Sunday, October 25, 2009

IRB language

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.

6 comments:

GB said...

Regarding safety during the trials:
The subjects should be monitored by a professional during testing. That is what happens in O&M

Steve said, “Ultimately, I am hoping that the commercial WiiCane project will not include any occlusion of remaining vision or hearing.”

I am incredulous at this statement. Regular O&M training uses occlusion, and as we have discussed many times, vision must be occluded for veering training (if the learner have vision). Hearing also must be occluded to avoid echolocating, or the training is nullified.

I cannot imagine.

In am having a difficult time understanding what you are talking about.

Dona said...

Hi Steve! It's very important to realize that verbal prompting should NOT be used as a safeguard to prevent crashes. All too often, students do not respond to our verbal commands -- O&M specialists know that we can not rely on the student to understand and process our directions, and that it is our responsibility to provide intervention when needed.

You asked a good question about the degree of injury potential. To me, the possibility of injury seems quite remote, and serious injury seems even more remote, unless perhaps the pole and lights fall onto the student, or the student is allowed to wander away from the site and fall down some stairs. Certainly the everyday O&M instruction that we provide is much likely to lead to injury (students get disoriented and don’t realize they are approaching stairs, students are crossing streets and taking buses, etc.)

Nevertheless, nothing is free of all risk, and I think that for the IRB, you need to acknowledge that injury may occur and that you have provided for it by having the monitor intervene if needed for safety. Failure to acknowledge that would probably raise red flags (grin). The student should be alerted that although it is unlikely to happen, the monitor may block their path or otherwise physically intervene if needed for safety.

I cannot imagine how the wiicane (or any feedback system) can be used to improve veering behavior if the vision is not occluded. I may be wrong, but I thought it was well known that walking straight by using visual or physical references does nothing to prepare people to walk straight without those references. Is that not correct? If it is correct, then how can the person improve the veering if those visual and physical references are not removed? Or were you thinking that people might use the wiicane in the dark?

Hmmm – are you thinking that visual occlusion introduces an unacceptable level of risk? No, Steve, trust me – what these kids will be doing is much safer than most things they do in O&M instruction, even with the occlusion. They will be in a very structured environment with close monitoring, which is not always the case in O&M. And we O&M specialists often occlude vision to provide specific training -- I don't know any other way it can be done. I’m sure Gene can help you draft the IRB explaining that this places the child at no more risk than is normal for O&M instruction.

One unrelated topic (thank you for bearing with me this far!). You said that your ultimate goal is to test a practical teaching system. Can you help me understand how a system that requires students to tap the cane can be used as a practical teaching system to our students, most of whom don’t tap the cane? Or are you trying to learn something specific at this stage that can't be learned by measuring arc width without a tap?

Thanks!

ting said...

I agree that our wii cane testing environment will actually be less hazardous than typical O&M training. The controlled environment, close monitoring, open space.....other than the equipment somehow falling on top of the kid, can't imagine what else could happen. As the subject is moving along the course, it would be a nice extra precaution to monitor the subject within a few feet away so as to be able to jump in for emergency protection if need be.

Regarding using the wii cane system as a practical teaching tool, I got the impression from our last meeting that as of now, the technology is good enough to track cane tapping movements. However, once the basic foundation of this technology is nailed solid, we (or rather, Steve and Zach) can make the system more sophisticated to give feedback on constant contact, which would indeed make this a practical teaching tool.

sl said...

Wow, that's quite a bit to digest. Thanks Gene, Ting and Dona for shedding light on this issue. It's really very revealing and interesting, and I hope that a lively discussion ensues. This is why I want to have the blog, because it leads to ideation (and controversy. This is a very important part of the development cycle (in the model for product development I am imagining), where we create a "thought trail". We will go back later and refer to this when we produce publications based on this work, and other researchers may be interested now or in the future.

It is clear to me now that you explain it why visual occlusion is necessary, and probably auditory also. I will revise my thinking about this subject. Dona is correct that a qualified instructor or other professional will be present for all testing during the Phase 2 project, so that means that there is no greater danger here than in any other O&M instructional activity. On the other hand, we should be good corporate citizens. Potentially, wiiCane set ups could be created in settings that we can't control. The TTT is a benign product that no one has ever gotten hurt using. But, I have no experience selling a product that people use as they walk around, and so I am trying to learn about this subject, but I am being cautious until I feel more secure about all of the legal issues, of which there may be none.

I guess the answer is to include careful disclaimers that go out with the product, saying that it is only meant to be used in the presence of a COMS. But, it might be fun if you were a teenager and drunk to put on the sleepshade and try walking; I think that wiiCane is going to seriously fun, and we are going to have the next Rock Star video game on our hands. Sighted kids everywhere will be learning expert cane skills, and then we will find that they prefer cane travel...

Anyway...thanks again for your vociferous commentary and careful and persuasive argumentation. I hope that my cluelessness about a subject that people are passionate about.
steve

sl said...

Wow, that's quite a bit to digest. Thanks Gene, Ting and Dona for shedding light on this issue. It's really very revealing and interesting, and I hope that a lively discussion ensues. This is why I want to have the blog, because it leads to ideation (and controversy. This is a very important part of the development cycle (in the model for product development I am imagining), where we create a "thought trail". We will go back later and refer to this when we produce publications based on this work, and other researchers may be interested now or in the future.

It is clear to me now that you explain it why visual occlusion is necessary, and probably auditory also. I will revise my thinking about this subject. Dona is correct that a qualified instructor or other professional will be present for all testing during the Phase 2 project, so that means that there is no greater danger here than in any other O&M instructional activity. On the other hand, we should be good corporate citizens. Potentially, wiiCane set ups could be created in settings that we can't control. The TTT is a benign product that no one has ever gotten hurt using. But, I have no experience selling a product that people use as they walk around, and so I am trying to learn about this subject, but I am being cautious until I feel more secure about all of the legal issues, of which there may be none.

I guess the answer is to include careful disclaimers that go out with the product, saying that it is only meant to be used under direction of a COMS. But, it might be tempting if you were a teenager and drunk to put on the sleepshade and try walking on your own; what if wiiCane turns out to be seriously fun? Will we have the next Rock Star video game on our hands? Sighted kids everywhere will be learning expert cane skills, and then we will find that they prefer cane travel...

Anyway...thanks for your vociferous commentary and careful and persuasive argumentation. Please forgive my cluelessness about a subject that people are passionate about.
steve

Bonnie DB said...

I agree with Dona's comments:
1. COMS need to provide intervention as needed as we cannot rely on verbal directions to prevent injury.
2. As COMS, we work with students in environments with a much greater potential for bodily injury than the environment being used in this study.

I'm glad to see Ting's comment reminding us that after the basic foundation for tapping movements is finalized and tested, then system will be developed to give feedback on constant contact.

I am pondering Steve's idea stating in a product disclaimer that the Wii cane is meant to be used under the presence of a COMS. I think this is on the right track.