The Division of Clinical Research provides support, education and consultation services to the vast clinical research community at Massachusetts General Hospital. Each Center and Unit has faculty director(s) providing one-on-one consultations to investigators. A full list of Centers and Units can be found below.
Biological Biomarker Consultation Unit
The broad goal of the Biological Biomarker Consultation (BBC) Unit is to provide consultations to investigators interested in the adoption of biological biomarkers in their studies and to constitute a consortium of experts in biological biomarkers within Massachusetts General Hospital (MGH) and Mass General Brigham (MGB).
The Unit’s speciﬁc approaches to meeting this goal include:
- Identifying experts in biological biomarker research and their clinical applications within MGH, MGB and beyond and constituting a consortium of such experts.
- Assessing the needs from both researchers and clinicians regarding the development and use of biological biomarkers.
- Providing information about the resources for biological biomarker studies upon requests and encouraging collaborations with biological biomarker experts locally, nationally and internationally.
- Advancing the research and clinical utilization of biological biomarkers at MGH and MGB.
Comparative Effectiveness Unit
The Division of Clinical Research’s Comparative Effectiveness Research Unit supports researchers that seek to improve the clinical practice of medicine and population health. The Division of Clinical Research’s Comparative Effectiveness Research Unit
(CERU) has two main objectives:
- To support clinical research aimed to improve the clinical practice of medicine and population health;
- To provide mentorship and advice to those seeking academic research careers in clinical epidemiology and effectiveness
The CERU focuses specifically on the “Second Translational Block” that exists between clinical trial and other research results and the implementation of their advances to improve clinical practice and public health.
The principal activity of the CERU has been research mentoring for Mass General trainees and faculty at all levels. We provide advice and support for research that addresses a spectrum of approaches and topics from disease pathogenesis to the effectiveness, efficiency, and equity of health care delivery and delivery systems.
Our clinical effectiveness consultations foster careers of junior faculty and support hypothesis-driven research, including operational evaluations that improve patient outcomes through changes in systemic, patient and provider behavior.
Drug Discovery Rounds Unit
Drug Discovery Rounds provide opportunities for meetings between our investigators and leaders in the pharma and biotech world.Via its Drug Discovery Rounds, the Massachusetts General Hospital Division of Clinical Research provides the opportunity for individual meetings between investigators at Mass General and leaders in the pharma and biotech world.
During these face-to-face meetings, a clinical investigator and/or a fundamental science investigator from Mass General will brainstorm about drug discovery opportunities in their field of interest with key advisors in pharma and biotech.
Topics may include how to approach companies, what companies are looking for and conceptual advice about working with pharma and biotech.
Global Health Research Unit
The Global Health Research Unit offers consultations on the conduct of global health research, and sponsors seminars on general principles for global health research.The Global Health Research Unit (GHRU) consists of junior and senior global health investigators along with their research teams. Studies are being conducted in multiple parts of the world with a focus on sub-Saharan Africa. Research is generally cross-disciplinary and reflects several clinical fields, such as internal medicine, infectious diseases, psychiatry, and behavioral science. Research methods are both quantitative and qualitative.
Funding experience includes the US National Institutes of Health, the Bill and Melinda Gates Foundation, other foundations, USAID, and philanthropic support. The GHRU also includes experts in grants administration and management.
Imaging Biomarkers Unit
The Imaging Biomarkers Unit in the Division of Clinical Research at Massachusetts General Hospital provides consultations to help clinical and fundamental investigators identify questions in their research that can be answered by using imaging technologies.
The unit then helps to connect investigators to resources (personnel and technological) within Mass General and the Partners HealthCare System.
Information Technology Unit
The Information Technology Unit at the Division of Clinical Research supports the increasing information technology needs of Massachusetts General Hospital’s clinical and fundamental investigative community.
The broad goal of the Information Technology Unit (ITU) is to support the increasing information technology needs of the Massachusetts General Hospital research community.
The Unit’s specific approaches to meeting this goal have been:
- Improving existing information management resources, while creating a broad, new information management infrastructure to support the work of the clinical research community at Mass General and Partners HealthCare
- Providing IT management support for Mass General clinical investigators, including assisting in the recruitment of study subjects and supporting the Division of Clinical Research’s (DCR’s) educational initiatives
- Establishing ongoing partnerships with clinical researchers to pilot applications and studies with new clinical informatics-based interventions that will create reusable technology platforms
- Envisioning and creating transformative informatics and IT solutions for the clinical research community and beyond
The DCR’s informatics tools help investigators identify potential study subjects, navigate the patient registry system and find relevant information to support the execution of clinical research studies.
K Consultation and Mentoring Corner Unit
The DCR offers assistance for mentees and mentors. Consultations are available, for example, to assist mentees in identifying appropriate mentors, and to provide mentorship tools.
The Omics Unit in the Division of Clinical Research assists investigators in genetic and genomic study design and execution.The missions of the Division of Clinical Research’s Omics Unit are threefold:
- Provide consultative support to clinical and fundamental investigators initiating or planning genetic and genomic studies at Massachusetts General Hospital
- Support investigators already performing such studies through educational programs and process improvements
- Serve as a link between the Mass General clinical research community and the educational and technological platforms in Omics research of the Partners HealthCare System and the greater Harvard medical community
As genomic medicine becomes a reality, the Omics Unit continues to make significant progress in arming Mass General clinical research teams with the knowledge and tools needed to incorporate or expand genomic and other omics in their clinical research studies.
Omics consultations from the Division of Clinical Research are designed to assist investigators in genetic study design and execution, human subject protection, career advice and resource identification.
A newer emphasis of the unit has been on emerging technologies for metabolomic and proteomic profiling of human samples, with the goal of optimizing sample throughput, cost and breadth of analytical coverage.
Requests are triaged by the Omics Unit and assigned to specific consultants depending on expertise and availability.
Patient-Centered Outcomes Research Unit
The Patient-Centered Outcomes Research Unit facilitates clinical research that addresses the comparative effectiveness of different healthcare options from the perspective of patient outcomes.
The Patient-Centered Outcomes Research (PCOR) Unit of the Division of Clinical Research (DCR) was established to address the research needs and funding opportunities provided by the creation of the Patient-Centered Outcomes Research Institute (PCORI).
Research supported by PCORI has three major components:
- It tests the comparative effectiveness of a range of healthcare interventions, including treatments, diagnostic tests, and system-level strategies;
- It focuses on outcomes that are experienced and reported by patients; and
- Research progresses in a model with substantial stakeholder engagement including input from patients, caregivers and providers.
The PCOR Unit seeks to facilitate research by providing support in each of these domains. Specifically, the PCOR Unit advances work through four complimentary strategies:
- Working with the DCR Education Unit to host a series of educational seminars and workshops to prepare investigators to submit PCORI applications.
- Providing project specific consultative services through review of investigator-initiated proposals in the pre-award phase.
- Supporting the expansion and evaluation of methods for collecting patient reported outcome measures, specifically as routine components in clinical care settings.
- Establishing best practices for patient and community engagement strategies and disseminating these resources to investigators.
The DCR’s PCOR services provide educational programming, proposal preparation consultations, outcome measures support and stakeholder engagement assistance to help investigators who are navigating the waters of the Patient-Centered Outcomes Research Institute or conducting PCOR studies.
Philanthropy Education Unit
The Philanthropy Education Unit coordinates meetings between past and present investigators at Massachusetts General Hospital to brainstorm the best ways to raise philanthropic support for clinical research projects.
Via its Philanthropy Education Unit, the Massachusetts General Hospital Division of Clinical Research provides the opportunity for individual meetings between investigators and leaders—past and present—at Mass General. During these face-to-face meetings, investigators will brainstorm about how to raise philanthropic support for their research with key advisors in the fields.
Qualitative and Mixed Methods Research Unit
Qualitative and mixed methods research helps investigators study the “why” and “how” of questions related to healthcare and biomedicine. The Division of Clinical Research’s Qualitative and Mixed Methods Research Unit provides consultations, courses, a monthly working group, and a repository of resources to support investigators with qualitative and mixed methods study design and execution. These services are offered only to MGH faculty and staff. Please note that the QMMR Unit does not provide access to qualitative research software.
The QMMR Unit’s consultations advise investigators on qualitative and mixed methods research, including study design, data collection, data coding, analysis and interpretation, dissemination of results, and the development of research proposals and protocols. Requests are triaged and assigned to consultants depending on expertise and availability.
The QMMR Unit leads an annual four-session overview of qualitative and mixed methods research, as well as monthly single-session classes on a range of advanced topics such as consensus methods, cognitive interviewing, content analysis, interviews/focus groups, data coding, data interpretation and presentation, and the use of qualitative research software.
The QMMR Unit hosts a monthly meeting for MGH investigators (fellows and faculty) who are planning or conducting qualitative and mixed methods research and are interested in learning from others. The group provides a highly interactive community for discussing and obtaining feedback on qualitative research works-in-preparation and works-in-progress. The group commonly discusses issues related to study design, data collection, coding, analyses, interpretation, and publication. This meeting occurs on the first Thursday of each month from 4-5pm via Zoom.
To support and supplement the QMMR Unit’s services, our Unit investigators have developed a growing repository of resources, including brief tip sheets, published articles, and example documents
Research Ethics Consultation Unit
Our mission is to assist Mass General investigators in considering and resolving ethical and IRB review issues and to work to improve the quality of IRB submissions.
- Guidance in planning and conducting human subjects research
- Assistance before, during and after regulatory review to address issues and discuss practical solutions
Examples of Service
- The consent process
- Appropriate and effective recruitment plans
- Confidentiality or handling sensitive information
- Disclosure of findings or results
- Enrollment of vulnerable subjects
- Using the Mass General Brigham QI checklist and delineating care/research activities
- IRB review of survey/interview methods
- Digital health/social Media uses
- Risk/benefit assessment and study design (e.g. mitigating risks)
- Best practices in IRB applications, communications and responses to review
Education and Other Activities
- Work with DCR’s Center for Clinical Research Education to supplement curriculum with offerings related to bioethics and pragmatic advice
- Liaison with IRB to stay up to date on new policies and procedures and to share investigator needs.
Study Hypothesis and Design Unit
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.
Survey Research Unit
The Survey Research Unit provides expertise in all aspects of survey design, implementation, analysis and reporting.
The Survey Research Program in the Division of Clinical Research at Massachusetts General Hospital provides consultation and training in survey methods to gather high quality, high value data from diverse patient and professional populations. Program leaders have demonstrated expertise in the use of surveys for health and clinical practice as well as health policy and have collaborated widely with leaders, programs and investigators.
This program provides consultations to leaders and investigators on survey design and development, sampling strategies, data collection and response rate enhancement, provides survey consultations and advice for all aspects of study design, execution and interpretation of survey data. Program faculty and staff have led hundreds of surveys in local, regional, national and international contexts, including surveys with patients and health professionals in more than 20 different languages.
Types of Consultation
- Proposal Development
- Sample Design and Sources
- Questionnaire Development
- Questionnaire Review and Training
- Interviewer Training
- Survey Translation
- Data Collection Methods
- Response Rate Calculation
- Data Quality
- IRB Submission and Review
- Data Analysis Strategies
- Reporting Survey Data
Trial Innovation Unit
The aim of the Trial Innovation Unit is to provide support and guidance to investigators in the start-up phase of clinical studies.
- Help get clinical research projects started
- Leverage existing space and resources of the Mass General clinical research infrastructure
- Target junior faculty and fellows, or senior faculty without access to infrastructure support
- Provide training/education for clinical research workforce
Computational data management, analysis, and interpretation have become both a major driver and major bottleneck in many areas of biomedical research.
The goal of the Massachusetts General Hospital Bioinformatics Consortium is to provide bioinformatics and wider genomics service, consulting, education and training for biological, preclinical and clinical investigators at Mass General and in the broader research community.
Through service and collaboration with partners from academia and industry, we develop and support the informatics component of fundamental, translational and clinical research projects.
Combined with our wet-lab capabilities for next-generation sequencing, this service provides a fully integrated resource for genomics studies in both preclinical and clinical settings. Through consulting, we help our partners design and execute experimental or clinical data generation and management, as well as implement best practices for quantitative analysis in order to produce powerful and relevant biomedical data.
Through educational outreach, we educate our partners in general Bioinformatics concepts and methods, and help them think about the data in quantitatively rigorous terms. Through training, we help researchers acquire hands-on computational skills in basic statistics, experimental design, and Bioinformatics workflows.
The Consortium includes highly acclaimed groups associated with Massachusetts General Hospital, Harvard Medical School, and Broad Institute, with outstanding record of both collaborative and independent Bioinformatics research.
Our expertise covers all major aspects of project workflow in both fundamental and clinical Bioinformatics: experimental/study design, high-throughput data generation, large-scale data management, state-of-the-art computational analysis, interpretation of the results in the context of specific project goals, and presentation of findings and hypotheses for further experimental or clinical validation.
Examples of our major areas of expertise include:
- Next-generation sequencing of biological and clinical samples: whole genome and targeted sequencing, profiling of gene expression, DNA methylation, chromatin modifications etc.
- Genome variant and gene expression analysis; interpretation of the results in the clinical context of disease and pharmacogenetic response
- Visualization and annotation of genome variants and other genomic data using custom knowledge
- Biomarker discovery, development of sequence-based genetic diagnostic tests
- Analysis of genome-wide patterns of DNA and chromatin modifications, protein DNA binding, and chromatin
interactions in wider contexts of publicly available biomedical data
- Analysis of protein sequence, structure, and molecular pathways
- Development of data management solutions for complex genomics and drug discovery assay datasets
- Development of platforms for collective management, sharing, and analysis of information related to
collaborative clinical studies and specimen bio-repositories available to project stakeholders and broader
- Development of custom knowledge bases of diseases based on large-scale curated literature analysis and
public biomedical databases
The mission of the Center is to engage in impactful trans-disciplinary collaborations involving quantitative methods in public health and biomedicine.
Our faculty and staff develop, evaluate and apply rigorous statistical and data science methods across a broad spectrum of research areas. These include studies in cancer, cardiology, emergency medicine, psychiatry, pediatrics, infectious diseases, neurology and many other areas of clinical and translational research. We have shared expertise in methods for clinical trials, observational studies, clustered and longitudinal data, missing data, survival analysis, machine learning, genetics and genomics, implementation science, and precision medicine applications.
The Biostatistics Center partners with the Mass General Division of Clinical Research, the Harvard Catalyst Program, the Harvard Cancer Center, and the Mass General Mongan Institute. We are home to a data coordinating center for Acute Respiratory Distress Syndrome and a Rare Cancer Genetics Registry. Our members are also engaged in local and global educational initiatives focused on contemporary biostatistical methods and state-of-the-art data science tools.
We always welcome new collaborations!
Center for Clinical Research Education
The Center for Clinical Research Education (CCRE) offers courses and seminars to address the unique and rapidly changing needs of the Massachusetts General Hospital clinical research community.
Center for Quantitative Health
The Center for Quantitative Health facilitates investigations drawing on large clinical databases, most notably large-scale electronic health records (EHR).
- Consultation with investigators to plan and refine investigations making use of large clinical datasets;
- Assistance in preparation of materials describing investigations of large clinical data sets for submission to IRB or other regulatory review;
- Assistance in generating descriptions of methods for incorporation in funding applications;
- Assistance in generating pilot data to motivate funding applications, and for incorporation in publications;
- Development of tools to allow researchers to address questions which would otherwise be difficult to study in large data sets;
- Assistance in accessing appropriate large data sets and integration of multiple data sets – for example, use of birth and death certificate data;
- Assistance in development of decision support tools which make use of results derived from large clinical data sets.
Clinical Research Center
Contact the CRC by phone: 617-726-3294
The Massachusetts General Hospital Translational and Clinical Research Center (TCRC) offers administrative and nursing services as well as metabolic and nutritional research information for our investigators.
- Metabolism and Nutrition Research
- TCRC Processing Lab
Mass General TCRC Study Locations
- White 12
- White 13
Community Access, Recruitment, and Engagement Research Center
The Community Access, Recruitment, and Engagement (CARE) Research Center at Massachusetts General Hospital aims to ensure that advances in medicine work for everyone. CARE is focused on creating a clear, testable science of research engagement, recruitment, and retention. This framework is based upon community-led partnerships as the foundation for health equity. We are committed to ensuring that these principles and practices are rooted in diverse and inclusive research design.
The Community Access, Recruitment & Engagement (CARE) Research Center at Massachusetts General Hospital was founded by Jonathan Jackson, PhD, in 2017 with the aim to improve representation in clinical trials at the hospital. We focus on disparities for underrepresented groups in clinical trials, including racial and ethnic minorities, LGBTQ+ groups, rural populations, individuals of low socioeconomic status, and identities that intersect with these areas.
In bringing clinical research into the community in a way that engages and enables the community to co-lead and contribute to these research endeavors, CARE sets the stage for a paradigm shift in the language, practice and design of clinical trials. Such changes will have a multiplier effect, forging a new landscape for clinical trial participation in Boston and beyond which will ultimately improve the validity of life-saving research related to a range of diseases and disorders.
CARE has three intersecting areas of interest:
- A quantified, testable science of engagement, recruitment, and retention to research studies
- Strong, sustained, reciprocal community engagement and partnership
- A robust network of researchers, clinicians and community voices to ensure that cutting-edge medicines can effectively reach those who need it most
Through research on clinical trials as well as broad and sustained community engagement, we hope to reengineer the process behind clinical trial engagement, recruitment, and retention to support the inclusion of diverse and marginalized groups. CARE works to achieve this aim by:
- Leveraging a community-led collective impact model to develop and engage in sustained local partnerships in underserved areas of Boston
- Improving health, medical, research and insurance literacies
- Focusing on research engagement within vulnerable communities, ensuring that studies provide a strong return of value for underserved groups
- Streamlining the clinical trial recruitment process at Massachusetts General Hospital through staff training and consultancy
- Facilitating collaboration across the United States via robust clinical and research networks to improve inclusive access to its clinical trials
Munn Center for Nursing Research
The Munn Center supports nursing research initiatives that advance clinical practice and optimize quality patient-centered outcomes.
The Yvonne L. Munn Center for Nursing Research, housed within the Institute for Patient Care, was inspired by the vision and dedication of Yvonne L. Munn, RN, MSN, a nurse leader at Massachusetts General Hospital from 1984-1993, and her desire to advance nursing research at Mass General.
The official dedication of the Munn Center in May 2008 acknowledged the hospital’s commitment to nursing and interdisciplinary research collaborations that foster high quality, cost-effective, patient and family-centric care.
Goals of the Center
- Accelerate research in core areas of focus: care of the elderly, ethics, symptom management, workforce evaluation, and complementary interventions to enhance healing and recovery.
- Design strategies to promote the development, use, and translation of evidence into practice.
- Foster innovation through the establishment, implementation and evaluation of interventions that promote changes in care delivery
- Implement mentoring strategies to support a research agenda for all nurses in Patient Care Services (PCS)
- Collaborate with other centers within the Institute for Patient Care to advance the strategic mission of PCS
- Generate new partnerships and funding mechanisms within Mass General and with external funding sources
- Actively participate in the Executive Committee on Research (ECOR) and the Mass General Research Council to develop new collaborative opportunities across disciplines
- Enhance visibility of research conducted by nurses at Mass General through dissemination in high-impact journals and presentation at internal and external scientific meetings
Research Areas of Interest
- Complementary therapies
- Geriatrics and care of the elderly
- Quality and safety of care delivery
- Transitional care
- Ethics and clinical decision making
- Innovation science
- Symptom management
- Workforce evaluation
- Electronic medical record evaluation
- Qualitative methodology
- Systematic reviews
- Instrument development and evaluation
- Quantitative methodology
Mass General Brigham Biobank at Mass General
The state-of-the-art Mass General Brigham Biobank at Massachusetts General Hospital provides researchers with access to high-quality samples to help foster research and advance the practice of medicine and our understanding of the causes of common diseases.
Researchers and clinicians at Massachusetts General Hospital, Brigham and Women’s Hospital (BWH) and other Mass General Brigham institutions are studying how genes, lifestyle and other factors affect people’s health and contribute to disease.
To do this research, we are asking patients at Mass General Brigham hospitals to participate in the Mass General Brigham Biobank (Mass General Brigham Biobank).
This state-of-the-art biobank will help researchers uncover the links between an individual’s genetics, family history and environment in the development of disease and in people’s response to medications. The Mass General Brigham Biobank will help bring us one step closer to preventive and personalized medicine.
Join our Biobank
To join the Mass General Brigham Biobank, patients are asked to provide a small blood sample that will be linked to health information and family history data and stored in a research sample and data repository.
In order to join the Mass General Brigham Biobank, you need to be:
- At least 18 years old
- A patient at Mass General or BWH
If you are not currently a patient at one of our participating institutions, but are still interested in joining, please contact our staff to find out more.
Please visit Mass General Brigham Personalized Medicine for information on how to obtain samples and how to collaborate with the Mass General Brigham Biobank.
You can also get started by sending us an email. Our staff will guide you through the process.
Pediatric Translational Research Center
The Pediatric Translational Research Center (PTRC) was founded to develop effective new personalized and preventative strategies for disorders starting in childhood.
The research mission of Pediatric Translational Research Center (PTRC) is to advance translational fundamental, clinical and population science related to the health and development of infants, children and adolescents. Research at MassGeneral for Children recognizes the challenges and opportunities for child health research dictated by the changing social, economic and health care policy landscape in the US, including the shift toward Precision Medicine. Across the Department, our research integrates multidisciplinary clinical and scientific expertise with local, regional, national and international collaborations.
Our focus is to develop new effective strategies for personalized and preventive medicine. The advent of genomics, proteomics, and now microbiome analysis raised the expectation of therapeutic solutions that never materialized. It is now becoming clear that many diseases affecting humankind are final destinations, but the path to disease development can be different from patient to patient. Unfortunately, the complexity, the multi-factorial nature and, most importantly, the lack of information on the environmental factors triggering the disease process have hampered the progress in defining host-environmental interactions causing disease in genetically susceptible individuals.
With the appreciation that the biological events in childhood can strongly influence disease onset in both childhood and adulthood, we intend to expand our integrated models focused on pre-clinical/early and translational clinical studies to provide the rationale of possible therapeutic and/or preventive interventions. Our strategic priority is to increase PTRC visibility and branding to expand our current research portfolio in order to become a unique asset complementary to the overall mission of the DCR and the Mass General Research Institute as a whole.
Our overarching goal is to improve the lives of children and families through science. A current strategic priority is to develop new effective personalized and preventive strategies for disorders starting in childhood by integrating multi-level, multisystem data ranging from the molecular to the whole child in order to prevent or reverse development of disease.
Translational Research Center
The Translational Research Center at Massachusetts General Hospital is a new 18-bed clinical research facility dedicated to first-in-patient clinical trials in collaboration with industry.
The Translational Research Center (TRC) is a new clinical trial facility located in the heart of the Massachusetts General Hospital campus.
The TRC is focused on the recruitment of patients into early stage proof-of-concept trials. This is different from trials run by many contract research organizations, which typically recruit healthy human volunteers.
Early treatment of patients with a potential therapeutic provides evidence for efficacy in the target treatment population. It also allows measurements of key biochemical, genetic, and radiological parameters to be made in affected individuals.
About Our Center
The TRC offers all the advantages of an inpatient hospital care in a setting that is specialized for clinical research.
The center includes 18 inpatient beds and four infusion chairs. Each bed has central monitoring and oxygen at the headwall. There are two private rooms with air flow monitoring suitable for studies involving gene therapy vectors or other agents where containment of biological materials is critical.
The TRC staff includes expert research nurses, nurse practitioners, research nutritionists, laboratory technicians, and project managers. Both adult and pediatric study participants can be accommodated.
The laboratory and imaging technical capabilities of the hospital (e.g., genomics, specialized immunological assays, PET scanning) are available to illuminate key research questions.
The TRC can draw from a pool of 3 million patients cared for in the Mass General/Mass General Brigham system and match them with the right clinical investigator from the 2,500 physician scientists at Mass General, who are leading experts in their respective disciplines.
Project Managers (PMs) from the Department of Clinical Research (DCR) at Massachusetts General Hospital provide administrative support including 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).
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.
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.
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 $50/hr.