What is research compliance?
Consistent with Chapter 8 of the Federal Sentencing Guidelines, the HMS research compliance program is designed to maintain and implement an effective compliance and ethics program for the HMS research community. The HMS Research Compliance team assists the HMS research community in understanding and complying with any and all research regulations and in making decisions about regulatory obligations affecting research. Information about the compliance services our office provides can be found by clicking the topic areas below:
Policy: Review, Interpretation, Guidance, Development and Support
HMS Research Compliance assists individuals, operational offices and leadership with policy questions, including interpretations and applicability. We also support the development, review and dissemination of new and existing policies and procedures to ensure they are clear, well-written and consistent with applicable regulations and related policies. We provide best practice recommendations for developing policies and can support policy development through the lifecycle of benchmarking, drafting, socializing, implementation and follow-on evaluations.
Education, Communication and Training
Fundamental to understanding and complying with applicable federal, state, local, university and school regulations is knowing what the policies, rules and expectations are and how to comply with them. Research Compliance is available to partner with operational offices in the development of tools, guidance documents, trainings and presentations related to any aspect of research rules, regulations and requirements. We are also available to address questions and help the research community develop a full understanding of regulatory and contractual requirements.
Auditing, Assessments and Monitoring
Measuring policy and program effectiveness through auditing, assessments and monitoring ensures that we have meaningful data to assess compliance program efficacy, correct noncompliance, inform policy improvements, promote resource allocation and identify areas for expanded education and awareness campaigns. Research Compliance periodically audits various aspects of our research operations for compliance to applicable regulatory and internal policy requirements, with priorities set in collaboration with research and operational leadership. Our goal is to identify areas for improvement and to provide recommendations based on best practices. Research Compliance can also help offices and departments develop appropriate monitoring and quality improvement processes for specific research regulatory areas.
Noncompliance Investigation and Correction
HMS Research Compliance is available to receive reports and complaints of noncompliance in research. Part of our mission is to responds to noncompliance concerns through investigations, root cause analysis, corrective action plan development and monitoring and ensuring appropriate reports regarding noncompliance are filed. We are also a resource for individuals that have general research compliance questions or are unsure if an issue needs to be reported. Should an issue arise, HMS Research Compliance can provide support related to the development and submission of reports and responses to inquiries from Federal and Non-Federal sponsors, regulators and agencies.
Please be aware that Research Compliance has an obligation to act on credible issues reported to us and we often partner with cognizant operational units and departments to investigate and correct noncompliance concerns. Anonymous reporting is available 24 hours a day through the Harvard SpeakUp Hotline at: https://reportinghotline.harvard.edu/ or 1-877-694-2275.
Risk Assessment and Advice
HMS Research Compliance actively monitors regulatory changes and provide advice to the research community and research community on how these changes may impact HMS work. We also identify high risk research areas and partner with business units to improve processes that enhance compliance with policies and requirements. We are available to consult on new and emerging issues related to our research enterprise and bring forward high-risk concerns and issues to HMS and University leadership.