Responsible Conduct in Data Management
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Introduction

Completing a research effort may not necessarily signify the end of a collaborative relationship. Any one of a number of factors (or combination of factors) may influence a collaborative group's decision to either conclude or continue the affiliation. This decision should be considered in light of its impact on the responsible conduct of research: the likelihood of making a significant contribution to a field of study must be balanced by the desire of each collaborator to continue as well as the rationale and cost for continuing the collaboration.

This section describes the points during collaboration when the decision to conclude or continue can be made, the factors influencing that decision, and the impact on the responsible conduct of research (RCR):

  • Stage of collaboration when a decision is made
  • Funding period ends
  • Stipulated in Memorandum of Understanding (MOU)
  • Research runs natural course
  • Collaborator has a change of priorities/interest
  • New or unintended direction in research
  • Impact of decision on RCR

Stage of collaboration when decision is made

The decision to conclude, continue, or modify a collaborative relationship can be made during various stages of the research process: 1) during conceptualization 2) during implementation, and 3) following implementation.

        During conceptualization - Collaborators may have originally intended to conduct an investigation that was limited to specific research parameters. Once the research goal and objectives were achieved, earlier agreements may have stipulated that the collaboration would conclude. Alternatively, collaborators might have intended that the collaborative research project was to be the initial phase in a series of planned research activities. The direction of subsequent investigations was expected to be determined by the initial findings. In this second case, the configuration of the research team could either remain intact, or new members, with additional expertise, may have to be recruited.

        During implementation - Despite intentions to continue the collaboration beyond the initial study, researchers may find they are unsuited to work together (e.g., disagreeing on staff training and supervision, consistently missing deadlines, and clashing over incompatible work styles). The opposite scenario may also occur where interactions between collaborators are so positive and productive, researchers begin to consider the possibility of engaging in further research endeavors together.

        Following implementation - Research that yields unexpected findings may encourage/discourage collaborators to pursue new and unanticipated research directions. This may necessitate collaborators to reconsider 1) maintaining the configuration of the current collaborative team, 2) modifying it (e.g., expanding or reducing), or 3) concluding and wrapping up the effort.

Funding period ends

The decision to conclude or continue a collaborative relationship is not always determined by collaborators. A sponsoring organization is likely to establish a set period of funding for competitive grants and contracts. Funding periods can be one or more years, depending on the nature of the research, mission of the organization, and availability of funds.

When collaborators consider, develop, and submit a research proposal to a funding source, they most likely have already established a timetable that corresponds to the sponsor's guidelines. For example, in a call for abstracts for a Quality of Care Grants Program, a private foundation posted information about awards of up to $2.25 million over three years to philanthropic initiatives focused on two significant health care issues: End-of-Life Care and Depression. Collaborators may establish a research plan to conduct and complete research during that three-year period of time. If the project remains incomplete, the researchers may request a no-cost extension, or seek funding from an alternate source. Other sponsoring agencies may limit funding to a single year. Examples include:

  • Community-Developed Initiatives that establish a grant period of one year. (CDI Funding Cycle 3 year 1 Calendar, 2005).
  • Applications for an NIH Research Project Grant Program which are generally awarded for 1 - 5 budget periods, each normally 12 months in duration. ( NIH Research Project Grant Program, R01, 2004 )

Collaborators who seek and receive funding from multiple sources may be able to continue their research efforts beyond any single sponsor's funding period. In addition, some sponsors may encourage awardees to re-submit in subsequent years to extend research efforts.

Stipulated in Memorandum of Understanding (MOU)

Researchers who have arranged to collaborate must discuss a number of essential agreements before research can be conducted:

  • establish research protocols and logistics
  • coordinate technology transfer agreements between institutions (if appropriate),
  • be prepared to respond suitably to issues that impede research progress or issues of compatibility between collaborators

In an ideal situation, any and all agreements would be clearly specified in a written memorandum of understanding (MOU) that is collectively reviewed and signed by collaborators. Inclusion of an MOU can be viewed as a proactive measure that can address misunderstandings and disagreements between collaborators. The decision to conclude or continue collaborative research, or even decide at a future time, is likely to have been included in the MOU. This decision might itself be influenced by the nature of the contract or grant from a sponsoring agency (see above) or the context in which the collaboration takes place (e.g. academic, government, private industry). For example, funding from private industry may require a relationship with academic researchers that specifies the duration of a relationship, expectations of both parties, as well as the form of deliverables. There may be a limited ability to modify the arrangement by either of the two parties.

Research runs natural course

Researchers may decide to conclude a collaborative endeavor when it is determined that work in a defined area of research may have run or completed its course. The researchers may determine that they have exhausted their collective pool of research questions, tested all their proposed hypotheses, and ultimately felt significant limitations on possible directions of research. The researchers may realize that a new direction would require a significant investment of time to re-conceptualize and possibly demand an effort to recruit new collaborators having additional necessary expertise. In addition, researchers may be discouraged from continuing the collaborative endeavor after recent research efforts yield minimal or disappointing findings. Finally, the collaborators may be working in a research area that had already been extensively investigated and current results of the collaboration seem to be making only a negligible contribution.

Collaborator has a change of priorities/interest

While research collaborators may at one point in time have had mutually beneficial interests and a desire to pursue selected research objectives, demands from professional activities (e.g. changing job/position/institutions) or personal life (e.g., retirement), may alter priorities and interests, and pull collaborators in different directions. These demands could include increasing or new administrative duties, evolving research interests, or even experiencing challenges from one's personal life. Any of these factors could result in researchers losing interest in what was once an area of prime focus. Research partners may individually or collectively determine that the effort required to sustain a collaborative relationship to be more costly than any possible benefits gained. Researchers who are unable to provide adequate time and attention to a collaborative endeavor could end up compromising research integrity.

New or unintended direction in research

Despite a previous agreement established in an MOU to conclude a collaborative relationship, a situation may arise that causes researchers to reconsider their decision.Researchers may decide to continue the collaborative relationship if their research yields unanticipated findings that could significantly advance a particular field of study. A new research direction could necessitate re-conceptualizing the original project and possibly require a revised collaborative configuration by recruiting additional collaborators with a different set of research skills and expertise. The re-conceptualization could present new possibilities not previously considered.

Impact on RCR

The decision to conclude or continue collaboration has implications not just to the researchers, but to the integrity of the research itself. Researchers must assess how productive and beneficial the research effort is to all parties concerned, how the findings contribute to the appropriate field of study(ies), and whether additional benefits could be derived from further collaboration. Essentially, collaborators must estimate the costs incurred versus benefits gained to either continue or conclude collaboration. Extending the relationship when some individuals may anticipate declining interest or availability could compromise future research efforts. The collaborative group may need to assess whether their decision to conclude or continue is based on a sound scientific justification, logistical expediency, and/or a desire to work with other researchers.

An important consequence of terminating a collaborative relationship is the need to clarify data ownership issues beyond the relationship, i.e., what party or parties will be responsible for the data, how the data can be used for future investigations, and what restrictions are placed on sharing the data. A related issue would be an understanding or policy that details the allocation of credit for intended subsequent publications. Collaborators may have reasonable expectations about contributing to one or more submissions following the conclusion of the research effort. These issues should be delineated in a collectively signed memorandum of understanding to reduce the chances of misunderstandings and disagreements.

References

2005/20062005/2006 Quality Of Care Grants Program Funding Cycle Two. Accessed on November 3, 2005. http://www.aetna.com/foundation/news/articles/2005/pr_20050630.htm

Report Calender.pdf. Accessed on November 3, 2005. http://www.first5.org/docs/Projects/CDI/101305/ReportCalendar.pdf

NIH Research Project Grant Program (R01). Accessed on November 3, 2005. (2004) http://grants.nih.gov/grants/funding/r01.htm

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