This spiral-bound, 5" x 7.5" book is a collection of recently finalized guidance documents issued by the US Office for Human Subject Protections (OHRP) under the Department of Health and Human Services. It includes nearly 100 Frequently Asked Questions on research, as well as brand new guidances on adverse events and research involving children as subjects.
Who Uses this Book?
Investigators, IRB staff, sponsor staff, and anyone else involved in the conduct of biomedical and behavioral research involving human subjects.
What's the Price?
• 1-249 copies: $15.95 • 250-499 copies: $14.95
• 500-749 copies: $13.95 • 750+ copies: $12.95
Custom Cover Prices*?
• 1-24 copies: unavailable • 25-100 copies: $2.00/book
• 100-249 copies: $1.00/book • 250+ copies: No charge
* Based on quantities of a single book title
• Code of Federal Regulations, 45 CFR Part 46, Protection
of Human Subjects (As of April 1, 2021)
• OHRP Frequently Asked Questions on:
• Assurance Process
• IRB Registration Process
• Protection of Human Subjects
• Research with Children
• Investigator Responsibilities
• Prisoner Research
• Reviewing and Reporting Unanticipated Problems
Involving Risks to Subjects or Others and Adverse
• Continuing Review
• Reporting Incidents to OHRP
• Written IRB Procedures
• Guidance on Children Involved as Subjects
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