University of Vermont (UVM) and UVM Medical Center are involved in important behavioral and biomedical research and are committed to assuring that all research activities are conducted in a manner that promotes the rights and welfare of the participants. The two committees listed below are responsible for reviewing and overseeing all research activities, and are known as the Institutional Review Boards (IRBs).
- CHRMS - Committee on Human Research in the Medical Sciences
- CHRBSS - Committee on Human Research in the Behavioral and Social Sciences
Submitting a Protocol
Federalwide Assurance (FWA) and IRB Registration
An Assurance is the documentation of institutional commitment to comply with Federal regulations and maintain adequate programs and procedures for the protection of human participants. This is the principal mechanism for compliance oversight by the Office for Human Research Protections. The University of Vermont Institutional Review Boards (IRBs) which serve the University of Vermont and UVM Medical Center are organized and operate in compliance with the US Department of Health and Human Services and the Food and Drug Administration regulations.
Federalwide Assurance Information
- University of Vermont's FWA Number FWA00000723
- UVM Medical Center's FWA Number FWA00000727
- The expiration date for these assurances changes frequently. If you need the expiration date, enter the applicable FWA Number, and click "Search".
- The Terms that apply for both FWAs are available under "A. Terms of the Federalwide Assurance for Institutions Within the United States"
The IRBs that serve the two institutions are registered to the University of Vermont and State Agricultural College (IORG 0000289) with the Department of Health & Human Services. Registration numbers for the IRBs are:
- IRB00000485 (IRB #1 - Biomedical I IRB - OHRP/FDA)
- IRB00000486 (IRB #2 - Behavioral IRB - OHRP)
- IRB00000487 (IRB #3 - Biomedical II IRB - OHRP/FDA)
- Expiration dates for the IRB registrations are available
A program of continuing education and training in the protection of human subjects is a federal requirement. We use our IRB listserve and specifically the Newsletters to partially fullfill this mandate. Key personnel listed on each protocol are required to receive and review information provided in this listserve. If at any time key personnel lose their ability to receive these notices (based upon return email notice), the principal investigator will be notified of the problem. Those key personnel will be inactivated in our system until the problem has been resolved. Of note, key personnel who have been inactivated in the IRB system should not be participating in any research until they have been reactivated.
Self-Audit Tools for Researchers
Human Gene Transfer
“Human Gene Transfer” or “HGT” is used to describe research involving the transfer of recombinant DNA, or DNA or RNA derived from recombinant DNA, into human subjects. It is also sometimes referred to as “Gene Therapy.”
Effective April 27, 2016, UVM Institutional Biosafety Committee will determine whether investigator-initiated research requires RAC review based on specific criteria. If the project is sponsored, the sponsor is responsible for determining if RAC review is required.
Review and approval of a gene transfer protocol can be complex, therefore we have developed a step-by-step guide for submission of a human gene transfer protocol at UVM/UVMMC.
A non-faculty researcher includes, but is not limited to, any of the following: fellow, resident, post-doctoral fellow, post-doctoral associate, post-doctoral trainee, and any student (graduate or undergraduate). Non-faculty researchers cannot conduct human subject research without having a faculty sponsor or faculty course instructor who is responsible for overseeing the conduct of the research activities. The faculty sponsor must be employed by the institution (UVM or UVM Medical Center) and these duties must fall within their role.
Policy Statement: The faculty sponsor or course instructor will assume the role of the responsible investigator on all research involving human subjects which is designed and carried out by non-faculty. The responsible investigator will advise the non-faculty researcher throughout the process of protocol development, submission, and review, as well as in the implementation of the research project. As the responsible investigator, the faculty sponsor or course instructor is required to complete the Human Subjects in Research training through CITI. Protocol approvals will not be released until that requirement has been met.
The faculty sponsor or course instructor, as the responsible investigator, will guide the non-faculty researcher in the development of the protocol, thus assuring that the content, quality, and timing of the submission meet the requirements of the Committee. Furthermore, the faculty sponsor or course instructor as the responsible investigator is accountable for ensuring that non-faculty researchers are aware of their responsibilities as investigators, and for ensuring that the Committee is immediately notified in the event of research-related, unanticipated events or findings during the study that would affect the risks or benefits of participation.
Undergraduate Student Class Projects (typically exempt)
Class projects are designed to provide students an opportunity to develop or practice various research methods such as interview, observation and survey techniques, as well as data analysis. Although such projects typically do not lead to generalizable knowledge and are not necessarily undertaken with that goal in mind, these projects often are precursors to future projects that may be generalizable. The Committee strongly recommends that undergraduate class projects fall into the “exempt” category. The course instructor is required to certify that the planned research projects are exempt from Committee review.
Course Instructor Responsibilities when Undergraduate Class Projects are Being Undertaken
When a course-assigned projects fall within an EXEMPT category under the "Federal Policy for the Protection of Human Subjects", the course instructor bears the responsibility for determining that projects are exempt and certifies this process with the Committee using the Instructor’s Assurance form. Course instructors are required to complete the Human Subjects in Research training through CITI.
The Instructor Assurance form covers one course. As long as the research assignment remains the same, and the course and instructor does not change, the Instructor Assurance form is valid for one year. Annual updates of course content and continued determination of exemption is required each year. A reminder notice of this anniversary is sent to instructors. All requests for review or certification of exemption must be received by the IRB at least one month before the students will begin their projects.
It is the responsibility of instructor to ensure that exempted class projects are conducted according to the ethical standards of the relevant discipline.
Graduate or Undergraduate Directed or Independent Research Projects (not exempt)
Directed or independent research conducted by students (graduate or undergraduate), that are not exempt, and that involve human subjects, must be submitted to the Committee for review and approval. This includes, but is not limited to, independent undergraduate research projects and honor’s theses, master’s theses, and dissertations. Students are required to have a faculty sponsor (this will most often be the course instructor) who is responsible for oversight of the student’s research activity.
Role of the Faculty Sponsor for UVM Student Directed or Independent Research (not exempt)
The faculty sponsor must
- take the Human Subjects in Research training through CITI;
- review the materials for submission to the Committee on Human Research for accuracy and completeness;
- assist and support the student in his/her interaction with the Committee on Human Research and for oversee the resolution of any issues arising during the review process;
- make it clear to the student that research activities cannot begin until they have an approval in hand;
- oversee the student's research activities to ensure that human subjects are protected, e.g., the protocol is followed as approved, any unanticipated events are reported as required, etc.; and
- verify that prior approval of Thesis or Dissertation Committee, if applicable, has been obtained.The Faculty Sponsor has all of the responsibilities listed in Section 10 of the Research Manual under “Investigator Responsibilities.”
NOTE: Typically student projects are short in duration and in many cases are completed in less than a year. It is important that the IRB be notified when the project is completed so that the IRB file may be closed. If the student does not do this, this responsibility falls to the faculty sponsor.
- Office for Human Research Protections (OHRP) (DHHS 45 CFR 46)
- Food and Drug Administration (FDA)
- FDA Investigational Device Exemptions - IDE Application
- FDA Drug Development - IND Forms and Instructions
- Public Responsibility in Medicine and Research (PRIM&R) is a national organization for advancement of strong research programs and for the consistent application of ethical precepts in both medicine and research.
- National Institutes of Health (NIH) mission is to improve overall human health through biomedical and behavioral research.
UVM Medical Center Information
UVM Medical Center Research Subject Registrations
As of January 1, 2014 researchers and research staff will need to complete a registration form for any UVM Medical Center patients executing a new consent form to participate in a research study. For more information please see annoucement from UVM Medical Center (PDF).
Completed forms must be submitted to “Registration – Research Studies” Outlook Mailbox (email@example.com) or FAX to 847-4179.