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[gdzombo]

1. What lessons could be learned from this case study in terms of the following;
(a) Collaborative research.
Whenever there is need to have a collaborative research, both the local and foreign researchers and institutions involved need to collective identify and develop the research proposal. In this proposal it should be clearly stated what are the objectives of the study and PIs/ institutions responsibilities, if there will be any sample transfers, which samples need to be transferred and how will the transfer process be as laid down in the MTAs. I also think that the local investigator and ERCs need to find out more background information of the collaborating PIs and their affiliated institutions. the proposal needs to be reviewed by all the countries involved including the sponsor country and each ERCs should seek for written documents on ethical approval by other countries. I also think there is need for a proper and functional monitoring systems by ERCs to ensure that research and data handling is done ethical and that the participants rights are protected and respected through out the study period.

(b) The importance of Material Transfer Agreements (MTAs).
MTAs is a very important component in any GCP and GLP. The MTAs need to be put in place prior the study approval and reviewed by the respective ERCs in all the collaborating countries. The MTAs guidelines should be strictly be adhered to by all the countries involved. If there is need to ship sample to foreign countries, it should be clearly stated, justified and explained to participants for consent.

(c) Bio-safety standards.
Humans and their environment need to be protected from any harm including harm from bio materials. Yersinia pestis is easily spread by small droplets in the air. This is a public health hazard. GCP and GLP requires strict bio-safety standards .

(d) Need for oversight of approved studies.
There is need for constant check and monitoring by DSMB and other monitoring systems to ensure that studies are ethical conducted and that what was stated in the protocol is adhered to the latter.

2. Should developing country Ethics Review Committees (ERCs) demand ethical clearance from all institutions employing overseas research collaborators?

Yes, developing country ERC needs to demand for ethical clearance form all institutions employing overseas collaborators. This is to to safeguard the welfare of the participants involved in the studies.

3. What are your views on other issues raised by this case study?
I think the way the case was handled by the US court was bias to the US affairs and issues concerning violation of human rights to the Tanzania government, the local researcher and the participants in that study were not tabled. Lack of stringent bio security regulations both by the US and Tanzania need to be developed and put into practice. Ethical clearance is needed from all collaborating institutions/countries including sponsor ERCs. Developed countries need to ensure that the developing countries participating in the collaborative research need to be capacity built and equipped with required technology/resources especially when there is need to ship samples abroad for certain tests.

George Dzombo

[fkombe]

1. What lessons could be learned from this case study in terms of the following;
(a) Collaborative research
There is need to clearly define the terms of reference in a collaborative research. My personal view is that it would even be better to develop a clear memorandum of understanding between the collaborating institutions before the research begins.


(b) The importance of Material Transfer Agreements (MTAs).
Formal agreements always help to avoid some major loopholes such as this. It is always advisable to maintain a written down agreement to clearly define the role of each collaborative partner.

(c) Bio-safety standards.
Bio-safety standards are like law. They are there to be strictly followed and ignorance/negligence is no defense before the court of law. I wonder though what would have happened to Prof. Butler were he to do the same mistake in Africa.


(d) Need for oversight of approved studies.
All research must be reviewed by both the collaborative institution ERC and the local ERC. This is important to ensure that all fundamental principles of research ethics are fulfilled. No studies should be allowed to go on before a proper review and approval by the ERC. This will ensure that research adheres to the ethical standards and principle without failure.


2. Should developing country Ethics Review Committees (ERCs) demand ethical clearance from all institutions employing overseas research collaborators?

Based on what happened in this case study, it is clear that there is need for ERCs to demand GENUINE ethical clearance from all institutions employing overseas research collaborators. This will ensure that there is clear understanding on what is expected of each and every collaborator. It must be said here though that apart from merely demanding for the ethical clearance, there is need for ERCs from Africa to scrutinize proposals beyond the immediate benefit of the institution and its staff such as injection of funds; capacity building etc. There is a tendency for African ERCs to allow international ERCs to arm twist them and bulldoze them into doing things that are obviously unethical by being blackmailed with promises of big cash flows and long term collaboration. In the process, pertinent ethical issues are overlooked for personal egos. It is high time African ERCs were empowered to keep aside individual and immediate benefits in favour of future benefit of the community. This way, mistakes such as this will become a thing of the past!


3. What are your views on other issues raised by this case study?

Apparently, It can be very difficult to trust collaborators. Looking at what Prof. Butler did, it is easy to imagine that this was a well planned game. It was only by “bad luck”…or was it good luck?? that someone became smarter than he was and stole the specimen. If it were not for this incidence, I believe these guys would have continued sharing these samples without due consideration to the plight facing the Tanzanian people. No wonder he later changed the story and said that the missing vials had been inadvertently destroyed after realizing his confession was getting him in trouble. Being a renowned scientist as he was, it is not so difficult to imagine any other person of his caliber doing a similar thing. This raises the need for local ERC not only to demand for clearance from international ERCs but also to put in place mechanisms to monitor what exactly happens to samples that are shipped to other collaborating partners.

[zinyama-gutsire]

1. It is important for researchers in developing contries to make sure that thier collaboarative partners have proof of being adequately cleared by their own coutries thics committes before they implement the research.

MTAs have to drafted and signed by all parties involved, clearly outlining how samples will be shipped, to avoid samples being transported in personnal luggage like what Dr Butler did in this case.

National Ethics committes in developing countries should lobby that there are adequate biosafety stndards for shipment of human samples which are potentially infectious.

All this happened because activities on this study were not adqately monitored by local ethics committes. The other lesson to learn is that there is an urgent need to build inspection and monitoring capacity in ethics committes in developing countries. EDCTP is one such donor interested in providing funding and building capacity within ethics commitees for such activities as monitoring of onging research studies.

2. Yes

3. Professor Butler got himself into trouble by saying conflicting staments about the whereabouts of the plague sample vials. He did not act in a professional manner. He raised the FBI's and everbody' curiosity by lying.

There are lots of ethical issues that can come out in collaborative research. This particular collboration was not adequately monitored.

Everything that happens in a collborative study has to clearly documented and proper procedures followed. Researchers in developing countries need to realise the importance of MTA agreements. National ethics committes can assist researchers by drafting MTA forms that can be used by all researchers for shipment of samples. And all shipment has to be approved and the method of shipment reviewed and approved.
_________________
Rutendo Zinyama-Gutsire (MSc, MpH)
Medical Research Council of Zimbabwe
Research Oversight Department
CY 573 causeway
Harare
Zimbabwe

[zinyama-gutsire]

1. It is important for researchers in developing contries to make sure that thier collaboarative partners have proof of being adequately cleared by their own coutries thics committes before they implement the research.

MTAs have to drafted and signed by all parties involved, clearly outlining how samples will be shipped, to avoid samples being transported in personnal luggage like what Dr Butler did in this case.

National Ethics committes in developing countries should lobby that there are adequate biosafety stndards for shipment of human samples which are potentially infectious.

All this happened because activities on this study were not adqately monitored by local ethics committes. The other lesson to learn is that there is an urgent need to build inspection and monitoring capacity in ethics committes in developing countries. EDCTP is one such donor interested in providing funding and building capacity within ethics commitees for such activities as monitoring of onging research studies.

2. Yes

3. Professor Butler got himself into trouble by saying conflicting staments about the whereabouts of the plague sample vials. He did not act in a professional manner. He raised the FBI's and everbody' curiosity by lying.

There are lots of ethical issues that can come out in collaborative research. This particular collboration was not adequately monitored.

Everything that happens in a collborative study has to clearly documented and proper procedures followed. Researchers in developing countries need to realise the importance of MTA agreements. National ethics committes can assist researchers by drafting MTA forms that can be used by all researchers for shipment of samples. And all shipment has to be approved and the method of shipment reviewed and approved.
_________________
Rutendo Zinyama-Gutsire (MSc, MpH)
Medical Research Council of Zimbabwe
Research Oversight Department
CY 573 causeway
Harare
Zimbabwe

[Constance Agwang]

Collaborative research is meant to be carried out among the collaborating groups and not any other people. It is against research ethics fro some one in a collaboration to take samples to another group that is not part of the collaborating team. All information and resources pertaining to the collaboration must be readily available to all those in the collaboration, there must be transparency and openness.

Material transfer agreements are very important such that in the event of a scenario like that of Prof. Butler, it would be very easy to account for the samples, and also incase he was discovered at the airport carrying such dangerous materials in his luggage, he would easily explain their use.

Biosafety standards should be followed so as to prevent un necessary exposure of the public to dangerous materials such as those in this case study.

Studies that have been approved should be constantly monitored to ensure that the researchers strictly follow the guidelines under which the study was approved. Many times researchers have a tendency of introducing other objectives into a study that has been approved and use samples without consent from the sample donors.

Employing and overseas researchers itself should not be an ethical issue, but the research carried out by the researcher is the one that should be reviewed and approved.

I think that even the people in the host institution in Tanzania should have been taken responsible for the illegal transfer of these samples. Taking the professor alone responsible was abit unfair for him and it did not call for stripping him off his benefits and title. It’s unfortunate that it happened that way.
_________________
Constance Agwang
Med Biotech Laaboraories
P.O Box 9364
Kampala, Uganda
Mobile: 256-77-257791