Human Subjects Research - Institutional Review Boards - IRBs
Non-Faculty (Student) Research Activities
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 tutorial. 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 Committtee using the Instructor’s Assurance form. Course instructors are required to complete the Human Subjects in Research tutorial.
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
|1.||take the Human Subjects in Research training;|
|2.||review the materials for submission to the Committee on Human Research for accuracy and completeness;|
|3.||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;|
|4.||make it clear to the student that research activities cannot begin until they have an approval in hand;|
|5.||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|
|6.||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.”|
Last modified November 07 2014 04:22 PM