1. MARK BARNES SENIOR ASSOCIATE PROVOST AND UNIVERSITY CHIEF RESEARCH COMPLIANCE OFFICER MARK_BARNES@HARVARD.EDU September 14, 2012 Responsible Conduct of Research Lecture 2 The Scientist as a Responsible Member of Society Mentor / Mentee Relationship and Respective Responsibilities Grant Writing, Budgeting and Management

2. Research as Collaborative and Social Endeavor 2 Obligation to Colleagues + Oneself “In learning something new the discoverer both draws on and contributes to the body of knowledge held in common by all researchers.” - “On Being a Scientist: A Guide to Responsible Conduct in Research” Collaboration built on a foundation of trust; individual actions can undermine foundation Violations of ethical norms can derail careers, undermine personal integrity Obligation to the Public Potential impact of research is wide-ranging: Public health and well-being of populations Policy (social, economic, environmental…) Much research is funded by tax dollars or by charitable funds, and with funds comes accountability

3. Applying common values to the research enterprise 3 Rigor following standards, avoiding haste and carelessness… Accuracy compiling data, reporting research results… Honesty reporting research results, citing others’ work, assigning credit, reviewing proposals… Openness sharing research materials and findings, acknowledging and correcting mistakes…

4. Two Cases of Note 4 2005: Seoul National University Stem Cell Cloning Falsification of stem cell research results, allegations of unethical practices (payment of donors etc.) wasted time of other scientists, journals undermined validity of stem cell field eroded public trust, undermined national pride compromised funding 1998: Claimed Link Between MMR Vaccine and Autism Lead author of influential journal article found guilty of serious professional misconduct claim led to numerous epidemiological studies undermined vaccination rates instigated expensive class-action lawsuits eroded public trust in science

5. Claimed Link of MMR Vaccine to Autism 5 “Authored by Andrew Wakefield and 12 others, the paper’s scientific limitations were clear when it appeared in 1998.2 3 As the ensuing vaccine scare took off, critics quickly pointed out that the paper was a small case series with no controls, linked three common conditions, and relied on parental recall and beliefs.4 Over the following decade, epidemiological studies consistently found no evidence of a link between the MMR vaccine and autism.5 6 7 8 By the time the paper was finally retracted 12 years later,9 after forensic dissection at the General Medical Council’s (GMC) longest ever fitness to practise hearing,10 few people could deny that it was fatally flawed both scientifically and ethically. But it has taken the diligent scepticism of one man, standing outside medicine and science, to show that the paper was in fact an elaborate fraud.”2345678910 BMJ 2011; 342:c7452

6. Advisors and Mentors 6 Advisor/Supervisor vs. Mentor: Advisor oversees research Mentor provides advice for mentee’s personal and professional development

7. HSPH Office of Faculty Affairs PostDoc Guidelines 7 Responsibilities of Postdoctoral Fellows and Faculty Supervisors (revised 07/21/2011) The Harvard School of Public Health recognizes that postdoctoral research fellows are trainees working in an apprenticeship mode in preparation for a career as scientific professionals. The mentoring provided to the postdoctoral fellow by the faculty mentor is critical to the fellow’s career development and advancement. In addition, postdoctoral fellows are generally expected to function responsibly and autonomously within the school’s complex and decentralized environment. Independent thinking and action are in fact requisite to successful careers in research. Responsibilities of postdoctoral fellows include the following: Assume primary responsibility for the development of his or her research and career. Play an active role in seeking career and research advice, both from the faculty supervisor and from other faculty members as appropriate. Perform the research required by the faculty supervisor to a high standard and in accordance with all institutional and federal regulations. Participate in the postdoc career development and annual review process.postdoc career development and annual review process Work in a collegial and cooperative manner with the faculty supervisor and other co-workers.

8. PostDoc Guidelines contd. 8 Responsibilities of HSPH faculty supervisors include the following: Ensure that mutually understood expectations and goals are in place at the outset of the postdoctoral training period. This may be best accomplished during the review of the postdoc's initial career development plan. Meet regularly (for example, once a month) to establish and foster a career development plan and to assess important aspects of the postdoctoral fellow’s progress. In addition, complete the postdoc annual progress review form as part of the postdoc career development and annual review process. Strike a reasonable balance between the postdoctoral fellow’s responsibility to participate in research directed by the faculty supervisor and opportunities to develop scholarship reflecting the postdoctoral fellow’s own interests. Respect the postdoctoral fellow’s individuality, working style, and career goals and be aware that the rate of progress of postdoctoral fellows will vary. Maintain an atmosphere in which the postdoctoral fellow feels free to approach him/her for advice or discussion of differences. Encourage each postdoctoral fellow to seek advice and collaborative opportunities from other faculty members, or even to identify a second mentor, since the training experience can only benefit from a variety of perspectives. Promote ethical standards for conducting research, including compliance with all institutional and federal regulations. Accord full recognition of the postdoctoral fellow’s contributions to scholarship, including appropriate authorship of published work. (The authorship guidelines developed by Harvard Medical School, available online at www.hms.harvard.edu/integrity/authorship.html provide guidance in this area.) www.hms.harvard.edu/integrity/authorship.html Establish clear plans for how projects will be divided when fellows complete their training. Support the postdoctoral fellow’s use of the full benefits of his/her employment at HSPH, including vacation time. Postdoctoral fellows and faculty supervisors may meet with Bernita Anderson, associate dean for faculty affairs, to resolve problems on an informal basis. HSPH also provides a formal process for the resolution of issues that may arise between a postdoctoral fellow and his/her supervisor (see grievance policy at http://www.hsph.harvard.edu/administrative-offices/faculty-affairs/postdoctoral-research-fellows/postdoc- guidelines/ grievance-procedures-for-non-faculty-academic-appointees.html). http://www.hsph.harvard.edu/administrative-offices/faculty-affairs/postdoctoral-research-fellows/postdoc- guidelines/ grievance-procedures-for-non-faculty-academic-appointees.html

9. Mentoring 9 Mentoring fosters community and strengthens the collaborative foundations of the scientific endeavor Mentoring is a symbiotic relationship; advantages for mentor and mentee: MenteeMentor Builds professional network Provides support in times of difficulty Fosters new ideas May lead to job opportunitiesPromotes engagement in current professional issues and challenges Exposure to different approaches and new ideas Personal satisfaction in assuring continuity of the field

10. Finding a mentor 10 Identify your goals and needs – what do you hope to gain from the mentor/mentee relationship? Take the initiative – identify a respected senior researcher with whom you are compatible and have mutual interests / work through an institutional mentoring program Ask for recommendations for mentors Be persistent – follow-up with prospective mentors Find more than one – no one mentor can have the breadth of experience to advise on all issues. Diverse mentors will offer different approaches, backgrounds and styles

11. Making it work 11 Mentee and mentor both have responsibilities: *J.T. Zerzan, R. Hess, E. Schur, R.S. Phillips and N. Rigotti, “Making the Most of Mentors: A Guide for Mentees” Academic Medicine Vol. 85 No. 1 / Jan. 2009 MenteeMentor “Manage Up”*:Take care not to abuse authority Be clear about expectations (accessibility, needs) Lead by example Set an agenda and follow throughBe clear and honest about availability, skills and expertise Ask questions, be actively engaged, listen and be responsive Prioritize mentee’s individual development and needs Respect mentor’s time and research agenda Respect mentee’s time and commitments to other faculty

12. Grant Proposals 12 Responsible conduct of research begins at the proposal stage and the Principal Investigator is ultimately responsible for all aspects of the proposal as submitted to the granting agency. Accuracy of the proposal is paramount to a successful and compliant research award.  Scope of Work  Budget  Collaborators:  Subcontractors, Consultants and Vendors

13. Grant Proposals 13 Proposals are reviewed for overall impact and influence over the research fields involved. Research Misconduct can occur if there is fabrication or falsification in grant proposals. Do not provide embellished or misleading information in the scope of work, CV or other agency-required documentation. There is a line between touting your expertise and experience, and exaggerating them – don’t cross it

14. Salary Charges to a Grant and Time and Effort Reporting 14 Grant Proposals must contain an accurate representation of the time commitment of the Principal Investigator and all Key Personnel.  Later significant deviations (i.e., 25 percent or greater time and effort reduction) should be approved by funder. Salary and Wages charged to an award must be both reasonable and actual. Time and effort reports are required to be completed at periodic intervals by employee or supervisor, and must be accurate and signed. Costs of administrative or clerical staff must be treated as a F & A Cost, and not a direct cost  In other words, departmental administrators cannot ordinarily be listed a Key Personnel and directly charged to your grant.

15. Budget 15 Estimate the project costs accurately.  Don't overstate or understate your expenses The budget should be complete and fully-loaded  Include all the costs of personnel, equipment, supplies, and activities required for the project  Use the correct F & A rate – on-campus v. off-campus Expenditures must be allowable, appropriate, and reasonable in accordance with applicable cost principles. Actual expenses must then match up to the budget proposed, or permissions must be obtained from your grant officer for budget variances.

16. OMB Circulars A-21 and A-110 16 Principles for Determining Costs Applicable to Grants, Contracts, and Other Agreements with Educational Institutions (OMB Circular A-21) provides:  the general accounting “rules” for colleges and universities.  These principles define those costs that are allowable and allocable to the federal government Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non- Profit Organizations (OMB Circular A-110) provides:  the general rules for managing grants responsibly, including procuring goods and services, equipment inventory, financial and other recordkeeping etc.

17. Cost Principles 17 Harvard and its Principal Investigators are jointly responsible for managing sponsored funds in accordance with the cost principles set forth in OMB Circular A-21. For a cost to be allowable under OMB Circular A-21,it must be reasonable, allocable, and consistently treated.  A cost is reasonable if it is necessary for the performance of the specific award and would have been incurred by a “prudent person” for the particular goods or services obtained.  A cost is allocable if its benefit, either in whole or in part, to the specific sponsored award can be demonstrated.  A cost is consistently treated if it is always institutionally treated as either a direct cost of research or an indirect (Facilities and Administrative; F&A) cost of research when incurred for the same purpose in like circumstances.

18. Cost Principles 18 Direct Costs  Expenses that are specifically associated with a particular sponsored award and/or can be directly assigned to that award with a high degree of accuracy Indirect Costs (Facilities and Administrative; F&A)  Expenses that cannot be specifically identified with a particular project or activity. Sometimes called “overhead,” these are the costs of administration, buildings, utilities, and the many other expenses necessary for the operation of the University

19. Choosing your Collaborators 19 During proposal development, discuss the relationship with your departmental administrator to determine whether the relationship is a subaward or a vendor procurement/purchased services transaction. The terms and conditions governing the relationship will differ depending on whether the relationship is with a subrecipient or with a vendor furnishing goods and/or services. At the same time, the Principal Investigator should assess the potential Collaborator’s ability to perform the work successfully based on:  Past performance  Technical/financial resources  Proposed scope of work

20. Subrecipient Monitoring 20 Subrecipient Monitoring is the process of providing oversight on subawards throughout their lifecycle. At the proposal stage, the Principal Investigator is responsible for choosing an appropriate collaborator as well as:  Obtaining the appropriate information prior to submitting the proposal (statement of intent, accurate budget, statement of work)  Reviewing appropriateness of subawardee  Executing an agreement consistent with federal requirements  Acquiring signed A-133 certification statements (from other A-133 institutions)  A-133 represents the federal audit standards, which in turn define how financial records must be kept for grants  Acquiring all required representations, certifications, and assurances (e.g., human subject assurance).

21. Subrecipient Monitoring 21 The federal regulations that describe subrecipient monitoring are general, but contain the following core elements of compliance:  Advising subrecipients of all applicable federal laws and regulations, and all appropriate flow-down provisions from the prime agreement  The routine receipt and review of Technical Performance Reports  The routine Review of Expenses-to-Budget  The periodic performance of On-site Visits, or regular contact, if necessary  The option to perform "audits" if necessary  Review of A-133 audit reports filed by subrecipients and any audit findings  Review of corrective actions cited by subrecipients in response to their audit findings  Consideration of sanctions on subrecipients in cases of continued inability or unwillingness to have required audits or to correct non-compliant actions

22. Subrecipient Monitoring 22 Principal Investigators are responsible for the overall monitoring of the subrecipients including if:  Subrecipient has performed the research in accordance with the Statement of Work  Subrecipient is continuing to meet compliance requirements  Subrecipient is meeting reporting requirements  Subrecipient is requesting reasonable expenditures Monitoring can be through reporting, regular contact and communication and detailed invoice review

23. Rights to Research Data 23 Research Data are critical to protecting intellectual property  Obtaining patents  Enforcing patents Government has right to inspect those data and research materials whose collection and analysis government has funded Disclosure and dissemination of Research Data is critical for University reputation and assures future research support.

24. Research Data Ownership and Use 24 Harvard retains ownership of all research data and materials, but researchers have rights to use the data and materials, publish their findings, and retain copyright Harvard does not ordinarily perform “classified research” or accept any significant restrictions on publication of research results

25. Harvard Principles for Access to and Retention of Research Data and Materials 25 1. Harvard researchers and staff should have systems or practices for maintaining the essential Research Records that they create in order to be able reasonably to support research findings, justify the uses of research funds and resources, and protect any resulting intellectual property. In determining which records are essential, Harvard researchers and staff should use prudence and reasoned judgment and may seek to refer to the prevailing standards in their relevant academic or professional disciplines. In general, researchers and staff should keep those records that will document research findings and justify the uses of research funds and other resources. 2 Research Records should be retained, generally, for a period of no fewer than seven (7) years after the end of a research project or activity.1 For this purpose, a research project or activity should be regarded as having ended after (a) final reporting to the research sponsor, (b) final financial close-out of a sponsored research award, or (c) final publication of research results, whichever is later. 3. As needed, researchers and staff must make Research Records available to the University so that it may respond to federal audits or other official requests, respond to subpoenas or other document demands, and conduct other internal and external oversight activities.

26. Harvard Principles for Access to and Retention of Research Data and Materials 26 4. The record keeping systems or practices used by Harvard researchers and staff should allow unmediated access by the University to the Research Records over their entire retention period. Such systems include, but are not necessarily limited to, electronic systems owned by the University or those located on the physical premises of the University. To the extent that use of University computing or other electronic systems for these purposes is not reasonably possible or is not preferred (e.g., research conducted off-site, electronic records that are required to be stored on non- Harvard servers, research conducted in collaboration with researchers whose primary affiliation is not Harvard), Harvard researchers and staff should assure that, if needed by the University for oversight purposes, such Research Records are readily available to the University. 5. The record keeping systems or practices used by Harvard researchers and staff should be designed to include the retention of important written correspondence (including mail and electronic mail, and copies of reports, analyses and progress reports) related to their research. The scope of the correspondence that should be retained should be sufficient to enable an independent party reviewing that correspondence to identify and understand primary findings, major events, and major strategic decisions or judgments made in the course of that research. 6. Harvard researchers and staff should be mindful that for research that has led to major academic findings or major scientific discoveries, a wider and more inclusive set of Research Records should likely be maintained, for historical purposes and for the protection of intellectual property.

27. MARK BARNES SENIOR ASSOCIATE PROVOST AND UNIVERSITY CHIEF RESEARCH COMPLIANCE OFFICER MARK_BARNES@HARVARD.EDU September 14, 2012 Responsible Conduct of Research Lecture 2 The Scientist as a Responsible Member of Society Mentor / Mentee Relationship and Respective Responsibilities Grant Writing, Budgeting and Management