Research Process

The Spectrum Health Office of Research and Education provides an array of services and core technologies to support researchers.

Honest Broker/Data Acquisition Services

Spectrum Health Office of Research and Education provides an honest broker and data acquisition services to assist in data collection for research studies. A honest broker provides de-identified datasets to researchers from the electronical medical record (EMR). A data acquisition personnel provides identifiable datasets from structured fields in the EMRs.

Prior to institutional review board approval, the services are available to provide a quick determination of patient numbers that can inform feasibility and aid in the review of your protocol to determine what service is the most appropriate.

After approval from the institutional review board, honest brokers may build data sets of protected health information and share de-identified, limited, or identifiable data sets with researchers who need assistance. For more information or to request assistance, contact us at honestbroker@spectrumhealth.org.

Biostatistics/Epidemiology Support

The Scholarly Activity and Scientific Support team provides statistical and epidemiological support for any research project that needs it. The areas where we can help include:

• Research Design
• Sample Size/Power Analysis
• IRB Protocol: Statistical and Sample Size Sections
• Data Collection Tool Creation
• Randomization
• Statistical Analysis
• Graphs/Visuals of the Data
• Abstract/Manuscript Review

The team of epidemiologists can also assist with public health surveillance, field investigations, analytic studies, evaluating the impact of activities, with respect to established goals, providing linkage for multi-disciplinary teams and policy development. For more information or to request assistance, contact us at sassassist@spectrumhealth.org.

Data Management – REDCap

SHORE information systems provides researchers access to REDcap, a secure application for building and managing online surveys and databases. For more information or to request assistance, contact us at researchassist@spectrumhealth.org. 

Scientist Content

The Scholarly Activity and Scientific Support team provides scientific support for any research project that needs it. The areas where we can help include:

• Study Design
• Hypothesis And Specific Aims Development
• Peer Review of Grants
• IRB/IACUC Pre-review And Design (Clinical and Wet Lab)
• Pre-clinical And Clinical Data Interpretation
• Scientific Editing Of Grants, Manuscripts, Posters, Symposia Seminars, And Protocols
• In vitro and in vivo research lab support

For more information or to request assistance, contact us at sassassist@spectrumhealth.org.

Publication

The Scholarly Activity and Scientific Support team can help you edit a manuscript or make a poster. We have expertise in the following areas:

• Review and Analysis of Study Data
• Peer Review of Manuscripts
• Scientific editing of manuscripts, grants, posters, symposia seminars and protocols to identify missing data and controls, spotlight significance and impact and validate written attributions

For more information or to request assistance, contact us at sassassist@spectrumhealth.org.

Resident and Fellow Assistance

The Scholarly Activity and Scientific Support team is the main contact and support for resident and fellow research. The team can assist from biostatistics, epidemiology or scientific standpoint. There are opportunities for resident and fellows to do various types of research within the research department. Projects can be quality improvement (QI), non-human subjects research (NHSR) and typical research. If you are starting up a new research project, reach out to sassassist@spectrumhealth.org and a contact person will be assigned.

Core Technologies

The Spectrum Health Accelerator of Research Excellence (SHARE) provides our patients the opportunity to participate in various research studies on a local, national and global scale. SHARE deploys a singular collection methodology that spans across all service lines under one consent and protocol from which basic medical research can be conducted.

The Office of Sponsored Programs supports, assists, and partners with the research and program pre-award process. The areas where we can help include:

Pre-Award Administration

• Central point of coordination for sponsored programs for industry, non-industry and internal grant funding 
• Support Spectrum Health Principal Investigators and Program Directors with the development, submission and management of their sponsored programs portfolio.
• Identify and help Principal Investigators and Program Directors pursue funding for new initiatives as well as existing projects
• Liaison with sponsors
• Educate and assist the Spectrum Health community with navigating the sponsored programs and research processes
• Manage all contracts related to research and sponsored programs including data use, non-disclosure agreements and material transfer agreements
• Partner with Principal Investigators, Program Directors and project teams to ensure sponsored programs are in compliance with: internal and external policies, regulations and laws; and project-specific terms and conditions

For more information or to request assistance, contact us at OSP@spectrumhealth.org.

Research Finance provides post-award administration and billing compliance support for sponsored programs funding. The areas where we can help include:

Post-Award Administration

• Award and grant work tag setup and maintenance within Workday
• Monthly accounting in accordance with Generally Accepted Accounting Principles
• Monthly award financial review; determine whether expenses are allowable, allocable, and reasonable; projections to determine spending is on track 
• Funds are drawdown accurately and on time
• Revenue recognition is properly accounted for within each award
• Invoicing and accounts receivable for sponsored programs
• Bi-weekly payroll monitoring and effort certification management 
• Procurement process and vendor payment/documentation assistance
• Audit and accounting regulatory compliance; includes leading the annual federal uniform guidance audit
• Financial controls to safeguard assets; includes the federal capital asset inventory 
• Financial reporting for internal and external stakeholders
• Financial reporting submission to sponsors
• Annual budgeting for sponsored programs 
• Indirect cost proposal development, submission and negotiation 
• Financial impact for new initiatives
• Partner with Principal Investigators, Program Directors and project teams to ensure sponsored programs are in compliance with: internal and external policies, regulations and laws; and project-specific terms and conditions

• Provide assistance and oversight of coverage analysis for research billing
• Clinical trial pricing and billing compliance
• Monthly reconciliation of clinical trial revenue and expenses
• Monthly reconciliation of research only clinical expenses
• Daily review of clinical trial patient claims
• Manage clinical trial subject payments 
• Patient insurance pre-authorization assistance for research
• Liaison between research operations and insurance payers for clinical trial coverage

For more information or to request assistance, contact us at FinanceResearch@spectrumhealth.org.

The Institutional Review Board at Spectrum Health protects the rights, safety and welfare of all research participants. The Institutional Review Board reviews and oversees such research to assure it meets ethical principles and complies with federal regulations that pertain to human participant protections and good clinical practices.

Members of the Institutional Review Board include Spectrum Health physicians, staff, community members, scientists and non-scientists and those who possess a broad range of interests and expertise that correspond with the areas of research conducted across the system. The Institutional Review Board at Spectrum Health is registered with the Office of Human Protections under an assurance of compliance (v.11.30.2020).

Pre-Study Work and Feasibility Discussions

• Facilitate site selection visits and ensure confidential disclosures are in place
• Write informed consents and partner with other SHORE groups to review and finalize
• Completes operational feasibility assessments

• Completes needed IRB submissions (ideation, intake, submission, continuing reviews, etc)
• Secures needed ancillary services
• Completes coverage analysis in partnership with the Office of Sponsored Programs and Research Finance
• Prepares Epic study builds
• Partners with  the Office of Sponsored Programs and Research Finance to prepare, review and finalize study budget
• Sets up and executes study site initiation visits
• Facilitates monitor visits and communications

• Ensures study documentation is kept in accordance with governmental and sponsor regulations
• Works with Research Finance and the Clinical Team to create and maintain clinical trial management system (CTMS)
• Closes out studies in accordance with governmental and sponsor regulations
• Prepares study modifications as needed

Clinical Operations supports investigators through the research process, whether that be investigator initiated work or industry sponsored clinical trials. Spectrum Health can support you through all stages of the research process from ideation through study close out, including protocol development, recruitment and enrollment, as well as follow up and data entry. These specialized teams are comprised of clinical research nurses, research specialists and research assistants that work together to help launch and complete your project. We look forward to working with you!

To connect with the clinical operations team appropriate for your service line, email researchassist@spectrumhealth.org.