amanet-trust.org

[kabongo]

1)Ethical Committee of developed contries are higher (with very stringent regulations) than of the developing contries the ethical level of developing contries is low and they make consessions in order to obtain funds, so may be in developing contries training in etihics are insufficiant
2) no
3) no
_________________
kamitalu

[Resign]

It is quite clear from this case study that the local ethics committees were a bit more focused on the proposed capacity building and community consultation programs. They were pleased that their institutions were going to get a substantial injection of research funds. This could have brought bias in the decisions that the local ethics committee made. Most developing countries still don’t have proper guidelines on shipment and storage of biospecimens and some foreign researchers have actually taken advantage of that and have shipped specimens to developed countries without proper ethical approval. This perhaps results in countries with lesser balances and checks for shipment of specimens attracting a great deal of researchers from the developed world as compared to those countries with proper guidelines in place. This is definitely an ethical issue of concern. While I agree with the concerns raised by Ethics Committee in the developed country, I feel that it is easier for that Ethics committee to make such comments as they don’t face the same challenges that developing countries are facing. The different ethics committees are definitely influenced by different factors, Issues of capacity building for example cannot affect an ethics committee in a developed country in the way that it does in a developing country
_________________
Resign Gunda
Medical Research Council of Zimbabwe (MRCZ)
Harare
Zimbabwe
gundazr@yahoo.co.uk
+263-912-876825

[Beverly Msambichaka]

Here we are talking about an investigation to address problems affecting developing countries, yet if you look at the study team the Lead Investigator (PI) comes from the developed countries. Is the PI a better expert of the research methodology, is the PI better informed about the disease and the environment?

De-linking data and providing access to the PI brings in another ethical concern. Data collected should have direct benefit to the community involved. Local PIs should be there and have full access to the data, procedures and all pertaining the study. In doing so, the Co PIs can make sure that rights of participants are protected, approved protocol is adhered to while maximum benefit of the project goes back to the community. A clear data sharing policy should be put in place right from the beginning to ensure that Co PIs can fully access data collected from their people. Without access to the data, the Co PI will not even be able to publish unless it has been decided by the PI.

The Ethical Committees should not have approved the study not knowing how the samples will be Stored, for how long and how will the samples be destroyed after the storage period. Moreover, if there are any known future studies, this information should be included in documents reviewed by the EC (ie the protocol as well as the Informed Consent Form).

Justification of shipping samples was due to lack of capacity to carry out the analysis in the developing countries. It did not specify whether it was lack of human capacity or equipments and machines. Training has been mentioned but not directed to building capacity for sample analysis of similar nature in the future.

It seems the EC in the developing countries where blinded on the fact that this is a genetic study that intends to analyse a large amount of samples on DNA particulars, clinical patterns as well as demographic information. This kind of study not only puts a risk of exposing the biological identity and social cultural patterns of an individual but also the community at large. In which case the implications need to be carefully analysed and communities educated on risks/benefits of their communities getting involved. Perhaps there might be a need to seek consent from the community as well. It was also noted that the PI was very clear about not wanting to be involved with community consultation. He could see ahead the potential of communities putting blame and he did not want to take any responsibility.

It was also noted that EC in the developed countries highlighted important concerns, without providing any solutions or direction of addressing them. They simply approved anyway. Perhaps the developing countries could have picked up from the concerns raised in the developed countries, sadly they did not.

[zinyama-gutsire]

Dear Dr Aceme

1.The concerns raised by the Ethics Committee in the developed country were sensitive issues therefore the various Ethics Committees in the developing countries should have attached great importance to the issues before granting approval. For instance, the use of archived samples without ethical approval or informed consent from patients, together with , not well established regulations regarding collection, storage and use of DNA samples and genetic database could encourage the Researchers to conduct any further analysis on the stored sample without prior consent from participants.

2. Generally, the local Ethics Committees were concerned about capacity building of local researchers and community consultation. The measures proposed by the researchers to address the concerns raised by the local Ethics Committee yes did address their concerns. To address the issue of capacity building it was proposed that the project would provide postgraduate training for the participating institutions. Training workshops would also be organized for junior researchers during the course of the project. To address the issue of community consultation, it was proposed that some of the postgraduate scholarships would focus on community consultation and informed consent issues surrounding genomic studies. In addition, an advisory group of renowned African professionals would be set up to advise the consortium on cultural and traditional issues.


3. No the Ethics Committee did not scrutinize the pertinent current and
future issues accordingly because they did not make arrangements for
future use of stored DNA samples. Capacity Building was important but the issues raised by the Ethics Committee in the developed country were not addressed at all.
_________________
Rutendo Zinyama-Gutsire (MSc, MpH)
Medical Research Council of Zimbabwe
Research Oversight Department
CY 573 causeway
Harare
Zimbabwe

[makamche]

Dear Dr Aceme,
We cannot compare nor contrast any issues here since both the ECs from developed countries or developing countries were satisfied with the terms of the research and raised no issues. This type of situation is very dangerous as this may lead to problems later on.
No Ecs committees in most developing countries are young and unexperienced. Their judgement is at times impaired by their immaturity and the huge sums of money sponsoring countries pour in studies. Thus I could say local Ecs lack at times the means to adequately address the concerns in practice.
No. they simply were interested by the training of post graduate students in developed countries.
_________________
Dr Marie Florence Makamche épse Dzukam
Ph.D Molecular Virology
CANTAM, CIRCB
P.O. Box: 3077
Yaounde, Cameroon
Mobil: 74 61 36 44

[Elizabeth Ochola]

Dear Dr.nyika,
1. Ethics commmitees in developing countries tend to overlook some aspects of research at some point i.e. lack of control regarding storage and use of old DNA and genetic databases, samples from teaching hospitals being used for future research purposes without informed consent from the patients from developing countries.

2.Not a well handled case by the local ethics commitee in the developing countries because they were more concerned with capacity building, training grants and workshops, an dethical concern came a distant third.

3.The Ethical commitee in developing countries did not scrutinise all the pertinent issues, in that DNA samples would be stored for unspecified period for future research and archived samples stored over many years were used for research purposes without ethical approval and informed consent
The ethical commitee in the developed country identified this issues but went ahead and granted approval., which was not right.
_________________
Elizabeth Ochola
NTD
Schistosomiasis Project
Kisumu,
Kenya

[makamche]

Hi!
We cannot compare nor contrast any issues here since both the ECs from developed countries or developing countries were satisfied with the terms of the research and raised no issues. This type of situation is very dangerous as this may lead to problems later on.
No Ecs committees in most developing countries are young and unexperienced. Their judgement is at times impaired by their immaturity and the huge sums of money sponsoring countries pour in studies. Thus I could say local Ecs lack at times the means to adequately address the concerns in practice.
No. they simply were interested by the training of post graduate students in developed countries.
_________________
Dr Marie Florence Makamche épse Dzukam
Ph.D Molecular Virology
CANTAM, CIRCB
P.O. Box: 3077
Yaounde, Cameroon
Mobil: 74 61 36 44

[jessegitaka]

Dr.Aceme,
1, The ethics committee in the developed country clearly understood the likely implications of possible genetic research findings on the populations. In their concerns, it should have been explicitly stated, the holding time of the samples, this was useful as the finding may have had important but perhaps controversial points in relation to the participants’ progeny. Also, samples that had not been consented for was going to be used, with the reversibility of the identification code, the participants or their community may at a future date be embarrassed by findings from a study had they known would not have consented for. The ethics committees in developing countries failed in grasping the possible ramifications of such research in the future. They were more concerned with the immediate benefits in capacity building, funding and community consultation. These are important factors to look at, but without proper foundation at ethics, these benefits may be wiped out.
2,The measures , community consultations, cultural evaluation and consent issues done properly would have helped in addressing the concerns, since the participants would have been empowered to make autonomous decision. But again this would not have covered for the already collected samples and the holding time frames should have been stated clearly and the participants educated on pros and cons.
3, The ethics committees clearly failed to scrutinize the potential issues at play, currently and more so future. They did not have a clear strategy for the future handling of the samples and findings.

[oujumeora]

The concerns raised by the Ethics committees in the developed countries and those from developing countries underscore the differences in capacity between both Ethics committees.
The developed countries’ ethics committees were concerned about protection of the research participants and the communities by focusing on critical issues in informed consent involving genomic studies as well as collection and handling of human genetic/biological materials. They also raised concern about ownership of collective data. They also realized the peculiarities of the different local ethics committees hence the conditional approval given the protocol in the developed country pending approval by the local ethics committees. On the other hand, the ethics committees in the developing countries, were concerned with capacity building and community consultation in the process of collection of biological specimen. They failed to focus on the informed consent process as well as the intricacies of studies involving genetic materials.
One is constrained to think that ethics committees in the developed countries must have realized the lack of expertise among local ethics committees in issues relating to genomic studies and went silent on it. The protocol should have been temporarily suspended till such a time that adequate capacity exists within the local ethics committees to review such protocol.
The measures to be undertaken to address the concerns of the local ethics committees may help but will not adequately address such in practical realities. In terms of capacity building the postgraduate training is worthwhile but it remains to be seen how many would be trained and by the time they are through, the study might have been far advanced. However, for community consultation, the proposed measure may not meet expectation. Improving capacity for community consultation must not just involve the researchers only but community members as well.
Finally the ethics committees did not adequately scrutinize the current and future pertinent issues surrounding the study. Such critical issues include, the use of samples obtained without consent for research (archived materials); the non specification of anticipated future studies on the materials, protection of community identity as the samples were ‘reversibly’ de linked and left with the PI. Also capacity building for local institutions to undertake storage and processing of genetic materials and the scientists to analyze genomic data were ignored.
_________________
Dr. OUJ Umeora
Editor, Ebonyi Medical Journal.
EBSUTH. Abakaliki - Nigeria



All men are born equal and with innate integrity

[Tekwu]

Dear Dr Aceme,
1. We have here the kind of Study focuses of the genetic information contained in the hereditary molecule, the DeoxyriboNucleic Acid (DNA).
This research proposal is an example of human samples that some were not collected for research purposes (hence there was no informed consent) and another were collected for research purposes, with informed consent explaining that the samples may be used in research and stored for future use. Here an important issue seems not to be cleared as related to the future studies mentioned. It is not ethically right to collect sample for one purpose and use it for another purpose.
I notice that the concerns of the two teams were very different. While the Ethical Committee in developed country raised ethical issues about the proposal like the storage of the DNA sample, the informed consent to be used for prospective collection of samples and approval, the local Ethics Committees were satisfied with the proposed capacity building and community consultation programs, they were pleased that their institutions were going to get a substantial injection of research funds and approved the proposals unconditionally.
Both the Ethical Committee in Developed country and the Ethical Committee in developing countries deliberately ignored the ethical issues about the human participants involved while they are meant to protect the rights and the welfare of the participants.

2. I don’t think that the measures proposed by the researchers to address the concerns raised by the local Ethics Committees have the potential to adequately address the concerns in practice. Maybe the postgraduate scholarships were good for capacity building but the measures for community consultation were not satisfactory. The proposed measures will benefit the researchers themselves and the academicians and not the participating communities.

3. The Ethics Committees did no scrutinize all pertinent current and issues surrounding the project. Although the ethics committee in the developed country raised up quite important ethical issues but they could have done more. What they raised up concerns especially the future but did not bother to follow up to make sure that they were handled before giving their approval.
A very little was done by the local Ethics Committees. It seems like they lack the capacity to review research proposals focuses on the genetic or they did not review the submitted proposal. This is observed in the fact that they did not do anything to ensure that the concerns raised by their counterparts were taken care of before approval.

Emmanuel Mouafo Tekwu
Ph.D student – Cantam TB Project
Laboratory for Tuberculosis Research
Biotechnology Centre/University of Yaounde I
Email: etekwu@yahoo.fr

[psoipei]

1) The concerns raised by both the Ethics Committee in the developed and the developing countries were valid and since concerns of the IRB in the developed country could have serous implications in future if not addressed, there should have been some consultations with the local IRBs on how to address and actually resolve them other than putting them under the carpet . I also feel that the local IRBs were more interested on the gains/benefits (financial, capacity building) than anything else.
2) No
3) No


Thanks
PS

[sithembile Ruzario]

1.Compare and contrast the concerns raised by the Ethics Committee in the developed country with those raised by the various Ethics Committees in the developing countries.

The issues raised by both ethics committees are genuine and important. The developed countries IRBs were more concerned about capacity building so that shipment will not be necessary in the future, they came up with own research objectives which according to them were of great importance. The problem with developing countries IRBs is because they lack education on ethical issues surrounding specimens, they do not have guidelines to follow and worse still, among the 35 countries you will be surprised to hear that some of them do not even have IRBs at all. Some of the IRBs are one man band and no discussions take place before approval. Due to lack of funds some IRBs meet once in 4 months, in the mean time proposals will be done with no approval or will be reviewed by one member. IRBs in developing countries are not funded and very difficult to run. The differences in the responses show that these people come from different backgrounds and they look at situations differently. They were more interested in getting grants than anything else.



1. Did the measures proposed by the researchers to address the concerns raised by the local Ethics Committees have the potential to adequately address the concerns in practice?

The measures proposed by the researchers to address the concerns raised do not have the potential to adequately address the concerns in practice. They were supposed to address the concerns raised by the IRBs from developing countries before hurriedly approving the proposal for harmonization purposes. This was actually a learning experience for the other IRBs in developing countries. They were supposed to take one by one of the issues raised by IRBs from developing countries and ask themselves why? In practice communities are to be involved from inception of study to finish and not only researchers are supposed to benefit from research but even the community that participated.
3. Did the Ethics Committees scrutinize all pertinent current and future (beyond the life span of the consortial project) issues surrounding the project?
The Ethics Committees did not scrutinize all pertinent current and future issues surrounding the project. The issue of how results were going to be published, how the community were going to be told of the results and how the specimens were going to be destroyed was not addressed These IRBs need education and even to hire external reviewers if they are not capable
_________________
Sithembile Ruzario
Medical Research Council of Zimbabwe
Research Training and Monitoring Officer
sithembileruzario@yahoo.co.uk

[Aida Nakawunde]

1.
The ethics committee in the developed country was basically interested in DNA samples, data and storage of the collected samples whereas the ethics committees of the developing countries showed more interest in capacity building and community consultations.

2.
The measures proposed by the researchers to address the concerns raised by the local ethics committees did not have the potential to adequately address the concerns in practice. It’s good to have capacity building within the local institutions but how many local researchers (trainees) are trained? Usually 1or 2 who are inadequate and not sure whether they would practice/apply the acquired skills In addition they will acquire the knowledge yes but if the samples are collected they will STILL be shipped due to lack of appropriate storage facilities in the developing countries and finally they wont be able to participate in the analysis. For community consultation and informed consent issues surrounding genomic studies few communities would really be interested.

3.
The ethics committees did not scrutinize all pertinent current and future issues surrounding the project.

No material transfer agreement was signed. Did not see any statement about seeking ethical approval for the future studies to be done on the collected samples. As it appears in the case study no one knows what will happen to the stored samples.

The duration of storage of the samples was left infinite which is unethical. Should specify the time

Usage of samples that are collected with out the consent of the participants is unethical I thought the local ethics committees would raise this

The PI and Co-PIs should have access to the overall database containing the pooled data derived from all the participating institutions and access to the de-linking code.
_________________
n aida

[sahmed]

The Ethical Committe in developing countries didn't look on the Scientific validity of the study.They were concerned about getting the grants and have capacity building for their researchers without much consideration on the conducting the study.
Issues like Informed consent process,Duration of Informed consent,Storage of the samples and ownership of the database and involvement of local scientist in processing and analysis could be crucial and could built capacity for African.

Becaus Our EC are weak so the developed country took opportunity and exploit poor African.The Representative didn't look beyond Grants available.

Did the Ethics Committees scrutinize all pertinent current and future (beyond the life span of the consortial project) issues surrounding the project?

The Ethic Committees in developing countries did not scrutinize all pertinent current and future issues surrounding the project . Consent should be asked and even permission for sample to be used for other purpose could be asked so that participants can know what was going on in that study.

Ownership of the database by Pi-that was unfair and all CO_Pi needed to have the de-link codes even before the project start(crucial issue in planning to do genetic studies).Sadly it didn't happen here.



Saumu.
_________________

[Abdulai Ali Martha]

1. I fully support Prof. Bomba Kabisa’s school of thought, the essence of the consortium is to be able to share data and results. This means that members should be able to access the data through the lifespan of the consortium and after that do that at their own cost.
2. All gatekeepers should discuss beforehand the issues surrounding data sharing policy.

3. The principle of justice and beneficence supports my assertion that the benefits and risks of a study should be fairly and equitably distributed.
4. All gatekeepers from collaborating institution should be involved