BA371 - Case Study

OSU Institutional Review Board Process and Information Management

Sponsored by Oregon State University - Office of Research Integrity
(Lisa Leventhal, MSS, CIP, CIM)

Preamble

Please note that this project represents the first phase of a two-phase project. This first phase covers problem definition, information flow process reconstruction, IS impact analysis, business process improvement and database design. The second phase --infrastructure, software design and prototyping--is covered in BA 372.

Project Description

In this project we'll analyze, model and evaluate OSU's process for the approval of planned research projects involving human subjects.

"Safeguarding the rights and welfare of humans in research is a general institutional policy of Oregon State University, with oversight delegated by the Vice President for Research to the Institutional Review Board (IRB), as mandated by federal regulation (45 CFR 46.103(b)(2)). The OSU IRB is charged with the responsibility of reviewing, prior to its initiation, all research (whether funded or not) involving human subjects. The IRB is concerned with justifying the participation of humans in research and protecting their welfare, rights, and privacy."
(http://www.oregonstate.edu/research/ori/hrh/irb.htm)

This mandate is implemented through a process through which OSU researchers, while planning research involving human subjects, must acquire approval for such research from their institution's IRB prior to conducting the research.

This process involves two core components:

• Assessing the compliance of the proposed research with IRB guidelines.
• The administrative process (work flow) of the application and IRB decision.

In this year's BA371 project we address this second component; i.e., the work flow. As you'll find out when we start talking with the OSU IRB people, this process is effective (it works) but would benefit from some efficiency improvements. Although IRB work flow systems are commercially available, they are expensive and OSU has decided to instead develop its own. In our BA371 class we will start this process by carefully analyzing and documenting the existing work flow, suggesting improvements, and the development of a database model for storing IRB data.

In the BA372 part of this project we'll explore several system architectures that can support the redesigned process, design a Web-based one and prototype parts of the application.

Design Project Requirements

In BA371, groups of four people conduct the following activities and report three times on their progress. Each of these are chapters that add to an overall Case Study Design report that we build up over the course of BA371 and BA372. This report will contain:

1. Introduction of the case study and a plan of IS impact assessment. This contains:
1. An introduction of the case study. This is a short write up that introduces the case study. It contains a description of the problem/opportunity the sponsor has asked us to address.
2. A long-term plan for evaluating the system's cost and benefits, including a description of the model-of-changes, and the methods for how to collect and analyze the supporting data.

2. Business process model and redesign. This contains:
1. The modified and cleaned-up version of report 1 (Intro & IS Impact analysis).
2. A write-up of the current business process in English. Use the three-column, quasi-narrative format discussed in class.
3. A UML activity diagram representing the information collected in b.

3. A write-up of the proposed changes to the process.
4. A UML activity diagram of the new and improved process.
5. Relational data model in third normal form to hold the case study's data. This includes:
1. The modified and cleaned-up version of report 2 (Intro, IS Impact analysis, Business process modeling & redesign).
2. Specification of all tables and their columns (names, data types and nullability) including an explanation of the choices you made.
3. Specification of all primary and all foreign keys.
4. Entity relationship diagram that shows all of b. and c.
5. A set of SQL database creation and drop scripts that can be run against a blank Access database using the SQL interpreter for Access that you programmed in Assignment 3.

Notice that as we progress through our work, we build (accumulate) a complete case-study report. Your instructor will provide you with feedback on each of the phases/partial reports you submit. You are strongly encouraged to revise your submissions accordingly before submitting the next edition of the report. You must summarize these changes in an appendix titled Revisions Log.

Design Report Guidelines

• A sample outline:
• Title Page:
• Project Title.
• Name Authors.
• Course and Instructor.
• Date.

• Executive summary (a very brief, no more than 1/2 page summary of the report).
• Introduction (summary of the case study).
• Return on investment plan.
• Business process models:
• Existing business process.
• Suggested business process changes.

• Database design.
• References.

  Suggested format:

  Smith, T.J. (2001) An Overview of Systems Design; Hammersmith Publ., Ottawa, Ontario.

  Smith, T.J. (2001) System Design Methods; Journal of System Design, 12, 551-561.

  Smith, T.J. (2001) Systems Design; New Developments; Available: http://www.wherever.com/smith/hereitis.pdf.

• Revisions Log.

• Format requirements:
• Use headings and separate your text in logical blocks and segments.
• Number pages (Title page has no number. First page with content has page number 1).
• Integrate figures and tables into the text; do not add them as an appendix in the back of the report.
• Properly number and caption figures and tables (use Microsoft Word support for this).
• Use cross-references to refer to figures and tables. DO NOT HAND-TYPE THE FIGURE AND TABLE REFERENCES.
• Spell check (both automatically and manually!).

• Add an automatically generated table of contents (TOC).
• Grammar check!!
  
• Peer review!! Before handing in your report, carefully (!!) read what you and your colleagues wrote. Clean up ambiguities, break up long and awkward sentences into shorter, more elegant ones. In other words: show that you care.