MGH Division of Clinical Research

What Does the IRB Really Want? How to Write a Human Studies Protocol

Sponsored by the MGH Division of Clinical Research and the Human Research Committee

Elizabeth Hohmann, M.D., Chair and Physician Director, Partners Human Research Committee

This practical lecture addresses "Full Review Protocols" - those of more than minimal risk which must be considered at a convened meeting of the IRB. It provides practical advice for those preparing protocols for IRB review. What is the IRB; how does it work; what is the best way to interact with it? Understand common pitfalls and errors in submissions and how to avoid them. Find out exactly what the IRB needs to review your study, and how to best and most effectively present your scientific, ethical, and logistical information to the IRB.

This lecture is designed for new research fellows and professional staff, research nurses and study coordinators submitting materials to the IRB.

Registration is required. Contact dcredu@partners.org with questions.

This program meets the requirements of the Board of Registration in Nursing, at 244 CMR 5.00, for 1.5 contact hours of nursing continuing education.

RCR Eligibility: Completion of this course will fulfill one lecture/discussion requirement.


Programs: Clinical Research Staff Program Experienced Clinical Research Coordinator Clinical Investigator Program Clinical Research Investigator Beginner Clinical Research Coordinator

Categories: Ethical Oversight IRB

Sponsor: MGH Division of Clinical Research

Modules

What Does the IRB Really Want? How to Write a Human Studies Protocol