Registration

CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY

STUDY TITLE: Sustaining and Training for Resilience, Engagement and Meaning

PRINCIPAL INVESTIGATOR: Dr. John Mahan

CONTACT TELEPHONE NUMBER: 615-722-4462

STUDY SPONSOR: Health Services and Resources Administration

1) INTRODUCTION
We invite you to be in this research study. Using this form as a guide, we will explain the study to you. If you have any questions about the study, please ask. If you do not want to be in this study, all regular and standard medical care will still be available to you here at Nationwide Children’s Hospital. Participation is voluntary. You can leave this study at any time.

2) WHERE WILL THE STUDY BE DONE AND HOW MANY SUBJECTS WILL TAKE PART?
This study will be done at several sites, including Nationwide Children’s Hospital. Overall, 10,000 participants will take part in this study. We hope to enroll 1000 participants here at Nationwide Children’s Hospital.

3) WHAT WILL HAPPEN DURING THE STUDY AND HOW LONG WILL IT LAST?
The purpose of this study is to determine how training sessions impact physician and resident mental health, resilience, engagement and connecting to the meaning of their work. Study participation: Participants will fill out questionnaires every six months for the duration of the study. If participants enroll in the training program, they will attend up to 4 STREAM sessions ranging from 60-90 minutes. They will have access to additional optional asynchronous virtual material.

4) WHAT ARE THE RISKS OF BEING IN THIS STUDY?
The risks for this study are no more than what happens in everyday life. Although we will take every precaution, there is a small chance of loss of confidentiality of your study information. No identifiable information will be recorded. This study involves questions or surveys that may make you feel depressed. You should call the Principal Investigator at 614-722-4462 if you notice any changes in your mood, ideas, or behavior. Immediate help is available if thoughts or feelings of hurting oneself come up. Call one of the numbers below or go to the closest Emergency Room.

Nationwide Children’s Psychiatric Emergency Evaluation Center   614-722-1800
Hopeline/Lifeline – 1-800-784-2433 or 1-800-SUICIDE

Although we will take every precaution, there is a small chance of loss of confidentiality of your study information. There may be other risks of being in this research study that are not known at this time.

5) ARE THERE BENEFITS TO TAKING PART IN THIS STUDY?
1.1 Although there may be no benefit to you from being in this study, we hope to learn something that could help others. If you are faculty, you will be eligible to for up to 6 hours of CME. You will also be eligible for up to 6 hours of MOC part 2 credit. Participants who complete the 6 month follow up surveys will be sent a promotional item of their choosing (t-shirt, hat, water
bottle, travel mug or notebook).

6) WHAT ARE THE COSTS AND REIMBURSEMENTS?
There are no costs to participate.

7) WHAT HAPPENS IF I DO NOT FINISH THIS STUDY?
It is your choice to be in this study. You may decide to stop being in this study at any time. If you stop being in the study, there will be no penalty or loss of benefits to which you are otherwise entitled. If at any time the Principal Investigator believes that this study is not good for you, the study team will contact you about stopping.

8) OTHER IMPORTANT INFORMATION
If you are an employee of Nationwide Children’s Hospital or the Research Institute at Nationwide Children’s Hospital, your job or performance appraisal will not be affected in any way if you decline to participate or withdraw your consent to participate in this study.

The Principal Investigator is being paid by Human Resources and Services Administration for the time and knowledge needed to do this study.

Nationwide Children’s Hospital is a teaching hospital and we are committed to doing research. Doing research will enable us to learn and provide the best care for our patients and families. You may be asked to participate in other research studies in the future. You have the right to decide to participate or decline to participate in any future studies. We will not share your contact information with researchers outside Nationwide Children’s Hospital.

9) HOW WILL MY STUDY INFORMATION BE KEPT PRIVATE?
Efforts will be made to keep your study-related information confidential. However, there may be circumstances when this information must be released. For example, personal information regarding your participation in this study may be disclosed if required by state law. The results from this study may be published but your identity will not be revealed. Some of the information collected as part of this study will be sensitive, such as information relating to your mental health. This information will be encrypted in a way that it will not be able to be linked to you. The results from this study may be published but your identity will not be revealed.

10) WHOM SHOULD I CALL IF I HAVE QUESTIONS OR PROBLEMS?
If you have questions about anything while on this study or you have been injured by the research, you may contact the Principal Investigator at 614-722-4462 Monday – Friday, between 9-5 EST. If you have questions, concerns, or complaints about the research; if you have questions about your rights as a research volunteer; if you cannot reach the Principal Investigator; or if you want to call someone else, call (614) 722-2708, Nationwide Children's Hospital Institutional Review Board, (the committee that reviews all research involving human subjects at Nationwide Children’s Hospital).

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