Module 1
- Overview
- Introduction
- Process
- Basic Principles
- Brief History
- What Research Must be Reviewed
- IRB Review Criteria
Module 2
- Overview
- Introduction
- Selecting Participants
- Describing Research
- Discussing Participation
- Ensuring Readability
- Assessing Understanding
Module 3
- Overview
- Continuing Review
- Unanticipated
Developments

- Adverse Events
- Consent Doc. Revisions
Module 4
- Student Test
- Faculty/Staff Test
Helpful Links
- NIH Protecting Human
Participants

- Office for Protection


JMU OSP

Module 3
Consent Document Revisions

Study participants need to be informed of any new and important information that might affect their willingness to participate. If new information, knowledge, or an adverse event has been discovered, it should be communicated to the subjects. This may require a revised consent document.

New information will require that the investigator evaluate the facts to decide on a revised consent document for future participants as well as what information should be given to former or current subjects. Unexpected complications, adverse events, or breaches in confidentiality all signify developments that may require a revised consent form. Consult the IRB to establish if a revised document is required.

You have reached the end of Module 3 and are now ready to take the IRB training test. Please see the links under Module 4 on the left of your screen or the links at the end of this page to take the test for students or faculty/staff.

Take the IRB training test for students

or

Take the IRB training test for faculty/staff

 

 

Useful Links:
-SPA Accounting
-Research & Public Service
-Academic Affairs
-Office of Technology
Transfer

Last Modified July 1, 2008

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