IMPORTANT ANNOUNCEMENT RE COVID-19 STUDIES
As the first COVID-19 human studies begin arriving in our area, we want to reassure you that the EVMS IRBs and IRB staff stand ready to assist. To that end, we have planned the following processes for these studies:
Studies already approved by an IRB (commercial or academic):
EVMS will seek to sign an agreement which allows the commercial or academic IRB to be the IRB of record for EVMS. Contact Betsy Conner, ConnerBC@evms.edu, for assistance.
Studies that require local IRB approval (investigator initiated, unfunded, or unable to use commercial due to cost):
Notify the IRB staff at IRB-INFO@evms.edu about the study. Submit through IRBManager as usual. The study will then be prioritized by the IRB. Staff will work with the site to have a consent and other documents that can potentially be approved without changes at a meeting (or at least with minimal changes) This process will be key to a quick review so please have someone assigned to work with the IRB staff if at all possible. The process, depending on the type of review needed, will be:
Expedited reviews: Studies that qualify for an expedited review based on the federal regulations will be handled by the IRB staff and two or three IRB members without the need for a sub-committee meeting.
Convened (Full Board) reviews: Once the consent and other documents are acceptable to both PI and IRB pre-review, then a meeting will be convened by teleconference with the appropriate quorum and a review completed. It is our hope that if the pre-review goes well, then the documents can be quickly stamped and released after the meeting is completed.
Emergency Use: Follow the guidance at our webpage: https://www.evms.edu/covid-19/research_guidance/irb_guidance/#d.en.139895
Please contact the IRB office at IRB-INFO@evms.edu if you have questions or need assistance.
Institutional Review Board
An Institutional Review Board (IRB) is an independent regulatory body established to protect the rights and welfare of human research subjects recruited to participate in research activities. The EVMS IRB reviews research involving the use of human subjects at EVMS and at other designated institutions and private practices. In addition to EVMS sites, services are available for sites such as Sentara, CHKD, Bon Secours, other medical facilities and private practices.
The IRB is charged with the responsibility of reviewing all research that involves human subjects. An IRB has the responsibility of protecting the welfare, rights, and privacy of human subjects. Under the federal regulations, an IRB has the authority to approve, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction as specified by both the federal regulations and institutional policy.
EVMS currently has two internal Institutional Review Boards that oversee both biomedical and social behavioral research. Meetings take place on the 1st Thursday and 3rd Tuesday of each month. Protocols requiring Board review are assigned to meetings on a first come, first served basis after the submission is verified as complete by the Research Subjects’ Protections office.
In addition, a sub-committee of each IRB holds meetings on the same dates to review certain exempt and expedited studies. Requests for Not Research and Not Human Subject Research determinations are made by the IRB staff who may consult with IRB members as needed.
Human Subjects' Protections Program
The Human Subjects' Protections Program oversees all aspects of human subject protection at EVMS, including administrative support of the Institutional Review Boards. Oversight of the office is provided by the Assistant Dean for Human Subjects' Protections.
Many of the EVMS Human Subjects' Protections Program staff are Certified IRB Professionals. Certification is overseen by a national leader in research ethics, Public Responsibility in Medicine and Research. Staff members also have varying backgrounds, including pharmaceutical regulatory management, post-graduate degree in science, graduate degree in public health, administration of a research unit in clinical practice, experience serving at a commercial IRB, and together have well over 40 years of direct IRB experience.
The Human Subjects' Protections Program offers presentations on many topics to help investigators and research team members understand the IRB process and requirements. If you are interested in having a presentation made to your department or group please contact:
Assistant Dean for Human Subjects' Protection
EVMS requires basic CITI training by investigators and research team members prior to starting any human subject research project. If a course has been completed through an institution other than EVMS please send the detailed completion report(s) to the IRB email for consideration.