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

Who We Are & Where You Can Find Us Staffed by: Director, Peter Harrington Office Coordinator, Tenzin Dawa ORC created in 2001 Gordon Hall, Suite 210 Telephone: 432-3884 ORC Helpline: 432-5555 Options for (1) Confidential/Anonymous Message (2) Questions for ORC Staff Harvard University Compliance Hotline: 1-877-694-2ASK website: https://integrity-helpline.com/HarvardUniversity.jsp eCommons (Harvard Intranet): http://ecommons.med.harvard.edu (under organization list, click ORC) New ORC Website http://medapps.med.harvard.edu/orc/

ORC Mission Statement (new) To contribute to the advancement of research excellence at HMS by undertaking activities aimed at: Ensuring full compliance with all applicable governmental and institutional requirements, and the implementation of appropriate best practices, related to the conduct, administration and reporting of research; and Fostering a culture of responsibility and stewardship that assures the proper use of sponsors’ grant funds; and Protecting the institution, its faculty, staff and students, as well as our research partners and collaborators, the human and animal subjects of our research, and the members of our local and global communities who benefit from and are affected by our research activities.

What is Research Compliance? NIH says Grantees should have a comprehensive compliance program consisting of at least 8 elements, which are: Implementing written policies and procedures that foster an institutional commitment to stewardship and compliance; Designating a compliance officer and compliance committee; Conducting effective training and education; Developing effective lines of communication; Conducting internal monitoring and auditing’ Enforcing standards through well-publicized disciplinary guidelines; and Responding promptly to detected problems, undertaking corrective action, and reporting to the appropriate Federal agency. Defining roles and responsibilities and assigning oversight responsibility.

Why Compliance is Important 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. The government thinks it is important. - Evidence: High profile enforcement actions (Harvard $3.3M, Northwestern $5.5M, Minnesota $32M) It is the right thing to do.

Substantive Areas Within Purview of ORC Grants Management Time and effort reporting Cost allocations Use of program income Cost Transfers Conflicts of Interest 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 Scientific Misconduct FDA Regulations (GLP, GCP, IND/IDE) Other Laws/Regs. Affecting Research, e.g. Federal Funding Restrictions & MA legislation re hESC research. Faculty Consulting Agreement Controlled Substances

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. Review and approve Faculty Consulting Agreement with Industry

Some Examples of Potential Compliance Problems Failure of investigators to disclose financial conflict of interest. Improper grant charges. Improper time and effort reporting. Unauthorized or improper use of animals for research. Data falsification/fabrication or plagiarism. Research trainees working and being paid for more hours than permitted. Improper assignment of inventions owned by the University. Noncompliance with IRB requirements for human subject research. Failure to follow safety protocols (e.g. regarding use/handling of animal, biological agents) Sending materials/reagents to external parties without approval.

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) If you aren’t sure about something or have questions: Ask the appropriate person to help you. If you see something wrong, say something.

Resources Available to You Your PI and your Department Administrators are your most important resources and can answer most if not all the questions you may have but they are not your only resources. In some case it will be appropriate to speak with other people outside your lab and your department. HMS offices are also very important and valuable resources: - SPA (grant questions) - OSP & FOA (cost questions) - ORSP (human & animal subject questions) - COMS (bio-safety questions) - ORC (all questions) - OMBUDS Office (employment, workplace questions, “other questions”) HMS Policy Matrix (http://ecommons.med.harvard.edu/ec_res/nt/D99E81D2-14C4-4E1E-9A06-E4C83DAA909F/Research_Policy_Matrix_(SPA).doc)