Institutional Review Board (IRB)
Submissions System

Background

Wikipedia definition: An institutional review board (IRB) is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the research subjects. In the United States, the Food and Drug Administration (FDA) and Department of Health and Human Services (specifically Office for Human Research Protections) regulations have empowered IRBs to approve, require modifications in planned research prior to approval, or disapprove research. An IRB performs critical oversight functions for research conducted on human subjects that are scientific, ethical, and regulatory.

Pace University, as most universities, has an IRB that oversees research conducted on human subjects to ensure that they are conducted in a scientific and ethical manner. Currently, applicants submit a paper proposal and application form to have their research approved.

Project

Pace University would like an IRB website and application submissions system. Applicants for IRB approval would submit their proposals and application forms online through the website. These documents would be stored in a backend database on a server in the Sponsored Programs and Research Office. The application would automatically receive a tracking number and the applicant would receive a message indicating that their proposal had been received and that a response could be expected within four weeks. Simultaneously, a notice would come to IRB co-chairs indicating that another proposal was awaiting action. The proposal and application materials would then be accessible to IRB members online along with an electronic checklist to evaluate the proposal and transmit the list back to the applicant for further action, if needed, or with confirmation that the proposal has met IRB approval and is good to go.

The system will be developed on the Utopia server in our School of Computer Science and Information Systems. By midsemester the customer must be informed of the necessary hardware and software required to run the system. One month prior to the end of the semester the system will be transferred to a server on the customer's site. During the last month of the semester the system will be in operation at the customer's location, tests will be performed to ensure proper operation, and all problems will be fixed.

Fast Agile XP Deliverables

We will use the agile methodology, particularly Extreme Programming (XP) which involves small releases and fast turnarounds in roughly two-week iterations. Some of these deliverables might be done in parallel by different members or subsets of the team. The following is the current list of deliverables (ordered by the date initiated, deliverable modifications marked in red, deliverable date marked in bold red if programming involved, completion date and related comments marked in green, pseudo-code marked in blue):

  1. 2/1 Your first task on this web design/implement project is to gather requirements from your customer and develop a strategy and plan to complete the project work. Part of this strategy will be to determine what software you will use. Your instructor prefers that you use straight HTML or Dreamweaver (definitely not Frontpage and the like) for web pages and PHP for accessing MySQL backend databases (PHP and MySQL are robust and free). This task should be completed in about a week.
  2. 2/11 Design and implement a rough prototype website for your customer using the chosen software (from Deliverable 1), and get feedback from your customer. This task should be completed by week 5, and certainly no later than week 6 (we are currently in week 4). This should be possible because the 80-20 rule says that you can complete 80% of the work on a project in 20% of the time (the last 20% is often difficult to do and requires considerably more time and effort).
  3. 2/11 Design and implement an almost finished website system, and get feedback from your customer. This task is to be completed by week 9 and presented at the Second Classroom Meeting. Remember that the website system is to be transferred to the customer's server one month prior to the end of the semester. Therefore, at this point you should be almost done, except for final in-house testing and then customer testing in his/her environment.