The guide contains directions, examples and sample text for filling out HRP-503, the protocol template. It correlates with the IRB template to be released in January 2016. It will be updated to ...

Follow the step-by-step instructions below to successfully prepare and submit a protocol to the IRB. Instructions below include information about single IRBs, student involvement in human subject ...

For Project Revision/Amendment forms (PRAF) to briefly describe the nature of the PRAF. * note that the version date is the version date of the Sponsor’s Protocol and not the date you uploaded the ...

A formatted template is available for you to fill in with your study's information and an example is also available. The IRB may ask you to include your recruitment materials in your protocol ...

Follow the step-by-step instructions below to successfully maintain and close a protocol with the IRB. Instructions below include information about continuing reviews, amendments, event reporting (new ...

Unless instructed otherwise, please make sure you have the following items to include with your application: consent/assent form (IRB Form 3.1) any written instruments, sample questions, and/or other ...

Example: You are a sociologist planning to conduct research in a country with one national institutional review board. You carefully prepare and submit your IRB protocol, only to be told by the IRB it ...

For example: Does the situation involve unapproved changes ... are made if further information is needed to assess the deviation. Each protocol deviation reported to the IRB is evaluated to determine ...

To submit a incident report, please follow the instructions below: Detailed instructions on how to add a "New Submission" to a current protocol ... participants without IRB approval, then a incident ...

PIs should consider the following issues when evaluating local context and address them in their IRB protocol: Scientific/ethical justification ... can reach out with concerns or questions. For ...