DOES MY STUDY REQUIRE APPROVAL?

Federal regulations and policies require IRB approval for research with human subjects. You are required to submit a formal application if your project or study meets both of these conditions:

1. It constitutes “research” with the intent to develop new or expandable knowledge.

AND

2. If human subjects are involved, either directly or through use of identifiable data about them.

Does my study constitute “Research”?

According to the Code of Federal Regulations, research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge [45 CFR 46.102(d)] — i.e., “with the intent to develop new or expandable knowledge.”

A. Is your study intended to develop new or expand existing knowledge?

B. Do you expect or intend to publish or present the results of your study?

If you answered YES to (A) and (B), your study is considered to be “Research” and you do need IRB approval before you can begin your study. If you answered NO to either question, your study is considered to be “Research” but it may be exempt.

Is my study considered to be research “on Human Subjects”?

A. Are you planning to obtain information from or about living individuals?

B. Will the study involve direct interaction with individuals or data linked to personal identifiers?

C. Will you gather information that would ordinarily be private?

D. Will you observe behavior in a context where the subjects would reasonably expect privacy (e.g., their homes)?

If you answered YES to (A) AND one or more of the other questions, your study is considered to be “on Human Subjects.” If you answered NO to all the questions, then you do not need IRB approval and can begin your study.

Do I need to submit an IRB application?

A. Does your study constitute “Research”?

B. Is your study considered to be research “on Human Subjects”?

If you answered YES to both questions, then your study or activity is considered “Research on Human Subjects” and you must submit an IRB Application (Word) and review the material found on the Principal Investigator’s Requirements page  especially the IRB Investigator’s Guide (Word).

If you answered NO to either question, then you do not need IRB approval and can begin working on your study.

NOTE: IRBs do not have the option of granting “retroactive” approval after research is done, so you are strongly encouraged to submit your research proposal or consult with the IRB if you are unsure whether you need IRB approval.

You may email your questions to the WCGME–IRB Administrator at: wcgme-irb@thewrightcenter.org or call 570-343-2383, ext. 2261.

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