IRB-01
HELP
Are you conducting human research?
Submit a NEW STUDY
TOOL: Research on Medical Records, etc.
REVISE/AMEND your research
Submit an ADVERSE EVENT
Submit a DEVIATION / NONCOMPLIANCE
Submit an UNANTICIPATED PROBLEM
Submit a HDE (Humanitarian Device Exemption)
Submit EMERGENCY USE
Submit a CONTINUING REVIEW
Do you need approval for Case Reports?
Which IRB do you submit to?
 
 
 

Submit a NEW STUDY

General Information - page 1 of 6

You must receive IRB approval before you may start your human subjects research. In order to approve your research the IRB needs to know what you hope to do. Our forms are designed to help give the reviewers the information they need to evaluate your research and verify that it is ethical and complies with appropriate regulations, laws, and policies.

But there are a lot of IRB forms, what do you need to submit? This help module will describe the basic categories of research and what paperwork is needed to submit research within each category.

Please note:
  (1) IRB forms continuously evolve because regulatory requirements change as well as the interpretation and implementation of those requirements dynamically shift and adapt. You must ALWAYS download and submit the newest version of forms on of our web site.
  (2) Our forms are meant to give the IRB the information it needs to review your research. Unfortunately it is impossible to create forms that account for every kind of research issue possible. Please submit any additional information that is pertinent to the review of your research via a coverletter or other means.

Regulatory requirements are based on protecting the subjects. As a result the more involved the research (not to mention the riskier the research), the more protection / regulations are required, and therefore the more paperwork that is needed to insure the regulations are met / protections provided. In short: more involvement/risk = more protection needed = more paperwork. This is important to recognize because it not only helps explain why some of our forms are lengthier than others, but also reveals how certain categories of research are more powerful than others. This will be expanded on later after reviewing the categories of research and what must be submitted for each.

Before proceeding you may want to review the definitions for human subject and research.

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