• Establishing critical research roles and responsibilities
• Deciding on the extent of the collaboration
• Selecting funding sources
• Disclosing conflicts of interest
• Agreeing on resource sharing
• Clarifying intellectual property issues
• Determining authorship
• Memorandum of understanding
• Impact on RCR

Establishing critical research roles and responsibilities

The number and types of roles and responsibilities assigned to collaborators should in large part be determined by the complexity, purpose, and scope of the collaborative research project. The quality of interactions between collaborators may be reflected in how clearly these roles and responsibilities are delineated (i.e., Who is responsible for what?, What will the responsibilities entail?, etc.), and how well this information is communicated to members of the research team. It is essential to establish a process to get roles both defined and assigned at an early stage of the project (Ryder, 2003). Individuals who are certain about their roles and responsibilities are more likely to see how their expected contribution will fit into the overall scope of research activities, more likely to stay on task, and more likely to conduct research in a responsible manner.

In collaborative research, the responsibilities of principal investigator can be shared among the group of lead investigators. Although one individual may have conceptualized the original research problem, other researchers may be invited to assist in refining the specific research questions asked, and to select an appropriate mix of methodologies. Responsibilities may include defining the parameters of the research including conceptualizing the full scope of the research project, establishing the aim, goal(s), and objectives, developing the research design, and preparing to submit the proposal for funding. When these responsibilities are shared, it is crucial to coordinate everyone's efforts when conceptualizing and writing the proposal to avoid discrepancies that could confuse proposal reviewers.

It is the principal investigator(s) who decides how to distribute the burden of conducting collaborative research, a task made more challenging by determining both role responsibilities and group accountability. Shamoo and Resnik (2003) have made an important distinction between these the terms 'responsibility' and 'accountability', "In a large research project with many collaborators, different people may be held accountable for the projects as a whole or its various parts. A person who was not responsible for some aspect of the project, such as recording data, may still be held accountable for the projects as a whole. Clearly, accountability and responsibility are both important in research, but it is also important to keep these notions distinct".

Appropriate individuals should be assigned the responsibility for implementing specific research protocols, conducting staff training sessions, collecting data, monitoring progress, conducting analysis, or contributing as an author for publication. Although each member of the collaborative team has an obligation to honor his/her own responsibilities (e.g., collecting data, monitoring progress), it is the principal investigator(s) who is(are) held accountable for the progress of the project. If there is a breakdown in how the responsibilities should be carried out, including occurrences of negligent errors, innocent mistakes, as well as scientific misconduct, the principal investigator(s) can be held accountable to the funding agency, affiliated research institutions, and members of research disciplines.

Deciding on the extent of the collaboration

The extent of each collaborator's participation in a joint project can be determined by his/her capability of handling assigned role and responsibilities, interest in pursing a particular area of research with other investigators, and availability to serve in the project. Compromises in any of these areas may weaken relationship and threaten the integrity of the research effort. There are a number of important criteria to consider when selecting suitable collaborators and deciding on the extent of their participation.

      Degree of expertise in required area - An indicator of expertise would include an established track record of research and publication in the desired area of specialty. If a potential collaborator is well known in the field, colleagues may share a consensus on a collaborator candidate's abilities and skills. Occasionally, it may be necessary for the principal investigator(s) to identify more than one person if a candidate declines to participate or exhibits poor performance in his/her capacity.

      Ability to meet deadlines - An important measure of competence in conducting research is the ability to stay on schedule while maintaining the integrity of the investigatory process. When working with others, the progression of the project may be compromised when a research team member fails to meet to the agreed upon schedule. Furthermore, delays may prevent others from fulfilling their own assigned tasks and responsibilities. Individuals who consistently meet deadlines are likely to develop a reputation for being reliable.

      Writing and speaking skills - Where appropriate, writing and speaking skills can be a valuable asset for collaborators who may be called on to contribute as an author or present findings either at professional meetings or before the general media. Because individuals who write or speak for the research team not only represent the findings, but also every member and his/her affiliated institution, it is critical for group spokesperson(s) to be a good communicator. In addition, all communications intended for dissemination should be pre-approved by the principal investigator(s) of the collaborative team and reported accurately.

      Preferred work style - Compatible work styles can enhance the success of a collaborative partnership. For example, individuals who prefer to plan ahead may be more likely to work well with like-minded individuals compared to those who have a preference for rushing to complete work at the last moment. Differences in work styles may result in disputes that can compromise research progress.

      Ability to work well with others team members - Collegiality, a concept related to but not identical with work style, is recognized by Merton (1973) as an essential component of science, and important in supporting a cooperative and trusting context between colleagues. Colleagues who treat each other with respect are more likely to avoid or resolve challenges to issues of intellectual property or authorship.

Selecting funding sources

The issue of selecting an appropriate sponsor for funding research can become more complicated within the context of a collaborative endeavor. While all collaborators may express a common interest in finding a funding source for the research, there may be divergence of opinion as to what factors will enhance the possibility of obtaining funding. The following is a partial list of those factors that may influence the selection of a funding source:

      Funding source preferences - Funding agencies may explicitly state a preference for funding the type of research that meets a particular profile. For instance, a sponsoring agency may state it is supporting research conducted by multidisciplinary teams to develop innovative approaches in expanding a new investigative direction. While this may be an incentive for investigators to invite researchers from diverse disciplines to participate in a study, the needs of the research itself should drive the decision to establish an interdisciplinary team.

      Appropriate to the nature of the research - Closely related to funding source preferences is the match of the funding source to the nature of the research. Based on the nature of the collaborative research endeavor, investigators must decide where to request funding from a possible pool of choices. In studies targeting a highly specialized or rare areas of research (e.g. drug therapy for fatal condition affecting a small number of individuals), the number of sponsors funding specific areas of investigation may be quite limited. On the other hand, there may be a variety of public and private agencies funding studies that seek to investigate problems affecting a significant portion of the general population (e.g. cardiovascular disease). In either case, members of the collaborative team must first discuss and then agree as to the nature of their research effort before identifying the appropriate funding source.

      Appropriate person(s) to submit proposal - While all members of the research team may have varying degrees of investment in the project, there should be agreement as to which investigator(s) should submit the proposal. Some members of the research team may take the bulk of responsibility for writing the proposal, or coordinating the contributions from other collaborators. A track record of successfully funded submissions can be a deciding factor as to who among several lead investigators will be selected to write and submit the proposal. Another factor influencing the decision could be based on the primary institution where the bulk of the research will be conducted, or where activities will be coordinated. It may be important for the person(s) submitting the proposal to be affiliated with that institution.

      Funding trends - The selection of an appropriate sponsor to fund research may depend on the profile of recent funding trends for selected areas of research in particular disciplines. Research team members in those disciplines may feel they may enjoy an advantage and could make a convincing case to particular sponsors. However, it may be important for researchers to value the research trends as truly worthy of pursuit and also within the purview of their expertise and ability.

      Nature of the funding source - The nature of the funding source is another key factor in selecting an appropriate sponsor since it may place restrictions on how research is conducted and the findings reported. For example, government funding sources may insist that studies they fund require researchers to make their data publicly available after submitting a final report or publishing the findings. On the other hand, restrictions imposed by private industry sponsors may limit researchers from publishing their findings in a timely fashion. Whatever the case happens to be, collaborators should decide if any or all of these restrictions are acceptable.

      Duration of funding - Depending on the nature of the research, the project life cycle may require sustain funding for a set period of time. Thus, selection criteria might include the period of funding, and whether investigators could re-apply for additional funding. Limits on the anticipated length of funding could compromise the research design and implementation of any proposed study.

      Multiple funding sources - Occasionally, collaborators may see the need to be creative in soliciting funds. This may require the orchestration of efforts to secure funds from multiple sources, with each collaborator receiving monies for his/her specific research component. Contingency plans may need to be developed if only partial funding is secured. All collaborators should be aware that partial funding may require implementing a modified version of the original research design.

Disclosing conflict of interest

Conflicts of interest (COI) are co-existing and competing obligations and interests. While conflicts of interest in and of themselves are not inherently 'bad', Steneck (2003) recommends three COI for researchers to avoid, "financial gain, work commitments, and intellectual and personal matters". Although COI may be unavoidable in some circumstances, it is strongly suggested that researchers provide full disclosure to all involved parties including fellow collaborators, affiliated institutions, funding sources, and editors to all journals to which articles are submitted for publication.

Failure to disclose a conflict of interest could have untoward consequences on any or all of these parties. For example, a researcher leading an investigation to assess the efficacy of a new medical device could 'appear' to hold a bias if the researcher failed to disclose having a financial stake in the medical equipment company manufacturing the device. Even if the investigation was conducted in the most objective manner possible, a research finding favorable to the device published in a recognized journal could compromise the credibility of the study, and tarnish the reputation of all co-authors and their affiliated institutions. Furthermore, in the cases where a bias did impact the outcome, additional victims could include the reputation of the collaborators' disciplines and could possibly threaten the welfare of the general public.

Brigham, Chausmern, Fraiser, Gutkin, Marshall, Spilman, and Tyrer (2004) have cited a number of instances where researchers may unintentionally find that their participation in a research project conflicts with other interests. For example, researchers who accept funding or needed equipment from private industry may be required to delay submitting their findings for publication. In another case, a researcher may be evaluating items that have a commercial application for which the researcher him/herself may have a financial interest. In another conflict of interest, an investigator may be acting as a consultant to a competitor of the funding source (e.g. competing pharmaceutical firms). In every conflict of interest instance, full disclosure should be made to all collaborators before any research begins. While it is important for investigators to accurately assess each other's competence in research skills, being clear about everyone's ability to maintain clear objectivity allows each individual to make better decisions about establishing a collaborative relationship.

Agreeing on resource sharing

Resources can be broadly defined as the items necessary to support completion of the stated research goal(s). Resources may include funding, personnel (e.g., research and administrative), data (e.g., preliminary and final), equipment (e.g., specialized, diagnostic, administrative), and even ideas generated from the research.

Agreeing how resources will be shared, distributed, and exchanged is another critical issue that needs to be addressed when establishing a collaborative relationship. A proactive policy that delineates how resources will be managed and shared can limit disputes arising from the perception of unfair distribution between collaborators. Left unaddressed, this situation may lead to resentment and ultimately sabotage research activities.

Shamoo and Resnik (2003) have identified numerous reasons, both practical and ethical, why collaborators should share, as well as why they may not want to share resources. Sharing resources promotes:

• efficiency, objectivity and progress,
• collegiality and trust,
• fairness and equity,
• is sometimes require by law or policies (e.g. data resulting from federally funded research).

Alternately, Shamoo and Resnik (2003) list reasons for collaborators to not share resources including a need to:

• protect preliminary work from criticism
• protect claims related to discovery and priority
• protect intellectual property
• protect institutional or local investments
• protect confidential information related to peer review or human subject research
• protect confidential information in private research, military research, or forensic research

Even though one could argue that the rationale for sharing resources would seem to support the responsible conduct of research, one could possibly make an equally convincing case that the stated reasons for not sharing could also be an example of conducting research responsibly. A resource sharing policy based on a consideration of these and other issues enhances the probability of establishing a successful collaborative relationship.

The policy should also include a contingency for changing how resources are allocated if needed, as well as an effective strategy for communicating this change to all collaborators. The rationale for sharing news and information is that all collaborators need to be equally informed of changes that could impact the progress and direction of the research. For example, an unexpected research finding could necessitate a disruption in the normal flow of resources, (i.e., additional lab time and research staff might be required to solve a problem than was initially expected). These resources might be 'borrowed' from another member of the collaborative team to accommodate the demand. However, while these redirected resources may support the project's overall goal and research objectives, the loss of shifted resources could compromise a particular collaborator's ability to complete their assigned task within an established timeframe.

Collaborators should be aware that even with resource sharing agreements in place that establish how resources will be distributed, access to resources can become competitive and counterproductive.

Clarifying intellectual property issues

Although the collaborative team as a whole shares the common goal of completing the research project, each member of the team may have separate interests or claims on the information generated from the study as well as intentions to continue analysis of the data. Consequently, when establishing the collaborative relationship, it is essential to address issues of intellectual property and data ownership.

According to Gardner (1999), individuals who hold intellectual property have rights to control the outcome of intellect. (Garner, B.A., (ed.), Black's Law Dictionary, 7 th ed. West Group, St. Paul , MN. ). In an overview and history of intellectual history, Shamoo and Resnik (2003) noted that although the Western world has recognized 'property' for thousands of years, attention to 'intellectual' property is a more recent development. For example, the protection of intellectual property is included as an article of the United States Constitution.

The twentieth century saw a dramatic increase in the number of academic-private industry and government-private industry collaborations. Consequently, the United States Congress saw the need to pass an amendment to the patent law in order to facilitate a transition of 'technology' from the public to the private area. Known as the Bayh-Dole Act of 1980, this allowed industry to commercialize research findings that was supported by government funds, typically as part of collaboration with university researchers. According to Shamoo and Resnik (2003), "To do this, the company and the university can sign a 'cooperative research and development agreement' (CRADA), which would delineate the intellectual property rights of the company, the researchers, and the university." The benefit of the Bayh-Dole Act and similar legislation is that it helps researchers understand their responsibility to better define their role in conducting research and its relationship to intellectual property. Shamoo and Teaf (1990) note that data is ownership is typically determined by agreements between research faculty and academic institutions. (Shamoo, A.E., Teaf, R., 1990. Data Ownership, CBE Views 13:112-14).

Each member of a collaborative team should be familiar with the existing intellectual property arrangements at their respective institutions, and how these arrangements may affect the collaborative relationship. Some of these arrangements are determined by state government initiatives, which can vary between states. This is particularly important for academic institutions that are likely to view important technological advancements from university researchers as potentially 'income generating'. Consequently, researchers have increasingly become accustomed to reviewing agreements from technology transfer office personnel whose prime directive is to protect the university's interest in collaborative research with investigators from other universities or from industry (Shamoo, Resnik, 2003). For example, Shamoo and Resnik state that an agreement between researchers, affiliated institutions, and industry, should delineate how data is controlled, "CRADAs usually address issues of data control, and many private companies require researchers to sign contracts giving the company control over all data generated in its laboratories." This can be offset by superseding federal law that obligates researchers receiving government funds to make data available to other researchers (see Agreeing on Resource Sharing).

Determining authorship

Authoring peer reviewed publications is an expected and desired outcome of research, highly valued by academic researchers because of its direct relationship to peer recognition, career progress, and professional success. The observed trend of increasing numbers of authors appearing in academic papers seems to reflect a tendency toward greater and greater collaborative research endeavors. While the mean number of authors per journal article may vary by what is the norm for each scientific discipline, an important consideration for collaborators in all fields to ponder when establishing a relationship remains the issue of authorship. Collaborators should agree and decide on the allocation of credit in order to determine who will contribute to the writing effort. Specifically, who will participate in drafting and submitting the research findings, how will the authoring position be determined, and what journals are deemed appropriate choices for submission.

Due to the varying degrees of investment each collaborator may have in publishing, efforts to work out agreements should ideally take place early in the research process rather than as an after-thought. In some cases, the agreements will be based on how research responsibilities are configured among the collaborators. Typically this is done by area of interest, expertise, and willingness to take the lead in writing and/or coordinating the writing efforts of select team members. For some research projects, the nature and complexity of research questions may have necessitated not just inviting more researchers to participate, but engaging collaborators from diverse disciplines.

One method of determining the allocation of credit is by reviewing roles and responsibilities for each collaborator wishing to contribute as an author. Disputes may arise when there are disagreements between what roles and responsibilities are considered 'author worthy'. Brigham, Chausmern, Fraiser, Gutkin, Marshall, Spilman, Tyrer (2004) note, "..some have argued that in some instances lab assistants could be listed as authors if they make an important contribution in addition to their technical expertise." While all members of a research team make a contribution to the overall project goal, collaborators must agree on what criteria will be used to establish authorship.

Shamoo and Resnik (2003) have proposed a series of guidelines to justify authorship. A partial listing includes:

• To qualify as an author, each person must be held accountable for the whole paper.
• To qualify to be the first author, the individual must have participated in all of the following: (a) conception or design, analysis and interpretation of data, or both, drafting the article for critically important intellectual content; (c) final approval of the version to be published.
• To qualify as a co-author, the individual must have participated in two or more of the following: (a) conception or design, or analysis and interpretation of data; (b) drafting or editing portions or revisions of the article; and (c) providing the intellectual proposals for funding the project.

A source of disagreement between collaborators from diverse disciplines are differences in discipline-specific guidelines which may clash in expectations and demands required to be eligible for authorship. Efforts to establish an authorship policy acceptable to all collaborators before conducting research can reduce disputes, enhance a trusting relationship, and facilitate the dissemination of scientific finds in a timely fashion.

Memorandum of Understanding

A memorandum of understanding (MOU) is a written documentation of a set of agreements and expectations between two or more parties. While MOUs are regularly used in the fields of business and law, it a less observed phenomena in research settings between collaborators.

Ideally, the MOU makes sure everyone knows what they are contributing to the overall research effort. By establishing accountability criteria, it becomes the basis for holding collaborators accountable for deliverables. The MOU specifies the time, effort and duration of the collaboration. It may delineate how resources will be managed and shared, how results will be disseminated, and how intellectual ownership issues will be addressed. An MOU can address routine, mundane activities (e.g., how frequently will collaborator meet for reviews) or those of critical importance to the progress of the research project. For example, an article in the MOU might clarify what level of contribution in a research project warrants a position for authorship. Thus, a MOU has a profound practical value because it can serve as a source of answers to collaborator queries.

The MOU may be modified if the research progresses in unanticipated ways. Collaborators should be aware that revisions are always a possibility. While the document does not necessarily have to take the form a legal contract, it does allow all parties to refer to a document if clarification becomes necessary.

Impact on RCR

This section described a number of issues that researchers should consider when establishing a research collaborative relationship. When the issues are proactively and appropriately addressed, threats to research integrity can be somewhat minimized. These issues include: 1) a clear understanding of roles and responsibilities, 2) determination of the extent of involvement in collaboration, 3) selecting funding sources, 4) disclosing conflicts of interest, 5) agreeing on resource sharing, 6) clarifying intellectual property issues, 7) accurate expectations of what is required to author publications, 8) documenting expectations in an MOU.

The manner in which a collaborative relationship is established can affect the quality of interactions between participants. Although clearly documenting and detailing expectations in a MOU can represent a commitment to conducting research responsibly, undoubtedly there will be instances where collaborators fail to honor agreements. While a MOU does not guarantee disputes between collaborators will not arise, it symbolizes an effort to keep the lines of communication open and encourages a sense of camaraderie while working toward a common goal. The following section will describe issues encountered while working together.

References

Brigham, J., Chausmern, A.B., Fraiser, K.S., Gutkin, C.E., Marshall, G.D., Spilman, S., Tyrer, H.W. (2004). Ethical Dilemmas in Research Integrity. US Dept of Health andHuman Services, Office of Research Integrity.

Garner, B.A., (ed.), (1999). Black's Law Dictionary, 7 th ed. West Group, St. Paul , MN .

Merton, R. (1973). The Sociology of Science. University of Chicago Press, Chicago.

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

Ryder, B.G. (2003). Establishing and Nurturing Research Collaborations. Accessed on August 20, 2005. http://www.cs.rutgers.edu/~ryder/cramentorCollab603.pdf.

Shamoo, A.E., and Resnik, D. (2003). Responsible Conduct of Research. Oxford University Press, Inc., Oxford .

Shamoo, A.E., and Teaf, R. (1990). Data ownership. CBE Views, 13:112-14.

Steneck , N.H. (2003). ORI Introduction to the Responsible Conduct of Research. Department of Health and Human Services.

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