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Research @ Union

Research @ Union

Institutional Review Board > FAQs

Frequently Asked Questions

All research that involves human subjects must be reviewed and approved by the Institutional Review Board (IRB) prior to initiation.

Q. What ethical principles guide the IRB in the protection of human subjects?

A. Three basic principles of ethics are particularly relevant to the protection of human subjects in research. They are:

Q. What are the components of IRB Review?

A. In reviewing research the IRB gives proper consideration to the following:

The IRB reviews research involving human subjects if one or more of the following apply:

Special consideration is required for research involving fetuses, pregnant or lactating women, human ova in vitro fertilization, prisoners, children, persons with cognitive impairment, or other potentially vulnerable groups.

Q. What is the difference between the three levels of IRB review (minimal, expedited, and full board)?

A. Research in the minimal review category is exempt from applicable federal regulations, although review by the IRB is still required. Minimal review research must be anonymous and at least one of the following:

Research in the expedited category is that which poses no more than minimal risk to the subject involving no more than:

Research which is neither minimal nor expedited requires the full board category of review.

Q. What happens to my protocol after it is submitted to the IRB?

A. The IRB Compliance Officer processes the submitted protocol, inputs necessary information into the database, and assigns the protocol a unique number and determines appropriate level of review. Investigators are notified as soon as possible of the decisions relating to the protocol (i.e., request for revisions or approval).

Q. What kind of timeline should I expect for being able to begin data collection?

A. Remember, no research may begin until IRB has given your research protocol full approval with no revisions. The review process for protocols submitted for minimal or expedited review takes at least two weeks. The review process for protocols submitted for full board review can take up to a month or longer to complete. You should expect at least a few minor revisions. Many of these can be considered by the IRB Chair alone. To speed the review process when revisions are required, please highlight the changes.

A sizable number of protocols at the full board level of review must be returned for revisions. Why? Typically these protocols were not prepared with care, and they require substantial revisions and additions. It is safe to say that the less conscientious the initial preparation, the longer it takes to receive final approval. The IRB cannot approve applications in which critical information is missing or poorly articulated.

Q. The site where I intend to conduct my research has its own IRB. Does my protocol have to be reviewed by the site IRB and the Union University IRB? If so, how do I do this?

A. Some sites of research activity, such as hospitals, community mental health organizations, and other universities, have IRBs to review the research conducted at that site. Each IRB must approve your project prior to implementation. You may submit your protocol for review to both boards simultaneously or to each board consecutively, whichever you prefer. Each board may request different revisions based on interpretations of the federal regulations. Remember that it is your responsibility as the investigator to notify each board of the decisions of the other board. You must also remember to submit any revisions to both boards and you must receive approval from both boards before implementing any aspect of the research.

Q. What about changes in the protocol once it has been approved?

A. All changes in a research protocol must be approved before the change is incorporated into the protocol. These should also be submitted to the IRB in memo form, including the protocol number to speed processing.

Q. What are the responsibilities of the Principal Investigator?

A. The principal investigator is responsible for:

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