Data collection without irb approval

  • Can you do a survey without IRB approval?

    If the project does not include any interaction or intervention with human subjects or include any access to identifiable private information, then the project does not require IRB review..

  • What happens if you collect data without IRB approval?

    Under 45 CFR 46.103, the IRB must review and approve all non-exempt human subject research.
    Failure to obtain IRB approval before conducting research could result in the researcher being unable to use data and other information collected through the research process..

  • What research does not need IRB approval?

    If the project does not include any interaction or intervention with human subjects or include any access to identifiable private information, then the project does not require IRB review..

  • Which method of data collection would not require IRB approval?

    Publicly available data do not require IRB review.
    Examples: census data, labor statistics..

  • Other types of secondary data analyses do meet the definition of human subjects research and must be submitted to the IRB for either an Exempt determination, or IRB review (either Expedited or Full Board).
    Secondary data analysis requires IRB review when the data is identifiable.
Jul 14, 2015Data collected for research purposes without prior IRB review and approval may be subject to review and discussion by the IRB at a convened 
Examples of Studies that Generally Do Not Require IRB Review Data collected for internal departmental or administrative purposes, such as teaching evaluations, student performance data, etc. Activities designed solely for quality improvement or evaluation of a program, course, etc.

Do I need IRB approval for research involving human subjects?

Collection and storage of data and/or biospecimens for future research uses and/or distribution (i.e., rather than using data/biospecimens only for pre-defined analyses as described in a specific IRB-approved protocol) are activities that meet the definition of “research involving human subjects;” and IRB review and approval is required (see .

,

Does research involving unidentified tissue specimens require IRB review?

Research testing the safety and effectiveness of an In Vitro Diagnostic (IVD) device using human tissue specimens (identifiable or unidentifiable) requires IRB review per FDA 21 CFR Parts 50 and 56, even though under DHHS regulations research involving unidentified tissue specimens would not be considered human subjects research.

,

Is a retrospective study a remit of an IRB?

As it is not research, it does not fall under the remit of an IRB.
Sometimes the data collected during this process evaluation look publishable.
You might be able to publish them straight up, sometimes a journal will ask for IRB approval.
In this case an IRB might grant you approval for a retrospective study.

,

What is the purpose of an IRB?

The main purpose of an IRB is to protect human research subjects.
If you are doing research, even a seemingly harmless questionnaire needs approval.
If you are not doing research, you can give humans that same questionnaire (and a lot worse).
IRBs do not have a role in the use of humans in improving "process".


Categories

Data logger without lithium battery
Data collection who
Data acquisition that
What are the major components used for data acquisition
Data acquisition in farsi
How much does data actually cost
Data acquisition
Data acquisition background
Database acquisition
Data-independent acquisition-based swath-ms for quantitative proteomics a tutorial
Matlab data acquisition background
First databank acquisition
Ballistic data acquisition system
Basic data acquisition using labview
Battery data acquisition systems
Based data acquisition system
Data acquisition camera
Data acquisition campaign
Data acquisition cart
Data acquisition card labview