Hi Nguyen,

Doesn't your university have an Internal Review Board (IRB) that requires you to get its approval for any studies that you conduct on human test subjects?  You say you have the data as you have been conducting "this test" for ten years; do you mean you actually performed the tests?  Or, are you just using statistical data that someone else collected; I mean is your laboratory just processing someone else's data?  Are the subjects' identities  protected in some way?  If so, can you guarantee continued anonymity?  And is the anonymity guaranteed for the parents of the Down Syndrome children as well as the children? 

I don't understand how or why you think your situation is similar to that of a census authority like the "national health statistics office" that is acting in an official capacity when collecting data on the population (and most likely does not identify the people by name if it is anything like the census authority here in the U.S.).

In addition to contacting your university's IRB, you may want to see what kind of proof of "informed consent" the journals you intend to publish your work in require.

Gwen

Thank you for your kind reply, Gwen.

Actually, I'm new to this kind of study (I have experienced with scientometrics and systematic review & meta-analysis only) so I don't know what to do, I just assume a situation to be enlightened by others.

If a laboratory directly performs the test and collects a copy of the results (without personal information), do we need any ethical approval from IRB? In case we are a independent laboratory, not a part of a university, what can we do to get ethical approval if necessary?

Could you please give me your advice and references about the correct strategy?

I think it is nosense requiring an approval by the ethics committee for retrospective observational studies, since data have already been collected. Nevertheless, this is the procedure, but it is relatively easy since every research hospital has an ethical committee. It seems time wasting, but it is little upset. The only request an ethical committee should do is the absolute anonimate of the patients.

Dear Dr Carlo Valerio Bellieni,

Thank you for your answer. 

In case we are an independent laboratory, no relating to any university or hospital, how can we get ethical approval?

Can we set up an Internal/Institutional Review Board (IRB) ourselves? Who or Which higher organization will validate and accept the competence of our IRB?

I also have another question:

Plos ONE requires Ethical Approval with these kind of Study "Humans (live or tissue), including studies that are observational, survey-based, or include any personal data".

Source: http://www.plosone.org/static/publication 

Even a survey-based research must have a ethical approval, why?

You can check the HIPAA, but I think all patients or study participants have the right to know how their health information will be used.

In the US, the ethical approval is typically part of the standard review of the institutional review board (IRB) by an academic center or hospital review committee.  This is a higher level review than an internal review which should be made prior to the IRB review.  In situations of retrospective analysis of de-identified subjects in existing databases where anonymity can be assured, often the investigator can get an 'expedited review' or 'non-review' determination made by the IRB which will show that you are in compliance with regulatory standards.

Thank you Dr Luis, Dr Kim for your answer.

I know much better now. 

Laws vary by country. In the US, federal law requires that investigators engaged in human subjects research have project oversight by their Institutional Review Board/Ethics Committee. Since you'll be working with already-existing data, your study would might qualify for expedited review although genetic information can be touchy. If you're not using any identifying information, your study might even be exempt from IRB/EC oversight. But laws in your country may differ. You have to ask your local people.

Everyone is entitled to an opinion, but IRB oversight of retrospective studies is NOT nonsense - during my 20 years of IRB experience I've seen many situations where investigators performing retrospective studies did not understand their responsibilities as investigators, the potential risks to their subjects, or ways to minimize risks.

Bottom line: contact your institution's IRB/EC, explain what you want to do, ask them how to proceed. They will help you to accomplish your study in a way that helps you to minimize risks and protects your research subjects. I'm guessing they will be friendly and helpful.

Good luck with your project.

Thank you so much, Dr James!

Question:

There is a question I want to ask: what is the purpose of this publication/research?

Answer:

The answer could/ would be any of the following (and perhaps more):

1. Publish for academic interest

2. Help improve detection rate

3. Make some sort of guidelines for detection

These purposes make this research different from a census. The data collected for census may be anonymous /non identifiable and is perhaps for internal publications only, as confidential report to guide policy etc., BUT this (your) research will be using that retrospectively collected data for external publication in a peer-reviewed journal, for consumption by a wider group of people (albeit academics).

Research Ethics Committee (REC):

Non-identification and anonymity are important for two reasons (both ethical):

1. Confidentiality and 2. Non-maleficence (the harm that may be caused by identifying that group/peoples). Having said this, I am sure you have thought of these yourself as well. However, it is important that a REC is contacted which will be able to guide you on how to:

1. Maintain confidentiality –so perhaps it may be that they say that if the data cannot be linked to individuals it is exempt from review. BUT if there is any possibility of identification they may want to review it –

2. Obtain consent (from the participants of the original data-set) for this publication (difficult though it may be with a retrospective study –from 2001-2010- to obtain consent from ALL those in the original data-set –even if it had it all the identifiers).

The above can be dealt with by a REC (which may exempt or expedite the review!!!).

National Bioethics Committee:

IF the publication is by an independent/private laboratory then there may be a National Bioethics Committee (NBC)-  perhaps the best bet is to write to your national research council for information on this.

Survey studies:

As regards survey based studies –it is /may be essential to obtain ethical approval because sometimes survey questions lead to identification of a group (no matter how small). And, briefly, if the survey is on a particularly sensitive issue then there is the problem of stigmatization/vulnerability.

I hope this is useful.

Good Luck

Thank you for your informative comment, Dr Aisha. 

Good day to all, 

I appreciated very much the above discussions and wealth of information. I would add just a small bit of general information that might be helpful.

Any study is supposed to be reviewed by an IRB or ethics committee so the committee can decide whether it is 1_ research or activity or public health activity (like the census), 2- whether it is human subject research or not. 

The researcher must have this decided by a body who is impartial and not related to the study. 

If you do not have this reviewing body in your institution, you can rely on another institution's IRB (and in some countries you can pay for these services).

It is not an easy process to start an IRB and you mentioned some of the requirements for this.

Wish you all success

Hi Nguyen,

First of all, you must read the WMA Declaration of Helsinki carefully.

Link is below:

http://www.wma.net/en/30publications/10policies/b3/

Hi,

in Austria we need for each (prospective and retrospective) study project on human  a positive ethical vote. In line with our Austrian Bioethics committee we have to use adequate informed consents. The Biobank Graz collects samples and data for specific research questions but also cross-sectional. For this reason, we use an one single time and broad informed consent. In this way our samples can be used for differ research questions. Since each project which want to use  Biobank Graz samples and data have to call that the ethics committee (within their study plan).

However, each country has other bioethical guidelines.

Best wihes, Tanja

Hi,

Great to read all those discussions about the use of human samples after the parent study has ended (retrospective). I think that, it largely depends on what was approved by the regulatory and ethics committees. In the ICF, consent would have been sought from the participants of the parent study and for any future study regarding the use of the samples. They would have to agree whether they would want their biological samples to be used for further studies in future. The IRB and the Ethics committees would have to approve this. For some countries, you might have to go back to the IRB and Ethics for approval but for others just the initial approval of samples to be used in future is OK. As stated by others, each country has their guidelines.

Best Regards,Elisha

When the data were saved automatically, were there any identifiers?