Human Subject Research Compliance: Program and Operational Consulting Services
We launched our research compliance program and operational consulting services in 2017 after recognizing that organizations often need assistance in ensuring that their research activities comply with all research related regulations to protect the participants during research.
Our research compliance consultants are available to provide services domestically and globally for every aspect of your research compliance and/or research quality assurance program, whether it be:
• ad-hoc staffing needs,
• top-down review of your entire program,
• execution of the research itself to ensure compliance,
• research study startup to closeout.
Our Research Compliance consulting portfolio includes:
• Education and training for responsible conduct of research both to improve your existing program offerings and also to satisfy federal requirements.
Program Formation and Policy Management:
• Whether you need to improve your existing integrity program and policy, or are starting from scratch, we are able to assist you in establishing a solid infrastructure and proper policies to ensure your program is compliant with the Office of Research Integrity (ORI) and Department of Health and Human Services (DHHS) expectations.
• We can provide guidance in how to structure your Allegation, Inquiry, and Investigation phases, or provide these services if your organization doesn’t have the resources available.
• We will assist you in understanding the sequestration (data collection) processes and requirements as defined by the federal Office of Research Integrity (ORI) as well as assisting you in the data collection.
• We can help you vet candidates or engage a forensics specialist.
• Building relationships with the federal ORI in the face of misconduct findings is essential. We have a presence in the ORI community and will assist you in navigating research misconduct investigations
• Staffing and Evaluation: Assessing your current workforce and assisting in education and retention measures.
• Regulatory and Compliance Infrastructure: Reviewing your organizational chart, positions, determining needs for resource requests, and logistical support with building your program.
Human Research Protection Program (HRPP):
• Building your HRPP from scratch or assessing and refining of your existing HRPP, and
• HRPP consulting in areas such as conflicts of interest, grant writing, contract negotiation, program budget planning.
Institutional Review Board(s) (IRB)
• Creation of an IRB charter and structure for your organization,
• Membership/Recruitment for your existing IRB,
• Workflow analysis geared toward performance improvement and increased productivity with limited resources,
• Virtual management of your IRB,
• Regulatory evaluation of your infrastructure, and
• IRB Policy and procedure creation and maintenance.
Human Subject Administration
• Assisting with interviewing potential staff members,
• Constructing and updating your compliance/business plan, and
• Organizational planning including: Recommending your initial infrastructure, evaluation of current infrastructure, and, if necessary, assist you in launching a complete reorganization.
• Creation of auditing/monitoring plans,
• Defining committees for data safety monitoring needs,
• Committee management,
• Performing auditing and monitoring for your program, and
• Providing pre-audit preparation for external governing bodies, sponsors, governmental agencies, accrediting bodies.
Association for Accreditation of Human Research Protection Programs (AAHRPP)
• Application preparation for accreditation,
• Preparing your team for initial or ongoing accreditation site visits, and
• Implementing changes in response to site visits.
Research Compliance Plan/Program
Ensuring your plan includes the essential processes:
• Evaluation and assessment
• Process Improvement,
• Program Development,
• Risk Mitigation, and
• Navigating unexpected FDA, IRB, or other regulatory entity unplanned visits.
Educating staff or preparing materials and resources for your staff to conduct the education yourself and
Assistance with obtaining vital certifications:
• Deciding which certifications best suit your organization strategically,
• Building employee professional development programs, and
• Preparation materials for individuals taking exams.
With our experience across every angle of the research enterprise, plus our access to industry professionals for one-off needs, our team provides comprehensive resources for your organization’s research compliance needs.
Department Vacancy Relief
About Our Management Consultants:
Our team comes to you equipped to handle today’s problems. And today’s health information management (HIM) environment is one that is dynamically changing. Unlike past years when the health information management department was a physical location within the organization housing some paper records but working within electronic health records, the HIM department has evolved into a different structure. HIM today is partially virtual, decentralized, and entrenched in information governance for the healthcare organization. It has taken on information security roles, data analytics and data mining of the entity’s Big Data, oversees privacy controls, disclosures,blocking and release of information practices, ensures revenue integrity through coding an CDI integrity, monitors patient identity, and governs the health information of your patients from a broader spectrum than the historical paper record days.
Today’s Health Information Management and Health Information Integrity directors are responding to challenges unlike the past and need to think “outside” the traditional 4 walls of yesteryear. They must play an integral role in EHR enhancement, staff productivity, cost reduction, regulatory compliance, external audit intrusions, revenue cycle enhancement, privacy protections, and a myriad of hotspots percolating in our industry. Additionally, these directors must serve as a change agent to streamline information governance throughout the organization and motivate staff to adopt change, focus on customer relations, encourage innovation, and foster collaboration within the healthcare organization and the community served.
Our team of professionals will be visionaries for your health information integrity activities and actively participate in creating solutions for the future information demands of your healthcare delivery system.
Finding an innovative Director or Manager for your HIM, and Coding Departments takes time. In the interim, these critical functions can drift off-course with a significant impact on your cashflow, the revenue cycle, privacy monitoring, and release of information disclosures.
Our approach to vacancy management is to assign an experienced Health Information Professional with a proven management track record to your organization while you search for the right Director or Manager. Our managers can effectively work 100% virtually.
Our manager will routinely update you on the status of the department and will:
• Assume day-to-day management (excluding payroll)
• Evaluate present daily operations
• Stabilize the department’s operations
• Organize workflow and processes
• Interact and collaborate with other department heads and leadership
• Serve as a liaison between medical, clinical, and financial staffs
• Collaborate with others to enhance revenue cycle performance
• Prepare budgets and update policies and procedures
• Participate on committees and taskforces
• Educate others as needed
• Establish and/or monitor productivity standards
• Evaluate capital and space needs and define requirements
• Monitor compliance with regulatory and accreditation agency requirements
• Orient your newly hired manager
We assist our clients with their recruitment efforts in two ways:
• Upon request, we will conduct a search for a candidate. The search services include advertising, screening interviews, and referral of qualified candidates to the client.
• We will conduct testing of coding skills for coding candidates. Results will be conveyed only to you, the client, to allow you to factor in the coding score in your selection criteria.
Services are provided on an hourly and/or percentage and cost-incurred basis.