amanet-trust.org

[mworozi]

Case study 10
1.It is the responsibility of the Sponsor to provide ITNs/LLINs for the control groip/communities.
2.It would take a shorter time because the manufacturers, know there is a ready market of rich people who can afford their products and therefore make quick returns and profits.
3.The communities that provided the research data/information should have been the first to benefit the outcome of the research.
4a)the ITNs/LLINs should be provided by the Governments. It is the responsibility of the Governments not the researchers.
4b)No this should not be the case because ,although ITNs have been proved to effective, they are not the only interventions in the control of malaria.
5a) yes, this an ethical issue , the different manufacturers should be given opportunity to compete as long as their products are of good quality and effective. Transparent competing is healthy .I think the Majority of the African NMCPs and Donors are right.
The donors should not dictate the standard of care for a country. On the Contrary it should be a consensus discussion and agreement by the different stakeholders led by Governments of the Concerned countries, after all, Governments bear the responsibility of providing quality health care to their people.

[kabongo]

1. The government with the National Programme of Malaria Control can autorised the ITNs/LLINs
2. Firms takes the financial profits in fist
3. One of ethical principe was abrogated, because the guideline 10 (of CIOMS in 2002) says that:the population that provided the research (study) should have been the fist to benefit the outcome of the research
4. a) Yes, iti is in harmony with the spirit and African ethics
b) the use of placebo effect in this case is inethical ( because vulnerable population are concerned), guideline 11 CIOMS.
5. a) yes
b) They are all right
_________________
kamitalu

[Prof Dora Akinboye]

CASE STUDY 10:
RESEARCH AND DEVELOPMENT OF INSECTICIDE TREATED MOSQUITO NETS. W. L. Kilama

Athough WHO has recommends to national malaria control programmes to purchase only LLINs, and to provide full coverage of all people at risk of malaria (universal coverage): there should be no controversy about which of the two types of LLINs national malaria control programmes should procure. The table comparing polyester and polythene LLINs, using various criteria, clearly shows the superiority of Polyethylene LLIN over polyester LLIN, although polyester is cheaper. This notwithstanding, Ethics requires phase III trial before adoption of usage: this phase has not been completed therefore the cheaper net should not yet be used.

Even though the achievements involved combined investments by major bilateral and multilateral donors, philanthropy, malaria endemic countries, affected communities, R&D institutions, and lately LLIN manufacturers: the Japanese company (Sumitomo Chemical Co) whose Olyset Nets incorporate an insecticide in the yarn, and is released slowly over the life of the net, should be the sole manufacturer, producer and provider of the product to the control group/community; neighbouring communities; far off communities, etc. The LLIN should be provided as soon as possible and the production should continue until there is an improvement in the production, which may render the current product irrelevant.

It has taken almost 30 years to scale up ITNs/LLINs for public health use: investments by the private sector were very late but they should not be blamed, they were only helping. The process wouldn’t have taken as long if the product was for a rich man’s market because the donors would have been more concerned about the production and possibly, the rich men could have funded the research in order to speed up production. The ethical principles which were abrogated were respect for persons and justice.

It will be unethical if African ethics review committees demand provision of ITNs/LLINs from all malaria researchers coming to study their communities.

Malaria researchers, particularly entomologists, should not make sure that ITNs/LLINs are compared to whatever new interventions they intend to test. Incorporation of LLINs into studies will complicate studies, unless specifically planned out as such from the proposal level. This will cause unnecessary difficulties which have not been budgeted for from the onset. Also it will be unethical to force the inclusion of ITNs/LLINs into researches to be conducted.

The only one African National Malaria Control Programme (NMCP), which is insisting that since polyester LLINs has only interim WHOPES approval, they are not yet ready for public health use, which can only be granted after phase III testing, is the only one country which is right. Is it impossible to find out eventually that the polyester LLIN nets are not suitable for human use during phase III trial!?

Donors have no right to dictate the standard of care for a country. The one NMCP should not give in to the donors demands for any reason.
Dora.

[smagesa]

# 1. ITNS and LLINs should be provided by study sponsors after completing their trials, particularly for the control group/community. For practical purposes, these should be provided only once to cover everybody willing to use them in the community. Asking for more than that will not be called for as managing the distribution will be too demanding for the sponsors. It is however important to note here that by having experienced using an ITN, communities will then be willing to put in their own resources to acquire the “next net” when the one provided free wears out. This is important for sustainability of ITN/LLIN usage.

# 2. Presumably it would have taken a much shorter period to scale up ITN/LLINs if the product was for a rich market. This is because development of the products depends so much on the private sector input which is driven by making profits. Being a product for poor communities, there happens to be low incentive for the private sector to invest into R&D that would lead to scaling up within a short period, unless assured of a lucrative market which is readily available in affluent communities.

#3. I am not sure which ethical principle is being abrogated here, but I would consider this as an unjust principle in the sense that rural communities have contributed a lot in developing the product. They have been the “subjects” of numerous trials, but in the end they are not the beneficiaries of the products when everybody is now assured that it can protect communities from malaria. To practice justice, they should have been the first beneficiaries of this “proven tool” against malaria. But this is not the case.

#4a. I would think that such demands would in the end not be worthwhile in terms of scaling-up use of ITN/LLINs since its just a few communities that will benefit. However, for practical reasons, trials testing ITNs/LLINs should provide the interventions at end of trial to the control groups.

#4b. having established ITNs/LLIns as the standard of care, and knowing their efficacy, I feel that studies testing whatever new interventions should use LLINs/ITNs as controls. Indeed doing otherwise will amount to use of placebo which is not ethically acceptable. Soon, everybody will be under an LLIN in Africa and this will cease to be a subject for debate.

#5. Indeed this is a failure on the part WHOPES/WHO as it has resulted in the stagnation of R&D for LLIN/ITN. Once companies are selling more of their Phase II approved product even more that those with phase III approval, why should they invest in going through Phase III trial lest their product fail the trial! That single product has been on the market for over fifteen years now, which is enough time for the other companies also to develop their products to that level.

# 5a. This is indeed an ethical question. Why should you provide a substandard intervention when there is already an approved product? Indeed the lone NMCP is right, because it has taken time to study and understand the LLIN.ITN state of the art.

# 5b. It is not proper for donors to dictate the standard of care for a country. Countries are sovereign states that ought to be advised only, decisions have to be made by the countries themselves. Countries ought to be adequately informed, but they also ought to be more proactive in searching for non-partisan information from independent sources. One would be surprised about what is currently happening at the doors of NMCP Managers in Africa. There is always a queue of combination of donors, partners, pharmaceutical company sales representatives, NGOs etc, each with own agenda that end up confusing these poorly informed NMCP Managers.

# 5c. NO, this lone NMCP should be encouraged and supported to make its own independent decisions. Others also should be made to emulate the same. No debate should be encouraged, rather make a decision and go into implementation

Stephen M. Magesa
NIMR Amani Centre, Tanzania

[Roland Bulu Martin]

CASE STUDY 10: RESEARCH AND DEVELOPMENT OF INSECTICIDE TREATED MOSQUITO NETS. W. L. Kilama

Synthetic pyrethroids were introduced for use in agriculture during the 1970s; studies for their use in public health started soon after. They were found to be highly insecticidal on surfaces including fabrics, and of low toxicity to mammals including humans. Early studies treated mosquito nets with pyrethroids leading to the term insecticide treated nets (ITNs). These ITN studies demonstrated the safety of pyrethroids and their effects on various entomological parameters, such as the feeding success, survival, vectorial capacity, and human-biting rates; they both killed and repelled mosquito vectors of malaria.

Follow up studies mainly undertaken in rural Africa, showed that use of ITNs reduces malaria parasite densities, and the frequency and severity of malaria. Epidemiological studies in areas of varying malaria endemicities revealed median reductions of 45% in malaria disease rates. Later randomized controlled field trials of ITNs were undertaken in multi-country studies, under varying epidemiological conditions; they showed a reduction (i.e. efficacy) of 17 to 63 per cent in childhood mortality. By the turn of the millennium scaling up ITN use started.

Mosquito nets treated by dipping retained their insecticidal power for between 3-6 months after which they required re-treatment to restore the killing effect. Early studies identified low re-treatment rates as a major drawback to the effectiveness of ITNs. Researchers then produced re-treatment kits, which were followed by small to medium European entrepreneurs who coated nets with an insecticide and a binder thus producing long-lasting insecticidal nets (LLINs). A follow up innovation was by a Japanese company (Sumitomo Chemical Co) whose Olyset Nets incorporate an insecticide in the yarn, and is released slowly over the life of the net (guaranteed for 5 years), thus surpassing the WHOPES requirement of withstanding 20 WHO standard washes and an efficacy of  at least three years.

Now WHO recommends to national malaria control programmes to purchase only LLINs, and to provide full coverage of all people at risk of malaria (universal coverage). The debate has now focused on which of the two types of LLINs should national malaria control programmes procure. These achievements involved combined investments by major bilateral and multilateral donors, philanthropy, malaria endemic countries, affected communities, R&D institutions, and lately LLIN manufacturers.




Table comparing polyester and polythene LLINs using various criteria

Criteria
Polyester LLIN (eg Permanet, ICONMAXX, ICON LIFE, Interceptor)
Polyethylene LLIN (eg Olyset)



Duration of insecticidal activity
At least 20 standard washes
Life long, seven years reported



WHOPES Phase approved
Phase II (interim WHOPES approval)
Phase III (full WHOPES approval)



Type of yarn
Multifilament
Monofilament



Insecticide application
Insecticide coated (with a binder) on yarn
Insecticide incorporated in yarn



Durability
2-3 years, no guarantee
Guaranteed for 5 years by manufacturer



Manufacturers
Mainly European SMEs
Sumitomo Chemicals Co, Japanese



Cost per net
c. $3 each
c. $5 each



Donor preference
Yes
No



Where used?
All but one scaling up NMCP
Only one NMCP is insisting on using them



Number nets sold 2004-06
Over 100 million
About 30 million



Discussion Points
1. ITNs/LLINs have without doubt proved their worth. Who should provide them after their trial: to the control group/community; neighbouring communities; far off communities, etc.  How long, and how soon should they be provided?
Malaria Control through local NGO’s. The local NGOs will then work with community leaders to get the nets to the residents. The same should apply to neighboring and far off communities. Malaria Control to local NGOs and local NGOs through local leaders to the people. Talking about how long and how soon they should be provided, I say, until malaria vaccine is discovered ITNS/LLINS should continue to be supplied. As soon as their trial is completed the supply of ITNS/LLINS should begin.
2. It has taken almost 30 years to scale up ITNs/LLINs for public health use. Investments by the private sector were very late. Would the process take as long if the product was for a rich man’s market? Explain.
No, the process would not take that long if the product was for a rich man & rsquo; market. Malaria is killing so many that it has claimed the world’s attention and lots of efforts are being made to eradicate or minimize malaria. Any investment in this project will gain good return and therefore those rich people investing will not hold back because they know they stand to gain. There definitely will be no delay when the money to get resources to work with is available
3. The R&D of ITNs/LLINs was almost exclusively undertaken in rural areas. Yet their marketing e.g on TV, targets urban and well to do communities. Explain what ethical principle is abrogated.
The ethical principle that is abrogated is Beneficence. The community in which the research is done should benefit from the outcome of the research.
4. Many African heads of state and government adopted the Abuja declaration in 2000 whereby they agreed to make ITNs/LLINs readily available, and therefore a standard of care in malaria control.
• Should African ethics review committees therefore demand provision of ITNs/LLINs from all malaria researchers coming to study their communities?
Yes, I think African ethics review committees should demand provision of ITNS/LLINS from all malaria researchers coming to study in their communities to conform to the Abuja declaration for 2000 that made ITNS/LLINS standard of care in malaria control.
• Should malaria researchers particularly entomologists make sure that ITNs/LLINs are compared to whatever new interventions they intend to test, since doing otherwise would amount to providing a mere placebo? Wouldn’t incorporation of LLINs into studies complicate study interpretation? Discuss.
Yes malaria researchers particularly entomologists should make sure they compare whatever new interventions they intend to test with ITNS/LLINS. In comparing them they will know if what they are coming out with is as effective as ITNS/LLINS, better or just no good. If it is as effective as ITNS/LLINS or better it can be accepted since in fact ITNs/LLINS are our standard of care in malaria. Anything less effective should not be accepted. As for whether the incorporation of LLINs will complicate the study interpretation, I think it depends on what outcome the researchers want. If they are studying the efficacy of LLINs, it would be an advantage for them.
5. Almost all African countries which are scaling up LLINs are utilizing any of the LLIN products approved by the WHO Pesticide Evaluation Scheme (WHOPES) following Phase II experimental hut trials, and donors insist on including these in bids. Many donors insist that since there is only one WHOPES Phase III (given following accredited community level field trial)   approved polyethylene net manufacturer, bids should be open to include polyester nets, in order to ensure transparency and competitiveness in procurement.

On the other hand one African National Malaria Control Programme (NMCP) is insisting that since all polyester LLINs have only interim WHOPES approval, they are not yet ready for public health use, which can only be granted after phase III testing.  This one country is therefore opting for polyethylene nets only.

• Is this an ethical question? Who is right, the majority of the African National Malaria Control Programmes and donors on one hand, or the lonely NMCP?
Yes, it is. Until polyester LLINS gets full approval from WHOPES it is not ready for public health use. I think the polyethylene nets that has met full approval should be used until the polyester LLINS gets full approval.



• Should donors dictate the standard of care for a country?
No, I think donors should not dictate the standard of care for a country. Every Country should decide its own standard of care. Since every country may have its own challenges as it relates the usage of LLINs donors should be willing to collaborate. What may prove effective in one country may not in another. There is a need for donor to understand this. Yes, there should be a standard of care for countries, but I think it shouldn’t be dictated.
Should the one NMCP give in to the donors’ demands, since prolonged debates are costing many innocent lives?
No, I don’t think the lone NMCP should give in to the donors just because they want to save lives. This will mean that they are allowing the donors to dictate their standard of care. I think the donors should be willing to collaborate and together let them find a mid point.


6. Further study the text and the table, then attempt to raise ethical, policy and any other relevant questions.
 Is it ethically prudent for population to use LLINs that has not been fully approved? How do donors intend to deal with side-effects, if they arise?


Roland Bulu Martin
U L PIRE Africa Center
University of Liberia
Monrovia, Liberia
West Africa
_________________
R. Bulu Martin

[Resign]

1. The sponsor of the study as well as the government (through the National Malaria Programme or equivalent) should provide ITNs after the trials. Since the ITNs have been well proven to be effective, it is the responsibility of the government and all stakeholders to make sure that the service is provided to those who are in need of it, particularly in malaria endemic areas.
2. Most of the private sector companies are profit oriented. The market for ITNs is perhaps not as lucrative as other money spinning markets. This may be an explanation why there was late investment. Also the market for the ITNs are seasonal and this may be less attractive for investors who would rather be making money throughout the year
3. It is unethical, in my opinion, to research in a community and then fail to benefit that community when it comes to the result of the research. Where possible, the community in which research was done should be the first to benefit from it.
_________________
Resign Gunda
Medical Research Council of Zimbabwe (MRCZ)
Harare
Zimbabwe
gundazr@yahoo.co.uk
+263-912-876825

[Resign]

1. The sponsor of the study as well as the government (through the National Malaria Programme or equivalent) should provide ITNs after the trials. Since the ITNs have been well proven to be effective, it is the responsibility of the government and all stakeholders to make sure that the service is provided to those who are in need of it, particularly in malaria endemic areas.
2. Most of the private sector companies are profit oriented. The market for ITNs is perhaps not as lucrative as other money spinning markets. This may be an explanation why there was late investment. Also the market for the ITNs are seasonal and this may be less attractive for investors who would rather be making money throughout the year
3. It is unethical, in my opinion, to research in a community and then fail to benefit that community when it comes to the result of the research. Where possible, the community in which research was done should be the first to benefit from it.
_________________
Resign Gunda
Medical Research Council of Zimbabwe (MRCZ)
Harare
Zimbabwe
gundazr@yahoo.co.uk
+263-912-876825

[Elizabeth Ochola]

Dear Dr. Nyika,
1.Sponsor is to provide ITNs/LLINs post study for the community that participated in the study but the government institutionsi.e. the ministry of health and other NGO's and also churches can provide to the greater population at large

2. The intervention wont be long in that the investors would look at what is in there for them
3.The ethical principle abrogated is justice in that the community that made the research successful has been taken over by events
4.African ethics review commitees should involve the researchers at the approval stage if the research at hand would provide the proven ITNs/LLINs to the masses if it is to keep malaria transmission at very low levels to the masses and prevent deaths
5. Malaria researchers should make comparison between the new interventions and ITNs/LLINs because the latter have been proven to be efficient
donors should not be in a position to dictate what is important to a country
NMCP should not give in to the out of question donor demands but should be able to stand by humanitarian and ethical grounds that will decrease mortality rates for malaria cases
6.Prevention treatment should not be left in the hands of donors but should be an intergration between the various stakeholders
_________________
Elizabeth Ochola
NTD
Schistosomiasis Project
Kisumu,
Kenya

[zinyama-gutsire]

1.The sponsor (s) of the study in collaboration with the government agencies and philanthropic bodies should provide ITN/LLINs to people after the completion of the study.

2. The cost effectiveness of the intervention would also have to be taken into consideration.

3.Most of the researches on ITN/LLINs were done in the rural areas mainly because that is where the disease is most endemic except in slums within urban cities. Whereas most of the marketing strategies were carried out in urban cities. This is because most of the rural communities lack infrastructural facilities.

4. (a) African ethics review committees should not demand for ITN/LLINs from researchers intending to study in host communities
(b) Malaria researchers should compare their new intervention they want to test against ITN/LLINs which should be regarded as a gold standard.

5.This is an ethical question. The lonely NMCP country is right because only products which has undergone phase 111 testing is ready for public health use. The donors should not have the total rights to dictate the standard of care for a country. They can only advice by giving guidelines. The lonely NMCP country should not give- in instead, ethic committees should fast-track the process of phase 111 testing of the products and make these available to the poor who bore the burden of being researched on. The poor communities have to benefit from the research that was done on them
_________________
Rutendo Zinyama-Gutsire (MSc, MpH)
Medical Research Council of Zimbabwe
Research Oversight Department
CY 573 causeway
Harare
Zimbabwe

[Aida Nakawunde]

1.
The sponsor should provide ITNs/LLINs to the control group/community as a benefit for participating in the study and may be the neighboring communities too. For the far off communities, it should be the government. The period could be 2-5 years

2.
The process would not take long because the private sector is mainly interested in making profits and they would have market for the ITNs/LLINs.

3.
It is the principle of justice and beneficence i.e. The poor were exposed to the risks of getting involved in the study but after the success of the intervention it’s the rich who benefit.

4.
African ethics review committees should not demand provision of ITNs/LLINs from all malaria researchers coming to study their communities because some studies have small budgets which cannot cater for the provision of ITN to participants. This would also limit research in such communities however if the researcher is willing to provide them well and good. Yes, entomologists should make sure that ITNs/LLINs are compared to new interventions to be tested provided they (ITNs) are considered to be the gold standard of care.

5.
a) Its not ethical. The fact is both nets are effective i.e. if an intervention is proved to be successful in Phase II, it can be recommended for use to save time and costs. Its up to the governments to choose the type of nets that they can afford.

b) Donors should not dictate the standard of care for a country instead they should guide the country to make feasible policies or decisions. If a donor dictates the standard of care ensuring its sustainability will become a problem.

c) The one NMCP should give in as a way of compromise

6.
Donor preference; mainly preferred manufacturers from European countries which clearly shows the donor’s conflict of interest

Costs should not hinder African governments from purchasing polyethylene LLINs considering the information given in the table (advantages like durability, insecticide application) and they should stop being vulnerable to there donors
_________________
n aida

[jessegitaka]

Dr. Aceme,
1, The sponsor should arrange to supply the nets to the control group after the study, and this should be immediately and with established benefits until governments or donors set in. The cost could be subsidized for the community but for the far off communities and nation, government, donors and other players should be responsible.
2, The process would have been faster were it in a rich man’s market, profits and revenue drive business processes of production, innovation and marketing.
3, Principle of justice is abrogated here, with the research happening with the rural communities, modes of communication most accessible to them should have been preferred rather than those giving clear edge to the urbanites who did not carry the burden of the research.
4, As a standard of care procedure, the ethics committees are justified to demand that participants be provided with the treated nets in any malaria research.
It is in order to require that new interventions are better than the nets or more realistically, the nets should be used concurrently. There is a possibility of the study findings being influenced by this new standard of care but this should be taken care statistically.
5, The question is as ethical as it is financial. Most of the countries would opt for the not fully approved because of their dependence on donors, perhaps had they sufficient funds they would opt for the fully approved polyethylene nets.
Donors should not dictate standard of care for countries unless they have sufficient evidence on the contrary.
The one NMCP should continue to press for the right thing but in the meantime work with the polyester nets, since they are definitely better than not using nets.
6 a) Why should the donors insist on the polyester nets which have a short duration in guarantee (2-3 years) as compared to the polyethylene nets (5years), lesser washes for efficacy. Are they in business with the manufacturers? Are they donors or marketers?

[makamche]

Dear Dr Aceme,
1) To control group and community, ITNs/LLINs should be provided by the local national control program. To neighboring communities and far off communities etc, they should be provided by national malaria control program. The ITNs/LLINs should be provided as long as the malaria threat remains upon the population and should be provided as soon as trials are over.

2) The process would not take as long if the product was for a rich man, this because, policy making in the world of business is driven by money. So long as the money is there, the procurement can be done as soon as possible.

3) The principle of justice is abrogated; the local population takes part in the trial and run the risk while the benefits are attributed to the urban population.

4)

• Yes, they should because every research has different objectives and different data to be collected. These make a study a different study for which an ethical clearance is needed.
• Yes, every biomedical tool (treatment, diagnostic tool) should constantly be challenge and against the best available to evaluate its efficacy and effectiveness in the society.

5)
• It is an ethical question, because without any phase III trial, the population might be exposed to unnecessary risk since phase III generally evaluate safety and efficacy.
• No, standard of care is specific to each country.
• No, the one NMCP should not give in to the donors&rsquo demands, since prolonged debates are costing many innocent lives because they are responsible of the live of these innocent.
_________________
Dr Marie Florence Makamche épse Dzukam
Ph.D Molecular Virology
CANTAM, CIRCB
P.O. Box: 3077
Yaounde, Cameroon
Mobil: 74 61 36 44

[psoipei]

1. The sponsor of the trial should provide for the control group/community, and the neighboring communities as well if it can afford. Otherwise, the government should take responsibility and provide for the whole nation. It can do this through allocating money to the ministry of health for this purpose or even approaching donor agencies to help out.

2. The process would have been a lot faster because the rich market is an obviously potential area of making not only very high but also very fast profits.

3. This is a breach of the ethical principles of beneficence and justice. I t is very unfair to have the rural folks carry the burden of the research then later direct the fruits of that research to the rich in the urban---this is pure greed!


4. All malaria researchers should be able to provide ITNs/LLINs as standard care and also as comparators to their new interventions.

5. It is an ethical question. The lone NMCP is ethically right to differ from the rest as its preference has gone through phase 111. It is not right for the donors to dictate standards of care to a country. Governments have rights to follow their own tailored policies.

· The one NMCP should not give in to the donors’ demands. It should instead go ahead and procure the product for it citizens



6. Could there be conflict of interest on the donor’s side and the NMCP who support the polyester LLINs?

Thanks
PS

[Abdulai Ali Martha]

1.The majority of the ANCMP agree because it could curb the high malarial morbidity and mortality cases even though it might have it buts. The lonely NMCP also prioritizes the safety and wellbeing of their people and will not expose them to the polyester LLINS since it is in the interim but they are dying anyway. I think the NMCP should succumb but still push for the full approval of the polyester LLINS. They should bear in mind that according to the declaration of Helsinki “even the best proven prophylactic, diagnostic and therapeutic methods must continuously be challenged through research for effectiveness, efficiency, accessibility and quality.
2.No they should align themselves with the country’s standard of care.
3.It is better to do something than nothing, if the wellbeing of their people is prime they should give the polyester LLINS a chance.

[Kwame Kesse Adjei]

1.I am of the opinion that sponsors and the principal investigators should provide them to the control groups and the community. Donor agencies, policy makers etc, can provide to neighbouring communities, far off communities etc. They can be provided at every given opportunity and the frequency should be based on the durability of the net.

2.No the process would not have taken so long. With the rich, investors will have lots of confidence in their investments knowing well that they actually stand to gain from their investments. The same cannot be said in this case.

3.I think the principle of autonomy is violated here. It involves the respect for other humans as moral equals. This was however not the case here. One group of people was seen as worthy of research and development of the nets whilst the other worthy of advertisement.

4.African leaders must not necessarily demand ITNs from malaria researchers. They should instead make sure that the right measures are put in place to provide people with ITNs. Besides that, there are other benefits the people and government could derive from an upcoming malaria intervention and not necessarily ITNs.
b. Incorporation of ITNs into a study will not really affect studies. It is already known that ITNs reduces the impact of malaria to a certain percentage and this can be incorporated into the study. Any difference can then be alluded to the test drug.

5.This is both an ethical and financial question. Financial because it is cost effective in the long run to provide ITNs that will last for a longer period even if they’re more expensive. Unethical however, because distribution will be biased especially so when donor agencies are not involved. Donors however do not have the right to dictate to beneficiary countries