Researchers and Collaborators
Join our network of investigators and collaborators committed to improving health care for all.
High-quality and impactful research is built on a foundation of strong partnerships with regional leaders in health care innovation. Learn more about our process for establishing new studies, Virtua’s research policies, and how you can collaborate with us.
Please contact irb@virtua.org for applications, forms, templates, and guidance.
Research Process
The research intake process at Virtua begins at the IRB. Our comprehensive IRB applications are designed to capture information for all involved parties. This information is then passed on to relevant departments to ensure all legal, operational and IT requirements are met. The IRB review occurs in parallel. Once all requirements are met and the IRB review is complete the Official Notice of Approval is issued to the study team.
Conflict of Interest
One priority of our research is to manage conflict of interest for all involved parties. We provide the following resources to make a determination:
- Policies
- COI form for Investigators/ Co-Investigators
- COI form for study personnel
IRB Applications
Types of IRB Review
| Full Board | Expedited | Exempt | |
|---|---|---|---|
| Risk Level | Greater than minimal risk to participants | Not greater than minimal risk to participants | Minimal risk to participants |
| Categories | Not covered under other review categories | Fits one of the 7 expedited review categories | Fits one of the 6 exempt categories |
| Example | Interventions involving physical or emotional discomfort or collection of sensitive data | Biospecimen collection by noninvasive means; research with existing documents/record collected for non-research purposes in which participants are identifiable/deidentified | Research with totally deidentified record, anonymous surveys, no collection of PHI |
Additional Information
This application is intended only for studies that present Greater than Minimal Risk to participants. These are studies that involve interventions that can cause physical or emotional distress to the participant or collect sensitive data.
The following documents are required to complete the application.
- Signed Full Board Application
- Proposed informed consent
- Virtua HIPAA consent (if not included in the ICF)
- Relevant surveys, questionnaires, patients’ diaries, or data collection tools
- Investigator’s brochure, device manual or package insert, if applicable
- Participant recruitment procedures and materials, if applicable
For each investigator/co-investigator listed on the study application:
- Signed conflict of interest form
- Current curriculum vitae
- Verification of CITI Training
For Study Personnel
- Signed conflict of interest form
- Verification of CITI Training
*Vulnerable Populations
The vulnerable populations refers to but not limited to children, minors, pregnant women, fetuses, human in vitro fertilization, prisoners, employees, military persons and students in hierarchical organizations, terminally ill, comatose, physically and intellectually challenged individuals, institutionalized, elderly individuals, visual or hearing impaired, ethnic minorities, refugees, international research, economically and educationally disabled and healthy volunteers. If your study involves any vulnerable population, please download and submit Vulnerable Populations checklist with your IRB application.
This application is intended only for studies that either present no more than minimal risk to participants and fall into one of the expedited categories authorized by 46 CFR 46 and 21 CFR 56 or involve minimal risk to participants and fits one of the Exempt categories authorized by 45 CFR part 46, Subpart A.
The following documents are required to complete the application.
- Signed Expedited/Exempt application
- Paper Survey/Questionnaire Consent Template, if applicable
- Separate Data Collection Sheet, if applicable
For each investigator/co-investigator listed on the study application:
- Signed conflict of interest form
- Current curriculum vitae
- Verification of CITI Training
For Study Personnel
- Signed conflict of interest form
- Verification of CITI Training
*Vulnerable Populations
The vulnerable populations refers to but not limited to children, minors, pregnant women, fetuses, human in vitro fertilization, prisoners, employees, military persons and students in hierarchical organizations, terminally ill, comatose, physically and intellectually challenged individuals, institutionalized, elderly individuals, visual or hearing impaired, ethnic minorities, refugees, international research, economically and educationally disabled and healthy volunteers. If your study involves any vulnerable population, please download and submit Vulnerable Populations checklist with your IRB application.
This application is intended only for patient record reviews. By definition this will only apply to studies in which data is collected from patient’s medical records; either retrospectively or prospectively.
The following documents are required to complete the application.
- Signed Chart Review application
- Separate Data Collection Sheet, if applicable
For each investigator/co-investigator listed on the study application:
- Signed conflict of interest form
- Current curriculum vitae
- Verification of CITI Training
For Study Personnel
- Signed conflict of interest form
- Verification of CITI Training
*Vulnerable Populations
The vulnerable populations refers to but not limited to children, minors, pregnant women, fetuses, human in vitro fertilization, prisoners, employees, military persons and students in hierarchical organizations, terminally ill, comatose, physically and intellectually challenged individuals, institutionalized, elderly individuals, visual or hearing impaired, ethnic minorities, refugees, international research, economically and educationally disabled and healthy volunteers. If your study involves any vulnerable population, please download and submit Vulnerable Populations checklist with your IRB application.
This application is intended only for studies that are multisite studies and /or industry funded trials where Virtua Health IRB is relying on another IRB for ongoing review.
The following documents are required to complete the application.
- Signed Admin Review Application
- Approval from the IRB of record
- All study related document approved by the IRB of record
- Virtua HIPPA (if applicable)
For each investigator/co-investigator listed on the study application:
- Signed conflict of interest form
- Current curriculum vitae
- Verification of CITI Training
For Study Personnel
- Signed conflict of interest form
- Verification of CITI Training
*Vulnerable Populations
The vulnerable populations refers to but not limited to children, minors, pregnant women, fetuses, human in vitro fertilization, prisoners, employees, military persons and students in hierarchical organizations, terminally ill, comatose, physically and intellectually challenged individuals, institutionalized, elderly individuals, visual or hearing impaired, ethnic minorities, refugees, international research, economically and educationally disabled and healthy volunteers. If your study involves any vulnerable population, please download and submit Vulnerable Populations checklist with your IRB application.
In the event of an emergency use of an investigational drug, biologic or device on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval [21 CFR 56.102(d)]. The exemption, which may not be used unless all of the conditions described in 21 CFR 56.102(d) exist, allows for one emergency use of a test article without prospective IRB review. FDA regulations require that any subsequent use of the investigational product at the institution have prospective IRB review and approval.
DEFINITIONS:
Emergency use means the use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval [21 CFR 56.102(d)].
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-56/subpart-A/section-56.102
Test article means any drug for human use, biological product for human use, medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the act or under sections 351 or 354–360F of the Public Health Service Act [21 CFR 56.102 (i)].
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-56/subpart-A/section-56.102
Life-threatening: for the purposes of section 56.102(d), includes the scope of both life-threatening and severely debilitating, as defined below.
- Life-threatening means diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted and diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival. The criteria for life-threatening do not require the condition to be immediately life-threatening or to immediately result in death. Rather, the subjects must be in a life-threatening situation requiring intervention before review at a convened meeting of the IRB is feasible.
- Severely debilitating means diseases or conditions that cause major irreversible morbidity. Examples of severely debilitating conditions include blindness, loss of arm, leg, hand or foot, loss of hearing, paralysis or stroke.
Post IRB Approval Requests
- Continuing/Closure Report
- Study Modification
- Reportable Event/SAE/UAE
- Marketing Guidelines
Please refer to Virtua policy to report to make sure that events are reported in a timely manner.
All forms must be signed by PI in order to be reviewed by the IRB.
Quality Assurance/Quality Improvement
For QA/QI project please submit the following
- Signed QA/QI assessment form
- Protocol
- Surveys/Data Collection Sheet etc.
Differences between Research and QA/QI
| Research | QA/QI | |
|---|---|---|
| Goal | To establish clinical practice standards where none are accepted OR to test a hypothesis | To continuously assess or promptly improve a process, program, or system; OR improve performance as judged by accepted/established standards |
| Initial Point | To answer a question or test a hypothesis | To improve already established standard |
| Benefits | Contributes to generalizable knowledge and may or may not benefit participants | Designed to promptly benefit a process, program, or system and may or may not benefit participants |
| Risks/Burdens | May place participants at risk and stated as such | By design, does not increase patient’s risk, with exception of possible privacy/confidentiality concerns |
| Data Collection | Systematic collection of data | Systematic collection of data |
| End Point | Answer a research question | Promptly improve a program/process/system |
| Testing/Analysis | Statistically prove or disprove a hypothesis | Compare a program/process/system to an established set of standards |
| Participation/Obligation | No obligation of individuals to participate; | Responsibility to participate as component of care |
| Effect on Program or Practice | Findings are generally not expected to immediately affect or change practice | Findings are expected to directly and immediately affect institutional practice |
Nursing Academic Research
Virtua supports academic and professional development. If your project involves a Nursing Academic degree, please contact AcademicAffiliations@virtua.org. More information can be found on the Academic Affiliation page of the Colleague Corner. Please log in to access this page.
Resources:
Helpful Links
- Belmont Report
- OHRP
- FDA: New Drug Development
- FDA: Medical Devices
- Human Subject Protection - 21 CFR Part 50
- Institutional Review Board - 21 CFR Part 56
- Protection of Human Subjects - 45 CFR Part 46
- FDA Information Sheet for PI and IRB
- OHRP Decision Charts
Policies
- IRB Policies
- Research Administration Policies
- Clinical Trials Office
- Conflict of Interest Policy
Templates
- Protocol Template (Interventional Research)
- Protocol Template (Non-interventional Research)
- Informed Consent Template
- Adverse Event Tracking Form Template
Tip Sheets
Need access to materials on this page?
If you do not have access to Virtua's Colleague Corner and need a document noted on this page, please contact us here.