UMES confers the responsibility for establishing IRB meeting procedures to the Dean of Graduate Studies & Research, Director of Research, and IRB chair. These procedures include limitations on the number of applications to be discussed at convened meetings as well as administrative tasks associated with the meeting. Convened meetings for the UMES IRB shall occur ad hoc until a regular and sufficient number of applications require routinely scheduled meetings.
Limitations on the Number of Applications to be Discussed per Convened Meeting
It is the policy of the UMES IRB, that a maximum of two applications requiring a convened board will be considered per meeting hour. Should consideration include expedited application discussion, the maximum number of applications reviewed by the convened board will be limited to one in addition to as many as two expedited applications.
Meeting Administration
It is the policy of UMES that the IRB Chair, or designee, will be responsible for all administrative tasks associated with convened meetings. These tasks include scheduling the meeting, preparing the agenda, assembling and distributing the meeting materials, selecting the primary reviewer, opening the meeting, calling items of business before the committee, providing oversite of discussion and member interactions during the meeting, facilitating comprehensive discussion and deliberation, recording and processing the minutes of the meeting, and communicating IRB actions to investigators.
Quorum
The Organization will follow general corporate law guidelines using total board membership when considering quorum and voting. A quorum is defined as one more than half the total committee membership. If it is determined in advance of a convened IRB meeting that a quorum of members will not be available, the meeting will be canceled. If a quorum is present at the beginning of the meeting but is lost during the meeting, no further actions will be taken and the agenda items that had not been voted on will be transferred to the next available meeting, and the loss of quorum will be documented in the minutes. A meeting cannot proceed without a quorum. At least one non-scientific member or unaffiliated member is needed for a quorum. The IRB Chair will determine whether a quorum is present.
Attendance
Members (scientific, non-scientific, and non-affiliated) may attend IRB meetings in-person or via teleconferencing. Member attendance will be recorded at each meeting by the IRB Chair. The presence of any member attending via teleconference will be noted in the attendance records. Total attendance will be correlated with the vote counts for accuracy.
Voting
The IRB Chair or designee will call each application or item of business, call on the primary reviewer to present the application, call for discussion, and then call for a vote. Members in attendance will vote orally or by a show of hands (depending on the Chair’s preference). The final action on an application will be determined by a majority vote of the attending, voting members.
Transparency
The UMES IRB operates in full compliance with the Maryland law on human subjects research (2002 MD House Bill 917, codified Article – Health-General, Title 13 Miscellaneous Health Care Programs, Subtitle 20-Human Subjects Research, Section 13-2003 https://casetext.com/statute/code-of-maryland/article-health-general/title-13-miscellaneous-health-care-programs/subtitle-20-human-subject-research) “Human Subject Research – Institutional Review Boards.” This bill applies the federal regulations on the conduct of human subjects research to all research conducted in Maryland, regardless of funding source. This bill requires IRBs to make their minutes (after redaction of any confidential or privileged information) available to any person upon request and empowers the Attorney General to seek injunctive or other judicial relief to prevent unlawfully conducted human subject research.
Any person who wishes to inspect the final minutes from a UMES-convened IRB meeting may do so by submitting a written request outlining the specific minutes to be inspected. The written request for IRB minutes should be submitted to the Dean of Graduate Studies & Research. The Dean of Graduate Studies & Research will provide the meeting minutes within 30 days of receipt of the written request. Prior to making the minutes publicly available, the IRB and or UMES Legal Council may redact confidential or privileged information in accordance with Maryland law.
