I conducted a study on screening for cardiovascular disease risk factors which partly involved checking glucose and cholesterol level in participants using Point of Care Test kits. When the study was done I had no idea of seeking for ethical approval. Now that I would like to publish my findings I would like to know if there is a way of phrasing the ethical consideration for publication in a good journal without experiencing rejection.
Dear Segun,
I am afraid this won't be possible. Now a days, ethics criteria in almost every country have been made stringent for the safety and welfare of the participants. Though there are some exceptions, almost all of the study either on animals or on humans need ethical approval. Generally observational studies on the already approved drugs which necessarily don't involve use of biological fluids are exempted from ethical approval process. However, this doesn't imply to all observational studies because studies being conducted on special population or on diseases such as HIV, Cancer, and STDs need mandatory ethical approval.
Your study includes clinical testing on participant, therefore from my point of view you must need a ethics committee approval.
I suggest expert guidance on this matter.
Best regards.
In my opinion 'clinical testing' means subjecting the patient (or study participant) to a pharmacological agent. In that respect the OP didn't specify if he has done any. Besides that, glucose and cholesterol can even be self-determined these days so really why an ethical problem there when the point of this study was in the field of cardiovascular disease, not some 'hot' topic like HIV.
I agree with both of you. Though it is becoming increasingly difficult to publish studies on huma.n without ethical approval but i still think that exceptions should be made
As an editorial board member and reviewer for several dozen professional journals over the past 30 years, I can say with some confidence that NO reputable peer-reviewed journal will accept research conducted on human subjects for participation without PRIOR IRB (i.e., duly constituted ethics review committee) approval. This process has "evolved" over the last 50 years in response to significant instances of abuse and endangerment of human research subjects --- sometimes with the "best" of intentions and sometimes simply as a means to achieve a desired end.
Unfortunately, "ignorance of the law" is, as they say, NO EXCUSE!!
I would suggest that, if positive or encouraging results were obtained in the first unapproved "study" , a new study be designed and receive appropriate IRB approval PRIOR to re-execution. Good luck!!
Sincerely,
Lou
As they say, there is always a way. I would suggest that when it's already done then why to let it go waste. Any study requires hard work and resources. There is no fun in wasting all these. Therefore, authors should present their case to IRB and ask for proper guidance.
In response to M. Watson's comment: my 'statement' is about what 'clinical testing' is,. because currently it is assimilated to 'clinical trial' aka testing a therapy/procedure on a patient/group.
In case of glucose and cholesterol testing, you should be aware they are routinely used in patient's assessment even in primary care, at least that's what I know from clinical experience. Glucose and cholesterol are among the tests done every year or 2 for patient monitoring here, so the point about not being in 'routine care' would not apply in my country. If they not performed over there , that's another discussion. These tests have been used for over 100 years (Fehling's time). They are certainly not 'new'.
To Tamas: Your point make a lot of sense to me and that is why I wondered if ethical approval should have been sought for such study knowing that these are routine tests for those who are diabetic or have hypercholesterolemia. With the use of POCT patients are encouraged to monitor their own BP, glucose, cholesterol levels and others. Participants were even happen getting it done for them free of charge. I do know that the whole essence of getting ethical approval is to protect the participants in any study from been unduly used and harming them. However in the case of my study there was not even any harm to the participants rather they were able to know the status of their health which i think was beneficial to them.
this is a difficult question and a difficult task !! If i were you I would state frankly that you could not get an ethical approval from IRB because either there is no such committee or the research did not include human subjects and no IRB approval was required.
well a very precarious situation however ,the essence of getting a finding and reporting such is that it could be reproduced by any one so if what you were able to get is worth publishing then i believe it should be worth redoing, in addition to that what benefit will your publication which i believe from how you sound rich but what will it bring if it end up in the rejection list because protocols were breached so please i urge that you painstakingly re do it thanks
As researcher and reviewer for many professional journals over the past 10 years, I can say with some confidence that NO reputable peer-reviewed journal will accept research conducted on human subjects for participation without PRIOR IRB (i.e., duly constituted ethics review committee) approval. This process has "evolved" over the last 50 years in response to significant instances of abuse and endangerment of human research subjects --- sometimes with the "best" of intentions and sometimes simply as a means to achieve a desired end.
Unfortunately, "ignorance of the law" is, as they say, NO EXCUSE!!
I would suggest that, if positive or encouraging results were obtained in the first unapproved "study" , a new study be designed and receive appropriate IRB approval PRIOR to re-execution. Good luck!! Recommendable for you
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