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How do I know if I am funded?
Who needs human subjects protection training?
Who approves my data monitoring plan?
What is a Certificate of Confidentiality and do I need one?
How do I develop consent forms and who reviews them?
Are there ethical concerns and conflicts of interest I must consider?
Do I need IRB, IEC or REB approval?
What other approvals are needed?
How do I track recruitment of research participants?
My study involves Medicare or third party support.
My study involves foreign grants and contracts.
How do I register my study?
When can I begin enrolling participants?

Glossary Box

 

Who needs human subjects protection training?

Education on the protection of human subjectsGlossary Term is required for any individual who will be involved in the conduct of NIH-supported human subjects research.
OERGlossary Term has provided a Frequently Asked Questions document to help you determine whether this requirement applies to you and your co-investigatorsGlossary Term.

Your budget office must submit documentation that all personnel involved in the human subjects research have completed research training before ANY subjects can be enrolled in your study (and before your grant will be funded).  Many institutions have a training program for research personnel conducting research at their institution.  The National Cancer Institute (NCI) provides a tutorial that satisfies the NIH requirement called Human Participant Protections Education for Research Teams and the NIH provides researchers with Computer Based Training on protecting human subjects.  Once either course is completed, a certificate can be printed for inclusion in your grant file.

 

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