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BMC Office of the General Counsel

The Office of the General Counsel provides legal support, advice, and counsel on a broad spectrum of corporate and medicolegal matters to Boston Medical Center, Boston Medical Center Health Plan, and the Faculty Practice Plan. In addition, the Office of General Counsel includes the hospital's program on Compliance.

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http://internal.bmc.org/generalcounsel/compliance/index.html

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Stephanie Lovell, General Counsel

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BMC Compliance Officer

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Karen Murphy, Corporate Compliance Officer

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Compliance Hotline: TOLL FREE 1-800-586-2627

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BUMC A-Z of Research Responsibilities

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BUMC Institutional Review Board (IRB)

All research or clinical investigations involving human subjects in which BUMC, its staff, its students, or its patients are involved may be subject to the authority of the IRB, regardless of funding source or other regulatory requirements.  The IRB was created to comply with federal regulations and state laws for the protection of the rights and welfare of human research subjects. The BUMC constituent members have designated the BUMC IRB as their IRB of record under a Federalwide Assurance.  The purpose of the IRB is to protect the rights and welfare of human subjects of research and to assure that clinical research is conducted according to corresponding federal regulations, state law, and IRB policies.

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http://www.bumc.bu.edu/Dept/Home.aspx?DepartmentID=293

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Office for Human Research Protections (Under DHHS)

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http://www.hhs.gov/ohrp/

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Protection of Human Subjects, 45 CFR Part 46 (DHHS Policy, Incorporates the “Common Rule”)

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http://www.access.gpo.gov/nara/cfr/waisidx_99/45cfr46_99.html

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Protection of Human Subjects Educational Requirements

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http://grants.nih.gov/grants/policy/hs_educ_faq.htm

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FDA Guidance and Compliance

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http://www.fda.gov/oc/ohrt/irbs/default.htm

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http://www.fda.gov/ora/compliance_ref/default.htm

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http://www.fda.gov/ora/compliance_ref/cpg/default.htm

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http://www.fda.gov/ora/cpgm/default.htm

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BUMC Institutional Animal Care and Use Committee (IACUC)

The mission of the IACUC is to consider the care and use of animals in research and teaching from an ethical perspective and to ensure institutional compliance with federal requirements through oversight of the laboratory animal care program.

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http://www.bumc.bu.edu/Dept/Home.aspx?DepartmentID=29

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BUMC Laboratory Animal Science Center (LASC)

The mission of the LASC and its staff is to provide top quality animal care to promote the judicious use of animals in the broad-ranging research programs of BUMC as well as numerous corporate clients.

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http://www.bumc.bu.edu/Dept/Home.aspx?DepartmentID=71

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NIH Office of Animal Care and Use (OACU)

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http://oacu.od.nih.gov/

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Office of Laboratory Animal Welfare

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http://grants.nih.gov/grants/olaw/olaw.htm

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Public Health Service Policy on Humane Care and Use of Laboratory Animals, Office of Laboratory Animal Welfare, Amended August, 2002

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http://grants.nih.gov/grants/olaw/references/phspol.htm

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USDA

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http://www.aphis.usda.gov/ac/polmanpdf.html

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BMC’s Policy on Code of Ethical Behavior and Research Misconduct of Science

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http://internal.bmc.org/policy/pdf/HospitalWide/09_13_000_EthicalBehavior_042005.pdf

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BMC Research Misconduct of Science

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Health Care Billing

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BU’s Policy on Misconduct in Science

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http://www.bu.edu/handbook/policies/ethics/misconduct.html

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Office of Research Integrity

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http://ori.dhhs.gov/education/rcr_resources.shtml

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Federal Policy on Research Misconduct

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http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2000_register&docid=fr06de00-72

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BMC Policy

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Hospital Conflict of Interest Policy - General

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Research Conflict of Interest Policy

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BU Policy

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http://www.bu.edu/research/policies/conflict/index.html

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BMC Policy

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http://internal.bmc.org/grants/policies_post/T%20&%20E_fin.doc

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BUMC Environmental Health and Safety (OEHS)

The Office of Environmental Health and Safety's primary mission is to provide a safe and healthful work environment for faculty and staff. In addition it assists BUMC in maintaining compliance with federal, state, local codes, and regulations.

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http://www.bumc.bu.edu/Dept/Home.aspx?DepartmentID=124

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BUMC Institutional Biosafety Committee (IBC)

The Institutional Biosafety Committee (IBC) is a University/Hospital-wide committee responsible for reviewing and approving recombinant DNA research and biohazard projects. The committee sets containment levels in accordance with the National Institutes of Health (NIH) Guidelines and the Center for Disease Control and Prevention.

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http://www.bumc.bu.edu/Dept/Home.aspx?DepartmentID=357

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Federal Regulations on rDNA & Gene Transfer (NIH Office of Biotechnology Activities)

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http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html

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BUMC Radiation Protection Office (RPO)

The Radiation Protection Office at the Boston University Medical Center is responsible for ensuring that radiation exposure to workers and members of the public are as low as reasonably achievable. To achieve this goal, the Radiation Protection Office has established policies, programs and procedures.

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http://www.bumc.bu.edu/Dept/Home.aspx?DepartmentID=100

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USA Patriot Act (H.R.3162)

The USA PATRIOT Act (Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001) is a law signed by President Bush on October 26, 2001, that, among other provisions, places restrictions on persons who possess select agents and provides criminal penalties for possession of such agents that cannot be justified for specified peaceful purposes.

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http://www.fincen.gov/hr3162.pdf

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Select Agents (Certain Biological Agents and Toxins)

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http://www.cdc.gov/od/sap/docs/%20faq.pdf#search='Patriot%20Act%20FAQ%20aclu%20.gov%20library'

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Office of Management & Budget Circulars

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http://www.whitehouse.gov/omb/circulars/index.html

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Uniform Administrative Requirements for Grants and Agreements With Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations, OMB Circular A-110 (2CFR Part 215)

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http://www.whitehouse.gov/omb/circulars/a110/a110.html

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Audit, OMB Circular A-133

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http://www.whitehouse.gov/omb/circulars/a133/a133.html

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http://www.whitehouse.gov/omb/circulars/a133_compliance/04/04toc.html

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Cost Principles (Allowable Costs), 45 CFR 74 Part E Appendix E (Hospitals)

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http://rates.psc.gov/fms/dca/cfr45pt74.html

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HIPAA Privacy Rule (45 CFR Parts 160 & 164)

The privacy provisions of the federal law, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), apply to health information created or maintained by health care providers who engage in certain electronic transactions, health plans, and health care clearinghouses. The Department of Health and Human Services (HHS) has issued the regulation, "Standards for Privacy of Individually Identifiable Health Information," applicable to entities covered by HIPAA.

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http://www.hhs.gov/ocr/hipaa/

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http://www.hhs.gov/ocr/hipaa/guidelines/overview.pdf

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http://privacyruleandresearch.nih.gov/

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Community Technology Fund – BU Office of Technology Development

OTD provides guidance to Faculty to BUMC’s approach to the translation of their ideas into useful products and services. OTD provides a perspective on the University’s overall philosophy towards inventions, commercialization and relationships with industry; a guide to the many resources and people available within Boston University to help you evaluate your idea and decide what path, if any, to go down; information and useful links; a realistic understanding of the effort that will be required and what the return to you might be.

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http://www.bu.edu/otd/

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Technology Transfer (Patents & Licensing)

Technology transfer is a term used to describe a formal transfer of rights to use and commercialize new discoveries and innovations resulting from scientific research to another party. Universities typically transfer technology through protecting (using patents and copyrights), then licensing new innovations. The major steps in this process include the disclosure of innovations, patenting the innovation concurrent with publication of scientific research and licensing the rights to innovations to industry for commercial development.

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Association of University Technology Managers (AUTM)

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http://www.autm.net

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Inventions

Bayh-Dole regulations require that government funded inventions be reported to the federal agency who made the award.

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https://www.iedison.gov/iEdison/

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Bayh-Dole Act, 37 CFR 401

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https://www.iedison.gov/iEdison/37CFR401.jsp

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BMC’s 501 (c) (3) Status

Nonprofit Organization means a university or other institution of higher education or an organization of the type described in section 501(c)(3) of the Internal Revenue Code of 1954 (26 U.S.C. 501(c) and exempt from taxation under section 501(a) of the Internal Revenue Code (25 U.S.C. 501(a)) or any nonprofit scientific or educational organization qualified under a state nonprofit organization statute.  Research, per se, is not a tax-exempt activity. Under the Internal Revenue Code, a tax-exempt organization must conduct research in the public interest. “Public interest” is defined by IRS regulatory interpretations and case law. If BMC, BU, or the Faculty Practice Plan (all tax-exempt organizations) conduct non-exempt research, they are liable to taxation on the net income, at corporate rates, of that research. The research activity cannot be an activity that typically is incident to commercial or industrial operations, such as “testing." An exempt organization that carries on “substantial”  (another term defined by IRS law and interpretation) non-exempt activity can lose its tax exemption.

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IRS FAQ page for Tax-Exempt Organizations

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BMC Policy Regarding Publication Restrictions

One indicator of public interest research is the freedom to publish. Therefore, BMC will not agree to ask permission to publish or give editorial control over the publishing of research results to any industrial sponsor and must remain independent in its reporting of results, which are not to be considered Confidential Information.

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http://internal.bmc.org/grants/policies_post/CORIProc_fin.doc