VA Whistleblower

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DynamicDidactic

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At this point it is one person making an accusation. We do not know the whole story and this is a, well, unusual population.

From my experiences at the VA, many high-risk veterans do not show up for appointments and refuse services. There are steps we can take to encourage them to come into treatment and also inform the suicide coordinator if they are very high-risk, but ultimately we have no control.
 
At this point it is one person making an accusation. We do not know the whole story and this is a, well, unusual population.
the person being

Dr. Steven S. Coughlin, a former principal investigator at the VA’s Office of Public Health, i

Coughlin, who helped write the ethics guidelines for the American College of Epidemiology,

its not like its Bob the janitor.
 
From my experiences at the VA, many high-risk veterans do not show up for appointments and refuse services. There are steps we can take to encourage them to come into treatment and also inform the suicide coordinator if they are very high-risk, but ultimately we have no control.
I think two different issues are being conflated here. As far as ethical research goes, if someone reports suicidal thoughts or behaviors it is the responsibility of the researcher to provide information about mental health treatment.

It has nothing to do with peculiar populations. I understand that particularly chronic conditions make things generally more difficult but if someone, for example, endorses a 2 or 3 on the BDI suicidality item its a clear cut case - You Need To Do SOMETHING. I believe most IRBs have this requirement nowadays.
 
the person being





its not like its Bob the janitor.

Right. He is an epidemiologist. Not Bob the Janitor but also not Joe: master of clinical judgment and assessment of suicidality. My point is was we do not know the whole story. My experience has been that the VA is hypersensitive to suicide risk, sometimes to a fault. This includes large scale research studies as well.
 
Right. He is an epidemiologist. Not Bob the Janitor but also not Joe: master of clinical judgment and assessment of suicidality. My point is was we do not know the whole story. My experience has been that the VA is hypersensitive to suicide risk, sometimes to a fault. This includes large scale research studies as well.

Do you have to be master of clinical judgement to know that if someone endorses an item 'I would like to kill myself.' as part of a research study that there should be some follow-up ?
 
Do you have to be master of clinical judgement to know that if someone endorses an item 'I would like to kill myself.' as part of a research study that there should be some follow-up ?

Agreed, but do you have knowledge that that is actually what was asked as part of the research? I do not. Just pointing out that we shouldn't just jump to conclusions. Things typically are not as clear cut as they may seem. I am not saying that there was no wrong doing, just that it may be less obvious than people are assuming.
 
Agreed, but do you have knowledge that that is actually what was asked as part of the research? I do not. Just pointing out that we shouldn't just jump to conclusions. Things typically are not as clear cut as they may seem. I am not saying that there was no wrong doing, just that it may be less obvious than people are assuming.

Yes. From the article: "One-third of those veterans responded to a 16-page survey about their health status and about 10 percent said they were suicidal. The majority never received a follow-up call ..." That seems pretty clear-cut.
 
Yes. From the article: "One-third of those veterans responded to a 16-page survey about their health status and about 10 percent said they were suicidal. The majority never received a follow-up call ..." That seems pretty clear-cut.

Not at all clear cut. You do not know the informed consent that was included, you don't know the scope of the study, and you are missing a lot of info about this. You also have no idea what was actually asked as you only a second hand report and are making an assumption that it asked about current suicidal thoughts. We just don’t know the extent of wrongdoing at this time.
 
Not at all clear cut. You do not know the informed consent that was included, you don't know the scope of the study, and you are missing a lot of info about this. You also have no idea what was actually asked as you only a second hand report and are making an assumption that it asked about current suicidal thoughts. We just don’t know the extent of wrongdoing at this time.

Another report stated the vets reported they would be "better off dead" -- this sounds like language from the PHQ-9, which asks about symptoms from the past 2 weeks. You are right that the crucial issue here is whether they were assessing present suicidality, but from what has come out so far it really seems like they were. I'm not sure how informed consent is relevant? Are you suggesting that putting certain language in informed consent can allow researchers to abstain from following-up on subjects w/current suicidality, esp beyond passive ideation?
 
Another report stated the vets reported they would be "better off dead" -- this sounds like language from the PHQ-9, which asks about symptoms from the past 2 weeks. You are right that the crucial issue here is whether they were assessing present suicidality, but from what has come out so far it really seems like they were. I'm not sure how informed consent is relevant? Are you suggesting that putting certain language in informed consent can allow researchers to abstain from following-up on subjects w/current suicidality, esp beyond passive ideation?

It appears to be a relatively large, survey based, epidemiological study and it may have been logistically near impossible to follow-up for a variety of reasons although mostly funding related (which is the real world like it or not). Informed consent could be relevant by provided information that follow-up would not occur and could provide contact information, hotline numbers, emergency clinic locations, other options on what to do etc.... for individuals who were in emotional distress. The researcher surely agreed to some protocol for this prior to starting the study, but apparently changed his mind. The IRB would have had to be okay with the protocol. So why did he change his mind? Like I said earlier, we do not know the whole story. I am not claiming to know the story, only that I have little information and can think of scenarios where this may not be as egregious as it sounds from the media.

If it was logistically impossible to follow up with everyone that screened positive for potential suicidal ideation, would you recommend simply not studying the population or would you accept a protocol that may not be perfect work acceptable, but within reason given available resources?
 
It appears to be a relatively large, survey based, epidemiological study and it may have been logistically near impossible to follow-up for a variety of reasons although mostly funding related (which is the real world like it or not). Informed consent could be relevant by provided information that follow-up would not occur and could provide contact information, hotline numbers, emergency clinic locations, other options on what to do etc.... for individuals who were in emotional distress. The researcher surely agreed to some protocol for this prior to starting the study, but apparently changed his mind. The IRB would have had to be okay with the protocol. So why did he change his mind? Like I said earlier, we do not know the whole story. I am not claiming to know the story, only that I have little information and can think of scenarios where this may not be as egregious as it sounds from the media.

If it was logistically impossible to follow up with everyone that screened positive for potential suicidal ideation, would you recommend simply not studying the population or would you accept a protocol that may not be perfect work acceptable, but within reason given available resources?

I have trouble believing that it would be "logistically impossible." I mean, perhaps if the PI was willing to stay at work later than 4pm and make a few phone calls... Also, has the VA not heard of a DSMB?
 
I have trouble believing that it would be "logistically impossible." I mean, perhaps if the PI was willing to stay at work later than 4pm and make a few phone calls... Also, has the VA not heard of a DSMB?

I agree that 1300 follow-up calls is not logistically impossible--they did end up making them, right? Of course it requires resources and investigators don't have unlimited funding, but if suicidal behavior is of scientific interest then follow-up should be a built in cost. I know it's easier said than done, but it's important enough that researchers should hold fast.
 
I agree that 1300 follow-up calls is not logistically impossible--they did end up making them, right? Of course it requires resources and investigators don't have unlimited funding, but if suicidal behavior is of scientific interest then follow-up should be a built in cost. I know it's easier said than done, but it's important enough that researchers should hold fast.

Wow, I assume the resistance to following up had something to do with funding?

Beat you :p

But really, wouldn't a large epidemiological survey about mental health have a DSMB that would look out for this type of stuff as the data is generated? I am not sure how these studies work in the VA, but if I were a PI doing this I can't imagine not having those safeguards in place - and those 1300 follow-up calls wouldn't all happen at one time. I'd have to make them as those screenings came in, or better yet, have a protocol in plae to implement at the end of the interview.
 
Not at all clear cut. You do not know the informed consent that was included, you don't know the scope of the study, and you are missing a lot of info about this. You also have no idea what was actually asked as you only a second hand report and are making an assumption that it asked about current suicidal thoughts. We just don’t know the extent of wrongdoing at this time.

This is key.
 
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