IRB

Institutional Review Board

             All research that involves human subjects must be submitted for Institutional Review Board.  This process ensures that research is undertaken in a responsible, careful and nonhazardous manner. 

            Research is defined as ’Äúa systematic investigation, including research and development, testing and evaluation, designed to develop or contribute to generalizable knowledge.’Äù

            Through review of research proposals IRBs are able to establish the risks and benefits of the research and if the recruitment, consent, potential risks and procedures for minimizing any potential risks is acceptable.  In addition, the board weighs the importance of the knowledge to be gained against the risks to the human subjects.  This process insures that all research is legal and ethical.

            There are three levels of review: exempt, expedited, and full review.  The review of our project fell under the expedited category because:

  • All research activities presented no risk to human subjects
  • Research involved the study of existing data, documents and records, that had been collected solely for nonresearch purposes.
  • The sources of these existing information was recorded in such a manner that subjects cannot be identified.

 Important in understanding IRB approval is calculating risk and benefits to human subjects.  In our study, there were no risks to the subjects studied, every effort was made to keep material confidential and to remove patient identifiers.  Although there were no direct benefits in our study, a list of all patients not up to date on immunizations will be extracted from the updated database and these patients will be outreached by a adolescent care nurse.

 

[Home] [MMR] [Hep B] [Td] [Diptheria] [Varicella] [Schedule] [Links]

This web site was developed by undergraduate students at Brown University as a project for a course in vaccine development (Bio 160). An effort has been made to present information on the prevalent opinions available at this time.  References to published articles and acknowledgements of other sources are cited in the text.  The authors of this web site are not certified medical professionals.  Biomedical research and clinical medicine are constantly evolving fields, thus it is possible that significant advances in research and treatments will come into existence following posting of this web site.