Human Research Protection Program

HITECH Act

Study Start-Up Consultation

The IRB understands that navigating the myriad rules and regulations surrounding the design and conduct of human research can be confusing and often frustrating for investigators, especially those new to research. In an effort to help ease the process, the IRB is offering a study start-up consultation service to investigators and their study staff who would like assistance in becoming familiar with the duties and responsibilities of conducting research involving human subjects at Yale.

The start-up consultation visit will last 1-2 hours and will address common investigator concerns, investigator responsibilities related to study conduct, subject interactions and communication with the IRB and sponsors, study specific documentation and retention requirements and University and Federal policies and regulations as they relate to the particular study. Research team members will have the opportunity to ask questions and discuss issues prior to actually starting the study to help ensure compliance with applicable regulations and an efficient study process.

In addition, we encourage you to take a look at the Checklists and Forms provided on the Compliance page. These forms and templates offer valuable information on study responsibilities and documentation.

Request a Study Start-Up Consultation