Office of Regulatory Affairs and Research Compliance
Office hours are Mon-Fri (8:30am-4:30pm)
Toll-free line: 1-866-606-0573
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90 Smith Street
3rd Floor, Suite 338 Boston, MA 02120
About Us
Scope of Service
The Office of Regulatory Affairs and Research Compliance is responsible for a broad range of regulatory affairs and research compliance functions:
- working in conjunction with various Harvard departments in areas such as conflicts of interest, data and information security, research integrity, intellectual property, animal research and biological safety;
- overseeing efforts in international research compliance, including the review of institution collaboration agreements/Memorandums of Understanding (MOUs), and providing global research ethics training, and
- providing operational support for the Harvard Longwood Campus Human Research Protection Program (HRPP) -a shared service across the Harvard Longwood Medical Area Schools (HMS, HSDM, and HSPH), which is responsible for providing independent review and oversight of human research conducted by Harvard LMA Schools faculty, staff, and students.
Mission
The mission of ORARC is to support and promote ethical research practices at Harvard Chan School and to protect the rights and welfare of participants involved in human research conducted by Harvard Longwood Medical Area School’s (Harvard Medical School, Harvard School of Dental Medicine, and Harvard Chan School) faculty, staff, and students. ORARC accomplishes this through education and reviewing/monitoring research studies to ensure compliance with federal, state, and local regulations and institutional policies.
Harvard Longwood Campus IRB (HLC IRB)
The HLC IRB is charged with the review and continuing oversight of human subjects research conducted by Harvard LMA School’s (HMS, HSDM, HSPH) faculty, staff, and students.
Harvard Longwood Campus QIP (HLC QIP)
HLC QIP works independently, but complementary to the HLC IRB, to facilitate the IRB review and approval process. QIP consists of 3 distinct units: Compliance, Education, and Human Research Support.
Research Integrity at Harvard Chan School
ORARC is committed to advancing a culture of compliance and scientific integrity among its investigators, postdoctoral fellows, research staff, and research administrators.
Lab and Biosafety at Harvard Chan School
ORARC, in conjunction with the Laboratory and Biological Safety Focus Forum (LBFF) and Environmental Health and Safety (EH&S), is committed to providing on-going support and education.
Memorandum of Understanding (MOU)
ORARC is responsible for reviewing, negotiating and approving the draft MOU (an agreement between two or more parties/institutions) before final approval by the Dean.