amanet-trust.org

[mahamatoure]

The aim of Ethics is to protect human and environment, basing on transparency. Therefore, I agree with the USA Ethics Committee because information must be universal for all. The Malawian Ethics Committee ought to protect its people above all when it is to save lives. National Ethics Committee should be the one who guarantee the good information for people. The principles of Ethics are universal. Ethics has the same goal everywhere in the world. Thus ethics of conducting research in developed countries are not (should not be) different from ethics of conducting research in developing countries.
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TOURE Mahama
Assistant-professor
Geneticist-molecular biologist
Mobile: (225) 05 09 89 08
22 PObox 580 Abidjan Côte d'Ivoire

[CHOUGOUO kENGNE Rosine D.]

I agree that the ethics committee American, since the disclosure of documents would be to ask for a full informed consent of parents of children participating in the search, as the Ethics Committee is there to regulate medical research on men to prevent abuse, when researchers hide this information means that research is biased. So I think the ethics committee of the U.S. that Malawi has not played its role as protector of the people, the guardian of the society by giving permission for the researchers. It is true that the study was designed to give a contribution to the damage arising from cerebral malaria but this is not clear.
Aspects of ethics in poor countries are different from those of developed countries for several reasons:
First Research is mainly carried out by researchers in the industrialized world sometimes in collaboration with scientists and researchers, but still subsidized by the industrialized countries.
Second in industrialized countries biomedical research is very well regulated by a framework of institutional guidelines, national and international, supported in most cases by appropriate legislation and a generally favorable environment, while in developing countries, such frameworks are almost non-existent which exposes them to serious risk of unethical research, especially since the current ethical guidelines formulated by the industrialized world, following their own vision and point of view, do not respond well in many respects the interests and concerns of the world developing.
At last Differences in cultural backgrounds
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Rosine Désirée spouse NKUITCHOU
Pharmacist UdM Bangangté/ CAMBIN Cameroon

[mahamatoure]

The aim of Ethics is to protect human and environment, basing on transparency. Therefore, I agree with the USA Ethics Committee because information must be universal for all. The Malawian Ethics Committee ought to protect its people above all when it is to save lives. National Ethics Committee should be the one who guarantee the good information for people. The principles of Ethics are universal. Ethics has the same goal everywhere in the world. Thus ethics of conducting research in developed countries are not (should not be) different from ethics of conducting research in developing countries.
_________________
TOURE Mahama
Assistant-professor
Geneticist-molecular biologist
Mobile: (225) 05 09 89 08
22 PObox 580 Abidjan Côte d'Ivoire

[CHOUGOUO kENGNE Rosine D.]

I agree that the ethics committee American, since the disclosure of documents would be to ask for a full informed consent of parents of children participating in the search, as the Ethics Committee is there to regulate medical research on men to prevent abuse, when researchers hide this information means that research is biased. So I think the ethics committee of the U.S. that Malawi has not played its role as protector of the people, the guardian of the society by giving permission for the researchers. It is true that the study was designed to give a contribution to the damage arising from cerebral malaria but this is not clear.
Aspects of ethics in poor countries are different from those of developed countries for several reasons:
First Research is mainly carried out by researchers in the industrialized world sometimes in collaboration with scientists and researchers, but still subsidized by the industrialized countries.
Second in industrialized countries biomedical research is very well regulated by a framework of institutional guidelines, national and international, supported in most cases by appropriate legislation and a generally favorable environment, while in developing countries, such frameworks are almost non-existent which exposes them to serious risk of unethical research, especially since the current ethical guidelines formulated by the industrialized world, following their own vision and point of view, do not respond well in many respects the interests and concerns of the world developing.
At last Differences in cultural backgrounds
_________________
Rosine Désirée spouse NKUITCHOU
Pharmacist UdM Bangangté/ CAMBIN Cameroon

[Dr. James Chipeta]

CASE TWO
What are your views?
I am of the view that the local IRB in Malawi should not have allowed this study to be conducted with incomplete disclosure to the participants of what was actually happening in the study. Clearly from the study protocol(consent) there was clear intent to withhold the truth of the study procedures and thus denying the participants of an informed consent. The fact that only 38% of the participants eventually agreed to participants shows the inadequacy of the informed consent. The local IRB should have known better is that what is paramount is the participants/volunteer’s rights first and not the study beneficial results.

Which Ethics Committee decision do you agree with? Give reasons.
I agree with the USA IRB as they seem to have the participants’ rights in perspectives.

Are the ethics of conducting research in developed countries different from the ethics of conducting research in developing countries? Give reasons.

In reality they are different though essentially they should not be different. What makes the little diference are the different norms/customs that may make the ethics conducting research different

[Friday Odey]

PARTIAL DISCLOSURE OF INFORMATION VERSUS POTENTIAL BENEFITS OF HEALTH RESEARCH
There was partial disclosure of information to the families of the deceased children by the researchers and approved by the Malawian ethics committee in the sense that families of deceased children were not informed in explicit language that the eyes of the children will be removed and replaced with artificial ones. This violates the element of full disclosure of information in the informed consent process. Thus the informed consent process is flawed.
While I sympathize with the ethics committee in Malawi that Africans for cultural reasons do not subscribe to autopsies, they are duty bound to give full information nonetheless. One way to reduce this misplaced emphasis on the perceived benefits of the research to the core issues in reviewing protocols is to train members of the various ethics committees.

I support the ethics committee in the USA for doing a critical appraisal of the protocol and rejecting it justly. Informed consent means that full information is given to participant in research such that they understand what is involved and voluntarily decide to participant.

The ethics of conducting research are the same in all parts of the world. The principle that equals should be treated equally applies to ethical review process. What is not good for humans living in USA is not good for people living in Malawi.
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Jesus is Lord.

[Ndam]

I agree with US committee. It should have been clearly mentionned that eyes would be removed as to me it’s not true that « you would not see any marks or changes on the face » Parents would certainly notice artificial eyes, this is more than partial disclosure but delibarate lie in the consent form. The African countries are facing the burden of disease and related death, they are in a position of welcoming any investigation that can help save lives. This is an unacceptable but natural weakness that can affect appreciation of health benefits/authorized ethical sacrifice ratio.
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Nicaise Tuikue Ndam, PhD
Mother and Child Health in the Tropics
UR010-IRD/ISBA Cotonou
Benin

[goadjei]

While it is true that in certain cases where potential benefits could outweigh the requirements for full disclosure, this point of view, which is underpinned by utilitarian precepts, has counter arguments. Partial disclosure in this case could result in a false sense of harmony, in terms of cultural norms and practices and it is unlikely that the local populace would not have understood the term ‘eyes’ if this, rather than the term ‘body parts’ had been used. There is a high probability that the partial disclosure in this case, with the use of the nebulous term "body parts" was to evade the potential cultural sensibility of full disclosure

[mworozi]

Case study 2
I agree with the USA ethics committee decision: the informed consent should give all information about its procedure and should have clearly stated that the eyes removed would be replaced with artificial parts. It should have clearly stated the truth as much as possible to the participants so that they can make an informed decision whether to participate or not.
The participants should also have had an explanation about the study, its objectives and what its benefits would be. It was also not correct to allow the study to continue based on the approval of the Malawi ethics committee decision only.
The ethics of conducting research in developing countries are not different from those in developed countries. The principal of the protection of the safety and rights of participants in research should be the same whether the study is done in developed or developing countries. Some differences may apply due to cultural or technological differences but this should be minimized as much as possible.

[FabriceBoyom]

1. Generating knowledge about the damages caused by cerebral malaria to the retina of children who in spite of treatment, die from cerebral malaria sounds good. But according to my view, the background looks weak because no relevant statistical data that could better orient the decision of study participants supports it. In addition, participants are not thoroughly informed on the outcomes and benefits from this study.
2. Although people from Malawi suffer from the malaria blast and are looking forward for efficacious control measures, they are not explicitly informed about the procedure and subsequent benefits. This might be why up to 62% out of the 161 (59+102) invited families refused to participate. Therefore, I agree with the American Ethics Committee.
3. Ethics of conducting research should be the same in developed and developing countries as far as human subjects are involved, though ethno-cultural believes and practices vary from one point to another.

[offianan]

1/ Investigator should adhere to GCP and to ethical principles which origin is in declaration of Helsinki. Investigator should fully inform research participant of all pertinent details of the study in order to enable them to give free informed consent.
The whole essence should be respect to research participants, beneficence and justice.
By approving the protocol of study with only partial disclosure on the consent form, Malawi ethics Committee did not respect the rights of participants to full information.
Malawi ethics Committee gave more importance to the potential benefits from the study which, most probably will contribute to reduce deaths on Malawian children.
In medical research on human subjects, considerations related to the well-being of the participants should take precedence over the interests of science and society.

2/ I fully agree with the United States of America Ethics Committee. Ethical decisions must be seen to be honest and transparent.
Participants should know exactly the full nature, benefits and all other implications of the trial for which their consent is solicited.
The participants in developing countries are more vulnerable due to their lack of knowledge on their rights.
According to ICH-GCP guidelines it’s an obligation for the researcher to inform parents of Malawian children about all procedures that were being carried out in the study for them to make informed decisions.
3/ According to the ICH-GCP guidelines ethics of conducting research in developed countries are not different from the ethics of conducting research in developing countries. The ethical principles are universal. The rights of participants are the same and must be protected.

Offianan Andre Toure
Malariology Department
Institut Pasteur Ivory Coast

[kabongo]

From 1990, there are many debats between researchers and bioethicans about legitime conditions of research in south contries wich depend of universitie of the north contries. Paradox remains because despite of many African researchers in anthropology, contectualisation of ethics remains very dificult.
The bioethics debats focused on the agreement confidentiality of data and informations about research subject but no contextualisationof those concept for HIV patients in African contries many researchers forget that this contextualisation must be negociated.
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kamitalu

[ALONI MICHEL]

The problem of Malawi study shows the alienation is consecutive to the absence of recognition about the perception of local context specificity for sickness.It is important to propose an alternative based on the prevention according to the needs evoked by the American ethic Committee.

Anthropology and epidemiology lead to the ethics thinking with nice judgement which include moral and descriptive evolution and normes.This will create a multidisciplinary discussion.This approach will aim to the to the applicated bioethics.The American ethic committee must think a lot about regulation of local research conditions,this will avoid conflict about researchers interest.Some concepts like consentment,data confidentiality are not included in Malawi context
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Aloni Ntetani Michel

[Constance Agwang]

My views on this case study:
I do think that both committees’ decisions are good and show that they clearly mind about the participants. On the other hand, the US based committee was so right to demand that the whole information pertaining to the study must be given to the parents. The Malawian committee was too quick to approve of the study inspite of the weaknesses pointed out in the study by the US team, probably they saw how these study would be beneficial to the children in Malawi. It is important that in a case like this whereby two different ethics committees are involved, there should be an agreement between the two for the good of the study subjects.

I would agree with the USA committee, because these people deserve to know everything about the study, it’s their right to know before they can consent to taking part.

Ideally, ethics are meant to the same everywhere, because the study subjects are all human beings who have equal rights o being protected
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Constance Agwang
Med Biotech Laaboraories
P.O Box 9364
Kampala, Uganda
Mobile: 256-77-257791

[zinyama-gutsire]

This study was unethical because there is a clear element of deceit in the informed consent form and process. The researchers did not clearly inform the participants that the removed eyes will be replaced with artificial ones.

l support the stand taken by the Ethics Committee in the US. Ethically it is important to show respect to research participants, to give them all information in the informed consent which pertains to the research study. This helps in building trust and confidence between researchers and participants.

So I conclude that the Malawian Ethics Committee members were quite aware of the cultural aspect that the people would not agree to their relatives being buried with their eyes removed. The ethics committee feared that people would not join the study if they knew about this clearly. The committee felt the befits of the study justified partial disclosure of information.

I agree with the Ethics Committee in the United States of America. If participants discovered that they have been lured into doing what they would not have done willingly through deceit, they are likely going to loose confidence in researchers to the extent that even when something is for their benefit they may still be suspicious, feeling that the researcher has some other agenda up his sleeves.

Problems faced by ethics committees in developing countries include:

1.Most Ethics Committees in developing countries do not have adequate expertise to review proposals. This results in some ethical concerns not being raised like this one of inadequate information being given to participants parents
2 Lack of funding for research in developing countries and perceived benefits of research and scientific publications that can help the researchers to be promoted. It is very unfortunate that Ethics Committee members in developing countries compromise standards.

3. Participants in developing countries are more vulnerable due to their lack of knowledge on their rights when they participate in research.
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Rutendo Zinyama-Gutsire (MSc, MpH)
Medical Research Council of Zimbabwe
Research Oversight Department
CY 573 causeway
Harare
Zimbabwe