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«11-18-2012 An Organizational Diagnosis Of A Centralized Investigational New Drug Core Within A Large Academic Health Center Kathleen M. Thomas ...»

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The lack of goals can cause confusion and uncertainty among individuals and groups in the system. The confusion can be twofold: either individuals are unclear about the goals, or unclear about which goals have priority. “Increasing the clarity of organizational goals or the degree of consensus about goal priority is associated with decreasing boundary permeability and decreasing the clarity of organizational goals or increasing the disputes about goal priority is associated with increasing boundary permeability" (Alderfer, 1980, p.270). Alderfer provides a detailed description of what to look for as consultants, but the question remains, how can we achieve optimality?

The second variable to be aware of is authority relations. The boundary type of the system can be influential to the leadership style and vice versa (Alderfer, 1980).

Within an organization the style of leadership impacts the organization as a whole as well as the individuals that are part of the organization. In an overbounded system there is usually a centralized and hierarchical approach to leadership. In this type of system, there is usually an agreement upon the goals, and purpose (Alderfer, 1980). On the contrary, the underbounded system results in unclear goals as well as a fragmented style of leadership. There will either be multiple authorities, or none (Alderfer, 1980). In my opinion, leadership is the important foundation and support to an organization. As consultants, during a diagnosis it is critical to review and understand the relationships with authority. Understanding how employees work with their leader can demonstrate the level of leadership involvement within the system and the level of comfort employees experience. These understandings will also help build the effectiveness of a feedback session.

The third variable is role definitions. “Individuals in organizations develop patterns of role behavior based on the expectations placed upon them by the organization modified by their own personal values, beliefs, abilities, and group memberships” (Alderfer, 1980, p.272). Often times, individuals will carry out responsibilities that are assigned to them as well as taking the initiative to find other responsibilities to complete.

On the contrary, individuals may alter the responsibilities assigned to them by narrowing the focus of said responsibilities and altering the scope of work within their role. The style of authority may also impact the roles of group members. Leadership may not be clear or direct about assigning tasks or defining, at the group level, the responsibilities.

This can often be seen in an underbounded system if the authority is not clearly identified.

The fourth variable related to this capstone is intergroup dynamics. Intergroup dynamics is defined as relationships among various groups within the system (Alderfer, 1980). Alderfer (1980) breaks intergroup dynamics into two classes: 1. Task groups and

2. Identity groups.

Task groups are defined by the kinds of work they perform and by the level in the hierarchy in which they are located. Identity groups refer to group affiliations that help individuals shape their personal identities (example: ethnic, gender, generation, and other groups determined by life experiences (274-275).

Alderfer theorizes underbounded systems will usually have intergroup conflicts between the identity groups whereas task group conflicts are more prevalent in overbounded systems. I would also note that tasks groups in underbounded systems may exhibit intergroup conflicts due to the lack of role clarity and leadership.

It is critical for a consultant to spend time determining the type of system they are entering in order to provide a successful diagnosis. Gaining a sense of understanding of the specific variables will give the consultant determination on if the variables can be changed to achieve an optimal system.

Planning I was unable to locate literature specific to planning processes within AHCs.

Again, I believe the lack of literature highlights the importance of this capstone and future research on this specific topic. Based on historical events, programs and regulations have been set in place as a reaction to a tragic event. I have not been able to determine if planning was done prior to implementation. The historical events demonstrate the lack of proactive approaches with enhancing compliance.

I reviewed literature that highlighted inaccurate planning in terms of projecting costs, demands and resources. This literature is relevant in highlighting how planning can be inaccurate, but it is not relevant to the purposes of this capstone.

History of organizations While the goal of this capstone is to determine why the IND core is not presently operating effectively, it is important to understand the historical events that shaped a centralized IND model as the history is a factor in the current state of an organization. For this capstone I am focusing on a specific unit within a large organization. Therefore, I will examine the literature on organizational history from this perspective. I will discuss the importance of gaining an understanding of the organization's history, and how history affects the current state. Following this, I will outline the history behind clinical research regulations.

There are few practitioners that focus on the past when entering a client system.





“Transformation cannot simply be mandated. To be effective, it must be undertaken in a way which builds on rather than runs over the past.” (Kimberly & Bouchikhi, 1995, p.9) Kimberly and Bouchikhi (1995) argue that an organization is somewhat analogous to an individual. There is a culture that appears within an organization, which in turn produces an identity that is easily noticeable. (Kimberly & Bouchikhi, 1995). When attempting to understand behaviors of individuals, practitioners/clinicians ask questions about the individuals past in order to fully understand why they behave in a certain way.

This same approach can be taken with organizations. Consultants can ask questions, and research the past to determine why the organization operates in a certain way.

We would argue that without an appreciation for past experiences, present behavior and future action cannot be fully understood for people or for organizations (p.10).

This argument presents the value of an organizational biography. “Biography is a vehicle for illuminating the lives of individual people.” (Kimberly & Bouchikhi, 1995, p.10) Over the past few years, there has been an increase in awareness as to the benefits of a biographical approach; however, some still argue over the function of the biographical approach to research. “Some argue that they should provide comparable data for building generalizable theories, while others argue that they should provide a means for underlining uniqueness.” (Kimberly & Bouchikhi, 1995, p.10) As I conducted my research, I found creating a biography of the IND core provided relevant knowledge that would benefit the current leadership, as well as providing external leadership and understanding of the uniqueness of our unit.

But, how can an organization’s historical events be obtained? Simmons describes the data available from historical research as that of memories and paper records (Simmons, 1985). Learning about the history of the organization can be gained through qualitative data, and a review of past records. Kimberly and Bouchikhi present a study demonstrating how history shapes an organization. In-depth interviews with the CEO and staff members were conducted over the course of five months. The purpose of conducting these interviews was to gather an understanding of the development of the company.

Kimberly and Bouchikhi noted in their article, “The Dynamics of Organizational Development and Change: How the Past Shapes the Present and Constrains the Future”, the limitations associated with the qualitative research approach. Individuals may not fully remember all of the details associated with the past. However, while there may be limitations, the stories being told by each participant are the stories that shape the organization's current state. Simmons argues there is a need to build models to understand distortion and fact (Simmons, 1985). She breaks her models into three categories: distortions about involvement, distortions about time, and distortions noted in the interviews. With the distortion of time, Simmons demonstrates the importance of selfdata (example: memories) because some things may be left out in the discussions. The next aspect of the model indicates that individuals may alter in their mind the length of time spent in specific relationships. The third aspect of the model demonstrates the importance of observing body language and expressions during interviews. Simmons was able to cross-examine her interviewees with paper documents to assist in recreating the history (Simmons, 1985). Utilizing several methods of data collection can help produce a more valid and reliable data set.

The authors demonstrate that learning the organization's history will assist in understanding the current structure and aid in production of successful and effective

change within an organization. Kimberly and Bouchikhi state:

And as biographies accumulate, the potential to do comparative work invariably increases, enabling one to examine the extent to which insights developed in one setting have wider adaptability and thus dramatically heightening the payoffs from this kind of work (p.17).

Over time, organizations change in terms of structure and culture. An organization is shaped by its identity. Can-Seng Ooi (2002) described identity by noting “Albert and Whetten defined organizational identity as the central, distinctive and enduring aspects of the organization” (p.606), According to Can-Seng Ooi (2002) this type of theory can marginalize the complexity of organizational change dynamics and decrease the reality (p.606). Ultimately, this may provide individuals with a skewed opinion of an organization based on a limited understanding.

How should history be presented to individuals? Ooi describes the following two processes for providing a packaged history to individuals. “The re-presentation of history involves interpreting the bygone for a uniformed public, and highlights the emotional dimension of communicating history, which has been taken-for-granted and undertheorized” (Ooi, 2002, p.607). I believe this statement highlights the importance of understanding history as well as learning effective ways to teach the history.

History is unique and defined as a narrative account of events. History is about facts of the past, but interestingly enough, these are facts that cannot be observed presently. Ooi (2002) stated “historical facts, meanings and significance have to be packaged for people” (p.607). The history needs to be packaged so that individuals can effectively understand what they are being taught without seeing it for themselves. A packaged past mainly consists of details of what happened, why it happened, and the significance of the events (Ooi, 2002). What is the motive for presenting a packaged history?

There are many reasons for presenting a packaged history. Ooi outlined the following reasons: traditions, reputation, claims and breaking away from the past. For this paper, I believed it was important to learn the history of the IND core in order to gain a deep perspective on the functioning of the core. In addition, I believe presenting these findings to current members and future members of the core will provide them with the facts of centralization and have an understanding of how to continue to assisting Investigators.

The dynamics of an organization are complex. “First, tapping into organizational pasts is a complex process and we, as researchers, have to take into account and reflect upon our emotional responses to what we have accepted as history” (Ooi, 2002, p. 619).

When we research history, our perception of what we read or hear may contribute to how we feel about the past. It is important that we do not allow inferences to get into the way of packaging history. “Second, we also re-present history, which our packaged pasts inevitably draw emotional responses from our audiences” (Ooi, 2002, p.619). When teaching people, we must be aware of the emotion that may be unleashed during the presentation. It is important to be prepared to manage these types of responses. These are important factors to take into consideration before researching organizational history.

Reviewing the past will guide individuals (organizations) to understand the behavior of the organization and learning about how to develop the future. Often times professionals wonder “why do we have to follow this process?” We may need to dig deep, but there is a reason the process was developed. Understanding the history of “why” will help organizations and managers build the knowledge base needed to define the reason a process is in place. I believe the history and past is really important as it paints the picture of what the organization has become today.

Clinical research regulations As outlined in chapter one, there have been multiple events leading to the development of clinical research regulations over time. There is limited research on the effectiveness of the regulations developed as a result of tragic events. However, there have been articles published on the evaluation of IND support programs at AHCs.

“Complying with the FDA's regulations can be daunting and an overwhelming burden to faculty research who are rarely familiar with their obligations as sponsors of an IND or IDE application” (Arbit & Paller, 2006, p.146). The University of Minnesota established an IND/IDE Assistance Program (IAP) in 2002 to assist Investigators with the IND/IDE process. The objectives of the program were two-fold: training/education for the research team about the regulatory progress and ongoing support to assure SponsorInvestigator responsibilities are being met. Many people may wonder why such a program would be established at an AHC where research is high on the priority list.



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