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AKA: Using Learning Curves to Redefine Training Requirements in General Surgery

This page is for surgical trainees whose programs are participation in the Variability in Trainee Autonomy and Learning in Surgery (VITALS) Trial (Using Learning Curves to Redefine Training Requirements in General Surgery).

University of Michigan

Southern Illinois University


Northwestern University

University of Kentucky

Virginia Mason Medical Center

New Hannover Regional Medical Center

Guthrie Robert Packer Hospital

Consent Form Template:


INFORMED CONSENT FORM

“Using Learning Curves to redefine training requirements in General Surgery”

HUM00140685


Sponsored in part by the National Board of Medical Examiners’ Edward J. Stemmler Medical Education Research Fund.

 

Multi-Site Principal Investigator: Brian George, MD, MAEd, Assistant Professor of Surgery, University of Michigan

Site Principal Investigator: [NAME & AFFILIATION]

 

Study purpose:

We are conducting an educational study at several ACGME-approved General Surgery programs that are also members of the Procedural Learning and Safety Collaborative (PLSC) across the United States. The goal of the study is to create learning curves for General Surgery “Core” procedures, to develop evidence-based policy guidance on current case-number standards for graduation requirements. To create these learning curves, we will supplement data from the SIMPL app with local EMR and ACGME case-logs.


Voluntary nature of study:

SIMPL users who are residents at an ACGME-approved general surgery residency can take part in this study. We expect at least 308 people from at least 6 institutions will be participating in this research study, including approximately [INSERT NUMBER] people at [INSTITUTION NAME].

 

Taking part in this study is completely voluntary. You do not have to participate if you don't want to. You may also leave the study at any time. If you leave the study before it is finished, there will be no penalty to you, and you will not lose any benefits to which you are otherwise entitled. If you decide to leave the study before it is finished, please notify one of the persons listed under the “Contact Information” section below.


What is involved in study participation:

If you choose to participate in this study, you will be asked to continue to use the SIMPL app to evaluate the performance and autonomy of your operative experiences. In addition, your local EMR and ACGME case log will be queried for instances of you performing the most common general surgery operations. Any published data will be aggregated and anonymous.


Length and time of study participation:

As the smartphone app, SIMPL, is already being used at your institution for educational assessment and feedback purposes, completing evaluations is already part of your expected workload. Each evaluation takes from 15 seconds to 2 minutes, and your program director will likely ask you to rate at least 50% of your cases with SIMPL.


The data collection specific to this study is expected to last 2 years, but data may be collected on a rolling basis after that while you remain eligible for study participation.


Study risks and benefits:

You may not receive any personal benefits from being in this study. However, others may benefit from the knowledge gained from this study. Using SIMPL to improve interoperative feedback for residents can benefit all surgical trainees and instructors through increased appropriate autonomy and performance in the operating room.


There is a risk of breach of data confidentiality, which is inherent in any study involving identifiable data. Though the possibility is remote and the potential impact is unknown, the information that is gathered and combined as part of this study could be used to assess performance in such a way that could negatively affect your reputation, career, or future professional opportunities. This information is already collected as part of your training.


The researchers will work to minimize these risks and prevent unintended disclosure by keeping all data on secure, encrypted, and professionally managed servers and encrypted computers that meet or exceed HIPAA requirements for the protection of sensitive data. Data will only be seen by credentialed researchers and analysts on a need-to-know basis. Furthermore, all study team members with access to the participant lists will be required to sign a confidentiality agreement.


As with any research study, there may be additional risks that are unknown or unexpected. The researchers will tell you if they learn of important new information that may change your willingness to stay in this study.


Certificate of Confidentiality

This research will be covered by a Certificate of Confidentiality from the National Institutes of Health. The researchers with this Certificate may not disclose or use information, documents, or biospecimens that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a court subpoena, unless you have consented for this use. Information, documents, or biospecimens protected by this Certificate cannot be disclosed to anyone else who is not connected with the research except, if there is a federal, state, or local law that requires disclosure (such as to report child abuse or communicable diseases but not for federal, state, or local civil, criminal, administrative, legislative, or other proceedings, see below); if you have consented to the disclosure, including for your medical treatment; or if it is used for other scientific research, as allowed by federal regulations protecting research subjects.


The Certificate cannot be used to refuse a request for information from personnel of the United States federal or state government agency sponsoring the project that is needed for auditing or program evaluation by the SPONSOR which is funding this project or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA).  You should understand that a Certificate of Confidentiality does not prevent you from voluntarily releasing information about yourself or your involvement in this research. If you want your research information released to an insurer, medical care provider, or any other person not connected with the research, you must provide consent to allow the researchers to release it.


The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, state, or local law.


The Certificate of Confidentiality will not be used to prevent disclosure for any purpose you have consented to in this informed consent document.


Future use of identifiable data:

We would also like your permission to keep your identifiable data collected in the main study for use in future research, which may be similar to this study or may be completely different. You can take part in the main study even if you decide not to let us keep your identified data for future research. As with the main study, any published data will be in deidentified, aggregated form. For example, potential future uses may include, but are not limited to: storing your identifiable data in a HIPAA-compliant repository for medical education research and/or quality improvement, linking your identifiable data with other information such as other assessment results or Medicare claims data, or conducting future research on relationships between assessments of your residency performance and your practice after residency.


With appropriate permissions, your collected information may also be shared with other researchers here, around the world, and with companies.


Your identifiable private information may be stripped of identifiers and used for future research studies or distributed to another researcher for future research studies without additional informed consent.


Research can lead to new discoveries, such as new tests, drugs, or devices. Researchers, their organizations, and other entities, including companies, may potentially benefit from the use of the data or discoveries. You will not have rights to these discoveries or any proceeds from them.


Consent/Assent to Collect for Unspecified Future Research:

This project involves the option to allow the study team to keep your identifiable data for use in future research, while any published data will be in de-identified and aggregated form. I understand that it is my choice whether or not to allow future use of my data.


[  ] Yes, I agree to let the study team keep my data for future research.


[  ] No, I do not agree to let the study team keep my data for future research.



Contact Information:

Please contact the researchers listed below if you would like to obtain more information about the study, ask a question about the study procedures, report a problem, leave the study before it is finished, or express a concern about the study.


Multi-Site Principal Investigator: Brian George, MD, MAEd

E-Mail: bcgeorge@med.umich.edu
Telephone: (734) 936-9690


Site Principal Investigator: [NAME & AFFILIATION]

E-Mail: [EMAIL ADDRESS]


Study Coordinator: Hoda Bandeh-Ahmadi, PhD
E-Mail:  hba@med.umich.edu


You may also express a question or concern about a study by contacting the Institutional Review Boards listed below:

[SITE IRB NAME AND CONTACT INFORMATION]


University of Michigan Medical School Institutional Review Board (IRBMED)
2800 Plymouth Road
Building 520, Room 3214
Ann Arbor, MI 48109-2800
Telephone: 734-763-4768
Fax: 734-763-1234
E-Mail: irbmed@umich.edu


A copy of this form will be emailed to you.

You can also request copies of this form at any time by contacting the researchers listed above, contacting your program director, and/or visiting the PLSC website: [ URL for WEBPAGE ]


Consent/Assent to Participate in the Research Study:

By selecting “Yes, I Agree” below, I am attesting that: I understand the information printed on this form. I understand that if I have questions or concerns about the study or my participation as a research subject, I may contact one of the people listed in the “Contact Information” section (above). I freely give my consent to participate.


Yes, I Agree: [  ]                         No, I Decline to participate: [  ]








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