D08 - Navigating the Regulatory Maze When Proposing Study Visits in Participant Homes

Thursday, November 18, 2021

1:30 PM – 2:30 PM ET

Location: Livestreamed

Proposals by sponsors and investigators to offer an option for study visits in participant homes have exploded due to the COVID-19 pandemic and Decentralized Clinical Trials. Research personnel may conduct such visits or a home healthcare agency may be contracted by the research institution or an industry sponsor. This session will explore the ethical, practical, and regulatory factors that must be considered. Before attending this session, attendees should have an understanding of human research protections regulations at the federal, state, and local level, understanding of thebasic ethical principles for human subjects research, and familiarity with best consent process.

Learning Objectives:

Identify the reasons for which a home study visit may facilitate recruitment and retention of study participants, and accommodate participants with mobility challenges
Create an awareness of the factors that must be addressed before approving home study visits, including, but not limited to, liability coverage, communicationbetween the research team and home healthcare agency, determining engagement and the need for IRB review, and training and documentation of procedures conducted in the home
Discuss the language that is required for consent documents when home study visits are an option or when they are optional
Outline home visit team safety issues and mandatory reporting requirements

Speaker(s)

Mitchell Parrish, JD, RAC, CIP

H Clinical
St. Petersburg, FL
Brenda Ruotolo, CIP

Columbia University in the City of New York
New York, NY

Resource Person(s)

Natalie M. Klein, PhD, CIP

DHHS Office for Human Research Protections
Rockville, MD