FAS Research Administration Services

Conducting Research Responsibly

Contents:

Introduction:

Trust in the integrity of Harvard research is one of the University's most valuable assets. All those associated with research owe it to their colleagues and coworkers to make sure that funds are expended properly, that research is conducted with due attention to ethical standards and applicable regulations, and that results are reported accurately and truthfully. In the case of externally-funded research, they also have legal and ethical obligations to the sponsors of their research and to the University in its administrative oversight role.

In particular, the University must certify to federal sponsors that its members, including administrative and research staff, understand the standards of professional conduct, and that it has established procedures to demonstrate that these standards are observed. See section on Regulatory Oversight below for more information. The policies and procedures for the FAS are collected in Principles and Policies that Govern your Research, Instruction, and Other Professional Activities (the "Grey Book"), which is available online at http://www.fas.harvard.edu/~research/greybook. All individuals in the FAS who conduct or support research should be familiar with the policies in the Grey Book that are relevant to their activities. PIs signal that they are aware of these policies by filing an "Affirmation of Awareness of FAS and Harvard University Policies Including Disclosure of Potential Conflicts of Interest And Conflicts of Commitment" annually at https://asperin.fas.harvard.edu/disclosure/web.

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Free Scholarship and Its Responsibilities

The right of investigators to choose the nature and direction of their research inquiries--and the understanding that they bear sole responsibility for their conclusions--are basic premises of free scholarship at the University. Individuals are appointed as members of the Faculty with the understanding that they are free to select the areas in which they will conduct research, subject to prevailing legal and ethical standards and appropriate use of University resources. Naturally, with freedom come responsibilities--to the University, to the intellectual community, and to the sponsors with whom research agreements have been made.

Sponsors of University-based research may not prohibit specific individuals or groups from participating in research on account of their beliefs or backgrounds.

Investigators must be free to share their research findings with the scientific and academic community. Secret or classified research may not be conducted at Harvard, and the University will not accept research that restricts investigators' ability to publish their results. This is particularly important for students and others at the early stages of their careers, where publication of research is crucial to recognition in the field.

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Confidentiality

While it is expected that research results will be published, care must be taken with two types of information gathered or developed during the course of research:  (1) personal or private information about identifiable individuals; (2) confidential information provided by sponsors, including industry know-how, trade secrets, business processes, and proprietary information. 

Personal or Private Information: For more information concerning the use of personal or private information about identifiable individuals, please see the Committee on the Use of Human Subjects (CUHS) web pages. CUHS is also referred to as the Institutional Review Board, or IRB.

Confidential Information: Agreements to accept and protect confidential information need not involve funding; for example, access to a data set may require signing a confidentiality agreement or data use agreement. Harvard's Office for Sponsored Programs (OSP) or, in the case of industry-sponsored agreements, the Office of Technology Development (OTD), in consultation with Research Administration Services (RAS), must approve any agreement involving the acceptance of confidential information by the University--whether or not external funding is involved--before the agreement is signed; if information is in electronic form and must be protected, the school’s chief information officer must also be consulted.  Key considerations regarding the acceptance of confidential information include the following:

  • Can the PI conduct the research without compromise? 
  • Will other scholars be able to verify and/or replicate the research results?
  • Will the PI and students involved with the project be free to publish their research results?
  • Are there potentially adverse financial implications for the University?
  • Will the information be appropriately protected from inadvertent disclosure?

In certain limited cases that do not involve or obligate the University in any way, it may be possible for an individual to accept confidential information that the University would not be able to accept. Guidelines regarding confidential or proprietary information can be found in Principles and Policies that Govern your Research, Instruction, and Other Professional Activities in the sections...

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Publication

In addition to specifying that certain information must remain confidential, some sponsors may request the right of advance review of any publication or presentation that could involve their confidential material. Within certain limitations, a sponsor may be allowed to review proposed publications to confirm that neither the sponsor’s background confidential information nor the sponsor’s proprietary information has been disclosed.  Agreement to delay publication briefly to seek patent protection of an invention may also be permitted.  Specific, appropriate protections and guidelines have been developed for these areas, and the University will not accept any agreement that gives the sponsor editorial control over publication of research results.

Experience has shown that satisfactory arrangements regarding confidentiality and publication delay can usually be negotiated, but PIs should be alert to the issues and remember the principal reasons for the University’s policies: to make certain that the exchange of information is not inhibited and that the ability to publish and communicate freely--for students as well as faculty--is protected.

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Conflicts of Interest and Conflicts of Commitment

FAS policies on conflicts of interest and conflicts of commitment stipulate that full-time faculty and staff owe their primary professional allegiance to the University.  Outside activities and obligations must be arranged in ways that respect this relationship and that do not interfere with individuals’ University responsibilities. Two areas of concern are: 

  • Conflicts of Interest — situations in which an individual’s University activities might be, or might appear to be, influenced by considerations of personal gain (financial or otherwise)
  • Conflicts of Commitment — situations in which an individual’s outside activities (consulting, public service, or pro bono efforts) may interfere or appear to interfere with the quality or performance of University duties. 

Both types of conflict can affect University-based research and both are addressed by University and sponsor guidelines. Policies on conflict of interest and conflict of commitment can be found in the Grey Book in the section Policies Relating to Research and Other Professional Activities Within and Outside the University (http://www.fas.harvard.edu/~research/greybook/policies.html). The FAS Committee on Professional Conduct administers these policies.  Applicants for support from the National Science Foundation (NSF), or to one of the agencies of the Public Health Service (which includes NIH and NIMH) must also comply with federal rules on conflict of interest. For more information, please see the Grey Book's Instructions for Meeting Federal Conflict of Interest Regulations at: http://www.fas.harvard.edu/~research/greybook/COI.insts.html

Please also see the RAS website's Conflict of Interest and Conflict of Commitment page at: http://www.fas.harvard.edu/~research/policy/coi.html

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Research Integrity and Oversight

The University has established policies and procedures and created structures to foster a proper research environment, to support and monitor research activities, and to deal promptly and effectively with misconduct or allegations of misconduct in research in the Faculty of Arts and Sciences. 

See the Grey Book at http://www.fas.harvard.edu/~research/greybook/index.html for more information on the various policies. The responsibilities of everyone associated with the research enterprise include an obligation to report questionable administrative or academic practices and/or policy deviations to the appropriate University official(s). 

The structures that the University has established include various committees:

The federal Office of Science and Technology Policy (OSTP) issued a federal-wide policy on research misconduct in December of 2002, defining research misconduct as "fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results."
See the Federal Policy on Research Misconduct for more information at: http://www.ostp.gov/cs/federal_policy_on_research_misconduct
OSTP acknowledges that research misconduct should be distinguished from honest error or differences of opinion.

Many other federal agencies have offices to oversee and audit the propriety of the research activities that they sponsor, and specialized boards of accreditation oversee procedures and practices in research involving human or animal subjects. Some of these include the Public Health Service Office of Research Integrity, the DHHS Office for Human Research Protections, the NIH Office of Management Assessment, the DHHS Office of Inspector General; the NIH Office of Laboratory Animal Welfare; the FDA Office of Regulatory Affairs; and the NSF Office of Inspector General.

In addition to the areas mentioned above, University policies and procedures address compliance with a broad range of applicable federal, state, and local regulations. These include:

Audits: The expenditure of sponsored (and particularly federally-sponsored) funds is closely regulated and monitored.  Each institution with annual federal sponsored research volume above $500,000 is subject to federal audit.  The federal agency assigned that audit responsibility depends upon the composition of that institution’s federal funding portfolio.  Because Harvard’s largest sponsor is the National Institutes of Health (NIH), the Department of Health and Human Services (DHHS) is the University’s "cognizant agency."  More information may be found in the Audits section of Managing Your Research (http://www.fas.harvard.edu/~research/managing_your_research/index.html)

OMB Circulars: Financial and audit responsibilities are managed in accordance with three circulars issued by the Office of Management and Budget (OMB). Recent high-profile cases involving unauthorized expenditures and/or questionable accounting practices at some major research universities have led to increased requirements to document that the University is monitoring and enforcing proper stewardship of the funds that taxpayers provide for research. For more information on circulars and other federal and state regulations, please visit the State and Federal Regulations page at http://www.fas.harvard.edu/~research/policy/fed_regs.html.

Negotiated Federal Rates: The cognizant agency (DHHS) also has responsibility for the negotiation of fringe benefit and vacation assessment rates and Facilities and Administrative Rates (also known as F & A, indirect cost, or overhead rates), through its rate-negotiation arm, the Division of Cost Allocation (DCA). In addition, the University is required by OMB’s Cost Accounting Standards Board (CASB) to file a Disclosure Statement (DS-2) describing its cost-accounting practices.  The DS-2 is audited and approved by the DHHS-DCA. 

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[Last modified: 06/29/11 ]

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