1 Research Compliance at HMS: What is it Why it is important Who is involved How it affects you and how you can get help Postdoctoral Fellow Orientation HMS Office of Research Compliance (“ORC”)

2 Who We Are & Where You Can Find Us WHO? Director, Jeff Assistant Director, Keri Godin Office Coordinator, Tenzin Dawa WHERE? Gordon Hall, Suite 407 CONTACT? Telephone: ORC Helpline: Options for (1) Confidential/Anonymous Message (2) Questions for ORC Staff University Compliance Helpline: ASK

3 ORC Mission & Purpose The Office of Research Compliance is dedicated to advance a culture of ethics, integrity and compliance with applicable laws, regulations and policies which govern institutions of higher education through awareness programs, monitoring and responding to non-compliance. Our commitment to compliance includes the development of general and specific training, policies and appropriate oversight and monitoring to assist members of Harvard Medical School’s community in conducting research activities based upon the highest standards of integrity and excellence through teamwork and professionalism. Protects employees, research subjects and members of local (and broader) communities from health and safety risks. Protects researchers and the institution from potentially serious financial and reputational risk (and possibly even career harms and criminal liability risk). Strengthens relationship of trust with government and other sponsors of research and ensures proper uses of public and philanthropic dollars. It is the right thing to do.

4 Substantive Areas Within Purview of ORC Grants Management –Time and effort reporting –Cost allocations –Use of program income –Cost Transfers Animal Care and Use/IACUC Human Subject Protection/IRB HIPAA and Information Privacy & Security Export Controls and Select Agents Regulation Biological & Environmental Health & Safety/COMS Intellectual Property and Tech Transfer FDA Regulations (GLP, GCP, IND/IDE) Other Laws/Regs. Affecting Research, e.g. Federal Funding Restrictions & MA legislation re hESC research.

5 Some Core Functions & Activities of ORC Serve as a resource to entire HMS community on issues and questions relating to research related laws, regulations, polices and best practices. Lead/Assist in creation/distribution of useful reference resources and on-line tools. Coordinate education and training of faculty, post doctoral fellows, trainees and research team and administrative staff members on compliance issues. Identify systemic and operational compliance risks (through assessments, audits, risk analysis and other means). Lead/Assist with compliance related QA/QI efforts, policy development and implementation, and business process improvements. Identify and champion investments in infrastructure and innovations/ improvements in business process to make compliance easier and more certain. Administer Helpline/Hotline. Respond to complaints and information indicating possible compliance problems and investigate, resolve and report problems and their resolution as appropriate. Provide advice and assistance concerning governmental audits, site visits and investigations. Assist with legislative and governmental affairs efforts.

6 Some General Advice Familiarize yourself with: Protocol requirements and conditions Lab/Department policies, procedures and SOPs Relevant University policies Your job description, responsibilities on specific grants/projects (including percentage of your salary/effort being charged to those grants) Don’t ship anything internationally without contacting us If you aren’t sure about something or have questions: Ask the appropriate person to help you. If you see something wrong, say something.