Trial mobile version Guidances- combined files 6_27_14 - page 8

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HUMAN SUBJECTS PROTECTIONS
 Search OHRP’s Human Research Protections Frequent Questions (FAQs)
This is a search tool from the Office of Human Research Protections (OHRP). You can enter
keywords for the information that you are seeking. Answers are provided in an easy to read
‘question and answer’ format. This can save the effort involved in reading and interpreting the
policy language in regulation documents.
 U.S. Department of Education Guidance on Engagement of Institutions in Human Subjects
Research
This document describes “engagement” and the applicable regulations for institutions and
programs receiving funding from the U.S. Department of Education.
 U.S. Food and Drug Administration (FDA): Investigator Responsibilities – Protecting the
Rights, Safety, and Welfare of Study Subjects in Clinical Trials
This is a guidance created for industry researchers, but will be useful to IRBs or any investigators
planning or conducting a clinical investigation of a drug, biological product, or medical device,
involving human volunteers.
It contains the following:
 Guidelines regarding qualifications of research study staff
 FDA “Statement of Investigator” form
 Explanation of FDA regulations on Investigational devices