/ research of a young resident in ortho!!

nathalie13 Feb 2020

Hi, I am a resident in orthopaedics in love with climbing!  I am doing a research on climbers' pathologies after many years of activity. I need your help, could you fill in and / or spread this easily filling online survey? It is very important for me to collect this data and I would be very grateful to you.

Thanks and have a good time outdoor!

Nathalie

english https://forms.gle/Tq2qJMZcCvrQd3KM7

italiano https://forms.gle/h6MrAEueN1Thg4NLA

français https://forms.gle/bgRXMRmuhp56smBB6

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scott titt 13 Feb 2020
In reply to nathalie:

What about trad grades?

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alx 13 Feb 2020
In reply to nathalie:

 been through research ethics.

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SouthernSteve 13 Feb 2020
In reply to alx:

>  been through research ethics?

There is no notice of institutional ethical review. Nathalie might not get her work published – at least not in a reputable journal!

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nathalie15 Feb 2020
In reply to SouthernSteve:

HI! I know all the rules and the importance of privacy. All the results will be anonymous of course!!

Nathalie 

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tjdodd 15 Feb 2020
In reply to nathalie:

I think you have missed the point.  Your survey as it stands does not meet standard research ethics guidelines.  As a result it is unlikely to get published and is bad research practice.

At the moment the information you provide is insufficient.  As a minimum you need a brief description of the project (I am not convinced what you have is enough).  You should also have a detailed participant information sheet.

The most important thing is that you need a clear statement that the survey has undergone an ethics approval process and meets the guidelines of your institution or professional body.

I am not an expert in this area and others may be able to provide better/more detailed guidance.

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Stuart William 15 Feb 2020
In reply to nathalie:

> HI! I know all the rules and the importance of privacy. All the results will be anonymous of course!!

> Nathalie 

Anonymous apart from the required field for name?
 

What are the limits on rights to withdraw data? Who apart from yourself will have access to the data, particularly names. What is the justification for collecting names if the results are going to be anonymous? How and by who will data be stored and processed? What are my rights under gdpr and are you compliant? Is the research affiliated with any organisation or institution (i guess not as you are using a personal email)? 
 

On a separate note, and entirely out of curiosity, why have you chosen free text fields for questions that are mostly quantitative? Feels like that is just making a headache for yourself when it comes to processing and analysing the data.

I have other questions but that’s a start.  

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Deadeye 15 Feb 2020
In reply to Stuart William:

Jesus folks. Calm down.

Stick initials in, or a false name, or don't take part. Why the feeding frenzy?

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MischaHY 15 Feb 2020
In reply to Deadeye:

Oh, this happens every time anyone posts any kind of survey. All the wankademics come out of their holes to lay down the sacred law of data gathering.

It's almost as potent as admitting to liking grigris. 

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SouthernSteve 15 Feb 2020
In reply to MischaHY:

> Oh, this happens every time anyone posts any kind of survey. All the wankademics come out of their holes to lay down the sacred law of data gathering.

That is disingenuous. Journals regularly have to refuse to publish work because the journal rules state these things must be done - this means people's data is protected. Not doing this can have a bad effect on your career as a scientist.

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Andy Reeve 15 Feb 2020
In reply to MischaHY:

> All the wankademics come out of their holes to lay down the sacred law of data gathering.

This seems like an unusually hostile response from someone who values the research base for training information

Southern Steve mostly beat me to it, but to go a bit further than what he said, for me the most important problem with not adhering to the full ethical standards is the risk of 'science' losing credibility with the public. When I was conducting my research (with people, not materials, for clarity) I was really aware of the time that they were giving me - it would be disrespectful if I were to not fully protect their rights by having had my research ethics reviewed by an independent board and taken every reasonable measure to protect their anonymity. 'Science' - despite being the best method we have developed to find out answers to most problems - is clearly lost on some people, hence the rise of anti-vaxers, climate-change deniers, alternative medicine, having had enough of experts etc.. The last thing that science needs is to revert back to the bad old days when research participants' rights were rode over roughshod, both because of the moral duty and the importance of maintaining scientific credibility. I think that's why academics hold the basic principles of ethical data gathering sacred and criticise research which does not do so.

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MischaHY 15 Feb 2020
In reply to Andy Reeve:

Don't worry Andy, I'm currently halfway to Seynes with a rotten cold after a whole winter of health. As such I am very hostile towards just about everything. 

I'm sure the situation will improve. 

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Andy Reeve 15 Feb 2020
In reply to MischaHY:

Rubbish timing! Recover quick and have a good trip  

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alx 15 Feb 2020
In reply to nathalie:

Also who is funding your research and what is your open access to data policy for transparency?

😂😂😂

Post edited at 12:08
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Stuart William 15 Feb 2020
In reply to Deadeye:

Partly because whatever the research purpose, basic ethics and data protection law are things they will want to think about. If this is for publication or academic assignments it will be immediately thrown out and a waste of everyone’s time. Particularly when you are asking for identifiable health information.

Partly because research often relies on the goodwill of potential participants, and research that possibly doesn’t even meet basic legal data protection requirements erodes that goodwill.

The OPs vague earlier reply of “I know the rules” would be perhaps understandable from an undergrad, although still poor and alarmingly flippant. From a doctor it’s really quite shameful.

Participants shouldn’t have to guess at the safety of their data or falsify information to maintain their privacy. 

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SteveX 15 Feb 2020
In reply to MischaHY:

> Oh, this happens every time anyone posts any kind of survey. All the wankademics come out of their holes to lay down the sacred law of data gathering.

> It's almost as potent as admitting to liking grigris. 

Any academic should be well aware of the etiquette of forums and the internet and of collecting surveys. 

Just the wording of the OP is rubbish, ie "It is very important for me to collect ". 

Its very basic undergrad stuff to know all this.

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wintertree 15 Feb 2020
In reply to Deadeye:

> Jesus folks. Calm down.

> Stick initials in, or a false name, or don't take part. Why the feeding frenzy?

They are trying to save the OP from wasting their time and others on an activity that will be unpublishable - it’s intended purpose one reasonably imagines - due to the data gathering not meeting the basic requirements of the field.

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Deadeye 15 Feb 2020
In reply to SouthernSteve:

> That is disingenuous. Journals regularly have to refuse to publish work because the journal rules state these things must be done - this means people's data is protected. Not doing this can have a bad effect on your career as a scientist.


But she's not making a career as a research scientist.  She's a doctor.

I imagine it will satisfy whatever re-validation process is used in ?France and/or may be initial scoping for a more formal study.  Or it might just be interest, or some thoughts about prevention.  GDPR is 90% nonsense as far as I can see.  If you're worried about someone knowing how long you've climbed and what your hands look like, then walk by.

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Andy Reeve 15 Feb 2020
In reply to Deadeye:

> But she's not making a career as a research scientist.  She's a doctor.

I'm not trying to make a career out of being a medic. That doesn't mean that I can start practising medicine and disregard the ethical issues associated with that.

> I imagine it will satisfy whatever re-validation process is used in ?France and/or may be initial scoping for a more formal study.  Or it might just be interest, or some thoughts about prevention. 

I'm not sure what you mean by 're-validation process'. If you are implying that this 'research' is for the purpose of having a qualification revalidated, then the OP should make this clear (this isn't how I interpreted the OP though). If this is just out of interest - idle curiosity - then it should not be dressed up as research. If it is a pilot study to assess the feasibility of running a full trial then it will still be subject to the same ethical checks and procedures, which are apparently lacking in this case.

> GDPR is 90% nonsense as far as I can see.  If you're worried about someone knowing how long you've climbed and what your hands look like, then walk by.

Pragmatic though this may be, this is not how research institutions would view it. I may appear to be being pedantic here, but this stuff matters because it affects the credibility of the research professions. That's not to say that research should be only undertaken by a select few. Indeed, more research by clinicians would likely improve the availability of evidence to inform practice as it would be more closely aligned with what frontline clinicians need to know. However, lowering the standards of ethical practice to facilitate this is wrong-headed.

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Stuart William 15 Feb 2020
In reply to Deadeye:

> But she's not making a career as a research scientist.  She's a doctor.

Yup, and can you think of no reasons why a doctor might be expected to have a decent grasp of confidentiality, informed consent, and the ethics of handling personal information? None of which is evident here.

Medical research is not exempt from research ethics. If anything there are even more hoops to jump through.

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MischaHY 15 Feb 2020
In reply to Andy Reeve:

Cheers Andy. Dumped the stuff in the flat, bought the guidebook and had a good old gander at the crag in the evening light. It'll be reet. Dinosaure looks immense as promised. 

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Andy Reeve 15 Feb 2020
In reply to Stuart William:

> Yup, and can you think of no reasons why a doctor might be expected to have a decent grasp of confidentiality, informed consent, and the ethics of handling personal information? None of which is evident here.

At the risk of appearing to be willy-waving, I've worked in healthcare as a clinician for almost fifteen years and have published research. Yes of course a medical doctor will (hopefully!) understand informed consent, confidentiality, and data security. But it is not enough to solely say 'I understand it because of my position therefore I can do research at will'. All research institutions have much stricter rules governing research than that.

> Medical research is not exempt from research ethics. If anything there are even more hoops to jump through.

This research has not jumped through these hoops. I can tell this for certain because there is not an adequate statement at the start of the research, explicit consent is not sought, there is no contact for the ethics board. Jumping through these hoops is what maintains participant safety, ensures that research is of sufficient quality as to not waste participants' time, and ensures that the general public can trust researchers. All of these are essential requirements for doing health research affiliated with any academic institution. The OP may be collecting data for their own curiosity, but if this is the case then it is disingenuous to call it 'research', and definitely unethical (i.e. I'm sure in the UK doing so would attract the interest of your employer and / or the GMC).

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Stuart William 16 Feb 2020
In reply to Andy Reeve:

I don’t think my post came across as intended! It was meant with a little dose of sarcasm in the first paragraph. Apologies, I thought in context it would come across clearer that I believe the OP is acting unethically both professionally and academically. 

I think that Deadeye saying that the concerns being raised are invalid due to the OP’s profession is claptrap, and that if anything there is even more cause for concern that such a lax approach is being taken by someone who presumably also has access to large databases of health information.

I agree entirely with your post and if found out I was being treated by a clinician who was asking people to send health information to their personal email with no ethical approval, no evidence of data protection considerations, and no attempt at informed consent, then I would be walking out the door and indeed contacting the GMC. I would feel deeply uncomfortable knowing that the same person had access to my health records.

(Edited to remove an erroneous “don’t” which entirely reversed the meaning of para 1)

Post edited at 09:24
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Andy Reeve 16 Feb 2020
In reply to Stuart William:

> I don’t think my post came across as intended! It was meant with a little dose of sarcasm in the first paragraph. Apologies, I thought in context it would come across clearer that I believe the OP is acting unethically both professionally and academically. 

Ah ha! My apologies - the tone of your post is obvious now I re-read it, which makes most of my last post redundant, oops!

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Stuart William 16 Feb 2020
In reply to Andy Reeve:

No worries, I should know better than to assume that tone is self evident in text!

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nathalie16 Feb 2020

Good evening everyone!! I am really sorry that my post generated such reactions!

I'll try to clarify some points:

One of my chief of the hand surgery department asked me to develop the "ageing hand after sport" for a one day course we are organising about "ageing hands". I love climbing so I thought about the ageing hand of climbers!! 

I'm enrolling local climbers and visiting them personally in our medical university hospital but as you can imagine the numbers are not big!! so, he suggested me to organise an online surveys and invite people to send picture ( that's why I asked at least for initials, because if you are so kind to send me picture I need to match the survey with the right picture! ). Of course the data collected personally and through the survey will be analysed differently because the amount and the quality of data collected is different! But it's a way to show my colleagues how many climbers there are than have climbed for years and that despite "ugly" hands can still do most of daily living activities!!

I have participated in the writing of articles that have been published on pubmed, so I perfectly know the standard rules and that's not the purpose of this survey. 

So, again,  no one will see your name on screens, and why should I do that??

I am very sorry for all of that and I really thanks people that will understand the point here: passion and desire to put together climbing and work!!

Nathalie

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alx 16 Feb 2020
In reply to nathalie:

I have participated in the writing of articles that have been published on pubmed, so I perfectly know the standard rules and that's not the purpose of this survey. 

🤣🤣🤣🤣

guess you must of missed the bit about doing research involving human beings. I would recommend you revisit your research standards training, even data only research studies involving people require at a minimum research ethical review.

Could you provide us with the name of research organisation you belong to?

Post edited at 22:10
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Stuart William 16 Feb 2020
In reply to nathalie:

So the rules don’t apply here and you offer no assurances about how you will safeguard personal information other than just saying you aren’t putting it on a screen publicly? Not reassuring.

Why are you using a personal email and not a work one and avoiding disclosing who you work for?

Assuming you are working for an EU organisation, where is your organisation’s privacy statement and how are you collecting consent for data to be processed when it has taken three posts for you to even vaguely say what you are using it for?

Ethics aside, I doubt this data collection even complies with EU law.

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nathalie16 Feb 2020

I really don't understand this "fury". I didn't say I wanted to publish this work. I'm just preparing a presentation about climbing injuries and climbing deformity after years of climbing. I want to observe which are the most common deformity and injuries, I am not gonna gain money, offer you treatment or medications or stole someone informations or training... really I don't understand why you cannot see that as a chat with someone training as a doctor that you meet during a day outdoor that seeing you hands ask you how much do you climb and if you're hands have some problems for that!!

Why I use my email? because the server email of my university in Italy is full of bugs and problems, and deletes email or don't accept wetransfer and other ways of send/receive pictures, that's why! really I don't understand all of that.

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alx 16 Feb 2020
In reply to nathalie:

🤦

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wintertree 16 Feb 2020
In reply to nathalie:

> I really don't understand this "fury"

There are some well explained reasons given up thread, and they are courteous not “furious” - people giving up their free time to try and help you understand.

It doesn’t matter what email address you are using - private or personal - this is a project undertaken in your role as an employee (edit: or student?)  There are - for good reason - laws over the collection and use (“processing” in the English language version of the GDPR) of personal data by a business or other organisation.  Given your role as a medical professional it is extremely discordant that your first post had multiple red flags against these rules, and that you have since doubled down on it.

I think a language issue means people mis interpreted your intention from your first post - “a research” is quite open ended.

I would expect a UK employer’s data controller to blow a fuse if they found an employee soliciting information on a medical condition with personal identifiers and without prior approval by internal ethics, and without a statement on informed consent, and with a statement on a right to withdraw participation, and without identifying the legal entity (your employer) that is collecting and using the data.

In not following appropriate procedure you open yourself up to potentially career ending consequences from your professional ethics body, to serious disciplinary proceedings from your employer or university and to legal proceedings against you.  

Doing this “by the book” is very little extra work and protects your position, as well has developing your ability to function efficiently within a system of professional ethics.p

I’m sure you’ve got plenty of responses to the survey but in my view the most useful information has already been given by posters up thread.

Post edited at 22:58
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tjdodd 16 Feb 2020
In reply to nathalie:

It does not matter if the work will be published or not.  Any research involving humans (even if just answering questions) must undergo an ethics assessment.  This is not a chat, you are formally requesting and gathering data.  I am sure there will be standard procedures in your university.  I would even expect undergraduate student projects of a similar type to undergo full ethics assessment.

You need to talk to your university ethics team as a matter of urgency.  You also need to talk to your university GDPR team urgently as well as currently I think you are in breach of GDPR.

We are giving you this advice as (i) everything you have said up until now is poor research practice; and more importantly (ii) we are trying to help you.  If you are not more careful you are at risk of affecting your professional career.

My strong recommendation is to pull the survey, talk to your university ethics and GDPR teams and then put it up again when it meets the relevant regulations.

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Stuart William 16 Feb 2020
In reply to nathalie:

Because it’s more than just a chat at the crag unfortunately. You are collecting and storing identifiable health information on behalf of an EU organisation. And there are laws and rules around this, regardless of what you want to use it for. 

Post edited at 22:53
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alx 16 Feb 2020
In reply to nathalie:

Hi Nathalie

I noticed your article on pubmed about your research from dissecting human hands lacks it’s ethical review compliance statement as well (in the notes at the bottom).

https://link.springer.com/article/10.1007%2Fs00276-019-02380-y

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nathalie16 Feb 2020

As said from someone, I think that there are lot of misunderstandings here.. first of all the word "research". My intention is to present the data as " my climbers friends", what my chief asked me is a "bibliography" topic (not a scientific research!), that I will write looking at books and published articles etc. I wanted to put an extra "cue" collecting more opinions than the ones I can collect locally... that's why I don't nominate the university, the ethic bureau etc.... 

really I think you took all of that more seriously than it is! Again, I am sorry for the misunderstanding and hope everyone will try to be more comprehensive!

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nathalie16 Feb 2020
In reply to alx:

my chief took care of every aspect! and I can assure that we made everything asked by the editor and the universities involved! do you think they would publish that otherwise? 

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alx 16 Feb 2020
In reply to nathalie:

Putting this mistake to one side. Why no ethical compliance review for dissecting human hands?

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nathalie16 Feb 2020
In reply to alx:

I really don't understand. We of course did everything under ethics law control, as in every research department. you can go at the department and ask all the papers!! it's not a sentence on an abstract that prove that!

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tjdodd 16 Feb 2020
In reply to nathalie:

I think you are misinterpreting what research is.  What you are doing is research.  Research is a very wide term and not just academic research in the narrow definition that I think you have.

Please please talk to your "chief" about what you are doing and seek proper guidance on conducting the work you are doing.

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ben b 17 Feb 2020
In reply to nathalie:

Hi Nathalie,

First, good luck with the symposium - it sounds interesting. 

You are recording identifiable health information and you are therefore required by law to comply with the GDPR for one, as well as the various articles of the Declaration of Helsinki and whichever regulatory version of GCP applies in Italy. If you had done this informally by chatting to climbers at the wall and were not collating results you "might have got away with it" but unfortunately you have a very visible post, globally available, asking health information in an identifiable manner without a consent process or statements regarding how and why the data will be used. Almost all of the above posts are very helpful as to why you just cannot do this.

You are putting yourself at significant risk here. Once you start collecting information you have to follow the very well defined rules. You need a chat with your institution's research office - they are there to help with this kind of work, although I appreciate the wheels turn slowly and it can be highly frustrating. However, doing it right lays an excellent foundation for future research and an academic career if you wish, or just the required professional progress of the orthopaedic training program. I regularly review applications for orthopaedic research and this would be fairly typical of  some of the requests for online surveys, which will one day make it to a poster at a conference or the basis of a research article. Without the required ethical approval you cannot do either of these things - and you can get in to a lot of trouble. 

My recommendation would be to go and talk to the RO. Work out what data you need to collect and why. Make sure you have a secure system to hold that data. Set up ethical approval for the study and get going. Email the mods and ask them to remove this thread, and come back in about 3 months with a link to your study and an informed consent process - you can often do this via SurveyMonkey or similar sites, again your RO can advise.

This won't help with a presentation next month, but for your career it is either this or nothing. Your initial study link looks like you have some good ideas and i'm sure there is valuable descriptive data that can make the basis of an interesting article, you just need to ensure that you aren't wasting your time on work that can never be published and at risk of censure over GDPR. If you had done this in my institution you would have a high chance of never receiving any research funding in the future. So I think this is one of those where it is worth listening to the feedback and trying again in the future.

Best wishes

b

(I am a clinician with academic interests and a joint hospital/university appointment, and sit on a bunch of funding panels locally and nationally; so have some experience of these scenarios) 

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Dave Garnett 17 Feb 2020
In reply to nathalie:

I completed your survey and I'm happy to provide the photographs you asked for.

I'm comfortable doing this because (a) there is very little information involved that I haven't already disclosed openly on this forum (b) I've been a been a research scientist, I regularly contribute far more detailed data to UK BioBank studies and (c) personally, I really can't see what the big deal is with information so anodyne and I'm frankly baffled by the irrational paranoia many Brits seem to have about their medical records (when they seem so keen to make every other part of their lives so public).

That said, there are some wise words about research ethics approval in the previous posts.  In particular, I think you need some more formal and detailed consent process.  

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alx 21:19 Wed
In reply to Dave Garnett:

I to am completely comfortable completing the survey as 1) all the information was made up, 2) I enjoyed putting myself in the position of Diedre the 9C boulder whom can’t hold a biro but can still hold a full glass of sherry.

I’m fairly confident I contributed to over a third of the current responses.

🤣

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