invasive.WHAT ARE THE POTENTIAL BENEFITS OF PARTICIPATING?There are no direct benefits to participating in the study. However, your participation will help us determine which finger should be used for oxygen saturation measurement which will inform current standards of care models and help clinicians make more informed decisions in the future. WHAT ARE THE ALTERNATIVES TO THE STUDY TREATMENT?The alternative is to not take part in the study. There is no study treatment as part of this study. If you do not take part in this study you will continue to receive standard care from your doctor.WHAT HAPPENS IF I DECIDE TO WITHDRAW MY CONSENT TO PARTICIPATE?You may withdraw from this study at any time without giving reasons. If you choose to enter the study and then decide to withdraw at a later time, you have the right to request the withdrawal of your information collected during the study. This request will be respected to the extent possible. Please note however that there may be exceptions where the data [and/or samples] will not be able to be withdrawn for example where the data is no longer identifiable (meaning it cannot be linked in any way back to your identity) or where the data has been merged with other data. If you would like to request the withdrawal of your data please let your study doctor know. If your participation in this study includes enrolling in any optional studies, or long term follow-up, you will be asked whether you wish to withdraw from these as well.What if new information becomes available that may affect my decision to participate?You will be advised of any new information that becomes available that may affect your willingness to remain in this study.WILL MY TAKING PART IN THIS STUDY BE KEPT CONFIDENTIAL?Your confidentiality will be respected. However, research records and health or other source records identifying you may be inspected in the presence of the Investigator or his or her designate by representatives of, Health Canada and the UBC C&W Research Ethics Board for the purpose of monitoring the research. No information or records that disclose your identity will be published without your consent, nor will any information or records that disclose your identity be removed or released without your consent unless required by law.You will be assigned a unique study number as a participant in this study.?This number will not include any personal information that could identify you (e.g., it will not include your Personal Health Number, SIN, or your initials, etc.). Only this number will be used on any research-related information collected about you during the course of this study, so that your identity will be kept confidential. Information that contains your identity will remain only with the Principal Investigator and/or designate. The list that matches your name to the unique study number that is used on your research-related information will not be removed or released without your consent unless required by law.Your rights to privacy are legally protected by federal and provincial laws that require safeguards to ensure that your privacy is respected. You also have the legal right of access to the information about you that has been provided to the sponsor and, if need be, an opportunity to correct any errors in this information. Further details about these laws are available on request to your study doctor.AFTER THE STUDY IS FINISHEDResearch data will be kept for 10 years after publication and then destroyed according to UBC policies. Data may also be used for future publications and secondary analysis publications during this time and your identify will be protected according to UBC policies. Study results will be shared with participants through an email newsletter. If mass emailing out documents, email addresses will be kept confidential (i.e. by using the BCC function) to protect participant confidentiality.WHAT HAPPENS IF SOMETHING GOES WRONG?By signing this form, you do not give up any of your legal rights and you do not release the study doctor, participating institutions, or anyone else from their legal and professional duties. If you become ill or physically injured as a result of participation in this study, medical treatment will be provided at no additional cost to you. WHAT WILL THE STUDY COST ME?There will be no cost to you for participating in this study.WILL I BE PAID TO PARTICIPATE IN THIS STUDYParticipants will not receive payment for participating in this study.WHO DO I CONTACT IF I HAVE QUESTIONS ABOUT THE STUDY DURING MY PARTICIPATION?If you have any questions or desire further information about this study before or during participation, or if you experience any adverse effects, you can contact Dr. Mohamed Elgendi, Co-Investigator at 604–875–2723. Any medical issues related to this study can be directed to Dr. Kenneth I Lim, Principal Investigator (or his medical designate), at 604–875-2665.WHO DO I CONTACT IF I HAVE ANY QUESTIONS OR CONCERNS ABOUT MY RIGHTS AS A PARTICIPANT?If you have any concerns or complaints about your rights as a research participant and/or your experiences while participating in this study, contact the Research Participant Information Line in the University of British Columbia Office of Research Services by e-mail at RSIL@ors.ubc.ca or by phone at 604-822-8598 (Toll Free: 1-877-822-8598).PARTICIPANT CONSENTDETERMINING THE OPTIMAL FINGER FOR HYPERTENSION AND PREECLAMPSIA ASSESSMENT USING PULSE OXIMETER COLLECTIONMy signature on this consent form means:I have read and understood the information in this consent form. I have had enough time to think about the information provided.I have been able to ask for advice if needed.I have been able to ask questions and have had satisfactory responses to my questions. I understand that all of the information collected will be kept confidential and that the results will only be used for scientific purposes.I understand that my participation in this study is voluntary.I understand that I am completely free at any time to refuse to participate or to withdraw from this study at any time, and that this will not change the quality of care that I receive.I authorize access to my health records as described in this consent form. I understand that I am not waiving any of my legal rights as a result of signing this consent form. I will receive a signed copy of this consent form for my own records.I consent to participate in this study.SIGNATURES:___________________ ____________________ ___________________________Participant’s Signature Printed name Date [dd/mmm/yyyy]Time [hh:mm]___________________ ____________________ ______________ _____________Signature of Person Printed name Study Role Date [dd/mmm/yyyy]Obtaining Consent ................
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