Title 21, Part 56 - IRB Flashcards
Definition: Emergency Use
The use of a test article on a human subject in a threatening situation in which no standard acceptable treatment is available, and there is no time to obtain IRB approval
Investigator
Someone who actually conducts a clinicl investigation
Sponsor
A person or other entitity that initiates a cinical investigation, but does not conduct
Sponsor-Investigator
A person who both initiates and conducts a clinical investigation
Who should register their IRB
Each IRB in the Us that reviews clinical investigation regulated by the FDA
How many members make up an IRB
5
-1 member whose primary concerns are in a scientific area
-1 member whose primary concerns are in a non-scientific area
-1 member who is not otherwise affiliated with the institution
-Members should be chosen by DIVERSITY, EXPERIENCE, and EXPERTISE
IRB Functions and Operations
1) for conducting initial and continuing review of research and for reporting findings
2)for determining which projects require review more often than annually
3)for ensuring prompt reporting to the IRB of changes
4)ensuring changes are approved
How does the IRB review research?
The IRB reviews clinical research through ….
- approving studies, requiring modifications in, or disapproving of research activities
-requiring informed consent
-documenting informed consent
-conducting a continuing review of research not less than once a year
How to receive IRB approval
1) risks to subjects are minimized
2) risks to subject are reasonable in relation to the anticiapted benefits
3) selection of subjects is equitable
4) informed consent will be sought and appropriately document
5)(when appropriate) if vulnerable groups are participating, additional safeguards should be placed for them
6) The research plan speaks about the monitoring of data collection
7) Provisions to protect the privacy of subjects and to maintain the confidentiality
Reporting Timeline
When should the Emergency use of a test article be reported and to whom?
Reported to the FDA within FIVE (5) working days
How often do IRB’s get renewed?
Renewal is every THREE (3) years
If a change is being made to an IRB, or in other words, Revising IRB Registration, when should the changes be submitted by?
Any changes should be submitted within NINETY (90) days of the change
IRB Record Retention
Records should be retained for at least THREE (3) years after completion of the research
IRB Registration info must be updated within ____ days after changes occur regarding the contact person who provided the IRB registration OR the IRB chairperson
NINETY (90) days
An institution or organizations decision to disband a registered IRB also must be reported to OHRP in writing within ___ days after permanent cessation of ORBs review of supported research (45cfr46.505)
THIRTY (30) days
IRB should prepare and maintain adequate documentation of IRB activities including…
1) copies of all research proposals reviewed
2) minutes of IRB meetings including voting information
3) records of continuing review activities
4) copies of all correspondence btween the IRB and investigators
5) A list of IRB members identified by name
6) written procedures for the IRB
7) statements of significant new findings provided to subjects
8) the records required by this regulation shall be trained for 3 years after the completion of the resear
