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IRB Protocol Review FAQs

What is an IRB?

An Institutional Review Board (IRB) is a committee within the University that reviews research proposals that use human subjects as participants in research. The Institutional Review Board reviews medically non-invasive proposals to determine if the research project follows the ethical principles for the protection of human subjects as required by federal and University regulations. The IRB has the authority to approve, disapprove, or require modifications of these projects.

How do I know if my project needs IRB review?

All proposed research that involves the use of human subjects requires review and approval by the IRB prior to the initiation of the research. Human subjects research is research that meets both the definition of research and involves human subjects as defined in the federal regulations. Research means a "systematic investigation, including research development, testing and
evaluation, designed to develop or contribute to generalizable knowledge.The definition of a human subject is "a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.If you have questions about whether your study needs to be reviewed e-mail or call the Office of Grants and Sponsored Research.

How do I submit my research for review by the IRB?

Complete the IRB review protocol form found on the "Forms" page of the CCU website, or from the Office of Research Services website under "Forms." Follow the instructions on the form and guidance document. Submit the form and appropriate attachments to the grants office. NOTE: You must submit a final version of all questionnaires, interview protocols, etc.
including the informed consent form(s).

If I know my project meets the exempt regulations, do I still have to submit an application for IRB review?

Yes! Only the IRB can determine whether a proposal is eligible for exempt status. EXEMPT DOES NOT MEAN THAT IRB REVIEW IS NOT REQUIRED.

How long will it take for my proposal to be reviewed?

It depends on the nature of the study and the level of risk to research participants. The times given below are averages for studies that are not given restrictions by the board or require additional information. Studies that are given restrictions or require additional information will take an additional amount of time depending on how fast these restrictions are met or additional information provided.

Exempt Review - 5 to 10 working days.

Expedited Review - two weeks.

Full-Board Review - 5 days following the monthly board meeting.

NOTE: The IRB does not meet during the summer.

How will I know if my project is approved?

Investigators will receive e-mail notification of approval followed by a letter sent by mail.

What do I do with the IRB date-stamped consent information?

Copies of the current, dated documents are the only versions that may be used by investigators when obtaining consent. Investigators should make copies of the stamped version returned to them by the IRB at the time of study approval or reapproval.

What do I do with the signed informed consent documents?

The principal investigator is required by University and federal regulations to maintain records of all correspondence, relating to the use of human subjects in research. Copies of the application, research progress reports, notices of approval and signed Informed Consent Documents must be maintained in the investigator's records. Copies of these research records must be retained for three years after the close of the study and are subject to inspection by federal authorities and the IRB.

Do I need to complete training on protections of human subjects before starting my work?

Yes. Investigators and all other key personnel are required to complete:

CITI TRAINING (click on the link to enter the site)

Online training will be required certification for all CCU faculty, students and staff participating in research and sponsored programs/projects by the fall of 2009. These modules need only be completed once and you must provide a copy of the certification of completion to the IRB. When finished with the training, be sure to print out the certificate of completion.

What if I want to make a minor change in the study (add or remove a question from a survey, add a second focus group, or put an advertisement in the newspaper to recruit more participants) do I need to do anything?

All modifications to human subjects research must be reviewed and approved PRIOR TO IMPLEMENTATION. The investigator should request modifications by submitting a request to the Office of Research Services.

What if my funding changes?

Investigators are required to keep the IRB informed about any changes in funding.

Do I need to notify the IRB when my project is finished?

Yes. When your project is completed you will need to submit a final report.

What are some links where I might find guidance and training?

THE BELMONT REPORT


45 CFR 46 PROTECTION OF HUMAN SUBJECTS


PROTOCOL EXEMPT FROM IRB REVIEW


RESEARCH THAT MAY BE REVIEWED THROUGH AN EXPEDITED PROCEDURE


Protecting Human Subject Participants 
(click on link to enter the site, register, and take the course)


Online training from OHRP is required certification for all CCU faculty, students and staff participating in research and sponsored programs/projects. These modules need only be completed once.