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jparsons
02-09-2010, 04:45 AM
Hi there,

Last fall, I sent out the following message:



Good morning,

I am a PhD student doing research into jump landing biomechanics and ACL
injury. I was wondering how other researchers doing ACL work have addressed
the ethical issues of re-creating the ACL injury mechanism during their
studies. Has anyone had an injury occur during testing? What types of
safeguards do you put in place when testing potentially injurious movements?

Any suggestions or comments would be greatly appreciated!
Below is a summary of the responses that I received. Thank you to everyone who contributed - I received only one email documenting an ACL injury during testing.

Sorry for the delay in sending the results...the busy life of a grad student....!





Joanne Parsons
MSc, BMR(PT), CAT(C)
Physiotherapist
University of Manitoba
Winnipeg, Manitoba, Canada



1. First, apply the concept of "do no harm"
Second, examine your experimental design and determine if you can test your hypothesis in a way that doesn't put the participant at risk.
Your institutional review board for research involving human subjects
most likely provides specifics regarding the risk-benefit relationship
in experimental studies involving human subjects.


2. We haven't done a lot of this, but in the three or four studies we've
conducted the biggest thing was that we kept the drop heights relatively
low. We had people dropping on a sledge in most cases, but
did one where they dropped from the ceiling onto one or two legs.

I guess our main way of insuring safety was to keep the load low, by keeping the drop low.


3. I also do research into jump landing biomechanics and acl injury. Our
studies are approved through IRB because while jump landing is a risky
maneuver for ACL injury, the percentage of landings that actually result in
injury are very, very low. It is considered a not-high risk activity because
so few landings actually result in a tear. I do not know how many people
have ever had an injury during testing, but I believe the numbers are
extremely low. Our lab has never had it happen before.

4. Just came across your email and thought you would be interested as back in the mid 1980's I had a subject rupture her ACL during one of my studies She was performing a typical netball movement (ie accelerating forward to catch a ball, to then stride out and land on one leg before stopping and throwing the ball to another player) as we were examining the effects of different footwear on landing mechanics in netball. We have used this movement pattern in numerous other studies for over 25 years and only ever had the one person actually rupture a ligament. If you really want to understand the demands of sporting movements, you need to ask subjects to perform movements that replicate those that they do in the actual sport.

The movement pattern has been accepted by our Human Research Ethics Committee as it is a typical sports movement performed on a very regular basis by many, many sports people. However, the initial rupture incident reinforced to us the need to have all appropriate safeguards in place BEFORE a study starts. ie make sure you have all proper ethics approval, obtain all the necessary informed consent from your subjects, conduct a participant screening relevant to your study, make sure your subjects undertake a warm up, complete a full risk assessment (including an emergency procedure should an incident happen) etc. We also have appropriate first aid/medical back up. When my subject ruptured her ACL we had a sports physician over-seeing the study and he was able to provide immediate medical assistance (and then we followed up to make sure the subject was okay etc). I was extremely relieved that we had followed all correct procedures!

5. I just finished my dissertation on this very subject.
None of my participants suffered injuries, but it is a risk that you
have to address to the IRB and in the Informed Consent document. My
protocol called for stretching and warmup exercises before participating
in the drop and cut maneuvers for my study. My participants did drop
jumps from a platform set at their maximum jump height (measured from
countermovement jumps with a Vertec). I know some studies have examined jumps from as high as 2 meters, but I never saw anywhere close to 1 meter (average height was about 35 cm).

6. I am a PhD student conducting research in ACL
injury. I have designed and received ethical approval on a number of studies utilising what could be termed high risk movements for ACL injury but the important thing to remember is that athletes perform these movements 9/10 times without any injury. I would say it is important to state that you are not trying to recreate a situation where they subjects may get injured but actually
recreating high intensity situations that athletes perform numerous
times in games without any risk. I have approved a study utilising a
drop-jump followed by a cut maneuver and have received approval to
perform this on previously injured ACL subjects, so I don't foresee that
you will have any issues, especially given the wealth of literature
utilising these cutting and landing maneuvers.


7. I have just completed a data collection of over 125 males conduction side steps (non-contact ACL injury mech) at 5 ms, without a single injury to report.

During all sport testing procedures, there is always risk of injury, but feel risk of injury during game situations is much greater as lab conditions are controlled environments. I feel that if the athlete is aware of the risks involved and is familiar with the sport task you are testing, ethical considerations are met in full.





8. As far as ethics is concerned I would never test a movement or skill that the athlete is not already using in their regular training or competition. If it is just movement replication in the lab, then the risks are no greater than what is occurring in their everyday life. I often have a tough job on this front as I often work with elite gymnasts so I don't want to lose the trust of their coach or injure a gymnast. So I either test at their training centre so that I now it is as safe as possible, or I replicate the gym in the lab. For general athletes it is a good idea to have a trainer or someone with similar skills available, if they do get injured.


9. As far as I know, nobody tried to create injuries in those studies,
which I think will not be approved by IRB. We only asked subjects to do
those movements in which ACL injuries frequently occur. The risk for
injury is no greater than that subjects have in their regular sports or
exercise activities. We do not have any safeguards in testing.


10. I just read your e-mail with some interest, and hope
that the following information will be of a help to you.

One of my graduate students completed a thesis on basketball rebounding in children (aged 8-10 yrs) with the aim of examining sex-related differences in movement and landing patterns. We were concerned about the potential for injury, but satisfied the ethics committees concerns by appropriately indicating that the
children (who were all registered in city basketball programs) were simply performing the same movement pattern as they would during their regular basketball activities. Hence, our experiment was of no greater risk to them than their engagement in the sport of basketball.

Second, as for whether or not anyone has ever had an injury occur during
testing, I did hear a presentation by Julie Cowling from Australia (see the
link below for an abstract of one of her papers form PubMed) at a conference I attended. As I recall, she and her colleagues captured via fluoroscopy an ACL rupture in an elite Australian netball player.

http://www.ncbi.nlm.nih.gov/pubmed/11205856?ordinalpos=3&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsP anel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum


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