Your Name
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First, Last
What School/College are you a part of?
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College of Health Professions College of Engineering College of Humanities and Sciences School of the Arts School of Business School of Dentistry School of Education Honors College L. Douglas Wilder School of Government and Public Affairs Richard T. Robertson School of Media and Culture School of Medicine School of Nursing School of Pharmacy School of Social Work School of World Studies VCU Graduate School VCU Life Sciences University College Other
If "other" selected above, please enter which school/college/unit you are a part of
Email address
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Project Working Title
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Provide a name/title for your project
provide the HM# of your IRB submission, if you have one
My research project involves or may involve the following Social/Behavioral/Education research considerations:
My research involves or may involve the following biomedical research considerations:
My research involves or may involve any of the following VCU Health system-related considerations:
My research involves or may involve the following IRB/regulatory considerations:
CITI Training VCU requires all investigators and research staff to have current CITI training in either biomedical or social/behavioral research, completed through their VCU affiliation in CITI. This means you may need to re-complete CITI training modules through your VCU affiliation, even if you have completed the training at a previous institution.
Learn more about VCU's CITI Training requirements at this webpage:
https://research.vcu.edu/training/citi-training/
Data Classification and Data Management Plan All data at VCU is required to be classified as Category I, Category II, or Category III data using the Data Classification Tool: https://redcap.vcu.edu/surveys/?s=mF448s6hYI
Category I data will require the creation of a Data Management Plan (DMP). DMPs are made using the Data Management System (DMS). In addition, even when a DMP is not required, the DMS is a helpful tool that can assist in identifying acceptable methods of storing, managing, and processing data.
More information can be found on IT's DMS webpage:
https://ts.vcu.edu/about-us/information-security/data-management-system/
Protocol Review and Oversight Committees (PROCs) You may be required to submit your research protocol to a Protocol Review and Oversight Committee (PROC). Currently, all research utilizing VCUHS patients, facilities, and/or data is required to undergo PROC review. The purpose of PROCs is to conduct scientific and feasibility reviews of proposed research projects.
Learn more about how to submit to a PROC, which PROC to submit to, and what to do if there isn't a PROC for your research area at the VCU ONETRAC website:
https://onetrac.vcu.edu/
If there is not a PROC for your area of research, email Mary Harmon at mary.harmon@vcuhealth.org for guidance on next steps. A copy of this correspondence with Mary may be required to be submitted to the VCU IRB to document the lack of PROC review.
Office of Sponsored Programs (Grants/Contracts) Grants/contracts and other funding sources go through the Office of Sponsored Programs (OSP). Go to the OSP website to learn more about them and how they can help you.
https://research.vcu.edu/proposals-and-awards/
Office of Sponsored Programs (DUAs and MTAs) When transferring data to or receiving data from another institution, usually a Data Use Agreement (DUA) is required. Likewise, for transferring samples/specimens, a Material Transfer Agreement (MTA) is usually required.
Go to the OSP website to learn more about how to get these agreements in place. You can also email mtadua@vcu.edu
https://research.vcu.edu/proposals-and-awards/
Institutional Biosafety Committee (IBC) If your research involves "biohazardous agents" then you will likely need to submit to the Institutional Biosafety Committee (IBC).
More information on what is considered a "biohazardous agent" and what the processes and procedures are for IBC review can be found on OVPRI's regulatory committees website, under the IBC accordion on the page.
https://research.vcu.edu/integrity-and-compliance/compliance/regulatory-committees/
Radiation Safety Committee (RSC) If your research involves administration of ionizing radiation that is not for clinical purposes, or which exceeds a standard of care dose, you will likely need to submit to the Radiation Safety Committee, or RSC.
You can find more information on the RSC, when you must submit to them, and points of contact for the committee on OVPRI's regulatory committees website, under the RSC accordion.
https://research.vcu.edu/integrity-and-compliance/compliance/regulatory-committees/
Massey Cancer Center Protocol Review and Monitoring Committee (PRMC) Review by the Massey Cancer Center PRMC is required when your research involves:
Research involving patients with cancer, their families or their health care providers Research involving cancer screening, diagnosis or prevention Secondary data collected from cancer patients or their medical records Cancer-related surveys (e.g., attitudes about risk, prevention and treatment) of the general population More information on requirements and processes for the PRMC can be found on the PRMC website:
https://www.masseycancercenter.org/research/protocol-review-and-monitoring-committee
ClinicalTrials.gov Projects meeting VCU's definition of "clinical trial" must be listed on ClinicalTrials.gov according to regulation. VCU's Wright Center's Research Navigator assists investigators in listing their clinical trials on ClincalTrials.gov.
Learn more about this requirement and request assistance at this website:
https://cctr.vcu.edu/support/consultation/clinical-trials-gov/
OnCore (Clinical Trials Management) OnCore is the enterprise-wide clinical research management system at VCU and VCU Health. The web-enabled system provides a centralized database for research teams and relies on role-based security to control study data access. You may be required to use OnCore for your clinical trial.
To learn more about OnCore and request assistance, visit this website:
https://cctr.vcu.edu/support/informatics/oncore/
FDA Regulatory Program VCU supports an FDA regulatory program that specifically supports investigators with Investigational New Drug (IND) applications, and Investigational Device Exemption (IDE) applications.
Learn more at the FDA regulatory program website:
https://research.vcu.edu/human-research/fda-regulatory-program/
You can also contact Lauren Kanigher, FDA Program Manager, at indide@vcu.eu
Investigational Pharmacy Services VCUHS has an investigational pharmacy that assists with the dispensing of investigational products for research use. Use of the investigational pharmacy is generally required, for both inpatient and outpatient research. If an exception is granted, then a Drug Management Plan must be devised with the Investigational Pharmacy and this plan must be included in the IRB submission.
Learn more at this website:
https://cctr.vcu.edu/support/clinical-research-service-providers/investigational-drug-pharmacy/
Informatics The Wright Center offers informatics support for research, including bioinformatics, extracting clinical notes, etc. You may be required to go through the informatics service in order to collect health information from VCUHS medical records.
Learn more and request assistance on the informatics website:
https://cctr.vcu.edu/support/informatics/
Clinical Research Coverage Analysis Coverage analysis is the process of evaluating each clinical research study to:
Determine if a clinical study qualifies for coverage of "routine care" costs in accordance with the requirements of Medicare and the U.S. Patient Protection and Affordable Care Act Document the appropriate responsible payer (i.e., third-party payer or study sponsor) of each study related clinical service/item Develop a comprehensive billing plan which supports compliance with essential reporting and clinical billing requirements throughout the conduct of a clinical study VCU requires a Coverage Analysis Screening Form for each clinical research study to document whether a coverage analysis is required for a particular study.
Learn more at the Clinical Research Coverage Analysis website:
https://research.vcu.edu/human-research/clinical-research/vcu-clinical-research-coverage-analysis/
FERPA/Records and Registration The Family Education Rights and Privacy Act (FERPA) governs the use of student records in educational institutions, similar to how HIPAA regulates health information at health care institutions. If your project involves using VCU student records (grades, assignments, student data, etc.) then you must go through Records and Registration (rar@vcu.edu ) to be assigned a FERPA "pathway" and to access the information you require.
Correspondence between the researcher and Records and Registration should be uploaded to the IRB application to document the assigned FERPA pathway.
Learn more at the Registrar's website:
https://rar.vcu.edu/records/family-educational-rights-and-privacy-act/
If you are working with student records at a non-VCU educational institution, you must work with that institution to follow their processes for managing FERPA data.
VCUHS Department of Patient Centered Services If your study involves specifically a satisfaction survey administered to VCUHS patients, you must submit the survey and the IRB HM# to the Director of Patient Experience, VCUHS Department of Patient Centered Services at nathan.cunningham@vcuhealth.org
A copy of the VCUHS screening determination for each survey is to be uploaded to RAMS-IRB.
Questions regarding this requirement should be referred to Nathan Cunningham, Director of Patient Experience, VCUHS Department of Patient Centered Services at 804-628-1795 or nathan.cunningham@vcuhealth.org
VCUHS Department of Pathology If your research will involve samples/specimens accessed from or processed by the VCUHS department of pathology, you must make arrangements for such access or processing.
Learn more at the VCUHS department of pathology website:
https://pathology.vcu.edu/research/
IRB Reliance Research that involves collaboration with non-VCU sites and research which is conducted at VCU but uses an external IRB for review (i.e.: WCG IRB, Advarra, or another academic institution's IRB) may require special forms, agreements, or procedures in alignment with IRB Reliance requirements.
Learn more about IRB reliance and request assistance at this website:
https://research.vcu.edu/human-research/hrppirb/irb-reliance/
Letters of Support If your research involves K-12 settings, the school with which you are working may have certain policies or procedures you must follow in order to conduct research in the school. You may also require a letter of support from the school prior to initiating your research.
Likewise, if you are utilizing equipment, resources, or personnel from a unit at VCU that is outside your own, you should seek a letter of support from that unit to ensure you will be able to use the equipment, resources, or personnel needed.
If you are working with a community organization, again, a letter of support may be necessary in order to ensure the community organization is able and willing to support the research.
Data Management System (DMS) All data at VCU is required to be classified as Category I, Category II, or Category III data using the Data Classification Tool: https://redcap.vcu.edu/surveys/?s=mF448s6hYI
Category I data will require the creation of a Data Management Plan (DMP). DMPs are made using the Data Management System (DMS). In addition, even when a DMP is not required, the DMS is a helpful tool that can assist in identifying acceptable methods of storing, managing, and processing data.
More information can be found on IT's DMS webpage:
https://ts.vcu.edu/about-us/information-security/data-management-system/
Research Navigation The Wright Center offers research navigation services, which includes:
Turning research ideas into studies Research start-up Starting data collection Managing ongoing studies Finishing and closing studies Learn more and request assistance on this website:
https://cctr.vcu.edu/support/research-navigation/
Consent Form Templates VCU offers templates for consent forms (both biomedical and social/behavioral), assent forms for children, templates for information sheets, and templates for specific types of consent forms (i.e.: registry/repository consent form).
Access these and other template documents on the HRPP's Forms page:
https://research.vcu.edu/forms/#d.en.412604
College of Health Professions In the College of Health Professions, the following individuals may be helpful contacts:
Director of Research Administration
Email: brmorris@vcu.edu
Shoou-Yih "Daniel" Lee, PhD Senior Associate Dean For Research and Strategic Initiatives
Email: leesd@vcu.edu
College of Engineering In the College of Engineering Professions, the following individuals may be helpful contacts:
Director of Sponsored Programs
Email: actankesley@vcu.edu
College of Humanities and Sciences In the College of Humanities and Sciences Professions, the following individuals may be helpful contacts:
Grant Research Administrator
Email: leveys@vcu.edu
Associate Dean of Research and Operations
Email: dpmays@vcu.edu
Phone: (804) 828-4623
Grant Research Administrator (Post-Award)
Email: perkeybilem@vcu.edu
School of the Arts In the School of the Arts Professions, the following individuals may be helpful contacts:
Grants and Financial Analyst
Email: tadunlap@vcu.edu
Faculty Liaison for Research, Associate Chair, Dance and Choreography
Email: lemarshall@vcu.edu
Phone: (804) 828-1711
Faculty Liaison for Arts and Health Projects, Associate Chair for Theatre
Email: adanderson@vcu.edu
Phone: (804) 828-6741
Coordinator, Arts Research
Email: tlleipold@vcu.edu
Phone: (804) 828-2713
School of Business In the School of Business Professions, the following individuals may be helpful contacts:
Director of Research
Email: dddavis@vcu.edu
Director, Finance and Research Administration
Email: cmtam@vcu.edu
School of Dentistry In the School of Dentistry Professions, the following individuals may be helpful contacts:
Director of Clinical Research
Email: sbencharit@vcu.edu
Phone: (804) 628-6486
Director of Research Managment and Postgraduate Research Programs and Associate Professor
Email: oloughran@vcu.edu
Phone: (804) 828-3910
School of Education In the School of Education Professions, the following individuals may be helpful contacts:
Director of Research Services, Office of Research and Faculty Development
Email: jgalcaine@vcu.edu
Phone: (804) 828-2009
Kathleen M. Rudasill, Ph.D. Senior Associate Dean for Research and Faculty Affairs
Email: kmrudasill@vcu.edu
Phone: (804) 827-9337
Grants Fiscal Analyst, Office of Finance
Email: wldawson@vcu.edu
Phone: (804) 827-6847
L. Douglas Wilder School of Government and Public Affairs In the School of Government and Public Affairs Professions, the following individuals may be helpful contacts:
Associate Dean of Research and Outreach and Associate Professor
Email: rdmcdougle@vcu.edu
Phone: (804) 828-2759
Director of Research and Outreach, Center for Public Policy
Email: keeganbs@mymail.vcu.edu
Phone: (804) 827-3404
Senior Research Director, Survey and Evaluation Research Laboratory
Email: mmoore@vcu.edu
Phone: (804) 827-4226
Director, Survey and Evaluation Research Laboratory
Email: jmellis@vcu.edu
Phone: (804) 828-2839
School of Medicine In the School of Medicine Professions, the following individuals may be helpful contacts:
Fadi N. Salloum Ph.D., FAHA Associate Chair for Research
Email: fadi.salloum@vcuhealth.org
Phone: (804) 827-2340
Richard Sterling, MD, MSc, FACG, AGAF, FAASLD Assistant Chair for Research
Email: richard.sterling@vcuhealth.org
Phone: (804) 828-4060
Rashmi Pershad, MPhil, CCRP, CRA Associate Administrator of Research
Email: rashmi.pershad@vcuhealth.org
School of Nursing In the School of Nursing Professions, the following individuals may be helpful contacts:
Associate Dean of Research
Email: salisburya@vcu.edu
Phone: (804) 828-2095
Assistant Dean for Research and Endowed Professor
Email: kinserpa@vcu.edu
Phone: (804) 828-9140
Pre-Award Business Manager
Email: cikyrus@vcu.edu
Phone: (804) 828-3221
Research Administrator
Email: elseward@vcu.edu
Phone: (804) 828-5151
School of Pharmacy In the School of Pharmacy Professions, the following individuals may be helpful contacts:
Associate Dean for Research and Graduate Studies Dean's Office
Email: alichtma@vcu.edu
Phone: (804) 628-5233
Contract and Grant Administrator Dean's Office
Email: ksdavis2@vcu.edu
Phone: (804) 828-3531
Contract and Grant Administrator Dean's Office
Email: ljones8@vcu.edu
School of Social Work In the School of Social Work Professions, the following individuals may be helpful contacts:
Associate Dean of Research and Professor
Email: cuddebackg@vcu.edu
Phone: (804) 828-7166
