Timeline for How to by-pass bioethics for a trivial bio-experiment?
Current License: CC BY-SA 4.0
10 events
| when toggle format | what | by | license | comment | |
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| Feb 13, 2019 at 2:09 | comment | added | Jagan Mohan | @BrianBorchers Agreed - Ethical clearance/waiver before the experiment starts. Sorry if my position was unclear. I recommended that the OP get a waiver with an initial study proposal or application where he makes a case that the experiment is a pilot, of low risk, one subject and a single sample of blood from a prick. Of course, he will have to repeat the experiment with either a clearance or waiver. | |
| Feb 10, 2019 at 19:40 | comment | added | Brian Borchers | @Jagan Mohan. At my US based institution, the IRB (I'm a member of the IRB) would certainly require approval before the first blood sample was taken. | |
| Feb 10, 2019 at 18:41 | comment | added | Jagan Mohan | @BrianBorchers OP had mentioned that the paper is on the Algorithm and Software and that the experiment was trivial, using blood of the OP only. In most Universities, such experiments (say, at a very initial, preliminary or small pilot stages) are exempted from getting Ethics clearances. The parameters for applying for ethics is involvement of human or animal subjects. If the quantity of biological tissue/fluid needed is very small, for e.g. a prick or drop of blood from the investigator itself, it qualifies in most places for waivers. This can be confirmed by any ethics committee. | |
| Feb 10, 2019 at 17:26 | comment | added | Brian Borchers | It would almost certainly be against the rules of the OP's institution to seek permission from an independent IRB for this research as a way to avoid dealing with the institution's IRB. | |
| Feb 10, 2019 at 15:12 | comment | added | Anyon | Clearly OP does have access to a local IRB though. Would it really be permissible to sidestep it (and its recommendations) by using an independent one? | |
| Feb 10, 2019 at 15:05 | history | edited | Jagan Mohan | CC BY-SA 4.0 |
Cited an article for reference and a web-resource
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| Feb 10, 2019 at 14:59 | comment | added | Jagan Mohan | ncbi.nlm.nih.gov/pmc/articles/PMC5839245 “…if no formal ethics committee is available, a statement indicating that the research was conducted according to the principles of the Declaration of Helsinki should be included”, alternatively stated “For those investigators who do not have access to formal ethics review committees, the principles outlined in the Declaration of Helsinki should be followed”. See: icmje.org/icmje-recommendations.pdf @SolarMike is correct. The way forward is to write to the reviewer that principles of the Helsinki were followed. | |
| Feb 10, 2019 at 14:34 | comment | added | Solar Mike | Most of your answer is relevant for future actions and does not address correcting a past action. | |
| Feb 10, 2019 at 14:32 | comment | added | WDC | Could you elaborate on Point 1 the independent Human Ethics committees? And elaborate on Point 2 please? From our application experience to IRB it seems there’s no difference if donor is me (student) or the PI. | |
| Feb 10, 2019 at 14:28 | history | answered | Jagan Mohan | CC BY-SA 4.0 |