CONSULTATIONS

The Massachusetts General Hospital Department of Clinical Research (DCR) provides free consultations to investigators seeking study assistance in the following areas:


Study Design and Implementation

The DCR's Study Design and Implementation consultations provide support for new clinical research studies and research networks, as well as resubmissions of federal grants. Consultations assist junior faculty in preparing new Career Development (K) grant applications, and support current K award recipients applying for independent funding.

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Biostatistics

The DCR Biostatistics Unit provides consultations to those seeking study design advice, analysis support for manuscript preparation, help with handling statistical considerations during IRB submissions and education on special statistical method topics.

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Biostatistics for K Awardees

All Mass General K-awardees are welcome to submit a request to consult with one of Mass General's biostatisticians as well as to develop a plan and then receive ongoing grant/research paper preparation support and guidance throughout the duration of their K awards.

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Comparative Effectiveness Research

The DCR's Comparative Effectiveness Research Unit (CERU) seeks to address second translational block issues (i.e. translating evidence from clinical studies into clinical practice) and provides mentoring and consultation on career development, hypothesis generation, study design and data analysis/data management for clinical effectiveness researchers.

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Operational Evaluation

The DCR's operational evaluation consultations support clinical investigators whose research focuses on patient-centered approaches to translating evidence-based care into health care practice. Consultations provide assistance to those focusing on health services delivery and outcomes research with developing research questions and hypotheses and designing rigorous evaluation of operational projects. Support is also available for analysis and publication efforts surrounding quality improvement activities.

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Survey Research

The DCR's Survey Research support program provides survey consultations and advice for all aspects of study design, execution and interpretation of survey data.

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Omics

The DCR's Omics Unit provides consultation and triage for the Mass General clinical research community. Assistance is provided in genetic study design and execution, human subject protection, career advice and/or identification of particular resources. Requests are triaged by the Omics Unit and assigned to specific consultants depending on expertise and availability. 

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Translational Medicine

The DCR's Translational Medicine Unit provides support to those seeking help with translating basic science discoveries into clinically applicable tools for the diagnosis or treatment of human diseases and/or exploiting clinical discoveries that require greater elucidation in basic science laboratories.

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Patient-Centered Outcomes Research

The DCR's Patient-Centered Outcomes Research (PCOR) consultations provide support for investigators who are navigating the waters of the Patient-Centered Outcomes Research Institute. Assistance is available for PCOR proposal preparation, identification and incorporation of patient reported outcomes measures into clinical research settings, and linkage with other clinical datasets as well as stakeholder engagement.

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Electronic Health Record Research

The DCR’s Electronic Health Record Research (EHR) consultations provide support for investigators who are considering studies making use of electronic health records data. Assistance is available for study design, research proposal preparation and generation of preliminary data to support such proposals, linkage with other clinical datasets, and identification of potential co-investigators and collaborators.

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Imaging Biomarkers

The DCR's Imaging Biomarker Unit provides consultations for investigators who are considering studies making use of the wealth of imaging technologies and expertise at Mass General and beyond. Assistance is available for study design, IRB submission, feedback on draft research proposals, and identification of potential co-investigators and collaborators. Requests are triaged and assigned to specific consultants depending on expertise and availability.

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Qualitative Research

The DCR’s qualitative research consultations advise investigators on qualitative research design, data collection, interpretation and publication of study findings. Requests are triaged and assigned to consultants depending on expertise and availability.

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SERVICES

Services from the Division of Clinical Research:


Project Managers

Project Managers (PMs) from the Department of Clinical Research (DCR) at Massachusetts General Hospital provide administrative support includes budget creation and management for new clinical research studies, study start-up support, monthly research fund review, study conduct and regulatory assistance, and oversight of study close out.

In addition, project managers work with investigators to respond to sponsor and internal audits, develop and implement corrective action plans and standard operating procedures (SOPs).

Fee Structure

The first six hours of service are free of charge. Thereafter, the scope of services is negotiated with the investigator based on a rate of $50/hour.

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Institutional Review Board (IRB) Support

The Department of Clinical Research (DCR) also provides Institutional Review Board (IRB) submission and regulatory support to clinical investigators. Our clinical research coordinators can prepare IRB applications, work with investigators to respond to the IRB's queries, and edit consent forms and other documents to support full and continued IRB approval of the study.

Fee Structure

Full IRB Board Review: $3,500 plus applicable overhead. An IRB expedited review, continuing review applications and other regulatory submissions are negotiated based on a rate of $45/hr.

Video Recording

Commercial/Independent IRBs

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