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Is it possible to get IRB approval after the fact?
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Generally speaking, peer reviewed journals will not publish research on human subjects that did not receive IRB approval.
If a study was done without the proper IRB approval, but the study itself was ethical and clearly would have passed IRB approval if it had been properly submitted, is it generally possible to get a post-facto IRB approval that is sufficient to publish in most journals, or is the work forever "tainted"? Is the fact that post-facto IRB approval is not often considered an option because it literally isn't allowed, or because research conducted without IRB approval almost always contains ethical infirmities that would have prevented IRB approval from the start? In other words, is the requirement to obtain IRB approval truly a "You absolutely must have prior IRB approval", or is it really more like "You absolutely must not conduct research unethically, and obtaining prior IRB approval is part of Best Practices in accomplishing this, because nearly all proposals that you or I might come up with are actually unethical and we need the wisdom of the IRB to show us the light and put us on the right path. If you forgo prior approval, you are wading in crocodile-infested waters, and you will have no one to blame but yourself, not the IRB, not your mom, not your advisor, but only you yourself, if you get your leg bitten off"?
To be clear, I'm not asking whether it is possible to "whitewash" unethical research to make it look like no one was harmed when in fact people were harmed, but about institutional procedural violations in otherwise ethical research. I am well aware that one of the primary reasons for seeking prior IRB approval (other than because journals expect it) is to avoid committing unethical acts, so for the purpose of this question, assume that the researchers either just get lucky or are just so competent in ethical practice that their actual research demonstrates sublime virtue (just without IRB approval).
publications ethics irb
asked 3 hours ago
Robert Columbia
5911619
add a comment |Â
up vote
5
down vote
favorite
Generally speaking, peer reviewed journals will not publish research on human subjects that did not receive IRB approval.
If a study was done without the proper IRB approval, but the study itself was ethical and clearly would have passed IRB approval if it had been properly submitted, is it generally possible to get a post-facto IRB approval that is sufficient to publish in most journals, or is the work forever "tainted"? Is the fact that post-facto IRB approval is not often considered an option because it literally isn't allowed, or because research conducted without IRB approval almost always contains ethical infirmities that would have prevented IRB approval from the start? In other words, is the requirement to obtain IRB approval truly a "You absolutely must have prior IRB approval", or is it really more like "You absolutely must not conduct research unethically, and obtaining prior IRB approval is part of Best Practices in accomplishing this, because nearly all proposals that you or I might come up with are actually unethical and we need the wisdom of the IRB to show us the light and put us on the right path. If you forgo prior approval, you are wading in crocodile-infested waters, and you will have no one to blame but yourself, not the IRB, not your mom, not your advisor, but only you yourself, if you get your leg bitten off"?
To be clear, I'm not asking whether it is possible to "whitewash" unethical research to make it look like no one was harmed when in fact people were harmed, but about institutional procedural violations in otherwise ethical research. I am well aware that one of the primary reasons for seeking prior IRB approval (other than because journals expect it) is to avoid committing unethical acts, so for the purpose of this question, assume that the researchers either just get lucky or are just so competent in ethical practice that their actual research demonstrates sublime virtue (just without IRB approval).
publications ethics irb
asked 3 hours ago
Robert Columbia
5911619
It might be relevant why IRB approval wasn't obtained. Did the researchers believe, reasonably and in good faith, that it wasn't needed? Did they try to get it, but unforeseen circumstances prevented the IRB from considering the case or giving approval? Or is it the case that they knew, or should have known, that it was required, but intentionally went ahead without it?
– Nate Eldredge
2 hours ago
2
Yes it is, but that is not your issue. At this point you should not be worried about publishing the work, you should be worried about losing your job and/or PI privileges.
– StrongBad♦
2 hours ago
I believe in the US there is no such thing as post hoc approval. If the study was done without it, then the best way is to report the study to your IRB immediately. Should the study really did not need an IRB, the committee can reconfirm that. If an approval was indeed missing, then corrective measures may be called for.
– Penguin_Knight
2 hours ago
Right- the common rule doesn't allow an IRB to give approval after the fact.
– Brian Borchers
2 hours ago
1
Can we please drop the "you're going to lose your job" talk and stop speculating on what the OP's circumstances are? I received similar comments once, and it's upsetting and feels somewhat threatening.
– Rebecca J. Stones
36 mins ago
add a comment |Â
up vote
5
down vote
favorite
up vote
5
down vote
favorite
Generally speaking, peer reviewed journals will not publish research on human subjects that did not receive IRB approval.
If a study was done without the proper IRB approval, but the study itself was ethical and clearly would have passed IRB approval if it had been properly submitted, is it generally possible to get a post-facto IRB approval that is sufficient to publish in most journals, or is the work forever "tainted"? Is the fact that post-facto IRB approval is not often considered an option because it literally isn't allowed, or because research conducted without IRB approval almost always contains ethical infirmities that would have prevented IRB approval from the start? In other words, is the requirement to obtain IRB approval truly a "You absolutely must have prior IRB approval", or is it really more like "You absolutely must not conduct research unethically, and obtaining prior IRB approval is part of Best Practices in accomplishing this, because nearly all proposals that you or I might come up with are actually unethical and we need the wisdom of the IRB to show us the light and put us on the right path. If you forgo prior approval, you are wading in crocodile-infested waters, and you will have no one to blame but yourself, not the IRB, not your mom, not your advisor, but only you yourself, if you get your leg bitten off"?
To be clear, I'm not asking whether it is possible to "whitewash" unethical research to make it look like no one was harmed when in fact people were harmed, but about institutional procedural violations in otherwise ethical research. I am well aware that one of the primary reasons for seeking prior IRB approval (other than because journals expect it) is to avoid committing unethical acts, so for the purpose of this question, assume that the researchers either just get lucky or are just so competent in ethical practice that their actual research demonstrates sublime virtue (just without IRB approval).
publications ethics irb
asked 3 hours ago
Robert Columbia
5911619
Generally speaking, peer reviewed journals will not publish research on human subjects that did not receive IRB approval.
If a study was done without the proper IRB approval, but the study itself was ethical and clearly would have passed IRB approval if it had been properly submitted, is it generally possible to get a post-facto IRB approval that is sufficient to publish in most journals, or is the work forever "tainted"? Is the fact that post-facto IRB approval is not often considered an option because it literally isn't allowed, or because research conducted without IRB approval almost always contains ethical infirmities that would have prevented IRB approval from the start? In other words, is the requirement to obtain IRB approval truly a "You absolutely must have prior IRB approval", or is it really more like "You absolutely must not conduct research unethically, and obtaining prior IRB approval is part of Best Practices in accomplishing this, because nearly all proposals that you or I might come up with are actually unethical and we need the wisdom of the IRB to show us the light and put us on the right path. If you forgo prior approval, you are wading in crocodile-infested waters, and you will have no one to blame but yourself, not the IRB, not your mom, not your advisor, but only you yourself, if you get your leg bitten off"?
To be clear, I'm not asking whether it is possible to "whitewash" unethical research to make it look like no one was harmed when in fact people were harmed, but about institutional procedural violations in otherwise ethical research. I am well aware that one of the primary reasons for seeking prior IRB approval (other than because journals expect it) is to avoid committing unethical acts, so for the purpose of this question, assume that the researchers either just get lucky or are just so competent in ethical practice that their actual research demonstrates sublime virtue (just without IRB approval).
publications ethics irb
publications ethics irb
asked 3 hours ago
Robert Columbia
5911619
asked 3 hours ago
Robert Columbia
5911619
edited 3 hours ago
asked 3 hours ago
Robert Columbia
5911619
asked 3 hours ago
Robert Columbia
5911619
asked 3 hours ago
Robert Columbia
5911619
5911619
It might be relevant why IRB approval wasn't obtained. Did the researchers believe, reasonably and in good faith, that it wasn't needed? Did they try to get it, but unforeseen circumstances prevented the IRB from considering the case or giving approval? Or is it the case that they knew, or should have known, that it was required, but intentionally went ahead without it?
– Nate Eldredge
2 hours ago
2
Yes it is, but that is not your issue. At this point you should not be worried about publishing the work, you should be worried about losing your job and/or PI privileges.
– StrongBad♦
2 hours ago
I believe in the US there is no such thing as post hoc approval. If the study was done without it, then the best way is to report the study to your IRB immediately. Should the study really did not need an IRB, the committee can reconfirm that. If an approval was indeed missing, then corrective measures may be called for.
– Penguin_Knight
2 hours ago
Right- the common rule doesn't allow an IRB to give approval after the fact.
– Brian Borchers
2 hours ago
1
Can we please drop the "you're going to lose your job" talk and stop speculating on what the OP's circumstances are? I received similar comments once, and it's upsetting and feels somewhat threatening.
– Rebecca J. Stones
36 mins ago
add a comment |Â
It might be relevant why IRB approval wasn't obtained. Did the researchers believe, reasonably and in good faith, that it wasn't needed? Did they try to get it, but unforeseen circumstances prevented the IRB from considering the case or giving approval? Or is it the case that they knew, or should have known, that it was required, but intentionally went ahead without it?
– Nate Eldredge
2 hours ago
2
Yes it is, but that is not your issue. At this point you should not be worried about publishing the work, you should be worried about losing your job and/or PI privileges.
– StrongBad♦
2 hours ago
I believe in the US there is no such thing as post hoc approval. If the study was done without it, then the best way is to report the study to your IRB immediately. Should the study really did not need an IRB, the committee can reconfirm that. If an approval was indeed missing, then corrective measures may be called for.
– Penguin_Knight
2 hours ago
Right- the common rule doesn't allow an IRB to give approval after the fact.
– Brian Borchers
2 hours ago
1
Can we please drop the "you're going to lose your job" talk and stop speculating on what the OP's circumstances are? I received similar comments once, and it's upsetting and feels somewhat threatening.
– Rebecca J. Stones
36 mins ago
It might be relevant why IRB approval wasn't obtained. Did the researchers believe, reasonably and in good faith, that it wasn't needed? Did they try to get it, but unforeseen circumstances prevented the IRB from considering the case or giving approval? Or is it the case that they knew, or should have known, that it was required, but intentionally went ahead without it?
– Nate Eldredge
2 hours ago
It might be relevant why IRB approval wasn't obtained. Did the researchers believe, reasonably and in good faith, that it wasn't needed? Did they try to get it, but unforeseen circumstances prevented the IRB from considering the case or giving approval? Or is it the case that they knew, or should have known, that it was required, but intentionally went ahead without it?
– Nate Eldredge
2 hours ago
2
2
Yes it is, but that is not your issue. At this point you should not be worried about publishing the work, you should be worried about losing your job and/or PI privileges.
– StrongBad♦
2 hours ago
Yes it is, but that is not your issue. At this point you should not be worried about publishing the work, you should be worried about losing your job and/or PI privileges.
– StrongBad♦
2 hours ago
I believe in the US there is no such thing as post hoc approval. If the study was done without it, then the best way is to report the study to your IRB immediately. Should the study really did not need an IRB, the committee can reconfirm that. If an approval was indeed missing, then corrective measures may be called for.
– Penguin_Knight
2 hours ago
I believe in the US there is no such thing as post hoc approval. If the study was done without it, then the best way is to report the study to your IRB immediately. Should the study really did not need an IRB, the committee can reconfirm that. If an approval was indeed missing, then corrective measures may be called for.
– Penguin_Knight
2 hours ago
Right- the common rule doesn't allow an IRB to give approval after the fact.
– Brian Borchers
2 hours ago
Right- the common rule doesn't allow an IRB to give approval after the fact.
– Brian Borchers
2 hours ago
1
1
Can we please drop the "you're going to lose your job" talk and stop speculating on what the OP's circumstances are? I received similar comments once, and it's upsetting and feels somewhat threatening.
– Rebecca J. Stones
36 mins ago
Can we please drop the "you're going to lose your job" talk and stop speculating on what the OP's circumstances are? I received similar comments once, and it's upsetting and feels somewhat threatening.
– Rebecca J. Stones
36 mins ago
add a comment |Â
2 Answers
2
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1
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As StrongBad has noted, publication is the least of one's worries in that particular context - you're talking about the kind of thing that people get fired for.
There's really no mechanism for "Oh, we totally would have approved this" post-hoc IRB approval. Indeed, there's an argument to be made that conducting the research without an IRB approval is inherently ethically suspect - in the same way that driving without a seatbelt on isn't only dangerous if you get in a car wreck. You are skipping the step meant to protect study subjects. That alone is a risk.
At this point in your scenario, the only real option is to seek the guidance of the IRB, and see what paths are available. This is absolutely one of those "This gets worse the longer it goes" situations.
answered 56 mins ago
Fomite
47k4101214
add a comment |Â
up vote
1
down vote
The human research ethics committee is in place to ensure that human research is undertaken in a way that safeguards the dignity, rights, health, safety and privacy of those involved. This assessment is difficult to make by the investigator because he or she has a vested interest in proceeding. Thus, an independent body is required.
In the institutions in which I've been involved, conducting human research without ethical review is, quite simply, research misconduct and subject to investigations and disciplinary actions. A priori ethical review is required. Regulations are in place that specifically disallow approval of research that has already been conducted.
I've been a member of institutional review boards and have chaired three -- one based in a hospital and two in research-intensive universities. I've been involved in these investigations in the past. As the original poster implies, most are found at the point in which the journal requires evidence from the IRB and the author quickly shoot an email to the office requesting one. In these investigations, it is often the case that there is a lack of training in the expectations and regulations of human research and offenders usually fall in three categories:
- inexperienced researchers, including students (often poorly supervised) or practitioners with no research training
- researchers trained "elsewhere", including those from countries with little to no requirements for ethical review
- researchers from fields that don't usually involve human subjects
My worst case was a person from an electrical engineering background who collected data on body image for an app he was developing. During these sessions, the person gave advice that drove one participant to self harm. During the investigation, the offender did not think that ethical review was necessary because the questions were "innocuous (his term)".
As I said, in most cases the consequences are far less severe than this. For example, a common scenario is a young doctor who collects information from patient files, performs a few statistical tests and write up the results of this audit and sends the publication to a journal that then requests evidence of IRB approval. In cases like this, IRB approval is not provided and the doctor is placed under supervision.
answered 23 mins ago
St. Inkbug
2,590625
add a comment |Â
2 Answers
2
active
oldest
votes
2 Answers
2
active
oldest
votes
active
oldest
votes
active
oldest
votes
up vote
1
down vote
As StrongBad has noted, publication is the least of one's worries in that particular context - you're talking about the kind of thing that people get fired for.
There's really no mechanism for "Oh, we totally would have approved this" post-hoc IRB approval. Indeed, there's an argument to be made that conducting the research without an IRB approval is inherently ethically suspect - in the same way that driving without a seatbelt on isn't only dangerous if you get in a car wreck. You are skipping the step meant to protect study subjects. That alone is a risk.
At this point in your scenario, the only real option is to seek the guidance of the IRB, and see what paths are available. This is absolutely one of those "This gets worse the longer it goes" situations.
answered 56 mins ago
Fomite
47k4101214
add a comment |Â
up vote
1
down vote
As StrongBad has noted, publication is the least of one's worries in that particular context - you're talking about the kind of thing that people get fired for.
There's really no mechanism for "Oh, we totally would have approved this" post-hoc IRB approval. Indeed, there's an argument to be made that conducting the research without an IRB approval is inherently ethically suspect - in the same way that driving without a seatbelt on isn't only dangerous if you get in a car wreck. You are skipping the step meant to protect study subjects. That alone is a risk.
At this point in your scenario, the only real option is to seek the guidance of the IRB, and see what paths are available. This is absolutely one of those "This gets worse the longer it goes" situations.
answered 56 mins ago
Fomite
47k4101214
add a comment |Â
up vote
1
down vote
up vote
1
down vote
As StrongBad has noted, publication is the least of one's worries in that particular context - you're talking about the kind of thing that people get fired for.
There's really no mechanism for "Oh, we totally would have approved this" post-hoc IRB approval. Indeed, there's an argument to be made that conducting the research without an IRB approval is inherently ethically suspect - in the same way that driving without a seatbelt on isn't only dangerous if you get in a car wreck. You are skipping the step meant to protect study subjects. That alone is a risk.
At this point in your scenario, the only real option is to seek the guidance of the IRB, and see what paths are available. This is absolutely one of those "This gets worse the longer it goes" situations.
answered 56 mins ago
Fomite
47k4101214
As StrongBad has noted, publication is the least of one's worries in that particular context - you're talking about the kind of thing that people get fired for.
There's really no mechanism for "Oh, we totally would have approved this" post-hoc IRB approval. Indeed, there's an argument to be made that conducting the research without an IRB approval is inherently ethically suspect - in the same way that driving without a seatbelt on isn't only dangerous if you get in a car wreck. You are skipping the step meant to protect study subjects. That alone is a risk.
At this point in your scenario, the only real option is to seek the guidance of the IRB, and see what paths are available. This is absolutely one of those "This gets worse the longer it goes" situations.
answered 56 mins ago
Fomite
47k4101214
answered 56 mins ago
Fomite
47k4101214
answered 56 mins ago
Fomite
47k4101214
answered 56 mins ago
Fomite
47k4101214
47k4101214
add a comment |Â
add a comment |Â
up vote
1
down vote
The human research ethics committee is in place to ensure that human research is undertaken in a way that safeguards the dignity, rights, health, safety and privacy of those involved. This assessment is difficult to make by the investigator because he or she has a vested interest in proceeding. Thus, an independent body is required.
In the institutions in which I've been involved, conducting human research without ethical review is, quite simply, research misconduct and subject to investigations and disciplinary actions. A priori ethical review is required. Regulations are in place that specifically disallow approval of research that has already been conducted.
I've been a member of institutional review boards and have chaired three -- one based in a hospital and two in research-intensive universities. I've been involved in these investigations in the past. As the original poster implies, most are found at the point in which the journal requires evidence from the IRB and the author quickly shoot an email to the office requesting one. In these investigations, it is often the case that there is a lack of training in the expectations and regulations of human research and offenders usually fall in three categories:
- inexperienced researchers, including students (often poorly supervised) or practitioners with no research training
- researchers trained "elsewhere", including those from countries with little to no requirements for ethical review
- researchers from fields that don't usually involve human subjects
My worst case was a person from an electrical engineering background who collected data on body image for an app he was developing. During these sessions, the person gave advice that drove one participant to self harm. During the investigation, the offender did not think that ethical review was necessary because the questions were "innocuous (his term)".
As I said, in most cases the consequences are far less severe than this. For example, a common scenario is a young doctor who collects information from patient files, performs a few statistical tests and write up the results of this audit and sends the publication to a journal that then requests evidence of IRB approval. In cases like this, IRB approval is not provided and the doctor is placed under supervision.
answered 23 mins ago
St. Inkbug
2,590625
add a comment |Â
up vote
1
down vote
The human research ethics committee is in place to ensure that human research is undertaken in a way that safeguards the dignity, rights, health, safety and privacy of those involved. This assessment is difficult to make by the investigator because he or she has a vested interest in proceeding. Thus, an independent body is required.
In the institutions in which I've been involved, conducting human research without ethical review is, quite simply, research misconduct and subject to investigations and disciplinary actions. A priori ethical review is required. Regulations are in place that specifically disallow approval of research that has already been conducted.
I've been a member of institutional review boards and have chaired three -- one based in a hospital and two in research-intensive universities. I've been involved in these investigations in the past. As the original poster implies, most are found at the point in which the journal requires evidence from the IRB and the author quickly shoot an email to the office requesting one. In these investigations, it is often the case that there is a lack of training in the expectations and regulations of human research and offenders usually fall in three categories:
- inexperienced researchers, including students (often poorly supervised) or practitioners with no research training
- researchers trained "elsewhere", including those from countries with little to no requirements for ethical review
- researchers from fields that don't usually involve human subjects
My worst case was a person from an electrical engineering background who collected data on body image for an app he was developing. During these sessions, the person gave advice that drove one participant to self harm. During the investigation, the offender did not think that ethical review was necessary because the questions were "innocuous (his term)".
As I said, in most cases the consequences are far less severe than this. For example, a common scenario is a young doctor who collects information from patient files, performs a few statistical tests and write up the results of this audit and sends the publication to a journal that then requests evidence of IRB approval. In cases like this, IRB approval is not provided and the doctor is placed under supervision.
answered 23 mins ago
St. Inkbug
2,590625
add a comment |Â
up vote
1
down vote
up vote
1
down vote
The human research ethics committee is in place to ensure that human research is undertaken in a way that safeguards the dignity, rights, health, safety and privacy of those involved. This assessment is difficult to make by the investigator because he or she has a vested interest in proceeding. Thus, an independent body is required.
In the institutions in which I've been involved, conducting human research without ethical review is, quite simply, research misconduct and subject to investigations and disciplinary actions. A priori ethical review is required. Regulations are in place that specifically disallow approval of research that has already been conducted.
I've been a member of institutional review boards and have chaired three -- one based in a hospital and two in research-intensive universities. I've been involved in these investigations in the past. As the original poster implies, most are found at the point in which the journal requires evidence from the IRB and the author quickly shoot an email to the office requesting one. In these investigations, it is often the case that there is a lack of training in the expectations and regulations of human research and offenders usually fall in three categories:
- inexperienced researchers, including students (often poorly supervised) or practitioners with no research training
- researchers trained "elsewhere", including those from countries with little to no requirements for ethical review
- researchers from fields that don't usually involve human subjects
My worst case was a person from an electrical engineering background who collected data on body image for an app he was developing. During these sessions, the person gave advice that drove one participant to self harm. During the investigation, the offender did not think that ethical review was necessary because the questions were "innocuous (his term)".
As I said, in most cases the consequences are far less severe than this. For example, a common scenario is a young doctor who collects information from patient files, performs a few statistical tests and write up the results of this audit and sends the publication to a journal that then requests evidence of IRB approval. In cases like this, IRB approval is not provided and the doctor is placed under supervision.
answered 23 mins ago
St. Inkbug
2,590625
The human research ethics committee is in place to ensure that human research is undertaken in a way that safeguards the dignity, rights, health, safety and privacy of those involved. This assessment is difficult to make by the investigator because he or she has a vested interest in proceeding. Thus, an independent body is required.
In the institutions in which I've been involved, conducting human research without ethical review is, quite simply, research misconduct and subject to investigations and disciplinary actions. A priori ethical review is required. Regulations are in place that specifically disallow approval of research that has already been conducted.
I've been a member of institutional review boards and have chaired three -- one based in a hospital and two in research-intensive universities. I've been involved in these investigations in the past. As the original poster implies, most are found at the point in which the journal requires evidence from the IRB and the author quickly shoot an email to the office requesting one. In these investigations, it is often the case that there is a lack of training in the expectations and regulations of human research and offenders usually fall in three categories:
- inexperienced researchers, including students (often poorly supervised) or practitioners with no research training
- researchers trained "elsewhere", including those from countries with little to no requirements for ethical review
- researchers from fields that don't usually involve human subjects
My worst case was a person from an electrical engineering background who collected data on body image for an app he was developing. During these sessions, the person gave advice that drove one participant to self harm. During the investigation, the offender did not think that ethical review was necessary because the questions were "innocuous (his term)".
As I said, in most cases the consequences are far less severe than this. For example, a common scenario is a young doctor who collects information from patient files, performs a few statistical tests and write up the results of this audit and sends the publication to a journal that then requests evidence of IRB approval. In cases like this, IRB approval is not provided and the doctor is placed under supervision.
answered 23 mins ago
St. Inkbug
2,590625
answered 23 mins ago
St. Inkbug
2,590625
answered 23 mins ago
St. Inkbug
2,590625
answered 23 mins ago
St. Inkbug
2,590625
2,590625
add a comment |Â
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It might be relevant why IRB approval wasn't obtained. Did the researchers believe, reasonably and in good faith, that it wasn't needed? Did they try to get it, but unforeseen circumstances prevented the IRB from considering the case or giving approval? Or is it the case that they knew, or should have known, that it was required, but intentionally went ahead without it?
– Nate Eldredge
2 hours ago
2
Yes it is, but that is not your issue. At this point you should not be worried about publishing the work, you should be worried about losing your job and/or PI privileges.
– StrongBad♦
2 hours ago
I believe in the US there is no such thing as post hoc approval. If the study was done without it, then the best way is to report the study to your IRB immediately. Should the study really did not need an IRB, the committee can reconfirm that. If an approval was indeed missing, then corrective measures may be called for.
– Penguin_Knight
2 hours ago
Right- the common rule doesn't allow an IRB to give approval after the fact.
– Brian Borchers
2 hours ago
1
Can we please drop the "you're going to lose your job" talk and stop speculating on what the OP's circumstances are? I received similar comments once, and it's upsetting and feels somewhat threatening.
– Rebecca J. Stones
36 mins ago