The USC Human Subjects Protection Program has developed and printed a wealth of human subjects booklets available to users online or in hard copy by request to firstname.lastname@example.org.
Are You the Holder of an IND or IDE?
These booklets describes the responsibilities of IND (Investigational New Drug) and IDE (Investigational Device Exemption) holders. A reference for investigators holding an IND or IDE and/or IRB staff who will be reviewing IND/IDE studies.
This series contains nine booklets each addressing a different theme in the responsible conduct of research: Use of Animal Subjects, Collaborative Research, Conflicts of Interest and Commitment, Data Management and Acquisition, Human Subjects Research, Mentoring, Peer Review, and Research/Scientific Misconduct. These materials will prepare the reader to complete the CITI online RCR course.
Guidance for medical students who conduct biomedical, social and behavioral research or otherwise participate in research activities at the Keck School of Medicine (KSOM).
This comprehensive manual aids student with the IRB process. Provides information about the intricacies of human subjects research.
An overview of informed consent: its importance, required elements of consent, the consenting process, and documenting consent. USC resources for informed consent information are included.
The mentor has the potential to draw the best from the student by acting as an adviser, teacher, role model, motivational friend and supportive advocate. This booklet is a guide and overview of that process.
Guides IRB community members through the human subjects research process and helps them transition into a valuable members of the IRB committee. It can also serve as a great introduction for anybody new to human subjects research and the IRB.
Aimed at assisting potential research participants in their decision to participate in research.
Also available en Español: ¿Debería participar en una investigación?
Designed to guide Principal Investigators through the IRB process. Includes information on defining human subjects, the levels of IRB review, and informed consent requirements.
A guide to help investigators determine if their project is human subjects research. Offers definitions and examples of human subjects research.
For Faculty Advisors (FA) serving on student IRB projects. Provides a brief overview of the FA role and tips for navigating the IRB process from the FA perspective.