Responsible Conduct in Data Management
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Introduction

Research collaboration involves a number of established activities that can be clustered and categorized into separate 'stages'. While each identified stage represents an important step in the research process, certain activities extend through multiple stages which can be quite interrelated. This section will briefly describe each identified stage within the context of collaborative research. The description in not intended to be an exhaustive inventory of all possible stages of collaboration.

In addition, related research issues that have an untoward impact on the responsible conduct of research will also be discussed. The stages and the impact on RCR include:

The occurrence of research issues in collaborative endeavors parallels what goes on in research conducted by independent investigators. However, the involvement of staff from possibly many different disciplines, research settings, and geographical locations adds a layer of complexity and a degree of difficulty to the research process. This may result in an increased probability of untoward research issues occurring. The challenge to collaborators is to determine an appropriate response to issues that may arise during any stage of collaboration.

Conceptualization

Research collaborations range from initiating a project with colleagues from the same discipline to participating with a mix of researchers from diverse disciplines and settings. In the latter case, collaborators may offer different theoretical approaches and strategies while attending to questions of research design. Macrina (1995) notes challenges of multidisciplinary collaborations during the conceptualization stage:

      "Collaborations involving scientists from disparate fields of study can be especially complicated, because the         parties may not have common vocabularies, compatible working styles, or shared assumptions about the         collaboration. These complexities can be increased when the scientists are working in different countries.         Interdisciplinary and international collaborations place special responsibilities and obligations upon the         participants".

In addition, collaboration can take place:

  1. between researchers from either a same-setting context (e.g., academic institutions)
  2. from different-setting contexts (e.g., between academic - government or academic - private industry)
  3. across geographical locations

A researcher's discipline and context will influence his/her philosophical assumptions about the nature of research. 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.

Regardless of how the collaboration is configured, the principal investigator(s) may seek each collaborator's participation when conceptualizing a research project. Agreements should be reached on 1) research goal(s), 2) specific objectives, and 3) the approaches/methodologies to achieve them. The investigators who conceptualize the research should be able to draw on findings from relevant literature, sometimes from diverse fields, and organize them into a meaningful and cohesive whole (Morse, 1995). If collaborators are from the same or similar fields, there is a greater likelihood that they will share an understanding of a common set of theoretical models and methodologies compared to researchers from disparate fields.

Disagreements over how to conceptualize can be greater 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. Macrina (1995) notes the challenges to a collaborative relationship this can pose:

      " Interdisciplinary collaborations regularly involve work on topics that appear very different from different         disciplinary perspectives and participants should be prepared to recognize the distinct problems with which         their colleagues must grapple. If the collaboration is to be fruitful, the researchers must be prepared to         understand the implications that the problems and solutions of one discipline hold for the problems and         solutions of the other and to address the problems appropriate to their own discipline".

During conceptualization, there should be a clear and convincing rationale for why the topic is worth studying (Conceptualizing Communication Research, 2005). Researchers who are considering initiating a collaborative endeavor may ponder a number of questions, such as:

  1. Is the outcome of the proposed collaboration worth the anticipated demand for resources?
  2. Will the outcome be a relevant and significant contribution to the scientific field(s)? To society?
  3. Is the proposed collaborative effort essential to achieving the goal and objectives of the project or can the investigation precede 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.

A successful coordination of each collaborator's input during the this stage may enhance efforts to partition the research project appropriately, as well as clarify how each collaborator's contribution fits into the 'big picture'.

Proposal preparation and submission

The activities involved in preparing a proposal for submission go hand in hand with conceptualization. Creswell (2003) recommends adopting a general framework that can provide guidance about all facets of a study ranging from assessing the general philosophical ideas behind the inquiry to the detailed data collection and analysis procedures. Creswell addresses three questions central to the design of research:

  1. What knowledge claims are being made by the research (including theoretical perspective)
  2. What strategies of inquiry will inform the procedures? (e.g. experimental, survey, ethnography)
  3. What methods of data collection and analysis will be used? (e.g., questionnaire, interview)

Creswell's framework encourages collaborators involved in preparing a proposal to orchestrate their efforts in addressing these questions. Where differences in 'knowledge claims' occur, collaborators will have to identify the areas of articulation between the different knowledge claims. For example, one group of collaborators may focus on micro level of analysis while another group investigates the macro level. Collaborators may also diverge in their preferred strategies of inquiry and methods of data collection and analyses (e.g., some investigators collecting data through participant observation, others through planned intervention). The challenge in preparing a proposal is more than having specialists write about their own area of expertise; it is also about being able to justify why these multiple strategies are valuable and necessary to the research study, and how they will be integrated.

The degree of collaboration and cooperation between investigators in preparing the proposal may be indicative of the anticipated quality of the research collaboration. While not all collaborators may have equal involvement at this stage, those individuals who review drafts and provide input can influence what form the proposal will ultimately take. Researchers who see that their input is valued can develop a sense of ownership in the proposed study, and perhaps an enhanced commitment to achieving the stated goals and objectives.

Management

Managing any collaborative relationship requires understanding the scope of the research, organizing participant priorities, allocating resources, maintaining the timetable, and demonstrating an ability to orchestrate all these components. While each member of the collaborative team may have his/her own assigned responsibilities, the principal investigator(s) ultimately is(are) held accountable for all that happens in the study. Accountability is defined as "The responsibility of program staff to provide evidence to stakeholders and sponsors of a program's conformity to its coverage, treatment, legal, and fiscal requirements" (Rossi, Freeman, 1993). This suggests that the person(s) accountable for the research project may be required to be both competent researcher and manager. The researcher/manager is responsible for allocating roles and responsibilities as well as ensuring that all aspects of the research are conducted in a responsible manner.

An important determinant of a successful collaborative relationship is the establishment of an effective system of communication. Maintaining good communication can enhance a rapid response to problems that arise, modify a flawed protocol, avoid unnecessary loss of data, and reliably disseminate critical information to all participants. The system of communication could include a protocol for identifying personnel designated responsible for gathering and sorting queries, referring or responding, and disseminating information.

Another aspect of communication is scheduling and conducting meetings and reviews. Meetings are held to discuss project status, identify advances as well as impediments, and share information and data. The outcome of the meetings can result in recommendations for addressing problems, modifying procedures, or even changing the direction of the research. Meetings may take place according to an established scheduled, with the option of limiting attendance to key personnel or requiring all participants attend. Reviews are more likely to occur one-on-one. Reviews focus on critiquing performance and may include recommendations for improvement if appropriate. The difficulty, logistically speaking, of scheduling reviews may be reflected by the complexity of the collaborative endeavor (e.g. number/location of research sites, number of collaborators/disciplines, and settings).

Another area where accountability is a deep concern is the handling of budget and finance issues. For example, while recipients of government grants and contracts are obliged to follow specific rules and regulations on a host of allowable and unallowable expenses (e.g., staff, equipment, and travel), restrictions imposed by other sponsoring agencies may be somewhat different. Steneck (2003) notes that "collaborative projects must be managed in ways that assure that all expenditures are in compliance, from those incurred by the primary investigators working at major research institutions to survey workers or clinicians working in the field". Larger and more complex collaborative efforts can increase the difficulty in managing budgets.

A management necessity is establishing 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.

Ensuring compliance is particularly important when dealing with collaborators who may be conducting research in separate and diverse locations. This aspect of management seeks to ensure that each staff member is behaving in accordance with institutional, state, national, or even international guidelines as they relate to research. Noncompliance could have untoward consequences for use of collected data, suspension of research activities, as well as possible sanctions against the members of the research team.

Implementation

This stage sees the coordinated implementation of the agreed upon research design. Whether the study utilizes quantitative, qualitative, or mixed approaches, all collaborators are obliged to honor their assigned tasks by 1) strictly adhering to the research protocol, 2) keeping to the established timetable, 3) and maintaining an open line of communication.

The ability for researchers to proceed with their assigned tasks may depend on fellow collaborators successfully completing their own responsibilities. Delays from one member of the research team may disrupt the sequence and progress of other members. If problems arise, an effective system of communication can be used to alert fellow collaborators to possible delays, as well as solicit assistance if necessary.

Implementing the research protocol can be said to begin with preparing staff to execute the research procedures in the appropriate manner. In some cases, where staff has significant experience, little or no training will be required, while others may need substantial training. Collaborators will need to agree on 1) the type of training to conduct, 2) who will administer training, and 3) how to monitor the quality of the training. Disagreement or uncertainty about any aspect of training may unduly influence the quality of the research, impugning the reputation of collaborators and their affiliated institutions.

Collaborator must also agree upon what 'data' will be collected, how it will be collected, who will be responsible for collecting it, where/how it will be stored and managed, and whether it can be shared or not. In some cases, certain members of the collaborative team will collect the data, while others will be responsible for management, analyses, and storage. It is essential that collaborators be clear on how they will be expected to articulate their tasks with specified team members.

There should also be mechanisms in place to identify and correct staff deviations from the research protocol. Staff can be monitored during both planned and unplanned site visits in order to observe performance on assigned tasks. In addition, periodic checks and/or reviews of recorded activities can also be implemented (e.g., lab notebooks, field notes). Regular supervision is a proactive strategy used to avert either unintentional lapses or to identify instances of scientific misconduct. Coordinating this activity between all collaborators may prove difficult, especially if research is being conducted at multiple sites.

Evaluation

There are two primary activities occurring during evaluation, 1) assessing the validity of the research process itself and 2) review and analysis of collected data. Assessing the research process is an ongoing activity useful in identifying deviations or violation of research protocol. Process evaluation, sometimes identified as 'process studies', has been defined by Freeman and Rossi (1993) as "Evaluation activities related to identification of targets and assessment of a project's conformity to its design.... the term is synonymous with studies of program implementation". This is an important mechanism to monitor how well the members of the collaborative research team are following the protocol.

During the conceptualization stage, collaborators should have reached 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. This decision-making process can range from agreeably clear cut to hostile and contentious, depending on shared or competing philosophical assumptions, past analytic experiences, and the resulting 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 the conventions prominent in specific settings (e.g., academic, government, private industry). Even when collaborators share a common discipline and setting, there may still be debate over the merits of various preferred analytic procedures.

Researchers are not required to understand the intricacies of each evaluative or analytic procedure conducted by their colleagues, especially if they do not share areas of expertise. However, researchers collaborating as authors should be prepared to explain how the interpretation of the findings was reached. According to Shamoo and Resnik (2003), "To qualify as an author, each person must be held accountable for the whole paper. This does not mean that each member is responsible for every part of the paper..since different people may perform different tasks, but each person should be prepared to explain the paper and defend it in public". Thus, as an author, they bear a responsibility to effectively communicate their findings.

Dissemination

Dissemination, in the context of collaborative research, refers to circulating, distributing, or publishing data, information, or research findings. In this stage of collaboration, there are two targets for dissemination: inside the collaborative group and outside the group. The dissemination of preliminary and final findings, in either written or spoken formats, requires collaborators to agree on:

  1. the process for approving all disseminated information,
  2. who will be authorized to speak for or represent the collaborative team,
  3. what audience(s) should be targeted,
  4. and whether to place restrictions on the free flow of information both inside and outside the group.

      Dissemination within the group - An important determinant of a functional collaborative relationship is       agreement on the flow of project-related information between collaborators. The agreement should establish       what is to be shared as well as the mechanism used to distribute it. Collaborators may also have to negotiate       issues that could impede the free flow of information within the group. Examples of project-related information       include progress reports, the minutes of meetings, modification of protocols, preliminary and final data, and       possibly the ideas generated from the research. The dissemination or sharing of data and ideas reinforces       the sense of trust and collegiality that forms the basis of the collaborative relationship.

      Dissemination outside the group - There are a number of reasons why information is disseminated outside       the collaborative group:

  1. the collaborators, as recipients of funding, may be obliged to submit a final report to sponsoring agencies
  2. the release of research findings to media outlets
  3. to share preliminary or final results with colleagues who are not members of the collaborative team
  4. to prepare submissions to professional journals

While conflicts may occur when collaborators fail to agree on any one of these issues, the issue of preparing and submitting an article for professional journals disproportionately affects academic researchers. It is essential that an agreement on authorship be made at an early stage of collaboration. The agreement should define: 1) an acceptable criteria for contributing as an authors, 2) a standard for acceptability regarding format and content of disseminated findings, 3) how credit for specific research findings will be allocated (authorship position).

Conclusion or continuation

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 - The original intent of collaborators may be to conduct an investigation with a       limited research parameter. Once the research goal and objectives were achieved, the 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 of a series of planned research activities where       the direction of subsequent investigations would be determined by initial findings. In this second case, the       configuration of the research team could remain intact, or perhaps new members with additional expertise       would have to be recruited.

      During implementation - Despite intentions to continue the collaboration beyond the initial study, researchers       may change their minds if they discover they are unsuited to work together (e.g., disagreement on training and       supervision of staff, unmet deadlines, and incompatible work styles). Conversely, the opposite scenario can       also occur when interactions between collaborators are so positive, with such productive outcomes,       collaborators may be influenced to continue the collaboration.

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

The decision to conclude or continue 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.

Impact on RCR

A brief review of the stages of collaborative research reveals a number of issues that can influence the responsible conduct of research. As noted previously, while the issues can also affect research conducted by independent investigators, the nature and added complexity of the collaborative relationship may demand an increased awareness for researchers during each stage of collaboration. As a result, researchers may be better prepared to avoid or address the consequences of unsolved issues, which may involve delaying or inhibiting progress through each stage.

While some issues may appear to be tied to a particular stage of collaboration, they may have implications to activities occurring in subsequent stages. For example, failure to agree on a policy regarding authorship or data ownership during the Management stage could have an impact on publication (Dissemination stage) and intentions to use collected data for future studies (Concluding or Continuing stage).

The use of multidisciplinary collaboration has been encouraged to provide a more comprehensive approach to complex research problems. In some cases, the problems require simultaneous approaches from a number of different perspectives. For example, efforts to control an outbreak of avian flu might require the participation of experts in the fields of virology, genetics, informatics, epidemiology, medicine, veterinary medicine, and history. Researchers participating in developing a proposal (Conceptualization stage) should be able to delineate each individual's expected contribution as well demonstrate how they will be integrated into a cohesive whole. This can represent a challenging prospect given the apparent differences in philosophical assumptions, theoretical frameworks, and methodologies. Once implementation has begun, effort will have to be made to ensure that every participant is aware of their roles and responsibilities, following protocol, and maintaining an open line of communication. A breakdown in communication can result in disrupting the progress of the research, incomplete dissemination of information, and a deterioration of collegiality.

Disagreements between collaborators can also occur between researchers sharing a common discipline and research setting. For example, a county health department may seek to release information about the number of cases from an infectious disease by city rather than county, a policy in stark contrast to the state health department's policy which withholds the names of cities where cases are reported. Both departments may justify their positions on ethical grounds (e.g. the right to know vs. right to privacy). This disagreement could have a negative impact on future efforts at collaboration.

The following section will describe issues critical to establishing successful research collaboration.

References

Conceptualizing Communication Research. Accessed on September 1, 2005.          http://64.233.167.104/search?q=cache:wQtgxK-PCk4J:www.uky.edu/CommInfoStudies/JAT/ISC/chike/isc321/Rsearchslide2.ppt+conceptualizing+the+research+ &hl=en&client=firefox-a

Macrina, F. (1995). Dynamic issues in scientific integrity: collaborative research. A report to the American Academy of Microbiology.

Morse, J.M. (1995). Qualitative Research Methods for Health Professionals. London : Sage Publications.

Rossi, P.H., Freeman, H.E. 1993. Evaluation: a Systematic Approach. Newbury Park : Sage Publications.

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

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