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NIH HRPP SOP 16 v.2 1012013 SOP 16 v.2 10/1/13 508compliant SOP 16. REPORTING REQUIREMENTS FOR UNANTICIPATED PROBLEMS, ADVERSE EVENTS AND PROTOCOL DEVIATIONS TABLE OF CONTENTS 16.1 PURPOSE .

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any unanticipated problems involving risks to subjects or others; any serious or continuing noncompliance with this policy or the requirements or determinations of the IRB; and. any suspension or termination of IRB approval.

Events that occur in studies involving drugs or biologics and are: Probably caused by or associated with study participation; and. Unexpected; and. Immediately life-threatening or severely debilitating to current subjects or others not participating in the study.

Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic or social harm) than was previously known or recognized.

An unanticipated problem involving risks to subjects or others may include any event that was not expected given the nature of the research, the population under study and the approved procedures or protocol for conduct of the study.

Is this an example of an unanticipated problem that requires reporting to the IRB? No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study. A researcher conducts a focus group to learn about attitudes towards hygiene and disease prevention.

Unanticipated problems that are serious adverse events should be reported to the IRB within 1 week of the investigator becoming aware of the event. Any other unanticipated problem should be reported to the IRB within 2 weeks of the investigator becoming aware of the problem.

suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

An unanticipated problem is by definition unexpected, whereas an adverse event may be either expected or unexpected. Unanticipated problems may or may not be adverse events. Adverse events relate to harm to participants; unanticipated problems may involve an increased risk of harm even if no actual harm occurred.

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© Copyright 1997-2025
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232