DELIA WOLF, MD, JD ASSOCIATE DEAN REGULATORY AFFAIRS & RESEARCH COMPLIANCE HARVARD SCHOOL OF PUBLIC HEALTH MARCH 7, 2014 Responsible Conduct of Research Lecture 6 The Scientist as a Responsible Member of Society Mentor/Mentee Relationship and Respective Responsibilities

Case Study # 8 2 A U.S.-based pharmaceutical company is conducting a drug trial in a resource-poor country; the protocol involves studying the safety and effectiveness of a new drug for hypertension. In addition to the research budget, the local investigators are being paid through consulting agreements to advise the company on research and political strategy and to liaison with local officials (the amounts, while modest by US standards, are 3 times what the investigators make in annual salary at their institutions).The consulting agreements give the company the rights to control access to data and approval any publications. The local institution’s Ethics Committee is comprised primarily of hospital management and prominent community members. In addition to the institutional EC, the protocol must be reviewed by a regional Ethics Committee, the Chair of which holds a prominent position in the local government. Local government officials have repeatedly expressed a desire to improve their reputation as a “research- friendly” locale. And the local health system, including the site, desperately needs investment in infrastructure, so the company has offered to invest a significant amount of resources in improving the site, building local health clinics, as well as providing infrastructure and resources for the EC. Since the standard of care for hypertension in the US is currently prohibitively expensive for the site’s patient population, the company has also offered to ensure that all patients at the site (whether on protocol or not) receive the standard of care for hypertension during the course of the trial and for 3 years following; additionally, if benefits are shown, the company has offered to make the new drug available to all patients at the site for the same time-frame.

Case Study # 8 continued 3  What conflicts do you see with this arrangement?  Whose responsibility is it to question the validity of the regional EC approval?  How should the reviewing ECs balance just reward to the site for participating against the potential to create conflicts?  What management techniques might work in this context?

Research as Collaborative and Social Endeavor 4 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

Research as Collaborative and Social Endeavor 5 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

Applying common values to the research enterprise 6 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…

Case of Note : 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

Advisors and Mentors 8 Advisor/Supervisor vs. Mentor: Advisor oversees research Mentor provides advice for mentee’s personal and professional development

HSPH Office of Faculty Affairs PostDoc Guidelines 9 Responsibilities of Postdoctoral Fellows and Faculty Supervisors (revised 07/21/2011) 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 annual review process Work in a collegial and cooperative manner with the faculty supervisor and other co-workers.

PostDoc Guidelines (cont.) 10 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 Meet regularly 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.

11 PostDoc Guidelines (cont.) 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 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

Mentoring 12 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

Finding a mentor 13 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 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

Making it work 14 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 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