Dear scientists,
We aim to conduct an analytic study on human bio-fluids which the patients will be recruited in three different countries. However, we are not sure about the process of ethical issues evaluation. Any advice and suggestions will be greatly appreciated.
Thank you.
Dear Long,
The work you are doing is extensive and requires special attention. The chain of workers involved from the site of initiation till the recording of the data requires expertise that must be present at every single stage.
I advise to make a board comprising of two stages, 1) watchdog, the group seeing the quality is adhered and every ethical issue decided in advance is followed.
2) ethical commission, who will be covering watchdog, addressing confidentiality, making sure of human subject anonymity and safe data entry.
The process may be tedious but it is very doable.
Of course demands in different countries are different. which studies are planned and in which countries?
Thank you Ahsan and Alexander for your answers.
I understand that the procedure will be different among countries. However, the principles should be similar. I herein include more specific question:
How to validate the quality of informed consent in different languages?
Best regards
.
FYI, I found a good reference.
http://www.ncbi.nlm.nih.gov/pubmed/21439178
Hello,
My experience of doing research in countries in which I have no language expertise can be convoluted, and entails extensive collaboration with the local population:
Put your ethics proposal in English to your Ethics Committee (few journals will publish without an ethical clearance). In Australia this must be in accordance with the NHMRC (see link below). Accompanying your proposal, there must be evidence from a committee of relevance in the foreign country that activities will be in accordance with their own ethical practice and can proceed. Letters of introduction to the participants must be in the appropriate language and presented to the HREC in both English and the second language. You will need people with a good command of your first language in order to translate for you in each country. Any differences in ethical issues will have to be presented to your ethics committee for discussion.
Once obtained, I cannot imagine the analysis of the bio fluids will be problematic for you. However, once conclusions are reached, the data must be presented in the original language to participants or the 'in country committee'.
https://www.nhmrc.gov.au/health-ethics
Email Holly Taylor or Adnan Hyder at Johns Hopkins - they are experts in this area. [email protected]
Thank you very much for your informative comments, Dr Bradley and Dr Bateman-House.
You are very welcome - good luck getting the guidance you need.
Dear Dr. Bonilla,
Thank you very much for your informative answer.
I am getting a little bit confused. Please give me your advice on this situation:
a. The samples from patients will be collected in country A and country B (team 1 and team 2).
b. Next, the samples will be sent to country C for analysis (team 3).
In this case, it is true that we still need to get the ethical approval from team 3's institution when they just receive the samples and perform biochemical analysis?
Respectfully yours.
Dr Bonilla,
Thank you for your opinion. I will follow your suggestions.
We are now working with local experts to make a correct procedures which the ethical issue is a first priority.
Respectfully yours
If you are transferring tissue samples (including blood and other fluids) across National Borders you are likely to need a special export license.
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