(AES) Data Registry

CONSENT AND RESEARCH AUTHORIZATION TO DONATE PAST AND FUTURE DATA FOR

RESEARCH PURPOSES

Office of Assessment and Evaluation Studies

Title: Assessment and Evaluation Studies (AES) Data Registry

Principal Investigator : Paul Mazmanian, PhD

VCU IRB NO.: HM20002166

If any information contained in this consent form is not clear, please feel free to contact Dr. Paul Mazmanian

(pemazman@vcu.edu) or Ms. Nital P. Appelbaum (npappelbaum@vcu.edu). You may take home an unsigned copy of this consent form to think about or discuss with family/friends before making your decision. You will be emailed a copy of this consent form for your records to your VCU email address.

You are invited to be part of this registry because you are a medical student or physician and participate in educational offerings for healthcare professionals.

Note to Residents/Physicians

Your employer will not be aware of who is or is not providing data for the registry. For quality improvement purposes, faculty and administrators may be provided with aggregate results in order to improve their educational methods and courses.

Note to Medical Students

Faculty members with grading or other influences on your academic standing will not be aware of who is or is not providing data for the registry. Likewise, they will not have direct access to the data registry and will not have access to any identifiers. For quality improvement purposes, faculty may be provided with aggregate results in order to improve their educational methods and courses.

Data Donation

You are invited to donate your past and future data to be stored in a registry where it can be used for future research projects and quality improvement efforts. The data registry is a method to store data; research data will be generated through independent studies approved by the IRB. Your consent to participate in the independent studies is not contingent to your consent to participate in the data registry. If you consent to participate in the data registry, your data from past and future IRB approved research studies will be stored in the data registry.

Your consent to participate in this registry allows us to store your data (see Page 3 for a detailed list of types of data) in a central database administered through the VCU School of Medicine Office of Assessment and

Evaluation Studies. Some of the data may be accessed directly through the data source (e.g., registrar) with your permission.

What is a Data Registry

A data registry is a collection of information related to a broad research area. It can be collected from a small or large number of researchers. The data can come from a single department or national/international sites.

Researchers who wish to use the data in the registry must apply and be approved by the Registry Review Panel.

If approved, coded data pertaining to the applicant’s research aim is provided. When the applicant’s research is done, the coded data they received is destroyed and their findings are contributed back to the data registry. The applicant may or may not publish results, with or without acknowledgement of the AES Data Registry.

Version 1/August 2014 Page 1 of 10




There is no known research data registry on the professional development of medical students, residents, and physicians. Your participation will be informative of how individuals like yourself progress through the continuum of professional development including medical school, residency and ongoing medical practice .

Purpose of this Data Registry

The data collected in this registry will be used by researchers/educators to increase understanding of the professional development of physicians throughout their education, training experiences, and medical practice.

The ultimate goal of this registry is to improve the lifelong learning and educational offerings for medical students, residents, and physicians.

Examples: o Identify knowledge gaps in medical education. o Tailor curriculum to address attitudes associated with better patient safety. o Identify psychological factors that influence professional development (e.g., psychological safety, patient safety attitudes, turnover, burnout, depression, etc.) o Improve current tests and measurements by evaluating constructs throughout time compared to one instance in time.

To decide whether you wish to donate your information for future studies, you should know about the possible risks and benefits in order to make an informed decision. This form gives you information about the research data registry and how the data may be used. Once your questions are answered about the data donation, storage, and usage process, you will be invited to take part in the registry and sign this form.

What Types of Data will be Stored in the Registry?

Several types of data from various sources will be stored in the data registry throughout your professional development. The type of data accessible to the research team is contingent largely upon your permission.

There may be data that already exist through your prior participation in research studies depending on your class year. If you consent to be a part of the data registry, these past data will be transferred into the data registry. Some examples of IRB approved studies with your data within the school of medical may include:

IRB Number

HM20000378

HM20001106

Study Name

Understanding patient safety attitudes and perceptions about error reporting behaviors across professions: Evidence to support more effective education

Using Levels of Confidence and Commitment to Evaluate Interprofessional Education in Continuing

Professional Development

HM12896 Assessing Patient Safety Perspectives of Medical Students

HM20001719 Assessing the Impact of a Web-Based Case System

HM20000945 Practice based learning to achieve systems based practice

HM14728 Comparative Outcomes of Interprofessional Education

HM13941 Team Process in Interprofessional and Co-Managed Care

HM14699 Understanding the influence of an IPE case series

Understanding the Influence of Team Based Learning Interventions to Student Teamwork Attitudes and

HM14593

Performance

HM14278 Interprofessional Education Competency of a Health Science Campus

HM14960 Multi-Institution Comparison of Interprofessional Education Competency





Below you will see a table that details potential data sources and types of data that have the potential to be stored in the data registry. Please be aware that some of these types of data may be considered private or confidential. You may elect to not share sensitive or private data by skipping any self-report items in future studies. Likewise, you can contact Dr. Paul Mazmanian and request particular data is omitted from the data registry. The data in the registry is coded and not identifiable, and your responses will only be accessible by select and necessary researchers to ensure confidentiality.

DURING MEDICAL SCHOOL

DATA SOURCE

Medical School

Registrar Office

Medical School

(Curriculum

Office &

Simulation Lab)

Independent

Studies

TYPES OF POTENTIAL DATA

Examples: medical school application data (e.g., MCAT scores, activities, personal statement), standardized test scores (e.g., MCAT, NBME), GPA (undergraduate and graduate), demographic information, transcript data (e.g., course grades, clerkships), matriculation and enrollment data, performance measures (e.g., Medical Student

Performance Evaluation, letters of recommendation, clerkship evaluations), residency match data, etc.

Examples: personality inventory, research, residency application materials, clinical experiences, match data, disciplinary actions, performance measures, research participation, simulation performance ratings, simulation coding, AAMC survey data,

Pivio portfolios, etc.

Examples: program evaluation of grant projects (e.g., Institutional Research and

Academic Career Development Award (IRACDA), Initiative for Maximizing Student

Development Program (IMSD), and Maximizing Access to Research Careers (MARC)); survey/assessment data on: beliefs/values/knowledge/attitudes/skills (e.g., career choices, interests in practice location, marital status, work/life balance, satisfaction, burnout, stress, salary), individual differences, board scores, etc.

Health System

Examples: quality of participant notes in Cerner, quality of participant handoff notes in

RAM Cores tool, etc.

Professional

Groups

Examples: AAMC’s career assessment data, etc.

Residency

Department

DURING RESIDENCY

Examples: board scores, performance measures, research participation, simulation performance ratings, simulation coding, CME/conference participation, fellowship applications, placement after residency, disciplinary actions etc.

Medical School

Curriculum Office

Examples: physician licensing data, alumni data, etc.

Independent

Studies

Examples: survey/assessment data on beliefs/values/knowledge/attitudes/skills (e.g., career choices, interests in practice location, marital status, work/life balance, satisfaction, burnout, stress, salary), individual differences, board scores, etc.

Professional

Groups

Examples: ACGME’s residency survey data, Pivio portfolios, etc.

DURING PRACTICE

Medical School

Curriculum Office

Examples: physician licensing data, alumni data, Pivio portfolios, etc.

Independent

Studies

Examples: survey/assessment data on beliefs/values/knowledge/attitudes/skills (e.g., career choices, interests in practice location, marital status, work/life balance, satisfaction, depression, burnout, stress, salary), individual differences, board scores, etc

Public Records Examples: malpractice cases, NPI Registry data (e.g., practice location), etc.





How your Data Gets Into the Data Registry

The research data that you donate for this research study will be put into the data registry with a unique code generated by REDCap. Your data will be linked to the unique code by your student or employee ID (e.g., V

Number) during medical school, and name or other provider identifier post-medical school. The code sheet that links the unique code and your personal identifier will be stored separately from REDCap.

How Your Data Is Stored and Used for Future Research

The researchers who are responsible for entering and protecting your information in the database will use your information to better understand the development of medical students, residents, and physicians throughout their education, training experiences, and medical practice. The ultimate goal of this registry is to learn more about physicians as learners and to improve educational offerings for healthcare professionals.

When your data is stored, we are careful to protect your identity from discovery by others. Strict security safeguards are in place to reduce the chance of misuse or unplanned release of information. This registry will follow VCU data security policies and the laws of the Commonwealth of Virginia. The research team will keep the data registry secure and make appropriate updates as new guidelines for data storage are presented by VCU.

Researchers will use your information in a coded manner. “Coded” means that the researchers using your information will not know your identity. Researchers will use your information with a unique code instead of your actual identifier; the code would allow results of the research to be linked to your longitudinal data. The

Principal Investigator, Dr. Paul Mazmanian, will keep and maintain the “key” which will link your code number and your identifier. This key will be kept separate from the data registry on the VCU secure server that is password locked.

In the future, researchers and third parties outside of the AES data registry team may request access to the coded data. Both VCU internal and external requests for data will be evaluated thoroughly by the Registry Review

Panel. Data will only be shared in a coded manner. One or more identifiers may be shared to maintain scientific validity. For example, if a researcher would like to link his/her data with the data stored in the registry with the

National Provider Identifier, then we would have to provide that information for them. The Registry Review

Panel will only allow identifiers to be shared if they are needed to maintain scientific validity, and only the minimum required identifiers would be shared, excluding names.

Since many medical student participants will leave the VCU system post-graduation, you will be asked upon your exit from VCU whether the data registry researchers can contact you post-graduation to continue studying your professional development. Participants who indicate continued interest in the data registry will be occasionally asked to provide data or allow access to data. Similarly, if you leave medical school before completing your degree, you will also be asked whether the data registry researchers can contact you after you leave the institution to see what influenced your early departure from the medical field.

Your data will be stored for an unlimited amount of time, and may be used as a for-profit database. The forprofit database designation will allow us to maintain the database, increase outreach to researchers, and create a source of revenue for VCU research efforts. We expect that there will be widespread sharing of research findings but individual responses within the data registry will be confidential and only shared amongst the researchers in AES. The data registry will be housed in REDCap. No identifying information will be shared with people who supervise or grade you. Any reporting or release of data will ensure that no combination of demographics or information will reveal the identity of an individual.





Protected Health Information (PHI) Data

Some research questions may necessitate capture of participant data that is deemed protected health information. The PHI data will be collected through independent studies that have their own IRB approvals and consent process. If you choose to participate in an independent study in the future and consent to be a part of the data registry project, then your associated PHI data will be stored in the registry. For example, to study the prevalence of burnout and stress amongst medical residents, a research team may ask their participants to complete a survey that has depression and stress related items (e.g., “Have you experienced any depressive symptoms during medical school”). Subsequently, the research team will want to submit their data to the registry for participants who consented to be a part of the registry. In order for this type of PHI data to be stored in the data registry, we need your consent to allow self-reported PHI data to be stored in the registry. We will only store PHI that is self-reported by you. We will not store any data that goes into your health records or ask your health providers to disclose any PHI about you.

Authority to Request Protected Health Information

The following people and/or groups may request your Protected Health Information (coded):

• Principal Investigator and Research Staff

• Research Collaborators

• Institutional Review Boards

Authority to Release Protected Health Information

You are consenting to allow the following PHI data to be stored in the data registry (only the ones that are self-reported from the participant)

Types of Information that may be Released (coded with no names)

The following types of information may be used for the conduct of this research:

Complete health record

Diagnosis & treatment codes

Discharge summary

History and physical exam

Consultation reports Progress notes

Laboratory test results

Photographs,

X-ray reports X-ray films / images

Complete billing videotapes record

Information about drug or alcohol abuse

Information about psychiatric care Information about sexually transmitted diseases

Itemized bill

Information about Hepatitis B or C tests

Other (specify): self-report information about depression, stress, etc.

Right to Revoke Authorization and Re-disclosure of PHI

You may change your mind and revoke (take back) the right to use your protected health information at any time. Even if you revoke this authorization, the researchers may still use or disclose information they have already collected about you for this study. To revoke this Authorization, you must write to the

Principal Investigator, Dr. Paul Mazmanian at pemazman@vcu.edu

.





Family Educational Rights and Privacy Act (FERPA)

The Family Education Rights and Privacy Act of 1974 (FERPA) states that a student must authorize in writing the release of his/her educational records. In order for the data registry to access and store your educational record information (e.g., GPA, grades, etc.) you need to complete the VCU FERPA Consent to Release Form and turn it into the SOM Registrar’s office [McGlothlin Medical Education Center (MMEC), 1201 E Marshall

St., 4th Floor]. If you cannot return the form to the registrar in person, you will need to have the form notarized.

The records will be released to the AES research team--- Drs. Paul Mazmanian, Moshe Feldman, Deborah

DiazGranados, Kelly Lockeman, and Ms. Nital Appelbaum.

The records that may be released include medical school application data (e.g., MCAT scores, activities, personal statement), standardized test scores (e.g., MCAT, NBME), GPA (undergraduate and graduate), demographic information, transcript data (e.g., course grades, clerkships), matriculation and enrollment data, performance measures (e.g., Medical Student Performance Evaluation, letters of recommendation, clerkship evaluations), residency match data, etc.

The reason for storing educational record data in the data registry is to answer research questions to improve medical education. For example, a researcher can predict what types of educational experiences during undergraduate medical education predict success on USMLE Step 1 for various cohorts within the school of medicine. Likewise, a researcher can investigate how individual differences predict the types of clerkships that students gravitate towards in their third and fourth years of medical school to provide better career mentoring during the early years of medical school.

You may request a copy of the records disclosed for the data registry in REDCap by contacting Dr. Paul

Mazmanian, pemazman@vcu.edu.

Risks and Inconveniences

There are no physical risks to you for donating and storing your data for use in future research studies.

However, there is a risk of breach of confidentiality (see the confidentiality section on page 7 for an explanation of how your information is protected).

There is a risk that your information could be misused. The chance of this happening is very small. We have protections in place to lower this risk.

If any subject discloses that they may cause injury to themselves or others, the researcher is required by law to report that information to the appropriate authorities. Depending on the circumstances, the report may need to be made to the university, health system, police, or child/adult protective services.

Certificate of Confidentiality

Dr. Mazmanian is in the process of applying for a Certificate of Confidentiality in order to give greater protection to the research data.

What is a Certificate of Confidentiality (CoC)? It is an authorization from the Department of Health and Human

Services (DHHS) that helps researchers and their institutions safeguard the privacy of research participants enrolled in sensitive biomedical and behavioral research by protecting against compulsory legal demands such as subpoenas for identifying information.





“Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. By protecting researchers and institutions from being compelled to disclose information that would identify research subjects,

Certificates of Confidentiality help achieve the research objectives and promote participation in studies by helping assure confidentiality and privacy to participants” [http://grants.nih.gov/grants/policy/coc/index.htm].

Confidentiality and Privacy

All identifiable information that is obtained in connection with the data registry will remain confidential and will be entered into the data registry through a unique code. Information about you will be protected through several security measures. Documents such as consent forms, surveys, and assessments will be stored in a locked cabinet in a locked office within a VCU protected building. The actual data registry will be stored on the

VCU approved REDCap database, and the code sheets that link participants to data within the registry will be stored separate from the registry on a VCU protected server. Electronic surveys completed outside of REDCap

(e.g., Qualtrics, etc.) will be uploaded to the REDCap data registry database to ensure secure data storage. Only select and necessary members of the data registry team will be able to identify your information with the code sheet. Access to de-identified and coded data may be granted for research purposes to investigators outside of the data registry research team; however, the requesting group must have their institution’s IRB approval for their study and submit an application that outlines their research plan and protocols/procedures to keep the data secure. When the results of future research are published or discussed in conferences, no information that would reveal your identity will be included unless your specific consent is obtained.

We will not tell anyone the answers you give us; however, information from the study and the consent form signed by you may be looked at or copied for research, monitoring, or legal purposes by Virginia

Commonwealth University. Personal information about you might be shared with or copied by authorized officials of the Department of Health and Human Services (if applicable). If researchers request and are authorized to receive data and the research is conducted in foreign countries, personal information pertaining to you may be shared or copied by authorized agents of governmental agencies in those countries.

What we find from this study may be presented at meetings or published in papers, but your name will never be used in these presentations or papers. Research results will not be returned to you.

Benefits

VCU participants may request access to view their data within the data registry by contacting Dr. Paul

Mazmanian at pemazman@vcu.edu. The tracking feature of the data registry allows participants to reflect on their professional development throughout various milestones. This type of insight into one’s professional journey may be of interest and beneficial to VCU participants. Non-VCU participants cannot request to view their data within the data registry, at this time. Currently, the data registry team cannot securely verify the identity of non-VCU individuals who request to view their data.

Donating your data for research will not help you directly. We do hope the research results will help better medical education and practice in the future. We hope that the information we learn in future research studies will increase our knowledge of the development of medical students and residents throughout their education, training experiences, and medical practice.





Economic Considerations

You will not receive any compensation for donating your research data into the research data registry. Your data will only be used for research and improving educational efforts. There is a possibility that this registry may charge researchers for sharing large data sets in the future. If this happens, there is no plan to share any financial benefit with you. Any financial revenue will be reinvested in securing and maintaining the registry

(e.g., staffing, information technology, etc.).

Voluntary Participation and Withdrawal

Your participation is completely voluntary. Contributing to the registry (or not contributing) will not affect your evaluations, student/class status, or employee status. You are free to choose not to donate your data to research.

If you do choose to provide your data you are free to change your mind at any time, but the researchers may still use the information collected before you changed your mind in order to complete the research that has already started.

If you choose to withdraw from the registry, the researchers will anonymize the data by removing and destroying all identifiers and links to identifiers so that it cannot be associated with you, but the researchers will not destroy the data.

This form and your permission will never expire unless you change your mind and withdraw it. To withdraw your permission to use your information, please write to: Dr. Paul Mazmanian, Associate Dean for Assessment and Evaluation Studies, School of Medicine, 730 East Broad Street, Richmond, VA; (804) 828-0492; pemazman@vcu.edu.

Privacy Rights

The information that we gather about you in this study is personal. The researchers are required by law to protect the privacy of information known as protected personal information (PPI). All reasonable efforts will be made to protect the confidentiality of your PPI, which may be shared with others to support this research and to comply with the law as required. Despite these protections, there is a possibility that information about you could be used or disclosed in a way that it will no longer be protected.

By signing this form, you give permission for the researchers to store, use, and/or disclose the information in this research database. You have a right to refuse to sign this form. Your education will not be affected if you do not sign this form. Information about you gathered during professional life and education will not be placed into the research data registry described in this form or used for future research if you do not sign this form.

You do not give up any of your legal rights by signing this form.

Thank you very much for your consideration in being a part of the Assessment and Evaluation Studies

Data Registry.





QUESTIONS

We have used some technical terms in this form. Please feel free to ask about anything you do not understand and to consider this donation of information and the consent form carefully – for as long as you feel is necessary

– before you make a decision.

If you have any questions, complaints, or concerns about your participation in this research, contact:

Dr. Paul Mazmanian

Associate Dean for Assessment and Evaluation Studies

School of Medicine

730 East Broad Street

Richmond, VA

(804) 828-0492 pemazman@vcu.edu

Secondary Contact (Researcher)

Nital P. Appelbaum

804.827.1856 npappelbaum@vcu.edu

Contact the individuals listed above if you have questions about your participation in this study. They are also the contacts if you wish to withdraw from the data registry.

If you would like to talk with someone other than the researchers to discuss problems, concerns, and questions you may have concerning this research, or to discuss your rights as a research subject, you may contact

(reference IRB # HM20002166 ) :

Office of Research

Virginia Commonwealth University

800 East Leigh Street, Suite 3000

P.O. Box 980568

Richmond, VA 23298

Telephone: (804) 827-2157

THE SUBJECT OR HIS OR HER PERSONAL REPRESENTATIVE MUST BE PROVIDED WITH A

COPY OF THIS FORM.





RESEARCHER COPY ADDENDUM

TEAR OFF THIS PAGE AND PLACE IT IN THE ENVELOPE

Authorization

I have read (or someone has read to me) this Consent and Authorization Form to donate research data for future research purposes and have decided to donate my data to the VCU School of Medicine Office of Assessment and Evaluation Studies (AES) Data Registry. I also allow AES to use any data collected prior for research purposes to contribute that data into the AES data registry. The general purposes of this donation, the particulars of my involvement and possible hazards and inconveniences have been explained to my satisfaction. By signing and dating below, I give permission for the described uses and disclosures of my information. I understand I will be emailed a copy of this consent form for my records to my VCU email address.

CHECK ONE:

___ Yes, I do wish to donate my past and future data to the VCU School of Medicine Office of Assessment and Evaluation Studies (AES) Data Registry with the broad aim of improving the professional life and educational offerings for medical students, residents, and physicians.

_______________________________________

Signature of Subject

__________________

Date

_______________________________________ eID or Employee ID of Person giving Consent

_______________________________________

Print Name of Subject

___________________

Date

___________________

Date

___ No, I do not wish to donate my research data to the VCU School of Medicine Office of Assessment and

Evaluation Studies (AES) Data Registry for research.

_______________________________________

Print Name of Subject

___________________

Date

_______________________________________ eID or Employee ID of Person giving Consent

___________________

Date

***This section will be filled out by AES Data

Registry Staff

________________________________________

Signature of Person Obtaining Consent

________________________________________

Signature of Consent Witness (if applicable)

________________________________________

___________________

Date

___________________

Date

___________________

Signature of Principal Investigator if different than above Date


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