Clinical Research Administration

Lahey’s Research Administration serves as a central resource to encourage, facilitate, support and oversee research with expert staff dedicated to ensuring compliance with federal regulations, sponsor requirements and clinic policies. Research Administration works closely with Lahey’s IRB to review and monitor any human subject research taking place at Lahey.

Research Administration is comprised of a diverse group of experienced administrators:

The IRB Office work closely with Lahey’s IRB to review and monitor human subject research taking place at Lahey. Hundreds of applications are made to the office every year. This averages about 100 submissions a month that need to be reviewed, corrected and processed for IRB committee approval.

With ~300 ongoing investigations at any given time and 1000 new patients consented annually, the IRB administrators perform under tight deadlines all the while ensuring that all research is in compliance with state and federal regulations and clinic policies.

The Office of Sponsored Research (OSR) is responsible for negotiating the budgets and contracts for all sponsored research studies. This complex task includes assuring appropriate legal and financial review of study documents, as well as reviewing all agreements for compliance with institutional and regulatory policies. Additionally, this team oversees research patient billing, sponsor invoicing and federal grants management.

When the work of the IRB Office and OSR is complete, the Principal Investigators, Clinical Research Coordinators, and Clinical Research Nurses and Specialists take over. This group represents the face of research at Lahey, interacting with research study subjects and ensuring that their day-to-day experience is consistent with the high quality care they receive at Lahey. Their duties include explaining research studies to new patients, following patients during their study participation and making sure that the study protocol is followed.

Finally, the Research Quality Assurance Program provides regulatory oversight to clinical trials conducted at Lahey and its affiliated sites. This team not only identifies and addresses quality and compliance issues with research throughout our institution, but also provides education and reference materials, support and training to all Lahey colleagues engaged in clinical research activities.

For more information on Research Administration and the services provided, please call our office at 781-744-8027.

All research activity conducted at Lahey is monitored by the hospital’s local IRB to ensure the safety of study participants. The IRB is composed of Lahey colleagues and lay community members. The board typically meets monthly but also convenes weekly for time sensitive review.

The primary responsibility of the IRB is to protect the rights and welfare of research subjects. The IRB follows rules that are defined in the United States Code of Federal Regulations.

All IRB correspondence at Lahey is facilitated through IRBNet. All protocols and procedures as well as consent forms are reviewed by the IRB prior to commencing the investigation and annually thereafter. All unanticipated events are reviewed by the IRB, and all changes to the protocols or the consent forms must be approved by the board.

We have above average recruitment success due to the following factors:

• A large geographical patient population
• Research pages on both the Lahey intranet and the Lahey website 
• Community education about the latest treatments and developments pertaining to individuals’ specific medical conditions
• An active marketing department that develops recruitment advertising specifically focused for research purposes
• More than 3,000 patients treated each day in Lahey’s ambulatory care center specialists in most clinical areas
• Complete clinical services offered to serve our extensive and diverse clinical population
• A very loyal physician and patient population
• An excellent compliance rate of participants in our studies
• Very low drop-out rate
• Based on these factors and our past success conducting clinical trials, we do not anticipate any problems recruiting patients for our clinical trials.

Managed by the Research Quality Assurance Program, all research administrators, investigators, study coordinators, clinical research associates and regulatory associates receive comprehensive training for their specific roles.

Training involves review of proper management of clinical studies, Good Clinical Practice (GCP’s), participant safety, maintenance of study data, regulatory forms, completion of case report forms (CRF’s) and research quality assurance.

All investigators and research staff participating in clinical trials must complete a research study session that includes Lahey-sponsored education and the CITI Research program with certification renewals every three years. Staff is encouraged to attend workshops and training as part of continual education.

Lahey’s various clinical departments provide an excellent clinical environment to conduct research. Each department has sufficient exam rooms and large, friendly and comfortable waiting area where receptionists greet patients.

All components of the study are conducted in the department, and, in the event other services are required (laboratory, radiology, etc.), they are usually available the same day at that location, reducing the need for repeat visits.

Lahey has a dedicated investigational pharmacy staffed by registered pharmacists. The investigational pharmacy monitors and maintains all study drugs and medications.

The pharmacists participate in the investigational study process from the initial start-up phase through the duration of the clinical trial. All study drugs are shipped directly to the investigational pharmacy, and the pharmacists maintain all receipt and dispensing logs.

The investigational pharmacists are an additional resource on research study drug questions, including side effects, concomitant medications and potential adverse events.

The Laboratory Department is concerned with supporting patient care activities through the provision of accurate and timely clinical laboratory information on blood, body fluids and other specimens, as well as providing consultation to the staff. Department sections include Phlebotomy, Immunology, Andrology, Hematology, Chemistry, Special Chemistry, Microbiology and Blood Bank.

Support services are provided by Information Systems, Specimen Processing and Client Services. The IATA (International Air Transport Association) has specific guidelines for handling and transportation of dangerous goods/hazardous substances. All personnel handling these substances require certification.

Several members of the laboratory involved with research study specimen packaging, labeling and shipping are IATA certified.

Lahey is one of two facilities in the area that has a GE Discovery Series 64-slice, hybrid positron emission technology (PET) and computerized tomography (CT) scanner as Nuclear Medicine. Our comprehensive PET/CT program is ACR accredited and is able to provide patients with the highest quality diagnostic PET/CT services currently available.

The Department of Diagnostic Radiology offers a full range of diagnostic imaging techniques and interventional services. The department maintains ongoing research partnerships with several high technology companies for the development of systems that apply computer technology to imaging processes. Consultations regarding individual cases are encouraged.

Neuroradiology is a subspecialty of Lahey’s Department of Diagnostic Radiology that is devoted to the imaging of the central nervous system (the brain and spine) and the head and neck. Imaging modalities used in neuroradiology include magnetic resonance imaging (MRI), CT scan, diagnostic angiography and myelography.