|
Policy and procedures for the conduct of research involving human subjects
Procedures: How and when proposals are reviewed
How proposals will be evaluated
When a proposal is received, the Board will determine if the proposal can
be reviewed through an Expedited Review Procedure, or if it will require Full
Review with a meeting of the Board (See below for definitions of "Expedited
Review" and "Full Review"). If a proposal can be reviewed through
the Expedited Review Procedure, the Board will review the proposal following
guidelines in 45 CFR 46.110. If a proposal is not in a category eligible for
Expedited Review, it will be considered under the Full Review Procedure. During
Fall, 2006 the Board will meet on Wednesdays to consider Full Review proposals.
Proposals requiring Full Review must be received electronically by 9 a.m. on
the previous Friday to be considered the following week.
In all cases, the Board will issue a notification to the principal investigator
regarding the decision on the proposal as soon as possible, but at most within
five class days of receipt. Submission of the proposal as an e-mail attachment
will generally lead to a faster response time.
Proposals Eligible for Expedited Review
A research project will be reviewed using the Expedited Review Procedure if
the project (1) presents no more than minimal risk to human subjects and (click
here for a definition of "minimal risk") and (2) falls into one or
more of the following categories:
• Research that collects data from voice, video, digital, or image recordings;
• Research on individual or group characteristics or behavior, such
as research employing survey, interview, oral history, focus group, program
evaluation, human factors evaluation, or quality assurance methodology;
• Continuations of projects previously approved by the Board if:
o no new human subjects are enrolled in the study
o all research-related interventions on human subjects have been completed
o the research remains active only for long-term follow-up of subjects
o no additional risks have been identified or the remaining research
activities are limited to data analysis;
• Certain classes of studies involving biological samples (click here
for a full explanation)
• Certain classes of clinical studies of drugs or medical devices (click
here for a full explanation)
• Research involving materials that have been collected or will be collected
solely for non-research purposes (such as medical diagnoses);
• Continuations of projects that do not fall into the above categories,
and have been previously subject to Full Review by the Board, which has determined
that the research involved poses not more than minimal risk, and no additional
risks have been identified.
Proposals Requiring Full Review
Any research project that cannot be reviewed using the Expedited Review Procedure
will be subject to Full Review by the Board. All members of the Board will
discuss the proposal. A majority vote of the Board is required for approval
of a proposal. Minutes of Full Review discussions will be kept, and a summary
of those minutes will be available, on request, to the principal investigator,
the human subjects of the research project, and relevant federal, state, or
local authorities and funding agencies.
Communication of the Board’s decision and procedures following project
approval
All decisions of the Board will be communicated to the principal investigator(s)
and the Mount Holyoke College liaison, if applicable. The Board will either
approve a project, request changes to the research protocol so that it can
be approved, not approve the project, or delay a decision and inform the principal
investigator how long it will take to review the proposal. If the project is
not approved by the Board, the proposal may be revised and resubmitted, or
the decision may be appealed. Board approval of a project is for a specified
time period. If additional time is needed to complete the project, or its scope
changes (for example, if a new experiment is designed and implemented, or if
additional human subjects are enrolled in the study), a revised proposal must
be submitted for Board review.
After a proposal is underway, it is expected that investigators will promptly
report to the Board, and other appropriate institutional officials, any unanticipated
problems that pose risks to subjects or others. Further, complaints or questions
regarding compliance with this Policy should be directed to the Board. Such
reports will lead to an investigation and may be cause for suspension or termination
of IRB approval for the project.
Records pertaining to human subjects that come under Institutional Board purview
will be kept in a locked space by the Office of Sponsored Research for three
years after the completion of an approved project, or declination of a proposal.
Records may include: certification of completion in human subjects protection,
applications for approval by the Board, descriptions of project protocol and
sample consent forms, sample questionnaires, copies of grant proposals, minutes
of Board discussions of proposals, and related memoranda and correspondence.
Appeals process
The decision of the Board may be appealed. The principal investigator(s) initiates
the appeal in writing to the Office of Sponsored Research. The investigator
may submit information pertinent to the proposal and may request a meeting
with the Board. The Board may request additional information relevant to the
proposal from either the investigator or others. The appeal will be considered
by the Board and the decision will be determined by the majority vote of all
members of the Board.
Click here to return to Main Page of Policy
|
