Responsible Conduct in Data Management
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According to Shamoo and Resnik (2003), contemporary research requires a great deal of collaboration among scientists because it can address the demand for an expanded capacity required of research projects demonstrating suitable scope and complexity. Collaboration is well suited to investigating research questions that cross over the parameter of multiple disciplines. Investigators, as members of a research team, can study different aspects of the same problem. Thus, collaboration can:

  • facilitate conducting research with a grander scope
  • invite experts from diverse yet relevant disciplines
  • handle larger number of study subjects
  • permit research to be conducted at disparate locations including local, national, and international levels

However, the greater scope and complexity of collaborative research requires a greater demand for orchestrating additional research staff and managing multiple resources. Efforts to coordinate collaboration may be made more difficult because collaborators may be from diverse disciplines, research settings (e.g., academic, government, and industry), have different standards of acceptability, and may have competing and conflicting research agendas.

The challenge to all researchers engaged in collaboration is to forge a common understanding of the project's main goal and determine the role each collaborator must play in order to achieve that goal. While collaborators may work independently from each other at certain stages of the research, they should always be cognizant of the larger picture of the project. Factors that can increase the likelihood of a successful collaboration include:

  • clearly delineating roles and responsibilities
  • developing effective management plans
  • fostering a high level of cooperation and communication
  • developing trust, collegiality, and a profound sense of fairness and accountability

When the above mentioned factors are largely absent, there is potential for a negative impact on the responsible conduct of research. Unless proactively addressed, a number of challenges could both hinder a collaborative relationship as well as compromise the integrity of the research process. This section will identify challenges, and offer suggestions to address them and their untoward impact on RCR. The topics include:

  • Disagreement on conceptualization
  • Breakdown of communication
  • Poorly delineated policies on authorship
  • Intellectual property disputes
  • Impact on RCR

Disagreement on conceptualization

Conceptualization is the process of establishing the parameters of a project, including identifying an appropriate theoretical framework(s), defining the research question(s) and hypotheses, and selecting suitable methodologies.

Although collaboration does offer investigators the opportunity to expand the capacity of a research endeavor, it can place greater demands on available resources. It may also require a high level of organizational and management skills as any number of participants may be invited to participate in the process of conceptualization. Collaboration thus offers opportunities to learn how approaches from complementary disciplines may be able to assist in bringing a new perspective to existing research problems and ultimately develop innovative solutions. This may occur when discussions between potential collaborators stimulate new ideas. Other ways that research conceptualization might be initiated include:

Collaboration can also be useful when devising a division of labor to complete project tasks in a timely fashion. This is particularly important when the tasks are sufficiently differentiated that it requires orchestrating efforts with collaborators having diverse research interests and specialization. A researcher's discipline and context will influence his/her philosophical assumptions about the nature of reality. Even researchers within the same disciplines and working in the same setting (e.g., academic, government, private industry) may not necessarily share the same assumptions given their exposure to different research experiences. These differences of opinion may present a challenge during the process of conceptualization, where collaborators share the responsibility for establishing the theoretical and methodological direction of the research. The challenge might originate during efforts to 1) coordinate participant input regarding research questions, hypotheses, and investigative strategies or 2) when collaborators try to envision how each contribution will articulate with each other.

Disagreements over how to conceptualize may be more likely to occur when collaborators bring different paradigms (e.g., quantitative vs. qualitative), use a separate and distinct knowledge domains, or operate under an alternate set of philosophical assumptions. Other areas of potential conflict might include disagreement over preferences for discipline-specific instruments that measure 'constructs' and collect data.

During conceptualization, collaborators should come to an agreement as to the appropriate instrument(s) needed to measure and collect the constructs and variables that define the data. Collaborators must also agree on the appropriate procedure(s) to analyze the data. The decision-making process can range from being clear cut and agreeable to highly contentious, depending on shared or competing philosophical assumptions, past analytic experiences, and methodological preferences. Disagreements are more likely to occur if collaborators hold distinctly different philosophical assumptions and perspectives about the nature of the data. Selection of analyses can also be influenced by conventions prominent in specific research settings (e.g., academic, government, private industry).

Collaborators should be aware of a number of issues that can impede conceptualization and ultimately disrupt the research process:

  • conflicting research paradigms, conventions, and standards of practice can compromise research integrity
  • collaborators may not share the same professional jargon, speak the same language, or understand critical cultural variations
  • there may also be a difference of opinion as to what the research mission is and how it should best be accomplished

As noted previously, there should be a clear and convincing rationale for why collaboration is necessary for initiating a research project. Researchers should perhaps consider a number of items before even conceptualizing:

  • Is the outcome of the proposed collaboration worth the anticipated demand of resources?
  • Will the outcome be a relevant and significant contribution to the scientific field(s) or to society?
  • Is the proposed collaborative effort essential to achieving the goal and objectives of the project or can the investigation proceed without a partnership?

Researchers contemplating these issues during conceptualization may gain clarity, proactively address areas of conflict with fellow collaborators, and enhance the responsible conduct of research.

Breakdown in communication

An essential element to a successful collaborative relationship is the establishment of a functional communication system. Ideally, collaboration is a mechanism to promote greater collegiality between colleagues, departments, and institutions. This can be particularly useful in opening dialogue between researchers from distinctly different disciplines where previous research was conducted in divergent, unrelated directions. A functional system of communication can promote and maintain this open dialogue between researchers throughout the duration of a research project. A system of communication should provide transparent feedback up and down the chain of command, encouraging open discussion in order to identify and address threats to research early on.

However, even a well conceived research plan may fail to be properly implemented if participants are unable or unwilling to share resources, exchange information, or behave in collegial manner. A breakdown in communication represents a major factor in the dissolution of collaborative research relationships and can lead to initiating a host of threats to the responsible conduct of research. For example, deviations from protocol can go unidentified and consequently unaddressed, compromising the integrity of the data collected and subsequent analyses. Collaborators who find themselves engaged in a combative and incompatible relationship may see their research efforts sabotaged, delaying project progress. Delays from one member of the research team may disrupt the planned sequence of activities of other researchers. Thus, a breakdown in communication between staff and supervisors reduces the likelihood of resolving disagreements, correcting violations of protocol, and addressing delays.

There have been a number of strategies to address the breakdown in communication. Advances in technology have been incorporated with the intention of improving the efficacy of communication. In addition to existing technologies such as telephone and fax service, advancements include the increasing reliance on email, teleconferencing/videoconferencing, access to project specific websites, and use of electronic chat. Despite these advancements, concern remains that an over-reliance on technology to promote communication cannot substitute for a shared commitment to accountability in following through on all assigned tasks. Individuals may still choose to be non-communicative with new or old technology. Any impediment to communication, technological or otherwise, may potentially be reflected in the quality of research.

As noted previously, a comprehensive training program would have addressed the importance of maintaining open communication, regardless of conditions or circumstances. The value of a system of communication, with its use of transparent feedback up and down, is its facility to allow collaborators to quickly identify and address problems before they escalate. Participants should be aware how a decision to not communicate with supervisors or others poses a threat to the integrity of the research project and the quality of deliverables. Supervisors should have the necessary management skills to deal with non-communicative and non-collegial staff.

Poorly delineated policies on authorship and publication

One of the expected outcomes of conducting research is preparing research findings to be disseminated to the scientific community. Scholarly disciplines advance through both dissemination and review of research findings at professional meetings, but particularly through publishing in discipline-related journals. The desire of collaborators to contribute as authors ranges from expressing little/no interest, to exhibiting intense competition. For example, authoring a peer reviewed publication is more highly valued and rewarded among academic researchers compared with researchers working in a private industry setting. The justification for this difference originates from pressures in academia to ensure job security, promote one's professional career, and from the encouragement received from colleagues, peers, and mentors to publish. Alternatively, there may be different pressures on researchers in private industry to limit or delay publication of research findings due to proprietary interests. Collaborations between researchers from both settings raises the issue of a possible conflict of interest that could impact authorship and publication.

Whether collaborative relationships prosper or flounder may rest on the clarity of agreements and understandings established early in the research process. These agreements may be based on a hierarchy of roles and responsibilities, established expectations, degree of contribution, and the expected quality of deliverables made. Agreements, usually detailed in a memorandum of understandings (MOU), delineate how research will be divided, who will be responsible for contributing as an author, and perhaps a list of recommended journals to submit. Commencing research without an advance plan for publishing can lead to misunderstandings, conflicts, acrimony, damage the collaborative relationship, and ultimately compromise research integrity. It should be noted that this can sometimes occur even with a signed MOU.

When collaborators agree to co-author their research findings, they should understand that their obligations and responsibilities are not only to each other or the project, but also to their sponsors, and the scientific community. The tacit assumption in publishing is a shared trust between the author(s) and readers regarding the accuracy and truthfulness of any submission. Ultimately, researchers must be able to trust in the integrity of their co-authors. The occurrence of scientific misconduct, whether it occurs intentionally or not, compromises the reputation of all co-authors, their affiliated institutions, sponsoring agencies, and the editors for journals publishing their works. Examples of scientific misconduct occurring among co-authors include:

  • misrepresenting research findings
  • engaging in plagiarism
  • practicing selectivity of reporting
  • failing to disclose conflict of interest
  • neglecting negative results
  • analyzing data by several methods to find a significant result (known as dredging the data)
  • reporting conclusions that are not supported
  • ignoring just attribution of authorship

As co-authors, each contributor is responsible for the contents of published material, even aspects of research they may not have had a direct hand in conducting. Some researchers support the position that authorship and accountability (defined as having an obligation to give an account of a designated action or activity) should go hand in hand, "..people should be listed as an author on a paper only if they can defend the paper or its results. (Rennie, Yank, Emanuel, 1997; Resnik, 1997). Additionally, although co-authors need not be responsible for every aspect of the paper, but they must be accountable for the paper as a whole. Thus, collaborative co-authoring demands that every contribution meets a high standard of acceptability. In addition, a fair and equitable understanding of each author's contribution to published research provides clear credit and acknowledgement for advancing a field of study.

Ideally, collaborative endeavors should provide a policy that clearly delineates:

  • an acceptable criteria for contributing as an author
  • a standard for acceptability regarding format and content of disseminated findings
  • how credit for specific research findings will be allocated (authorship position)
  • what specific responsibilities for writing will be assigned

Intellectual property disputes

An important rationale supporting collaborative research is the enhanced ability to combine, exchange, and share resources that can benefit the scientific process. Since by definition, collaborative research involves more than one person working together, the interests of each party need to be accounted for and protected. Each party's interest may focus on issues of intellectual property, broadly defined as the legal rights which results from intellectual activity in the industrial, scientific, literary and artistic fields. (WIPO, 2004).

In managing most collaborative endeavors, it is necessary to establish formal agreements (e.g., material/technology transfer agreements, data ownership, copyright/patent issues) between institutions, researchers, and sponsoring agencies. These agreements are typically written in a legal format to protect and preserve the collaborators' best interest. The formal agreements clearly specify ownership rights to research material, how the material can be used, what obligations are incurred, the benefits enjoyed, and the need to provide proper acknowledgments of the source in order to avert conflicts that may arise during or after research.

Collaboration between academic institutions and private industry has increased significantly since the passage of the The Bayh-Dole Act in 1980. The authors of this legislation intended to encourage U.S. universities to patent their innovations and to license them to private-sector companies in order to encourage their commercial use. According to Shamoo and Resnik (2003), private funding of research and development is greater than $200 billion per year, accounting for more than 60% of total funding. Observers of collaborative research have witnessed an increase in the use of formal agreements that delineate the mechanism for transfer of public research to the private sector interest. In addition, there has been a marked increase in the number of public-sector patents and the licensing of technology to the private sector (Atkinson, Beachy, Conway , Cordova, Fox, Holbrook, Klessig, McCormick, McPherson, Rawlings, Hunter, Rapson, Vanderhoef, Wiley, Young, 2003). Lawler (2203) suggest that, "slow growth in funding by the federal government chased universities in the early 1990s into the arms of industry". Shamoo and Resnik (2003) propose that the increase in funding from the private sector and increase in the number of public-sector patents and the licensing of technology to the private sector are important reasons for universities, research institutions, professional societies and scientist to increase their awareness of the importance of ethics in research.

Intellectual property issues have been discussed within the context of public-private partnerships in agricultural biotechnology (Atkinson, Rawlings, et. al. 2003), technological innovations in medicine (Gelijins, Their, 2002), and the pharmaceutical industry (Scheffler, Pathania, 2003; Lawler, 2003). Aktinson, Rawlings, et. al. (2003) note, "Agricultural technologies pose a particular challenge for university technology transfer programs in balancing the objectives of technology commercialization with humanitarian purposes or for applications to specialty crops. Some offices have addressed these challenges by instituting licensing practices that foster commercialization while preserving rights for philanthropic purposes or by working to keep certain technologies in the public domain". Scheffler, Pathania (2005) voice a similar concern in their review of the status of the global pharmaceutical industry and its research and development focus in the context of the health care needs of the developing world. These researchers focus on the implication of intellectual property influencing access to critical drugs and vaccines, and increase the research effort directed at key public health priorities in the developing world, "Much of the focus is on HIV/AIDS where the debate on the optimal balance between intellectual property rights (IPR) and human rights to life and health has been very public and emotive" (2005). Gelijins and Their (2002) pose critical questions about the potential negative aspects of highly productive means of encouraging innovation, with concern focusing on blurring roles between academic research and the commercial world and the implications of universities' newfound readiness to benefit financially from their intellectual property. They note, "... medical innovation depends on extensive interactions between universities and industry, with knowledge and technology transfer flowing in both directions. These interactions have had important public health and economic benefits. Yet, there is a risk to the university-industry relationship if the cultural and ethical principles of one partner overwhelm those of the other" (2002).

Lawler (2003) reviewed the research deals between pharmaceutical companies and two university research facilities. The basis of the arrangement was to have broad access to research labs and the scientific discoveries coming from them. A major concern was how collaboration would impact academic independence given the dependence of the university on industry funding. Specific concerns included:

  1. Overburdened faculty neglecting other duties and responsibilities
  2. Intellectual-property restrictions that could limit what faculty could publish

Lawler's review of the two case studies indicated that administrators from both academic institutions felt their researchers benefited greatly from the relationship in terms of funding. Indeed, it was reported that researchers did not feel they were compromising the integrity of the science. According to one researcher interviewed, "It was a phenomenal success for basic research... there was no attempt ... to change the direction of our basic research" (Lawler, 2003).

It is noted that the findings of the Lawler study are not intended to be representative of all academic-industry collaborations. Academic administrators and researchers may still want to assess how any proposed relationship with commercial interests might impact the above mentioned concerns.

Impact on RCR

While this section focused on a number of challenges to research integrity in the area of authorship and publication, the challenges identified only represent a partial listing of the total possible. While collaboration offers many incentives to investigators seeking a more comprehensive approach to conducting research, they should be aware of concerns that could compromise one's intention to publish findings. First and foremost is the need to establish a clear policy on authorship and publication, which stipulates criteria for authoring or co-authoring research findings. Any signed agreements should specify the authorship and publication expectations and responsibilities for all interested collaborators. Secondly, collaborators should have confidence in the competence and integrity of each co-author. This is based on the trust and collegiality earned from the collaborative experience.

The next section will discuss the decision to conclude or continue the collaborative relationship.


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Resnik, D. (1997). A proposal for a new system of credit allocation in science. Science and Engineering Ethics. Vol 3:237-43.

Scheffler R.M., Pathania, V. (2005) Medicines and vaccines for the world's poorest: is there any prospect for public-private cooperation? Global Health 2005 Jul 21; 1: 10

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WIPO Intellectual Property Handbook: Policy, Law and Use (WIPO Publication No. 489 (E). (2004) Second Edition. Geneva .

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