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Submissions :: Protocol review process :: Special issues

Special Issues for Protocol Review

What if I don't agree with the Board's recommendations?

The Board strives to make recommendations that will ultimately protect participants, but they do not want to compromise the research process either. The protocol process is not always perfect; although the Board is very diligent in trying to understand the study, sometimes details get lost in translation.  If you are concerned about a recommendation made by the Board, first, talk to your pre-reviewer.  He or she may be able to help you better understand what the Board is asking and help you determine if the Board’s request has any flexibility.  Second, if the recommendation for your protocol still needs to be altered, devise alternative solutions to present to the Board.  Generally the Board’s underlying concern behind their recommendation is the most important part to satisfy.  For example, if the Board recommended that you make a change in your data collection process because they felt like the proposed process would compromise the participant’s confidentiality, but you find that the recommendation actually doesn’t protect participants or makes it impossible for you to collect the data, you should re-evaluate your data collection process and propose a solution that will improve your ability to protect participant confidentiality while maintaining your data collection. In most cases, the Board may be willing to consider alternative solutions if the underlying goal is met.  However, if you refuse to consider the concerns of the Board or decide that their recommendations are inconvenient, the Board will be less willing to work with you. Please know that the Board is bound by the federal regulations which determine how the Board makes its decisions; the Board cannot approve measures which violate the regulations that they follow.

Data collected without intention to conduct research

The IRB regulations require that researcher obtain IRB approval/ exemption prior to collecting any data.  The Board cannot retroactively approve the collection of data that falls under our definition of research.  However, the regulations recognize that there are instances where data is collected without the intention to conduct human subjects research and this data could prove to be valuable information in a later study.  For example, information collected in a pilot study to test the feasibility of conducting a full study may be viable data to include in the full study.  A pilot study doesn’t necessarily qualify as “research” according the IRB regulations.  The same could be true for a class project where data was collected for a brief paper submitted to a professor, but later provided necessary information for a full dissertation or thesis project.  This should not be considered a loophole for avoiding IRB review, however.  In order to approve the use of this data, the IRB will review the collection of the data and hold it to the same standards required for any collection of data.  If the IRB finds that the data was not collected according to our ethical guidelines and regulations, the Board will not allow that the data be used. For example, if you collect sensitive information that can be linked to an individual but the participant did not consent to the collection of this data, the Board may not approve the use of this data because of the manner in which it was collected. In order to avoid this scenario, we recommend that you contact our office for further guidance regarding data collection.  Depending on the project, we may advise that you submit a protocol for a pilot study or class project, which will help you avoid any question about the viability of your data.  If you don’t need to submit a protocol at this time, we can provide suggestions and recommendations for collecting your data so that it can be approved at a later date if you decide to use it. 

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