Mount Holyoke College 

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. 

 

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