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[Munsoor Mohammed Munsoor]

Dear Aceme
My view to case study 8 is that
First of all I support Professor Bomba Kabisa’s school of thought and fully agree to the fact that lack of access to the pooled data negates the whole purpose of forming a consortium in the first place. When data has to be collected under such arrangements, most of the time each participating institution will be dealing with a small sample size that only make significant statistical sense to analyze when you pool the data from other institutions together. Therefore, even if you have access to your own data, this may provide some picture about the research question. Moreover, the kind of study that has to do with population-based genomic epidemiological study is highly sensitive and therefore affording equal access to all participating institutions. I think continuing access after the expiry of the project can help follow up on unforeseeable issues that may arise in future and as such when new technology develops, more future analyze can be done that can still be to the benefit the community.
I think data sharing policy should be implemented in away that allowing all parties access to the information for at least the 5 years of the project. However, if there is a need for the data at the end of the project, they can do so very easily. I think it is still appropriate that one institution can be coordinating the pooling of data from the other institutions but for all planned interim analyses and final analysis.
I think that, representatives from the collaborating institutions (local Principal Investigator or Co-Investigator and a Biostatistician) should be involved in determining an appropriate data sharing policy for such a consortium
Munsoor M. Munsoor
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munsoor

[reno]

1- I strongly support Prof. Kabisa point, because lack of access by the local collaborators to the pooled data generated from the project would negates the purpose of the consortium. This may look like a ploy to use the local collaborators by the international collaborator, exploitatively use their data and abandoned them. The fact that the local collaborators may be deficient in some of the state of the art research equipment, do not mean that we should be starved of some vital research data or information. For so long, our international collaborators think that the local collaborators would be satisfied with “fish” and not both the “fish and hook” which they have. Unfortunately, they are wrong , what we now want in the 21st century are both “ the fish and the hook”.

2- The consortium could have created at the onset of the project(during negotiation) a data management system which enable all the co-investigators to get access to the data base.

3- Ethical principles are aso duties in a consortium. Data must be frankly shared.

4- For the determination of an appropriate data sharing policy, a committee comprising of representatives from all the participating regions/countries is being suggested.
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malaria and the others tropical diseases are an obligation for the african scientific commumity. I would like to have a part from this heavy labour

[mahamatoure]

I agree with the first school of thought; all the data should be shared by all collaborators, at least, after the 5 years duration of the project. The point of view of the second school is like trading. When collaborating in a research programme, the real benefit should be the outcome of the findings for human being and not profit for a group of researchers who got scholarships and other opportunities.

The data sharing policy can be implemented by having a website for the consortium. Workshops and conferences can be tools to share information and data.

I agree with the first school of thought and I think that all the data should be shared by all collaborators. Indeed, this school respects two major principles of Ethics which are TRANSPARENCY and EQUAL RIGHT. All collaborators must be at the same level of information (i.e. the same data for all). This transparency means that collaborators would have the same Right.

A committee of all the countries involved in the programme can determine the appropriate data sharing policy. Anyway, a bioinformatician should be involved in such a decision.

[Friday Odey]

DATA SHARING IN AN INTERNATIONAL COLLABORATIVE RESEARCH PROJECT.

1. I share the views expressed by Professor Bomba Kabisa. The aim of the consortium was to collect adequate samples to achieve a significantly high statistical power in a population-based genomic epidemiological study. Denying the collaborating centers access to the data means that they cannot have sample size with adequate statistical power to reach conclusions. It will appear therefore that they were used mainly for data collection. This is against the principle of justice that the risk and benefits of the research should be equally shared.

Every one on the consortium should continue to have access to the pooled data both during and after the 5 year period. The pooled data belong to all members of the consortium and not only to the coordinating centre. To deny others access to the data they contributed in a consortium is deception in the research process. New information may emerge that the data already collected may be used to further straighten the objectives of this research.

2. The coordinating centre should continue to custody the data but every institution on the consortium has access to the data. This is because conceptualization of ideas could come from any of the collaborators. The coordinating centre should inform others on any new idea from any of the centers and allow them to contribute to that new idea and those that are not interested can then be left out. But everyone should have any opportunity to decide on their positions.

3. The ethical principle that supports my position is the principle of Justice. Equals should be treated equally. All collaborators should bear the risk and benefits of the research. It is only fair that all those that contributed data should have access to it. First the research protocol for the project should have clearly stated this from the beginning. If this was not stated then it constitutes deception in the research process.

4. All the coordinating investigators or their representatives should be involved determining the data sharing policy for the data they jointly owned. This has to be part of the protocol. If it was not there already, it should be in the amended protocol.
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Jesus is Lord.

[CHOUGOUO kENGNE Rosine D.]

1) I agree that Professor Kabisi Bomba, a local employee of the co-principal investigators based in a developing country. Because during the work of research, the results must be published so that even the research participants know what they served. This case study appears unjust, and the spirit of superiority that developed countries to developing countries. Normally because it is a consorption all parties who have contributed to the collection of databases should share the data bank provided that each researcher is not used to these late own, so the ethics committees of the various Countries should ensure equality and good management of data, or it should have a workshop bringing together all parties that either developed or developing countries to discuss this a reach agreement.

2) The data sharing policy should be determined by the participating institutions and a common agreement should be reached.

3) Ethical principles supporting my opinion are
The principle of Beneficence - equal distribution of benefits and risk.
The principle of Justice – fairness and equity

4) All the partners from the various collaborating institutions should be involved in the decision of the data sharing policy and The WHO and her sister organizers because they most appropriate to undertake this task.
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Rosine Désirée spouse NKUITCHOU
Pharmacist UdM Bangangté/ CAMBIN Cameroon

[goadjei]

All parties in a consortium should ideally have access to all the data - provided it is mutually agreed what can and what cannot be done with data collected from each respective institution beforehand. The reasoning that management of the database would be cumbersome after five years is short-sighted at the least. it is incumbent on the researchers to put measures, as part of the research process, to be able to manage the data generated from the researchs. The opportunity to get research funds is not sufficient justification to place such limitations on data collected from institutions from deprived countries. The population from which the data was collected should have been involved. The local ethics committee could also be involved in the decision on potential fate of the data.

[mworozi]

Case study 8
1. To some extent I agree with Prof. Bomba Kabisa. I think that her argument that co. investigators should have access to pooled data after the expiry of the consortium is justified. However, this should be requested for specifically and the purposes for which it is being requested stated. In addition other co. investigators should be informed about this and their permission sought. Not all pooled data should be requested but specific data.
We are not informed if the participants were informed that apart from their data being reported as pooled it could also be given to other investigators from other sites.
The other benefits such as capacity building and publications though very important are secondly because these are part and parcel of research studies.

2. The data sharing policy during the duration of the consortium and after its expiry should have been discussed and agreed upon before the implementation of the study.


3. The ethical principles to consider here are:
Confidentiality of the participant data, transparency, respect, professionalism and protection of intellectual property rights.

4. The responsibility for determining an appropriate data sharing policy for such a consortium in this case study lies with the PI and Co-PIs of all the sites, and participating institutions. These should select a committee from among themselves to implement the policy.

[Ndam]

1. I totally support the views of Professor Bomba Kabisa about full access to data by all partners. From the time it’s a collaborative approach all participants should have to share knowledge and information generated from the study without restrictions.

2. The principles of ownerships rights, confidentiality, benefit - sharing among others, with the details of such sharing agreement explicitly stated and would have been discussed and understood by all before being a partner of the consortium.

3. There’s no reason that institution because it is based in a developing country be denied access to pooled data from most developing countries, while at the same time the Partner from the developed country have. There’s something wrong in the concept !!!
benefit –sharing process which relies on equitable benefit sharing would be violated otherwise.

4. All the partners from the various collaborating institutions and funding organisations/agencies (sponsors) should pay attention and insist on clear data sharing Policy before initiation of the project.
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Nicaise Tuikue Ndam, PhD
Mother and Child Health in the Tropics
UR010-IRD/ISBA Cotonou
Benin

[Dr. James Chipeta]

1. I share the informed school of thought of the Prof. for the simple reason that co-investigating in a study entails that the results and data thereby should be also be co-owned otherwise what is the purpose of being a co-investigator if one cannot access the rest of the study data other than his/her contribution. He/she could as well independently done the respective study component alone.
2. In a co-owned study data the participating groups/investigators should as a matter of principal jointly work together updating one another on the study as a whole.
3. The ethical principal to adhere to is justice and fair play.
4. The research consortium/group under the chairmanship of the PI

[Dr. James Chipeta]

1. I share the informed school of thought of the Prof. for the simple reason that co-investigating in a study entails that the results and data thereby should be also be co-owned otherwise what is the purpose of being a co-investigator if one cannot access the rest of the study data other than his/her contribution. He/she could as well independently done the respective study component alone.
2. In a co-owned study data the participating groups/investigators should as a matter of principal jointly work together updating one another on the study as a whole.
3. The ethical principal to adhere to is justice and fair play.
4. The research consortium/group under the chairmanship of the PI

[FabriceBoyom]

This case resembles the case study number 5, with the difference that one of the collaborators from a Developing country has raised an issue on data sharing, and specifically the access to the pooled data in the database, during and after the consortial project. I personally support this school of thought, because collaborators should contribute to the success of the whole project, and consequently share benefits during and after its completion.
The implementation of such a data sharing may be through a database protected by a unique password that is accessible to all collaborators.
The study is been carried out mainly for mankind benefit. Therefore, data should be shared and used according to established rules where there is need. This is according to me the basic ethical principle underlying this position.
The determination of the data sharing policy should be established by all the involved investigators in consideration of ethical issues. The views of study patients may be taken into account in some cases.

[offianan]

1/ I support Professor Bomba Kabisa’s school of thought and agree with her to the fact that lack of access to the pooled data negated the whole purpose of forming a consortium in the first place. All investigators from the various institutions forming the consortium should have benefit and equal access to the complete database trough out the life span of the consortium.

2/ the data sharing policy I support would be implemented by having a meeting with all institutions forming the consortium for data analysis and report writing.
Conditions to publish results should be known by each investigator in order to avoid conflict of interest.

3/ Respect of persons, justice and autonomy are the ethical principles which could help to support my position.

4/the PI and Co-PI from all institutions forming the consortium should be involved in the determination of an appropriate data sharing policy for such a consortium involving developed and developing countries.

Offianan Andre Toure
Malariology Department
Institut Pasteur of Ivory Coast

[kabongo]

1. Professor Bomba; because the equality among all searchers in this study must necesary for a good ethics
2. Establish a ethical protocol of research and collaboration, accepted by all
3. informed consent
4. a) government
b) Ethical National Committee
c) all searchers concerned
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kamitalu

[Prof Dora Akinboye]

Dear Dr. Aceme,
Case study 8: DATA SHARING IN AN INTERNATIONAL COLLABORATIVE RESEARCH PROJECT.

This case is similar to case study 5, in which there was also conflict of interest. None of the schools of thoughts in this case seems to be right. The local collaborating co-principal investigator, based in one developing country, Professor Bomba Kabisa, was not sure of her stand. She merely expressed that she “was not happy”. She definitely had conflict of interest and thereby failed to put her case forward in very strong and clear terms. She was being careful not to offend the foreign collaborators because of what her country would gain from the project. She was not firm in her expression. She could have stated categorically that the decision, which would enable the coordinating centre alone, to have access to all the pooled data of the consortium was wrong. Her sentimental expression was shared by some of the other contributors.
On the other hand, if she was able to express her views in stronger terms, her view, which was right, could have been supported by more members and they could have out-voted the opposing members. Obviously, there was conflict of interest, which was exhibited by Professor Bomba Kabisa and shared by other local collaborating investigators. All the local collaborating investigators should be involved in the determination of an appropriate data sharing policy.

All of them should have access to the pooled data.

Dora.

[Aida Nakawunde]

1. I agree with Prof. Bomba Kabisa because data should be shared by all the collaborating institutions/collaborators

2. By establishing a coordinating centre to support the whole process and also budget for long data use

3. The ethical principle of equity and justice ie fairness in sharing information and research findings

4. The principle investigators' intitutions
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n aida