Office of Research Compliance May 2010

Background

Section 7009 of the America COMPETES Act of 2007 (America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education and Science) directs the National Science Foundation to require institutions receiving financial assistance from the Foundation for science and engineering research, or
education, to implement mentoring and training in the responsible and ethical conduct of research for undergraduate students, graduate students, and postdoctoral researchers.

In response to this requirement, NSF published a revision to its NSF Proposal & Award Policies and Procedures Guide requiring that, effective January 4, 2010, institutions must, at the time of proposal submission, certify they have a plan to provide appropriate instruction and oversight in the responsible and ethical conduct of research to all undergraduates, graduate students, and postdoctoral researchers who participate in NSF funded projects.

Subsequent to the publication of the new NSF requirements, NIH published its own updated requirements for instruction in the responsible conduct of research for institutions receiving funding for training grants. These requirements are outlined in NOT-OD-10-019, the NIH Update on the Requirement for Instruction in the Responsible Conduct of Research. This notice is applicable to all NIH Institutional
Research Training Grants, Individual Fellowship Awards, Career Development Awards (both institutional and individual), Research Education Grants, Dissertation Research Grants, and other grant programs with a component requiring instruction in the responsible conduct of research.

Purpose

The purpose of this document is to outline Boston University’s plan for implementing NSF and NIH requirements for instruction in the responsible conduct of research (RCR) and for supporting RCR instruction programs at Boston University.

Definition

For the purpose of this Plan, responsible conduct of research (RCR) is defined as “the practice of scientific investigation with integrity. It involves the awareness and application of established professional norms and ethical principles in the performance of all activities related to scientific research.”

Policy Statement

All members of the BU community are expected to adhere to the highest ethical and professional standards as they pursue research and scholarly activities. In doing so, BU requires the vigilance of all members engaged in research and scholarly endeavors to comply with the legal, regulatory, and ethical requirements established by the University, regulatory agencies, funding sources and professional
organizations.

The Office of Research Integrity (ORI), organized under the U.S. Department of Health and Human Services, the Office of the Secretary of Health and Human Services (OS), and the Office of Public Health and Science (OPHS), is the federal agency charged with the responsibility of oversight in the responsible conduct of research. ORI encourages researchers to make a special effortThe term Effort is used for persons charged to Sponsored Res... More to understand, discuss, and teach others the responsible conduct of research. It is understood that RCR can be taught and learned in many ways, and that principles can vary from discipline to discipline. For this reason, it is the intent of the BU Plan for RCR instruction to provide flexibility in its content and delivery methods in such a way that it addresses the specific needs, issues, and concerns of various target audiences among numerous disciplines.

RCR Content Areas

Instruction in the responsible conduct of research (RCR) consists of (but is not limited to) the following core content areas:

  • Mentor/Trainee Responsibilities
  • Data Acquisition, Management, Sharing and Ownership
  • Publication Practices and Responsible Authorship
  • Peer Review
  • Collaborative Science
  • Research Ethics and the Role of the Scientist
  • Research Misconduct
  • Conflict of Interest and Conflict of Commitment
  • Human Subjects
  • Animal Welfare
  • Safe Laboratory Practices

Instruction in the content areas related to human subjects research, research involving animals, and safe laboratory practices will be conducted and verified in accordance with federal regulatory requirements governing those specific content areas and as specified by institutional policies established by the Boston University IRBs, IACUCs, and LSCs, respectively.

Basic Principles and Successful Strategies

In its Summary of a Workshop on Ethics Education and Scientific and Engineering Research, the National Academy of Engineering identified a number of components that characterize successful strategies for ethics and RCR education programs.

In addition, NIH elucidates (in its Update on the Requirement for Instruction in the Responsible Conduct of Research) basic principles and key concepts that, based on best practices, are considered components of an effective educational program designed to promote the responsible conduct of research.

BU endorses these principles and strategies, which are outlined below, and considers them to be key components for successful implementation of this Plan.

  • RCR is an essential component of research training
  • RCR education is a grant compliance requirement for the following individuals:
    • Those individuals supported financially, in whole or in part, by NSF research or educational awards. This requirement is targeted at:
      • Undergraduate students
      • Graduate students (both Master’s and Doctoral level)
      • Post-doctoral fellows
    • Those individuals supported financially, in whole or in part, by institutional or individual NIH training grants, fellowships, career development awards, research education grants, dissertation
      research grants, or other awards having a training component that requires RCR instruction. This requirement is primarily targeted at (but may not be limited to):

      • Doctoral level graduate students
      • Post-doctoral fellows
      • Faculty members
  • RCR instruction will encourage the active participation of faculty in ways that allow them to serve as effective role models
  • BU RCR instruction programs will be conducted on a recurring basis and in formats that allow active (face-to-face) interaction of trainees with faculty mentors
  • BU RCR instruction programs will provide discipline-specific training to address the needs of investigators in their specific fields of research
  • RCR instruction will require active involvement throughout a scientist’s career, and will be appropriate to the career stage
  • Individuals must assume personal responsibility for their instruction in RCR

Considerations in Developing the Plan

The following Plan was developed with the requirements of NSF, NIH, and best practices in mind, as well as with local considerations. In developing the Plan for implementation, the following considerations were determined to be relevant:

  • What strategies will be used for implementation?
  • What content and delivery methods will be used?
  • Is there a need for content development, or implementation of other pedagogical methods, in order to meet requirements?
  • Who will be responsible for administering the various components of the institutional RCR instruction program?
  • What institutional policies, guidelines, and procedures will facilitate implementation of the plan?
  • What resources are available to support implementation of the plan, and are they sufficient?
  • Who will provide institutional oversight and verification that requirements have been met?
  • How will completion of instruction be reported?
  • How will the overall efficacy of the RCR instruction program be evaluated?

Plan for Implementation

Goal: Implement a plan for compliance with RCR instruction requirements that meets federal funding agencies’ compliance requirements and provides the resources needed to support broader RCR instruction at Boston University.

Grant Application Requirements:

  • NSF: NSF requires an institutional certification that the institution has developed a plan to provide instruction and oversight in the responsible conduct of research (RCR) at the time of proposal submission.
  • NIH: NIH has published different requirements for institutional applications and individual applications. Principals Investigators must include an RCR section in their grant applications.
    The Office of Research Compliance will provide guidance for Principal Investigators on how to prepare the RCR section of NIH training grant applications and reports to NIH on these grants.

Centralized and Decentralized Development of BU RCR Programs

Instruction in RCR is to be provided throughout a scientist’s career at every career level: undergraduate, post-baccalaureate, pre-doctoral, post-doctoral, and faculty levels. Instruction must be undertaken at least once during each career stage, and at a frequency of no less than once every four years.

Various combinations and modes of instruction will be available for completion of training requirements to afford maximum flexibility in meeting the needs of a broad range of stakeholders. In this sense, the program will be customized and appropriate for the target audience. For example, RCR requirements for a postdoctoral researcher in engineering may be different from those of an undergraduate student in psychology.

The Office of Research Compliance, in consultation with the RCR Education Advisory Committee (RCREAC), will establish and communicate minimum instruction standards for each target audience (undergraduates, graduate students, postdoctoral fellows, and faculty). These standards will incorporate minimum requirements of funding agencies, such as the NIH requirement of participating in at least eight contact hours.

  • Core RCR Instruction Programs: Each year, the Office of Research Compliance offers a core program for instruction in the Responsible Conduct of Research, in coordination with participating schools and departments. This program will be reviewed by the RCR Education Advisory Committee and will be open to target audiences (undergraduates, graduate students, post doctoral fellows), regardless of their funding sources. Certificates of Completion will be provided to individuals who complete the program, and such individuals will be deemed by BU to meet both NIH and NSF compliance requirements. It is anticipated that the Core program will include at least the following two instruction programs:
    • An introductory web-based instruction program for undergraduates;
    • An advanced instruction program, utilizing a selection of web-based resources, together with four, two-hour live sessions with group-based discussions lead by faculty “facilitators” from various
      departments
  • Alternative RCR Instruction Programs: Departments, schools, and programs may propose alternative RCR Instruction Programs for their degree candidates, their postdoctoral fellows, or open to a wider audience. These RCR instruction programs may be, for example, part of a full course in research methods, or may be stand-alone RCR instruction programs. Proposals for these alternative programs will be reviewed and approved by the Office of Research Compliance, in conjunction with the RCREAC, to ensure that minimum standards are met. Office of Research Compliance will provide assistance and resources to any departments wishing to develop their own alternative RCR Instruction Programs.

Post-doctoral Researcher Mentoring Plan

Mentoring is an essential component of education in the responsible conduct of research. Each proposal that requests NSF or NIH funding to support post-doctoral researchers/fellows must include, as a supplementary document, a description of the mentoring activities that will be provided for such individuals. In no more than one page, the mentoring plan must describe the mentoring that will be provided to all postdoctoral researchers supported by the project, irrespective of whether they reside at the submitting organization, any sub-awardee organization, or at any organization participating in a simultaneously submitted collaborative project.

Mentoring may consist of informal or formal meetings to discuss topics that are related, but not limited, to: career counseling, training in the preparation of grant proposals, publication and presentations, improving teaching and mentoring skills, reconciling dual roles as mentor/mentee, effective collaboration with investigators from diverse backgrounds and disciplinary areas, implications of temporary appointments on data and project ownership, and responsible professional practices.

Faculty mentors are to provide Individual Development Plans (IDP) to post-doctoral fellows that identify both their professional development needs and their career objectives. The Federation of American Societies of Experimental Biology (FASEB) has developed a useful guidance document which outlines steps for executing the IDP process. The research and career progress of post-doctoral fellows should be formally documented in an annual review, which can serve as a useful performance evaluation tool.

Responsibilities under the RCR Plan

NIH/NSF Principal Investigators’ Responsibility for Compliance: Principal Investigators on NSF or NIH funded research, education, or training projects have primary responsibility for ensuring that any individuals supported under their grants have participated, or plan to participate, in an approved RCR Instruction Program. Accordingly, such Principal Investigators have the following RCR responsibilities:

  • For NSF grants, file an RCR informational form as requested by the Office of Research Compliance for each applicable audience (undergraduate/graduate students and postdoctoral researchers/fellows and faculty) participating in projects funded in whole or in part by an NSF award
  • For institutional and individual NIH grant applications (both new and renewal), include a section addressing the requirements for RCR instruction
  • Specify and monitor completion of RCR instruction for required students, post-doctoral fellows, and faculty
  • Review attendance reports and ensure timely completion of BU-approved RCR Instruction Programs

Principal Investigators also have the following mentorship responsibilities:

  • Engage in compacts with post-doctoral appointees that outline the commitments of both the PIPrincipal Investigator View Boston University's policy on... and the post-doctoral appointee relative to the post-doctoral appointee-mentor relationship
  • Complete an Individual Development Plan (IDP) and Annual Review for postdoctoral fellows

The Office of Research Compliance (ORC) is responsible for:

  • Designating an Authorized Organizational Representative who will certify the existence of an institutional plan for RCR instruction on NSF proposals
  • Developing and allocating sufficient resources necessary to conduct and report completion of training, including development of RCR educational resources
  • Monitoring training activities
  • Verifying compliance with the RCR requirements established by federal funding agencies
  • Establishing and providing administrative support to the RCR Education Advisory Committee
  • In conjunction with the RCREAC, coordinating reviews and approval of RCR curricula developed by BU schools, departments, or programs
  • Developing an assessment tool or tools for the evaluation of the effectiveness of RCR instruction and educational activities
  • Collaborating with departments and schools to promote faculty involvement in the core program

The RCR Education Advisory Committee (RCREAC) is responsible for:

  • Providing institutional leadership for implementing and evaluating the RCR Instruction Programs
  • Assisting in the development and review of RCR educational resources
  • Serving as a liaison between the Office of Research Compliance and Schools/ Departments/Programs for implementation of the RCR Instruction Programs
  • Developing minimum standards of RCR instruction for each target group Recommend implementation of policies that promote the institutional goals of education in the responsible conduct of research

Institutional policy, guidelines and procedures

The development of institutional policy, guidelines, and procedures relevant to RCR practices and the BU RCR Instruction Programs underscores its legitimacy as an institutional priority and advances the responsible and ethical conduct of research within the BU community.

Audit and verification of compliance

Periodic compliance audits will be conducted by the Office of Research Compliance. Information on salary paid to individuals from NSF and NIH funds will be extracted from institutional databases on a quarterly basis and compared to existing RCR attendance information, to ensure that all individuals required to complete RCR training have done so, or are in the process of doing so.

Training previously completed at other institutions

Personnel who have documented completion of RCR instruction at another institution may be considered to have met BU requirements. Such RCR instruction will be evaluated on a case-by-case basis that is predicated on the equivalency of that institution’s RCR program to that of BU’s.

RCR Resources

RCR instructional resources that will be made available include:

  • Case studies: A catalog of case studies for use in alternative RCR instruction programs will be made available on the Office of Research Compliance RCR website.
  • Instructional Materials: Office of Research Compliance will maintain a library of instructional materials to complement formal RCR instruction.
  • RCR On-demand Instruction: Office of Research Compliance will provide formal classroom instruction in various content areas of RCR upon request.

Program Assessment

Overall efficacy of the RCR Instruction Program will be evaluated based on meeting the goals and objectives of the program outlined below. These goals are more practically focused on skill development rather than knowledge (as articulated in the NAE’s Summary of a Workshop on Ethics Education and Scientific and Engineering Research). The goals of the RCR Instruction program are:

  • To serve as a catalyst for the questioning of decisions, practices, and processes related to the responsible conduct of research, with the objective of arriving at better informed decisions
  • To promote skill development by:
  • Recognizing and defining ethical issues
  • Identifying relevant stakeholders and socio-technical systems
  • Collecting relevant data about stakeholders and systems
  • Understanding relevant stakeholder perspectives
  • Identifying value conflicts
  • Constructing viable alternative courses of action or solutions and identifying constraints
  • Assessing alternatives in terms of consequences, public defensibility, institutional barriers, etc.
  • Engaging in reasoned dialogue or negotiations
  • Revising options, plans or actions
  • Collecting relevant data about stakeholders and systems

This concept of skills development is consistent with the guidelines developed by the AAMC concerning the student-mentor relationship as outlined in their Compact between Biomedical Graduate Students and Their Research Advisors. The compact outlines core tents of pre-doctoral training, including the following:

  • Institutional Commitment
  • Program Commitment
  • Quality Mentoring
  • Providing Skills Sets and Counseling that Supports a Broad Range of Career Choices

These core tenets are supported in principal and practice by Boston University through implementation of this Plan. Although the AAMC document is intended for use by advisors and students within the biomedical community, its concepts have broad application across many disciplines.

In addition to the compact developed by AAMC for pre-doctoral students and advisors, the AAMC has also developed a Compact between Postdoctoral Appointees and Their Mentors which outlines similar tenets, as follows:

  • Institutional Commitment
  • Quality Postdoctoral Training
  • Importance of Mentoring in Postdoctoral Training
  • Foster Breadth and Flexibility in Career Choices

The AAMC Compact between Postdoctoral Appointees and Their Mentors underscores the importance and value of mentoring in postdoctoral training:

“Effective mentoring is critical for postdoctoral training and requires that the primary mentor dedicate substantial time to ensure personal and professional development. A good mentor builds a relationship with the trainee that is characterized by mutual respect and understanding. Attributes of a good mentor include being approachable, available, and willing to share his/her knowledge; listening effectively; providing encouragement and constructive criticism; and offering expertise and guidance.”

Boston University supports this philosophy; it is the principle upon which program success will be measured.