Sunday, October 25, 2009
I agree with Annette that we should avoid the word "injury" in the informed consent documents. I would have preferred to leave this out altogether, since we have never included a statement like this in the past. But in thinking through potential scenarios, however, I imagine that someone could fall down and get injured while using the system, especially since we are occluding subjects' hearing and vision. Apart from IRB considerations, what are the real risks here? What if someone does crash into a wall or trip over something and fall? Gene, given your experience with this kind of instruction, and based on what you imagine will happen in the testing, is there a real risk of people getting injured, and is this risk greater than what would be encountered in standard O&M training? What special training or precautions should we be taking? While I don't want to raise any red flags that could interfere with our IRB certification, I also don't want to do anything that could be construed later as reflecting a failure to adequately protect our subjects or users of any commercial products that come out of this research.
One precaution that I think we should consider is to allow the test administrator to speak directly to the subject via the wireless headphones. While this will not work for d/b subjects, it could be a good way to intervene in the case that a subject is veering widely and is heading for a crash. The administrator could wear a headset with a microphone, and then we would mix his voice prompts with the system-produced feedback in the computer. Ultimately, I am hoping that the commercial WiiCane project will not include any occlusion of remaining vision or hearing. I understand why it is needed from the experimental design perspective, but I am not sure that this is a requirement from the pedagogical perspective. While we want to add to the literature by developing experiments that are comparable to those carried out by other researchers (e.g., Guth), our ultimate goal is to produce a practical training apparatus for teaching cane travel techniques, so we have to satisfy both of those cases.
I would like to go forward and resubmit the two informed consent documents in their latest form. Let's see what the IRB does; if they are comfortable with this, then we can proceed. But I want to go on record as saying that we will need to be highly vigilant at the test sites. If we are occluding hearing and remaining vision in children and then asking them to walk around, we have to be absolutely sure that we are not placing them in a dangerous situation, regardless of who actually has to pay in the event that one of them gets injured. Our goal is to test a practical teaching system, and we should be less concerned about the absolute purity of our experimental design. I think that this is a very important issue, and while we are addressing it very late in the day, I believe that this is a subject that requires further consideration and discussion before any testing can take place.
I would be grateful for any and all comments on this subject.