Research Compliance Program

Stewardship

• The effective management of public, private and endowment funds to maximize research outcomes.
• The avoidance of serious cases of fraud, institutional mismanagement, or poor management of federal and private funds.

Areas of Risk Management

1. Human Subjects Protection: The Institutional Review Board (IRB) is responsible for informed consent and protection of confidentiality of human subjects participating in clinical research. The Federal Drug Administration (FDA) and Office for Human Research Protection (OHRP) regulates these areas with support from the newly legislated Health Insurance Portability and Accountability Act (HIPAA).
2. Grants Management Practices: Hartford Hospital adheres to the Public Health Service (PHS) grants policy for all federally funded research projects. Likewise, in conducting industry sponsored clinical trials, funds are monitored to ensure that all research-related costs for patients are allocated to the project with safeguards to prevent errors in billing against Medicare or third party payers. Procedures are established that identify and communicate "restrictions” on grant awards to the investigative team, as well as support and monitor federal, state and agency grant policies to ensure sound financial management and safeguards, as well as fiscal propriety.
3. Conflict of Interest: Investigators with financial holdings in companies or that receive financial support in the form of consultant fees or honorariums for extra-curricular activities are mandated to document the relationship in writing with Research Administration. Additionally, to prevent investigative bias in the presentation of research findings, RA provides institutional oversight and guidance and ensures that external fiduciary relationships are acknowledged and appropriate.
4. Contract Relationships: Research Administration is responsible for ensuring that contracts with external sponsors contain language and assurances that protect the Hospital from liability in the conduct of clinical and basic research. Also, in support of United States Code (USC) Sec 335a, all contracts are reviewed to guarantee that companies and its employees are without criminal record and have not been debarred.
5. Potential for Private Inurnment: Research funds are monitored by Hartford Hospital’s Research Administration and Accounting Departments to ensure that research funding is expended appropriately.
6. Investigational Drugs and Devices: If drugs and/or devices are considered investigational, the Federal Drug Administration (FDA) guidelines apply.
7. Cost or Expense Transfers from Research Projects: Hartford Hospital’s Research Administration and Accounting Departments are responsible for oversight of cost allocations to projects and the transfer of expenses between research accounts. Institutional checks and balances are in place that ensure proper allocation of expenses to individual research accounts, including costs for wages and supplies. These Departments are accountable for overseeing clinical trial budgets, administrative expenses (including institutional overhead), residual income, institutional cost sharing, and consulting fees and services.
8. Gifts and Endowments: Hartford Hospital provides oversight for gifts and endowments to investigators through the Fund Development and Research Administration Offices.

Program Overview

1. The roles and responsibilities of all individuals involved in basic and clinical research (Vice President, Department Heads, Investigators, Administrative staff, and Accounting) are institutionally defined and provide support for a climate and value system that promotes compliance with federal, state, and agency regulations.
2. Research compliance policies and procedures are supported institutionally. The overriding organizational intent is to reduce potential unlawful conduct. Corrective action plans are available to counsel investigators and protect Hartford Hospital and its investigators and research staff against risk. Current compliance policies are distributed to staff and investigators that apply to federal, state, and internal/external funding sources. A definition of "program income from federal grants” is outlined in the Public Health Service (PHS) Grants Policy Statement, and this is disseminated to all investigators receiving PHS funding. Principal investigators are held accountable for reporting all grant related income.
3. The Vice President for Research and Corporate Compliance Officer are responsible for research conformity to corporate compliance policies and procedures.
4. The research program must ensure adequate training of employees, i.e. research administration and investigative staff, as well as Institutional Review Board (IRB) members. Training information and material is readily available within a broad-based curriculum that includes clinical trials research, human subjects protection, and grants and budget management. Training materials are updated frequently to include contemporary patient and research issues with the goal of ensuring that all staff responsible and involved in research or its administration is well informed and competent to carry out their research roles. The Corporate Compliance Officer for Research is responsible for overseeing the training programs.
5. A quality assurance program is in place that supports the Compliance Program by providing systems that monitor and audit research projects, programs, and staff and ensures that systems are operating effectively. The research program audits research accounts monthly and reviews revenue, expenses, cost transfers, and gift income, in order to maintain fiscal propriety. Special focus is directed to overseeing accounts of investigators who are principal investigators on multiple, ongoing research trials. In addition, periodic random samples are taken of all research projects to ensure compliance to Human Subject regulations.

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