amanet-trust.org

[Aceme Nyika]

DATA SHARING IN AN INTERNATIONAL COLLABORATIVE RESEARCH PROJECT

International collaborative consortium
In order to collect adequate samples to achieve a significantly high statistical power in a population-based genomic epidemiological study, institutions in developed and developing countries formed a consortium in a 5 year project. A coordinating centre was established at an institution in one of the collaborating developed countries. Due to lack of adequately equipped laboratories in the developing countries, the local collaborating investigators in the developing countries collected samples and shipped them to the institutions in the developed countries were genotyping of the samples in high-tech laboratories could be performed. In order to enable genetic associations to be calculated, corresponding clinical data and sociodemographic data for the samples were also submitted to the coordinating centre of the consortium.

Data sharing policy of the consortium
The coordinating centre established a database for the genotypic data generated from the samples, as well as for the clinical and sociodemographic data submitted by the collaborating institutions. Each collaborating institution could access genotypic data for the samples it submitted, but not genotypic data for the pooled samples from the various collaborating institutions in the developing countries. Similarly, each institution could access its own clinical and sociodemographic data, but had no access to the pooled clinical and sociodemographic data. The coordinating centre had access to all the pooled data of the consortium.

Divergent schools of thought regarding the data sharing policy
At a meeting of the consortium collaborators, Professor Bomba Kabisa, one of the local collaborating co-principal investigators based in one developing country, indicated that she was not happy with the fact that local collaborating institutions did not have access to the pooled data in the database, during and after the consortial project. She felt that whereas the coordinating centre could continue using the pooled data long after the 5 year life span of the consortium, the individual collaborating institutions and their local collaborating investigators would not have access to the pooled data. She felt that from the point of view of her institution, such lack of access to the pooled data negated the whole purpose of forming a consortium in the first place.

Although a few investigators supported her view, the majority of the investigators from the developing countries were of the view that looking beyond the 5 year period of the consortium was unreasonable. They argued that it would be practically cumbersome to manage such continued access to the database by all collaborators after the expiry of the project. They felt that the local collaborating investigators from the developing countries should be content with such benefits as injection of research funds into institutions in the developing countries, post-graduate scholarships for students from the developing countries, possibilities of being co-authors of peer-reviewed publications and opportunity to be associated with an international research consortium.

Some questions to guide discussion

1. Which school of thought do you support, and why?

2. How would the data sharing policy that you support be implemented?

3. For the school of thought that you agree with, what ethical principles could help to support your position?

4. Who should be involved in the determination of an appropriate data sharing policy for such a consortium as the one in this case study?

[orimadegun]

I share the views of Prof. Bomba Kabisa. I think the value of having access to the data after the 5 years project duration is beyond those immediate benefits listed.

To implement this, it should be stated that local collaborators interested in further use of the data would have access to it but at their cost including the technologies and travel expenses.

The principle of justice demands fairness in the treatment of individuals and communities and the equitable distribution of the burdens and benefits of research.

The representatives of the various collaborating centres should be involved in making such decision.
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ADEBOLA

[ukamaka]

1.I share the views of Prof Kabisa because the issue of the develpoing countries being content with the research funds should not arise becuse it is just a secondary benefit and not the fundamental objective of the project.
2,The data sharing policy should have beeen implemented by allowing all parties access to the information for at least the 5 years of the project and if the feel the need for the data at the end of the project, they can do so at their own cost; but is being cumbersome to manage the database really the issue?

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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U G OKAFOR

[Seth]

I also support Professor Bomba Kabisa in one way or another. She had a point although other investigators did not support her. the essence of performing a consortium is to get more generalized data. Those benefits listed are there but to my opinions they are not the only one a partner should focus on since they are not primary. There is more value in the data as well. Those benefits are part of the overall gains an institution stands to get and should not be substituted for others. If converted to researcher-participant relationship, it will be like gathering a number of research participants simply because you have offered them some gifts or because they have nowhere to get health-related services except from you. We therefore need to observe the ethical issues within research consortia so that the more powerful do not dominate the less powerful. The issue of management of continued access can be discussed and a feasible solution may be reached on how to use the database after expiry of the project.

The data shering policy should be determined by the participating institutions and a common agreement should be reached.
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LET'S JOIN HANDS AND FIGHT OUR WAY THROUGH AS ONE. TOGETHER WE'LL GET THERE!!!
Misago Seth
National Institute for Medical Research (NIMR) Tanga Centre
Amani Biomedical Research Laboratory (AMBRELA)
P.O.Box 5004
Tanga, Tanzania

[alemnew]

1. I support Professor Bomba Kabisa because of the reason that lack of access to the pooled data negated the whole purpose of forming a consortium. More over, the principle of justice demands fairness in the treatment of individuals and communities and the equitable distribution of the burdens and benefits of research.
The issue that the local collaborating investigators from the developing countries should be content with research funds, post-graduate scholarships, etc at the cost of not having access to the pooled data is an inducement.
2. By creating a database where each collaborating institution must be able to share results with others and access data generated by others, the data sharing policy could be implemented.
3. The principle of justice help to support my position.
4. Each collaborating institution should be involved in the determination of an appropriate data sharing policy.

Alemnew Fitayehu, Ethiopia

[bola]

I am in full support of Prof Kabisa. The principle of fairness and equity is a major plank on which ethics rest. Access to the pooled data which one institution enjoys should be a benefit equally shared by all.
It is pertinent that such views prof kabisa raised should have been well discussed at the onset of the study.
Being content with carrots such as association with an international consortium is not good enough.

[victor chalwe]

1. 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, but may not be adequate as to draw reasonable and statistically supported conclusions. Further, 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 can best allow for consensus on what can be the focus for analysis and 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.
2. 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, representatives from the collaborating institutions (that may include the local Principal Investigator or Co-Investigator and a Biostatistician) should be invited to workshops for data analysis and report writing.
3. The ethical principle that could help support my position is the principle of justice: 'addressing the resolution of the question of who ought to receive the benefits of research and bear its burdens.' This is so because I feel the institutions and therefore consequently the communities in which the data is being generated will not fully benefit from small datasets that they will access since much of such data will not have statistical power to draw conclusions that form basis for meaningful interpretation to inform policies etc. By having one institution in a developed country coordinate, pool and access all data will by this principle unfairly exclude from the potential benefits of research participation for the other institutions and their respective communities.
4. As earlier stated, representatives from the collaborating institutions (that may include the local Principal Investigator or Co-Investigator and a Biostatistician and if possible Institutional Directors) should be involved in determining an appropriate data sharing policy for such a consortium

[chiprimus]

1. Which school of thought do you support, and why?
While I largely support the position taken by Prof. Bomba, I however differ with her on the fact of investigators accessing the entire data base (individual and pooled) after the expiry of the consortium. I believe that investigators from the various institutions forming the consortium should be able to access the complete data base through out the lifespan of the consortium. What should be an issue of concern is what the accessed data is used for? The contrary position taken by most of the other investigators from the developing world is seemingly ‘mediocre-like’. They ought to think above those ‘contentment’ raised. It appears researchers in the developed world are literally paying their counterparts in the developing world to collect data for their research work. I think investigators from the developing world should have raised and addressed the concerns of Prof. Bomba before committing themselves to the consortium. It’s unfortunate that many African researchers are more concerned about ‘grabbing’ research grants than utilizing the findings of their research to enhance the wellbeing of their people. The firmly believe that the spirit surrounding the formation of some such consortia is unethical.

2. How would the data sharing policy that you support be implemented?
While the submitting institutions can freely access the database of the coordinating centre to obtain data for their submitted samples (perhaps through a specific ID and password provided by the centre), specific data from pooled samples should be requested by the institution concerned in writing to the coordinating centre. The centre may then provide that specific data after due satisfaction that the data requested will not be used against the specificities stated in the policy document that the participating institutions signed onto.


3. For the school of thought that you agree with, what ethical principles could help to support your position?
Equal and complete access but restricted usage of data during the lifespan of the consortium should be based on respect and equality; the person who collects the data is as important as the person who pays for the collection.


4. Who should be involved in the determination of an appropriate data sharing policy for such a consortium as the one in this case study?
Just like the Universal Declaration of Human Rights that all UN member countries are obliged to implement its prescriptions, International Independent organizations/authorities that have a stake in global health should equally draw-up ‘standard operating procedures’ for such consortia. The WHO and her sister organizers will be most appropriate to undertake this task.

[bibimbete]

Which school of thought do you support, and why?
1. i support prof. Bomba's school of thought. i believe that the objective of such team based research project is that each group must be able to share data with others and also to share results generated by others. The sharing of data leads to benefits of advancing science by facilitating collaborative research and enabling access to needed data obtained by others without duplication of research work. The benefits listed for the other school of thought seem not convincing to the developing world.

2. How would the data sharing policy that you support be implemented?

There should be databases developed for all the data that received. also other institutional specific databases need to be developed and used by the respective institutions when need. there had to be proper documentation requirements that need to be approved by a committee elected by the consortium.

3. For the school of thought that you agree with, what ethical principles could help to support your position?
Respect of persons and justice

4. Who should be involved in the determination of an appropriate data sharing policy for such a consortium as the one in this case study?
representative from all the institutions in the consortium.

[Elias F. Onyoh]

1. Which school of thought do you support, and why?

As a matter of fact, I’m in support of the minority’s opinion about full access to data. As a scientist whether based in a developed nation or developing nation, we all have to share knowledge and make good use of information generated without restrictions.

2. How would the data sharing policy that you support be implemented?

The implementation of the full access policy to all institutions involved in the consortium would have been discussed and agreed upon before being a partner of any consortium.

3. For the school of thought that you agree with, what ethical principles could help to support your position?

Strongly, I see no reason why one institution because it is based in a developed country should have access continuously of pooled data from most developing countries, while at the same time these institutions from the developing countries have to be denied access. Therefore scientists in developing nations have to be more careful with the type of partnership they enter with scientists or institutions in the developed world. We have to be aware that the benefit of any pooled data to scientists in the developed world should also be the same to scientists in the developing world may be not now but in the nearest future. Research funds, scholarships and co-authorships should not be used as reasons for scientists in developing countries to “sell their birth rights”. These are the same reasons some researchers have put forward to being part of unethical studies in developing nations.


4. Who should be involved in the determination of an appropriate data sharing policy for such a consortium as the one in this case study?

I believe, brilliant research ethicists representing each partner to the consortium should be involved in deciding on an acceptable and appropriate data sharing policy.

[Mopareaddo]

Which school of thought do you support, and why
I support Prof Kabisa and his colleagues for expressing their displeasure for not having access to the pooled data. It is expected that benefits and risks of a study should be fairly distributed. I am of the opinion that pooled data should have been shared among all collaborators, that it what a consortium should be addressing.
How would the data sharing policy that you support be implemented

I would expect that a Data sharing policy is developed by all stakeholders and signed before the beginning of the study. this policy should address issues of who has access to the data, and how the data can be accessed eg. writing a proposal and submitting it to the IRB for approval .

For the school of thought that you agree with, what ethical principles could help to support your position?
Ethical principles supporting my opinion are
The principle of Beneficence - equal distribution of benefits and risk.
The principle of Justice – fairness and equity

Who should be involved in the determination of an appropriate data sharing policy for such a consortium as the one in this case study
The Sponsors, Investigators , members of the collaborating institutions and the IRB.

M Opare-Addo
Ghana

[adugyasidennis]

I support the school of thought that collaborating institutions should have access to pooled data but not only to the genotypic data of the samples an institution submit.
I wonder why such a policy restricting access to pooled data does not affect the collaborating institutions from the developed countries. What has happened to the principle of equal opportunity?
One would want to say that they have invested a lot of fund into research institutions in the developing countries. That’s true but I don’t think it should amount to a kind of exploitation. The money alone cannot generate the data required. That’s why there should be such collaborations. Therefore all collaborating partners should benefit and have equal access to the data generated out of the collaboration.
Well, in giving equal access to the data, some agreement could be reached between the institutions rather than complete restriction to the pooled data.
Access to pooled data should be allowed to help formulate policies in the developing countries rather than the ideas always being sold to us by the developed collaborators. May be that’s where they can recoup the money they invest in such collaborations. Who knows?
When these things happen, it is tantamount to exploiting the vulnerable groups. Such breaches the principle of respect for persons and institutions. The fact that the institutions from the developing countries earnestly need financial assistance for research and development and are ready to agree to any term in a contract or collaboration does not mean they should be taken advantaged of.
I see it as undermining of ones integrity.
For effective determination, I believe there should be a import from the governments of the collaborating institutions, say MOHs, but not only the sponsors and the investigators. Also, with correct agreement between the institutions, there should be access to the pooled data. Being co-authors, post-graduate scholarships for students and injection of funds into the institutions alone is not enough as Professor Bomba Kabisa indicated in the case study.
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dennis adu-gyasi

[DAnum]

CASE STUDY 8

I support the views of Professor Bomba Kabisa .The benefits mentioned are the immediate ones. An institution would normally own any intellectual property that is made, designed ,discovered or created by a member of staff, students, guest researchers etc in the course of their employment and responsibilities or which makes significant use of the institutions resources(including institution-administered funds or R&D institution-funded time, facilities or equipment in connection with its development and therefore all kinds/types of benefits(near-term ,medium-term and long-term) should be shared fairly and equitably with all institutions whether they contribute through resource management and/or scientific process.

There is the possibility of managing IP in public- private partnerships, strategic Alliances, Joint Ventures, merge & acquisition (M&A).The principles governing ownerships rights are related to relevant agreements which should include participation agreement, service agreement, invention notice /disclosure, invention ownership agreement, confidentiality agreement, agreement to settle disputes, material transfer or bailment agreement ,contract agreement and benefit - sharing among others, with the details of such sharing agreement explicitly stated and should be understood by all concerned. There are benefits, such as transfer of technology, access to IP –protected technology, training of researchers locally, sponsoring of researchers to undertake post-graduate research locally and/or abroad, transfer of equipment, and exchange of information. In this case there must be a balance of benefits linked to uncertain, longer-term commercial success, as against the non-monetary benefits that may be available immediately. In this issue, collaborating partners must resort to dialogue and/or litigation to settle the dispute since all participating partners contributed to the project but none of the above mentioned agreements was addressed before the project took off especially the steps in the access and benefit –sharing process which depends on fair access, equitable benefit sharing, and IP legislation.

The Belmont principle of Justice ensuring harms and benefits of research are equitably distributed to populations and individuals.

All the partners from the various collaborating institutions should be involved in the decision of the data sharing policy.
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S2007

[Naana A.Wireko Brobby]

I totally agree with Prof Bomba Kabisa,in the sense that if the collaborating countries would have no access to the pooled data,then what was the purpose of forming the collaboration in the first place?Once they are all researchers in pursuit of knowledge,its only fair that they all have access to the information that they have all worked and contributed to collate.And the issue of the investigators from the developing countries having to be content with benefits like scholarships and co-arthurship possibilities, in my opinion was very demeaning.Why should the investidators from developed countries not be content with the same benefits then?Surely,we are not revisiting the days of the animal farm,are we?
I think the issue of justice and beneficence are totally lacking here.
And some kind of commitee with representatives from all the collaborators should be able to sit and come to an agreement regarding the access to the pooled data.I also think that all these benefits,both short and longterm should have been discussed thoroughly and the necessary agreements made way before the start of the study.
I guess thats one of the problems we have in Africa,we hardly pay attention to and consider the longterm effects and / or benefits of what we are agreeing to,and its only when its almost too late that we realise that we got the wrong end of the deal from the very people we are convinced are trying to help us.
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Naana

[AJAARI]

Naana, Thank you very much for your excellent piece. I absolutely agree with you. What is collaboration? What is the essence of collaboration if it is not mutually beneficial to the parties involved in the collaboration.
It is high time we do selfless and objective critical analysis of any proposed collaboration before making a decision to be part.
Thank God for people like you.
_________________
Justice Ajaari
Kintampo Health Research Centre
Ghana Health Service, P.O.Box, 200
Kintampo, Brong Ahafo Region,
Ghana
Tel:00233-61-28871
00233-61-28869