Ethical approval in multi-country study

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carlos

Frequent user

19 Mar 2009, 13:01

ENN in collaboration with a number of agencies are conducting an
observational study on defaulting from emergency supplementary feeding
programmes. The study will take place over a year in four separate programme
sites and involve administering a questionnaire to help understand key
factors in defaulting.

Can anybody help with information on what are the right procedures for obtaining ethical
approval in a multi-country study (4 countries)? The agencies implementing
the supplementary feeding programmes and participating in the study do not
have Ethical Review Boards (ERB).

Does an independent ERB exist that can provide overall approval for the
study?

Does any one know of up-to-date guidelines on obtaining Ethical reviews
for international studies ?

John Borton

Technical expert

20 Mar 2009, 13:07

Hi Carlos

This is not an area in which I have any direct experience. However, I hope the following resources prove helpful.

UNESCO's Global Ethics Observatory is a free global repository of updated information on ethics institutions, experts, legislation, codes of conduct and teaching programmes around the world. An interactive geographical search tool indicates the relevant laws and codes of conduct relating to research ethics in many (but admittedly not all) countries
http://portal.unesco.org/shs/en/ev.php-URL_ID=6200&URL_DO=DO_TOPIC&URL_SECTION=201.html

The Nuffield Council on Bioethics has produced two publications on "The Ethics of Research Related to Healthcare in Developing Countries". The main report was produced in 2002. A follow-up workshop in Capetown resulted in a discussion paper with the same title published in 2005. Both reports can be downloaded from http://www.nuffieldbioethics.org/go/ourwork/developingcountries/introduction

CODEX is the Swedish Research Council's gateway to various research ethics guidelines which it runs in conjunction with The Centre for Research Ethics & Bioethics at Uppsala University. It looks very comprehensive and helpful.
http://www.codex.vr.se/codex_eng/codex/index.html

An important point for nutrition researchers to take account of are the specific codes and ethical issues relating to research involving children
http://www.codex.vr.se/codex_eng/codex/oversikter/manniskor/barn.html

Another important site to view is that of the Council for International Organizations of Medical Sciences (CIOMS) which is related to WHO in Geneva http://www.cioms.ch/
I see that the 1991 International Ethical Guidelines for Epidemiological Studies are in the process of updating and a provisional text of the new version is available.

If your planned research involves refugee communities I would suggest you also take a look at
Temple, Bogusia and Rhetta Moran, eds. (2006) [i]Doing research with refugees: Issues and guidelines[i] Bristol:The Policy Press

I would hope that other 'en-neters' who have been involved in multi-country studies will be able to offer suggestions based on their own experience.

Regards

John

Mark Myatt

Frequent user

1 Apr 2009, 16:06

The usual practice is to obtain ethical approval in all countries and in the research institution of the primary investigator. In my experience this usually means formal review at all points but you may be able to proceed with formal review at your host institution and permissions from a responsible officer in each Ministry of Health if your are not involved in experimentation (e.g. a clinical trial). In one (ongoing) case I have had to go through review at my university, at several national levels, and again at the individual hospital level. This can be quite an involved process and may take several months or longer. Since your study is "observational" you may be able to speed up the review process. This is usually done by direct representation to the chairs of the relevant review bodies. In some "observational" studies it may be sufficient just to obtain permission from a responsible officer at the MoH. Some countries allow this. The important thing is to have a clear and well-presented protocol that makes direct reference to the key paragraphs of the Declaration of Helsinki. This just helps the review board to do their work and avoids lots of to-and-fro correspondence.

carlos

Frequent user

1 Apr 2009, 16:34

Thanks Mark. Your comments are very useful.

However, the primary investigator and the organisations hosting the study are not big enough to have their own review board. Is there an alternative review board that we can address ? Or do you think that, in this case, obtaining authorisation in each of the countries would be enough ?

Mark Myatt

Frequent user

1 Apr 2009, 16:59

One option is to find a review board that is willing to take the case. You may be able to use the review board of a university that you attended or is local or has a relationship with one or more of your collaborating agencies (e.g. SC-UK has ties with LSHTM). Another option is (e.g.) a hospital or district health authority in the UK. I'd approach the chair of the board explaining the situation and asking if the case can be considered with a brief summary of the protocol and some evidence that you understand and have addressed ethical issues (i.e. so they get the imprssion that you will not be causing a great deal of work).

This is an observational study. Ethical issues are not that complex (primarily data protection issues) and, strictly speaking, the Declaration of Helsinki does not apply. I think that you may be able to proceed with permission from a responsible officer in the local MoHs. I'd put together an "ethical briefing" which refers to appropriate legislation. In observational work I have done before I usually explicitly refer to data-protection legislation and how I will comply with this.