PLS 595 JOURNAL ENTRY 12

IRB Review Discussion

Hi Heather,
I went online last night after meeting with Kevin and found what you were referring to. (See the meeting notes from 10/8.) First, I want you to know that I appreciated your bringing this matter to my attention again. It actually helped solidify my understanding of IRB review. Second, I went through most everything and then wrote my summary of the issue with my preliminary findings, which you should have already gotten on the basecamp and by e-mail. Like you, I was led to believe by the information provided that IRB submission was almost a given.

However, my faculty supervisor, Dr. Imperial, reassures me that based on his long experience with IRBs and the regulations about review, there will be no compelling reason to submit the design for approval to the UNCW IRB. Since I trust his word, I believe that we can safely forego submission. The primary reason for this decision is that the data collected will belong to the Center, an independent third party who is the sponsor of the investigation. The data will be used for third party research. Third party collected data is simply exempt from the IRB oversight. Only if federal money were involved, which it is not, would the Center be required by federal law to submit a protocol for NIH-approved review. Hope that clears things up for you.

Were I to submit the evaluation to the UNCW IRB, Imperial informs me they would more than likely assert their authority over us needlessly, but ONLY because I submitted it. That would complicate matters immensely as you know. Unless another faculty member recommends otherwise, I believe we should avoid such a needless delay. I will wait on your response. Thanks again for the attention to detail.


Heather Sandala replied…

Chris,
Whether you choose to submit is your decision. But, as you pointed out in the original email that you sent last night, “All research projects involving human subjects must be approved by the IRB” and “Researchers may NOT make their own determination as to the appropriate type of review. Only the IRB Chair or designate, can determine which type of review is applicable.”

The material provided by the University concerning IRB review is quite ambigious and leaves much to interpertation. Much of my confusion in this matter stems from a lack of understanding of your research purpose and design. I am not an expert on IRB policy and procedure. Having gone through the process of submission and clearence I felt compleled to voice my concerns.

Good luck in moving forward in the project.

Heather Sandala