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Free 20-minute phone/video discussion.

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HRPP staff, IRB member, or research staff training.

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AREAS OF EXPERTISE

■ Research ethics ■ Research integrity ■ Research compliance ■ E.U. and non-U.S. institutions compliance with US regulations ■ International research

■ Minimal risk ■ Expedited review ■ Risk/benefit analysis ■ Equitable selection of participants ■ Informed consent (drafting and editing) ■ Key information ■ Broad consent ■ Plain language

■ Institutional policies and SOPs ■ Forms/templated language ■ Answering/appealing IRB determinations ■ Compliance ■ IRB effectiveness

ABOUT

Jaime O. Hernandez J.D., M.B.E.

Jaime O. Hernandez J.D., M.B.E.

Jaime Hernandez is the Founder and Chief Consulting Officer of Practical Ethics-Research Solutions. In his more than 20 years in research ethics and compliance, Jaime has been an IRB administrator, IRB reviewer, investigator submitting to the IRB, educator and trainer, auditor, and Federal regulator.

For the past decade, he was a Senior Policy Analyst at the U.S. Department of Health and Human Services (HHS), Office for Human Research Protections (OHRP) focusing on research participant protections policy and education. Before that, he was a Senior Research Investigator at the University of Pennsylvania, Department of Medical Ethics and Health Policy. Earlier, he also served as an IRB reviewer and IRB administrator at the University of Pennsylvania Office of Regulatory Affairs and as a commercial litigator at Hugues Hubbard and Reed, LLP. He obtained his Juris Doctor at the University of California, Berkeley, and his Master of Bioethics at the University of Pennsylvania, Perelman School of Medicine.

Simplicity, practicality, and collegiality mark the work of Jaime Hernandez. He has been celebrated for his ability to find creative solutions to complex regulatory issues and to explain such complexities in clear and actionable ways.

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