Research at MedStar Health:                            Frequently asked questions

MedStar Health has more than 400 active clinician-investigators and scientists across specialties who have gained national and international recognition for their groundbreaking contributions to medical research. We also regularly collaborate with our academic partners at Georgetown University to advance the health and wellbeing of our patients and communities through research.

In addition, the MedStar Health Research Institute plays a vital role in supporting a network of more than 1,000 dedicated MedStar Health associates involved in research. Our research teams are committed to advancing medical research and enhancing patient care across various disciplines, including medicine, nursing, public health, and biomedical science. As a learning healthcare system, the Institute strives to translate research findings into practical applications that benefit patients and communities by fostering collaboration and innovation.

MedStar Health Research Institute is the executive oversight entity for all research activities taking place across our health system of 10 hospitals and more than 400 care sites in D.C., Maryland, and Virginia. The Research Institute is organized into seven different scientific networks:

• Cardiovascular care and cardiovascular imaging
• Cancer care
• Orthopedics and sports medicine
• Neurosciences and rehabilitation
• Women and child health
• Health services research or healthcare delivery (health equity, accessibility, affordability, human factors, safety science, diagnostic errors and implementation science)
• Other Medical and Surgical specialties that include burn/critical care, diabetes and endocrinology, gastroenterology, infectious disease, nephrology, pulmonology, rheumatology, community-based clinical research, violence intervention, and palliative care
• Use of AI in healthcare

MedStar Health is one of the largest healthcare providers in the mid-Atlantic region, with 10 hospitals and more than 400 sites of care.

MedStar Health’s primary service area stretches over 26 counties and touches nearly 900 zip codes throughout Washington D.C., Maryland, and Northern Virginia. The current population in the service area is diverse:

• African American: 26%
• Hispanic: 16%
• Asian: 10%
• Multiple Races: 10%
• Other: 9%
• White: 44%

With hospitals based in urban, suburban, and rural areas, our patient demographics cover a broad socioeconomic spectrum, ranging from underserved populations to affluent suburban neighborhoods, including a mix of insured, underinsured, and uninsured patients.

In 2024, MedStar Health saw more than 118,000 inpatient admissions and 6.1M outpatient visits across home health, emergency department, physician offices, and ambulatory facilities.

MedStar Health is particularly renowned for its urban trauma centers, such as MedStar Washington Hospital Center, as well as for treating stroke and neuroscience patients, cardiac and transplant patients, and oncology patients across the health system. The organization also actively serves military and veteran populations due to its proximity to federal agencies.

MedStar Health supports more than 1,000 active studies at any given time, including investigator-initiated research, industry-sponsored trials, and clinical studies.

Our work spans clinical innovation, drug development, medical devices, and health service delivery research, driven by a commitment to improving care and outcomes for our patients and advance the health for all in the communities we serve and beyond.

The MedStar Health Research Institute recognizes that study start-up time is critical to the success of a clinical trial. We have been invited to join multiple site alliance networks due to our organization’s start up efficiency and enrollment stats.

Because of the importance of study start up time, we routinely monitor and seek methods to optimize the start-up time while maintaining operational efficiency across several different mechanisms. Our goal is to be top quartile versus national benchmarks. Since start-up varies across different types of studies and is constantly improving, please ask your MHRI representative for the latest and most relevant information that applies to your study.

For over a decade, MedStar Health has been an active member of the CTTI (Clinical Trial Transformation Initiative), seeking to work with national colleagues to improve clinical trial efficiencies.

While the Institutional Review Board (IRB) is required for approval of human subject research, our process prides itself on efficiency.  We were early adopters for central IRB and commercial IRB partners.

Most studies do not need additional committee approval. For select studies, an ancillary review and approval may be required to ensure research projects comply with various institutional and regulatory requirements, such as those related to radiation or biological safety. Our ancillary review committee runs concurrently with our standard IRB review. In addition, other essential start-up activities, including contract negotiation, budget development and coverage analysis are conducted concurrently with IRB review to accelerate the start-up process.

Yes. To complement the growing trend towards decentralized clinical trials, MedStar Health offers both remote and on-site monitoring with robust procedures to ensure secure data management and maintenance of private health information.  MedStar Health is an active member of Decentralized Trial and Research Alliance (DTRA).

Yes. MedStar Health is a distributed care network and currently conducts research across more than 40 hospital, outpatient, and ambulatory sites. Through our study start-up process and other site evaluation conversations, we can work with you to assess your research question and/or study and prepare a plan to include satellite sites if that is of interest. The Research Institute's research networks span all clinical facilities which enables easy set up for satellite sites for clinical trials or studies should that be of interest. As with any site selection, study site availability may vary depending on equipment, clinical staff, and patient population.

While the average data entry timeline post-research visit is around two business days, variations exist depending on study-specific factors and adhering to the specific timeline stipulated in the sponsor contract. MedStar Health prides itself on always meeting study sponsor expectations.

Situated within MedStar Harbor Hospital in South Baltimore, Parexel recently renovated a state-of-the art, 72-bed early-phase clinical research facility. Through this collaboration, Parexel is equipped to host early-phase and PK studies that require overnight stay to patients in surrounding communities in an environment where patient experience is of the utmost importance.

MedStar Health’s Recruitment Center offers every study team a consultation during study startup to discuss recruitment strategies, proactively address potential challenges, develop effective study recruitment plans, and ultimately improve the likelihood of meeting enrollment targets, ensuring a more successful and efficient clinical trial.  Recruitment support services vary by study-specific requirements but can include such things as use of the electronic health records to identify patients, social media recruitment strategies, call centers or other digital, traditional, or human resources.

MedStar Health Research Institute takes a strategic, tailored approach to staffing, aligning each study with the right experts based on its goals, complexity, and timeline.

Our diverse research teams include coordinators, nurses, regulatory specialists, biostatisticians, and analysts, many of whom are embedded within clinical departments to seamlessly integrate research with patient care. We use a portfolio management system to match staff and resources precisely to each study’s needs. This includes the ability to pull staff from a pool as studies end while others are starting.

Our research administration includes centralized support services, such as regulatory guidance, contracting, budgeting, and data management, to streamline operations so study teams can focus on science. Ongoing staff development, training, and career growth opportunities ensure our teams remain highly skilled and adaptable.

In partnership with Georgetown University, we also tap into shared expertise and talent to expand our research capabilities and deepen our community impact.

MedStar Health Research Institute uses a rigorous feasibility and prioritization process to evaluate and manage competing studies. Each proposal is assessed based on factors such as patient population, staff and facility capacity, investigator availability, existing studies in similar areas, and potential conflicts of interest.

We also consider the study’s scientific value, technological feasibility, and potential to advance knowledge or fill critical gaps in care.

Our Office of Contracts and Grants Management (OCGM) offers full-service contract management, from proposal development to contract execution and award management. OCGM ensures compliance with local, state, and federal regulations and provides and facilitates funding opportunities to researchers across the MedStar Health System.

OCGM represents the Institute in obtaining the final institutional signature on proposals/contracts, negotiating terms and conditions for all contracts, grants, subcontracts, and other award mechanisms, and functioning as the liaison and administrative representative to all external sponsors on issues relevant to sponsored programs administered by MedStar Health Research Institute.

Yes, MedStar Health was an early adopter of central commercial IRBs and has partnerships with most of the large, national central IRBs.

All research involving human subjects conducted at MedStar Health, whether funded or not, must be approved by an Institutionally designated Institutional Review Board (IRB) before it begins, in compliance with federal and local regulations. All Human Subjects Research projects conducted by MedStar Health associates, on behalf of MedStar Health, are also subject to the policies and procedures of the MedStar Health Human Research Protections Program.

Through a reciprocal master reliance agreement with Georgetown University, investigators from either institution may use a joint IRB to streamline collaborative research.

MedStar Health also permits the use of external IRBs. Investigators must request and receive a formal Letter of Acknowledgment or a Letter to Approve Reliance before submitting to an outside IRB.

We work closely with sponsors and collaborators to determine the most appropriate IRB path for each study, based on regulatory and institutional requirements.

As a clinical trial site that demonstrates a strong capacity to recruit and enroll a large number of research participants into a clinical trial, we experience a higher frequency of FDA inspections.

While Establishment Inspection Reports (EIRs) are not directly published on the FDA website, and sponsor contracts include clauses about confidential and proprietary information, careful consideration is given when dealing with inquiries about FDA findings. However, recent FDA inspections yielded no significant findings.

Diversity, equity, and inclusion are central to MedStar Health’s mission both as the region’s largest healthcare provider and leading research organization. Serving one of the most diverse patient populations in the country, our research seeks to enhance and build the standard of care for our system and industry to one that is grounded in equity, inclusion, and diversity.

To ensure broad and representative participation in clinical trials, we use a multi-pronged approach:

• Community Engagement: We invest over $400 million annually in community benefit programs and collaborate with local organizations and leaders to build trust, raise awareness, and address barriers to participation.

• Culturally Competent Recruitment: We tailor recruitment materials and outreach strategies to meet the cultural, linguistic, and health literacy needs of each population, using trusted community channels to share information.

• Data-Driven Monitoring: We monitor enrollment demographics (race, ethnicity, gender, language) and adjust strategies to promote equity and address disparities.

• Accessible Trial Locations: Our trials are hosted in urban centers like Washington, D.C., and Baltimore, MD, which are home to culturally and ethnically diverse communities comprised of many underrepresented patient populations in clinical research. In addition, MedStar Health has led the effort to decentralize clinical trials by supporting technology that enables e-consent forms and innovative partnerships with home healthcare providers and other clinical research organizations.

These efforts help ensure our studies reflect the real-world diversity of our patients, leading to more inclusive, equitable, and impactful research outcomes.

The MedStar Health Research Institute (MHRI) has a robust research administration to support the entire research lifecycle, from concept to close-out. This structure ensures compliance, efficiency, and collaboration across departments, hospitals, and investigators.

Key administrative offices include:

• The Office of Contracts and Grants Management (OCGM) manages all sponsored research activities within the MedStar Health System. This includes creating standard operating procedures for grant proposals and contract submissions, ensuring all activities comply with local, state, and federal regulations.
• The Office of Research Integrity (ORI) is the primary agency for managing human research policy, oversight, education, training, IRB management, and extramural relations within the institution and is dedicated to upholding MedStar’s commitment to safeguarding the rights and welfare of human subjects against research-related risks.
• MedStar Health Research Compliance team supports, monitors, and audits research conducted within the system. As part of MedStar Health’s Office of Corporate Business Integrity and working closely with senior leaders at the MedStar Health Research Institute, the program ensures compliance with all research-related laws, regulations, and policies, and ensures regular audits on conflicts of interest among our clinician-investigators.
• The Office of Financial Management (OFM) oversees financial operations at MedStar Health Research Institute and ensures financial stewardship and accountability in research funding and operations.

MedStar Health Research Institute offers several core scientific services to provide our investigators with scientific and technical support, including biostatistics, biochemistry, biorepository, and pharmacy capabilities.

• Center for Biostatistics, Informatics, and Data Science (CBIDS): The mission of MedStar Health Research Institute’s Center for Biostatistics, Informatics, and Data Science (CBIDS) is to design and analyze clinical and epidemiologic studies, offering expertise in statistical methods, clinical informatics, data science, and health information technology for researchers. Our team has extensive experience in biostatistics, epidemiology, outcomes research, data management, machine learning, and application development.
• Biomarker, Biochemistry, and Biorepository Core:  The Biomarker, Biochemistry, and Biorepository Core (B3 Core) is the core research laboratory of MedStar Health Research Institute. For over 20 years, staff members of the B3 Core have provided scientific, laboratory, and biorepository services to researchers conducting clinical studies, trials, and epidemiological investigations sponsored by the National Institutes of Health (NIH), other federal agencies, foundations, and pharmaceutical sponsors.
• Research Pharmacy: A full-service research pharmacy offers essential services for clinical trials, including protocol review, secure storage of materials, preparation and dispensing of medications (including gene therapies), patient randomization, and documentation of drug accountability. It also has experience with multi-center, national, and international studies, providing comprehensive research support.
• Recruitment Center: We offer marketing and communications support for research teams working to recruit patients to participate in studies or clinical trials. Offerings include graphic design support for recruitment materials, communications counsel, advertising, community outreach, and follow-up with participants post-study.