Human Subjects Research at Scripps Health

This Powerpoint presentation by Barbara Bigby, Director of Regulatory Services, outlines the framework, policies, and procedures for conducting clinical research at Scripps Health.

View presentation.

Clinical Research Proposal Form

This form assists in outlining a new protocol with your mentor and projecting a timeline for project completion. It is required of all Scripps Green Internal Medicine Residents early in R2 year.

Download the form.

Human Subjects Protection Training

All investigators and key personnel who conduct human subjects research must have minimal education in human subjects protection. Human subjects research should be considered any use of Scripps Health patient data that is not for the express purpose of providing medical care for those patients, and it includes presentation or publication of case series.  This education requirement must be fulfilled before IRB approval of your proposal.

Complete training.

Scripps Institutional Review Board (IRB)

Scripps IRB includes physicians, scientists, and members of the community who review research to ensure that human participants are not exposed to unnecessary risks during the conduct of Scripps research.  All research conducted at any Scripps facility or by any Scripps employee or agent must be reviewed and approved by an IRB.  Residents and fellows are welcome to attend IRB meetings to observe this important process.

Complete or revise an IRB application.

Clinical Research Progress Report

This form provides an update for ongoing research projects and is required of all Scripps Green Internal Medicine Residents twice yearly beginning R2 year.

Download the form.

Sample Data Collection Tool

  • Collect data into an Excel file – rows are patients, columns are variables (demographics or outcomes). See sample.
  • On this file, patients should NOT be represented by their MRNs or other personal identifier. Keep a master list for yourself and assign each patient a number on that master list.
  • Digitize dichotomous variables as 0 or 1, with a key to what each means.
  • M or F are okay for gender.
  • Continuous variables are just their values.
  • Master lists and data files must ALWAYS be secure and password protected, kept on Scripps’ server.

See sample data collection Excel spreadsheet.