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Investigator's Handbook

The Investigator's Handbook is a resource for investigators to use to clarify policies and procedures regarding human subject research.


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Investigator Handbook

Table of Contents:

Scope and Purpose of the IRB

Institutional Review Boards
The Office of the IRB (OIRB)
What needs IRB review
Who Needs HSC IRB Approval?
How are new human research studies reviewed by the IRB (initial review)?
Is there required education for researchers?
What is the procedure for submission of new research (initial review)?
What is the procedure for requests for re-approval (continuation review)?
Besides the IRB, are there other approvals before research can start?
How do I handle approval by another (non-HSC) IRB?
Informed Consent
Special Considerations - Informed Consent
Consent from Legally Authorized Representative
Assent
Distribution and Storage of signed consent forms
Guidelines for consent in research using surveys and interviews
Waiver of the requirement for a signed consent document
Waiver of the requirement to obtain consent
Recruitment and selection of subjects
Staff and students as subjects
Finder's Fees
FDA regulations
Principal Investigator Responsibilities
Emergency Use of an Unapproved Drug or Device
Click here to access the IRB Policies