T2D Reversal Case Series
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Informed Consent for:
Submission of a Case Report to the American College of Lifestyle Medicine’s Case Series on Type 2 Diabetes Reversal

Title:
Reversal of Type 2 Diabetes Case Series

UNE IRB #:
19.12.24-019

Principal Investigator (PI):
Micaela Karlsen, PhD
Research Director, American College of Lifestyle Medicine
Adjunct Faculty, Masters Programs in Applied Nutrition and Global Public Health, University of New England
 
Introduction:
You are being asked to consider submitting information from your patient’s medical history and related treatment for their illness as an anonymous case report in a series of case reports (case series) being collected by the American College of Lifestyle Medicine. Case reports and case series are typically used to share new unique information experienced by patients during his/her clinical care that may be useful for other physicians and members of a health care team. A case series may be published (in print or electronically) for others to read, and/or presented at a conference. This form explains the purpose of using your patient’s information for this case series. Please read this form carefully and take your time to make your decision and ask any questions that you may have.  
 
Why is this case series being done?
The purpose of this case series is to inform other physicians and researchers about the effectiveness of lifestyle changes in reversing type 2 diabetes and/or managing the disease. 
 
What will happen if I agree to submit a report for this case series?
You will use an electronic form, titled Patient Data Collection Form, hosted in QuestionPro, to submit information from your patient’s medical record to submit to the American College of Lifestyle Medicine (Micaela Karlsen) for writing academic reports on your patient’s disease presentation, course of treatment, and outcomes. You will be invited to submit a chronological account of your patient’s medical history of type 2 diabetes, which may include laboratory values, operative reports, pathology reports, and physician notes from the episodes of care related to your patient’s type 2 diabetes. 
 
Click here to download a Word document of the data requested in the Patient Data Collection Form
 
As a healthcare practitioner, you are obligated to protect your patient’s privacy and not disclose their personal information (information about the patient and their health that identifies them as an individual, e.g. name, date of birth, medical record number) when submitting your case report for the case series. When the case series is published or presented, your identity and your patient’s identity will not be disclosed. No photos or images that could identify you or your patient will be used.  
 
You will be asked to certify that you have collected a Patient Informed Consent Form from your patient granting permission for their medical history to be anonymously shared in this case series. However, this consent form containing your patient’s name must remain on file in your records and will not be shared with the American College of Lifestyle Medicine.

Click here to download a Word document of the Patient Informed Consent Form.
  
You are welcome to submit more than one case report. If you would like to do so, you will need to complete this informed consent form and the Patient Data Collection Form on the following pages for each patient’s case report separately. 
 
Risks:
Although your personal information that is collected or obtained will be kept confidential and protected to the fullest extent of the law, there is a limited risk associated with submitting this case report that it could result in a loss of confidentiality by virtue of the unique experience of your patient. 
 
Benefits:
You will not directly benefit personally from participating in this case report. The information that can be shared with other health care professionals, however, may improve the care that is received by others in the future. 
 
Allowing your patient’s information to be used in this case report will not involve any additional costs to you, nor will you receive any compensation. 

Voluntary Participation:
Whether to submit a report for this case series is your choice (voluntary). You may choose to take part, or not, and you may change your choice at any time. However, once the case series is written and published, it will not be possible for you to withdraw it. Your decision will not result in any penalty, loss of membership benefits in the American College of Lifestyle Medicine, or other benefits to which you are entitled. 
 
You will be informed about any new information relating to this case series that may affect you or your patient. 
 
Your signature below means that you have read the above information about this case report and series, and have had a chance to ask questions to help you understand how your information will be used, and that you give permission to allow your patient’s information to be used in this case report.  
 
If you have any questions, you may contact ACLM through Micaela Karlsen at mkarlsen@lifestylemedicine.org.
 
By signing this form, I confirm that: 
 
The case series, and the use of medical history for that, has been fully explained to me and all of my questions have been answered to my satisfaction.  

I have been informed of the risks and benefits, if any, of allowing my patient’s information to be used in this case series.I understand that I will not receive any compensation for participation in this case series.

I understand that my patient’s identifying information will not be shared with the American College of Lifestyle Medicine or the Investigators, and that efforts will be made to conceal their identify, but that full anonymity cannot be guaranteed.

I have been informed that I do not have to participate in this case series, and this refusal will not affect my status or benefits from the American College of Lifestyle Medicine in any way.

I have read each page of this form.

I give consent for the material I share in this case report to be shown to appropriate health care professional staff, and published in educational publications, journals, textbooks in any form or medium anywhere in the world without time limit.

I understand that after submitting this case report, I may be contacted by the investigators for clarification or follow-up.

I certify that I have collected a signed Patient Informed Consent Form for this patient and am maintaining this document in my records.

I have agreed to submit this case report, in sound mind, and free of any duress. 

Click here to download a PDF copy of this consent form.
I agree to participate in this case series as described above:
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