Human Research Protection Program



HRPP Study Consultations

The HRPP understands that navigating the myriad rules and regulations surrounding the conduct of human subject research can be challenging for Yale investigators, especially those new to research or new to a sponsor-investigator role. Questions or concerns can arise during the conduct of research. In an effort to assist investigators with these challenges and to proactively address issues and provide clarifications to the Yale research community, the HRPP offers a study consultation service to investigators and their study teams and/or departments.

HRPP study consultations are tailored to meet the requests and needs of the investigator and study team. Each session time can vary depending on the need/request. Sessions are led by various members of the HRPP staff, including the HRPP compliance team, and are individually tailored depending on the topics involved. Other research entities from Yale may be asked to collaborate (e.g., YCCI, HIPAA Privacy Officer, HIPAA Security Officer).

Study Consultation Topics may include:

Investigator Responsibilities related to study conduct

Consent process (including documentation requirements)

Reporting of Deviations

Study Modifications

Source Documentation

Utilizing Notes to File

Regulatory Binder

Communicating with the IRB and sponsors

Any Principal Investigator at Yale that conducts human subject research can request a study consultation. Please contact Monika Lau ( for more information and/or as soon as you believe you would like a study consultation.

Please note that consultations are only advisory in nature and do not take the place of a formal IRB review.

The YCCI also offers resources and expertise throughout the research process. Please see their site at

The HRPP Educational webpage also offers targeted educational sessions that can be viewed on your computer at any time. New sessions are added frequently to meet the ongoing needs/requests of the Yale research community.