PLS 595 JOURNAL ENTRY 11

I met with Kevin today to discuss the delays. It turns out that the Center’s UNCW intern Heather Sandala has suggested that we submit our evaluation surveys to the UNCW IRB for review. I had planned on just such a submission early in the semester and even put it onto the original timeline. Basically, for any type of investigation involving human subjects, a protocol of the investigation may well need to be submitted for IRB approval. Specifically, any “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge,” that meets certain qualifications must be submitted to an NIH-approved IRB, according to federal law. This is especially true where faculty, grad students and external research are involved, as in this case.

A Human subject is defined as a living individual, about whom an investigator (whether professional or student) conducting research obtains:

1. Data through intervention or interaction with the individual
2. Identifiable private information.

“Systematic investigation” is defined as “a cohesive approach involving data collection (quantitative or qualitative from one or more individuals and analysis to address a question or test a hypothesis.” Certainly, identifiable information will be disclosed in the case of our surveys—at least to the interviewer, if no one else. Thus, at face value, it appears we will have to submit for review no matter what. However, according the Dr. Barth, we may be able to get thing expedited. We will have to jump through some hoops to to that in time, however.

In addition, any person(s) involved in the conduct of such research must complete an online human subject protections training program offered by the National Institutes of health. I, myself, have already taken this training. Since, however, I could not find a record of that fact, I am taking it again. As for the personnel at Carousel Center, I’m not sure that applies to them, but I am looking into that. The link to register for this training module is: http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp.

Unfortunately, the next review submission deadline is November 22, 2006, and the next meeting that our surveys could be considered is December 6. Projects that qualify for exempt review are projects having such a low level of risk to subjects that further IRB oversight is not required with the exception of protocol amendment forms. Amendment forms are required on exempt studies since a change to the study may alter its exempt status. Projects qualifying for expedited review are also minimal risk to subjects, but may involve other aspects that require continuing IRB oversight and annual renewal of protocol approval. A project may require full review for a number of reasons such as the subjects belonging to a potentially vulnerable population or a higher degree of risk to subjects. 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.

I will get back to Kevin later this week about the final call on this, but I think it is a given that some kind of submission is necessary. This is a tad unexpected since I thought that our little study, being anonymous and strictly non-experimental, would fall outside the requirements. That is why I took it out of the original timeline. I look at as just one more hurdle to get over. We shall see what the call will be. Meantime, I also shared with Kevin the SPSS database design and went over the demographics I recommend be collected. There may be some minor adjustments to those. More on that later.