Linda Coleman, JD, the director of the Yale Human Research Protection Program (HRPP), which assists the university in meeting its ethical and regulatory obligations for the protection of human participants in research, has accepted an appointment to the Secretary’s Advisory Committee on Human Research Protection (SACHRP).
SACHRP provides advice and recommendations to the Secretary of the Department of Health and Human Services on issues and best practices regarding the protection of human research participants. As a member of SACHRP, Coleman will evaluate and provide recommendations on current issues related to human subjects research.
Coleman, who came to Yale in April 2016, says that one of her greatest challenges has been to address ways to streamline the review process for studies conducted at Yale.
“We are constantly trying to figure out ways to improve efficiency so that we can better support the needs of investigators without compromising quality and compliance,” she says.
A further complicating factor relates to the implementation of the revised Common Rule, the U.S. federal policy designed to protect human subjects. After January 21, 2019, when most of the provisions of the revised Common Rule went into effect, research projects conducted at Yale are held to varying standards depending upon what set of regulatory criteria applies to the research activity. Adjusting to these different standards requires several changes to HRPP processes and forms, and its electronic institutional review board (IRB) submission system, Coleman says.
Coleman is actively involved with several professional organizations and initiatives at Yale centered on human subjects research. Some of her areas of involvement include IRB harmonization, good clinical practice, decentralized (virtual or telehealth) clinical trials, single IRB implementation strategies, research data protection, and overall clinical trial process improvement.
Before coming to Yale, she worked at an organization that provides independent IRB review services and consulting services and as an attorney, where her practice focused on health and employment law.