Case Study: Human Subjects Protection Assesment System

Project Title: Human Subjects Protection Assessment System

Client: NIH Office of Extramural Programs

Project Duration: October 2009 – April 2010

Ripple Effect Contact: Yvonne Lau, ylau@rippleeffect.com

Background

The Human Subjects Research Protection staff in the NIH Office of Extramural Programs is responsible for assessing NIH grants to ensure the appropriate protection of people who participate in scientific studies. Reviewers may express concern for human subjects during a grant’s peer review. If this occurs, OEP staff must assess these concerns before extramural funding is provided.

Challenge

Previously, the OEP staff managed the assessment process through a redundant system composed of (1) paper, (2) electronic file sharing, and (3) a Microsoft Access database.  Staff had to consult all three components to adequately process and administrate the case at hand.

Solution

Ripple Effect consolidated the three components into a single, web-based Human Subjects Protection Assessment System (HS-PAS). The new system allows NIH Institutes and Centers (ICs) to submit change requests, provides a platform for ICs and OEP staff to communicate, and stores and processes statistical information (e.g., case load, response time to IC requests, staff workload).

Harnessing the technical and statistical expertise of Ripple Effect staff, we initiated the creation, design, and development of SharePoint lists that allow the OER staff to access real-time data that is calculated and presented in simple, yet meaningful ways. In addition, the new system generates statistical tables that provide access to information such as:

• Waiting time for all cases in process
• Frequencies for different types of human subjects concerns
• Submission and review status

Achievements:

• Replaced redundant, paper-based system with a one-stop, electronic system
• Increased staff efficiency
• Improved processes using real-time reporting
• Received NIH Office of the Director Honor Award