amanet-trust.org

[Ndam]

1. There are several ethical issues surrounding this case. First, ethical approval was not obtained to perform the research on orphans. The Oxford researcher Dr Sarah Rowland-Jones claimed she “had been led to believe by Dr. Moses Otsyula that ethical approval to collect blood samples and to conduct the study had been granted”, but she should have required written documentation of this. Similarly, before conducting the study, she should have required documentation about the informed consent of children and the authorisation of Kenyan authorities (to perform research on orphans). She also argued “the Oxford team had been given permission by Father Angelo D’Agostino to conduct the research on the orphans”. This “presumption of permission” should not be enough to collect blood samples from anyone, especially from minors, and orphans here.
For the stealing of blood samples, it is not clear here who says the truth, Dr Sarah Rowland-Jones or Dr Otsyula. In all cases, this controversy would not have raised if all authorisations had been clearly documented before conducting the study.
Despite this controversy, two papers were published. It points out that scientific journals should be stricter in requiring ethical approval and agreement of all researchers before publication.

2. In the context of Health Research, it is first the responsibility of legal representatives of the minors to protect their welfare. Here, as they are Orphans, this responsibility comes to the Kenyan government body. The head of the institution should also grant approval but this should not dispense from the authorization of legal representatives. It is also the responsibility of all researchers involved in the study, and of the local Ethics committee, to ensure that the welfare of orphans is protected.


3. If such research on orphans can provide critical leads to the development of protective vaccines against HIV infection, I think this research should be conducted, provided an adequate ethical process was followed. I believe useful research can be performed in any vulnerable group, if ethical considerations are correctly addressed.
_________________
Nicaise Tuikue Ndam, PhD
Mother and Child Health in the Tropics
UR010-IRD/ISBA Cotonou
Benin

[goadjei]

The ethical issues surrounding this case study - conducting research in vulnerable populations. In the context of health research, it is responsibility of the investigator to protect the welfare of the subjects under study - in this case institutionalized orphanswith HIV, are a particularly vulnerable population. If it is true that the natural immune responses of some HIV-infected children could provide critical leads that could contribute towards the development of protective vaccines against HIV infection, research can indeed be conducted on these children – but on condition – that all necessary safeguards are in place to prevent exploitation. all major stakeholders - researchers, health institutions, the government, the legal and social welfare institutions and human rights organizations could all contribute towards protecting the rights and dignity of participants in such research - if necessary. In some cases, it may even be beneficial to conduct research in a sub-group rather than healthy adults if the results could benefit the group particularly and if results obtained from another population could not be easily extrapolated.

[mworozi]

Case 4
The ethical issues regarding this case are very clear. It is obvious that Dr. Sarah Rowland Jones took the blood samples collected by Dr. Moses Otsyula without the latter’s permission which was unethical. Secondly, even if Dr. Jones had given permission, still it would be unethical because samples collected for one study cannot be used for another study without consent by the participants and approval by the Ethical Committee. The argument by Dr. Sarah Jones that the Oxford team had been given permission by Father Angelo D’ Agostino to conduct the research also does not hold water. Father Agostino could only give permission for the children to participate in the study as their guardian, but still the researchers needed to get ethical approval from the Ethics committee. Without Ethical approval it was unethical. It is clear that by applying for ethical approval in 2002, the Oxford research Team had realized that the samples which were collected in 2001, were collected without authority to do so.

In the context of health research, orphans are a vulnerable population. The fact that these were institutionalized orphans makes them even more vulnerable. It is a constitutional right for the vulnerable populations to be protected. The responsibility for the protect ion of. institutionalized orphans who are minors, in the first place lies with the Institutional Management, and Board, the relevant Government Ministries and Departments such Ministries of Gender Labor and Social Development, Justice, Internal Affairs and National Council for Children were it exists and agencies responsible for the care and protection of children such as UNICEF and NGOs.

For research purposes Ethical Committee and National Councils for Science and Technology are responsible. As far as carrying out research on the orphans to investigate the potential leads, this is alright as long as it is curried out ethically after obtaining the necessary approvals and permission from their care takers. If this is done accordingly, the question of exploitation of defenseless and desperate minor will not arise.

[Dr. James Chipeta]

1. What are the ethical issues surrounding this case study?
There are several ethical issues in this case including
a. There are no clear clue of the protocol involved in the research (what were the documented research objectives and who was responsible, PI and which was the investigative team and institution)
b. There was no documented IRB (LOCAL NOR FOR FOREIGN RESEARCHING INSTITUTIONS) Clearance
c. Orphans rights seem to have been transgressed. Who signed for their consent, the priest or designated government social worker?
d. Transportation of samples without legal approval is a violation of the individual rights of the orphans in this case .
2. In the context of Health Research, whose responsibility is it to protect the welfare of institutionalised orphans who are minors?
Within the Human rights it should be the legal custodian of the institutionalized orphans who has clearly been certified by an independent board such as social welfare officials of the Government/nation in which the institution is located. Generally such vulnerable minors may not be qualified to participate in any Health research except in exceptional cases.

3. If the natural immune responses of some HIV-infected children, who happen to be orphans (institutionalised or not), could provide critical leads that could contribute towards the development of protective vaccines against HIV infection, should research be conducted on the orphans to investigate the potential leads or would that be tantamount to exploitation of defenceless and desperate minors?

No, never, as there is no exceptional case condition here. This type of research /data can be sought by other alternative means. Exceptional cases on research to be allowed on vulnerable groups include circumstances of say some outbreak of an unknown disease or phenomenon within such group whose results will directly benefit the warefare of the group or will solve problems peculiar to that group and such that cannot be solved/found otherwise.

2. In the context of Health Research, whose responsibility is it to protect the welfare of institutionalised orphans who are minors?

Legal board certified or appointed by the state

3. If the natural immune responses of some HIV-infected children, who happen to be orphans (institutionalised or not), could provide critical leads that could contribute towards the development of protective vaccines against HIV infection, should research be conducted on the orphans to investigate the potential leads or would that be tantamount to exploitation of defenceless and desperate minors?
Certainly not as it would be tantamount to exploitation of the defenseless minors whatsoever benefits. Minors cannot be expected to have an informed and valid consent.

[FabriceBoyom]

1. Based on Dr. Otsyula’s allegations, I think it is unethical to steal samples, and to collect some more without approval. Secondly, taking samples to a third institution (University of Oxford) that was not involved in the collaboration talks in addition to subsequently publish out coming results raise an intellectual property rights issue.
2. The Nyumbani orphanage has full responsibility to protect the welfare of institutionalised orphans who are minors. In addition, the entity granting the ethical approval should ensure that orphans’ rights are respected throughout the study.
3. The rights of orphans as human beings and minors MUST be respected. Only if this basic condition is fulfilled, and considering the potential benefits that may arise from this investigation, research should be conducted towards the development of protective vaccines against HIV infection.

[offianan]

1/ several ethical issues in this case study:
- The orphans are very vulnerable participant and it’s must be the last option if no others groups can be found. Orphans need special protection and attention because many of them can not give or refuse consent for themselves.
- It’s unethical for Father Angelo d’Agostino to allow researchers conduct studies at the orphanage without IEC/IRB requirement and approval to carry out the study. Father Angelo is not family representative of the orphans. Also he is not en IEC/IRB.
- Dr Moses Otsyla did not obtain any approval to conduct his research. The orphans did not sign any inform consent. Although they are in an orphanage , it does not take away their rights
- It’s unethical to collect additional samples without ethical clearance
- The ethical principle on nonmaleficence was violated because samples were stolen
- Dr sarah Rowland have published papers from research with all samples collected at the orphanage without any IEC/IRB approval. This is unethical

2/ It’s the responsibility of the state to protect the welfare of institutionalized orphans who are minors and very vulnerable.

3/ Research can be conducted on the orphans after applying and obtaining approval from IEC/IRB.

Offianan Andre Toure
Malariology department
Institut Pasteur of Ivory Coast

[kabongo]

1) a)informed consent
b)consideration between searchers
c) establishment of a good (ethical) protocol of collaboration in reseqrch field
d) establishment of a good (ethical) protocol of research
e) several studies in a very short time in the same population
2) Kenyan State
3) a) If there is a possible profit for health but in regulation with ethics
b) an adequate legislation will permit the saety of this populaton
_________________
kamitalu

[fsaguti]

1. ethical issues to this case
- Ethical clearance was not clear to this matter, to local researcher- you should have your collaborator in hand before getting even collecting your first sample( even it should be stated in your proposal for ethical clearance application)-you do NOT collect samples and then run with samples to fetch for collaboration! Same applied to abroad researcher/s(he) stole-use the sample without assurance of the ethical clearance letter in handle from appropriate authorities( neither the local researcher nor ophanage institute)- the journal publishing this work should have demanded for ethical clearance in the first place before publishing the work. then penalties should have been given before granted another ethical clearance in 2002.
-appart from that, the ophan was above 21 year old, then based on the facts above two among four ethical principles were ruled out this case. first is principle of autonomy- there is not clearly direct involvemnt of giving a consent form to the kid(ophan) to participate in this study neither to the local in the first time nor to the Dr Rowling, apart from that the principle of JUSTICE to the kid was also ruled out.

2. Ethical committee authority for human research should have been up front to defend this ophans in the first place and all other stakeholders

3 it is ok to do research to ophans if all ethical principles and regulation demands are followed and accepted

[Roland Bulu Martin]

1. What are the ethical issues surrounding this case study?
The ethical issues surrounding this case study is documentation and failure to followed approved standards set. Is it only the Father who is clothed with the authority to sign the papers for blood to have been taken from the children? Why did Doctor Sarah Rowland-Jones break away from her Kayen partners to get additional blood.

2. In the context of Health Research, whose responsibility is it to protect the welfare of institutionalised orphans who are minors?
In the context of Health Research, it is the responsibility of the head of the orphanage, the head of the Board of the orphanage and the Ministry of Health and Social Welfare that arm of government that supervises orphanages

3. If the natural immune responses of some HIV-infected children, who happen to be orphans (institutionalised or not), could provide critical leads that could contribute towards the development of protective vaccines against HIV infection, should research be conducted on the orphans to investigate the potential leads or would that be tantamount to exploitation of defenceless and desperate minors?
It started with them, institutionalized orphans, it is them that showed the difference that have raised eye brow and therefore it must continue and end with them except that proper guidelines must be put in place and followed to avoid exploitation and make it to appear like the orphans are defenseless. Though they are orphans who don’t have parents they belong to the Country and the Country must play the role of parents.

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

[Constance Agwang]

1. First, no proper ethical approval to conduct the study, then there’s no transparency among the collaborators themselves. I also see an issue of personal interests at the forefront and not the interest of the orphans.
2. The body responsible for issuing ethical approval has the responsibility to protect these orphans. Then, the orphanage board should be one with the primary responsibility of protecting these orphans
3. Conducting research among these orphans would be considered due to the benefits that it’s likely to bring, however, an ethical review board needs to examine the objectives of the study clearly to ensure that there’s no exploitation of these vulnerable minorities.
_________________
Constance Agwang
Med Biotech Laaboraories
P.O Box 9364
Kampala, Uganda
Mobile: 256-77-257791

[zinyama-gutsire]

Dear Dr Aceme
The ethical issues surrounding this case study are as follows:
All the necessary approvals were not obtained before the study started.
•Dr. Moses Otsyula ever collected any blood samples for any research, he did not keep the samples safe and allowed some to be stolen. It is unethical not to keep specimen very secured.
•Dr. Sarah Rowland- Jones being a researcher and knowing the importance of ethical approval should not have been led to believe that ethical approval had been granted. She should have asked for practical evidence.
•Information sheet and informed consent form documents were not presented to the participants to give their consent.
•The Kenyan's National Council for Science and Technology and the Nyumbani Orphanage Board did not review the protocol concurrently to ensure that the study was appropriate for the population in the institution.
•The Researchers were allowed to do their own things without any regulatory bodies to monitor consent processes of studies and adherence to protocols, and finally lack of documentary evidence.

2.I believe the primary objective of the Nyumbani Orphanage Board is to ensure and guarantee the rights, dignity, safety and protection of the orphans. Furthermore, in the context of health research it is the responsibility of the Kenya's National Council for Science and Technology and other existing welfare bodies to protect the welfare of the institutionalised orphans.

3.It is allowed and ethical to conduct research on vulnerable populations like orphans, children as long as adequate justification to do the research is given. It should be research that can only be done on that group and should directly benefit the participants. If the orphans would enjoy the benefits from the results of the research, then definitely they have to bear the risks and burdens of the research.
_________________
Rutendo Zinyama-Gutsire (MSc, MpH)
Medical Research Council of Zimbabwe
Research Oversight Department
CY 573 causeway
Harare
Zimbabwe

[Resign]

I think that it is the role of regulating authorities to make sure that the protection of vulnerable groups is ensured. Being minors and vulnerable does not take away the right of the children to give assent to research. One of the ethical issues here is that there is no mention of ascent by the children themselves. There is need for constant monitoring of research involving vulnerable groups. What this case shows me is perhaps a lack of monitoring of on-going research. Had that been done, I am sure these loopholes would have been unearthed in good time
_________________
Resign Gunda
Medical Research Council of Zimbabwe (MRCZ)
Harare
Zimbabwe
gundazr@yahoo.co.uk
+263-912-876825

[Beverly Msambichaka]

Consent process – it was not clear whether Fr Angelo D’Agostino or the Nyumbani Orphanage Board gives consent for recruiting the orphans as study participants. Either way, the study participant himself/herself has got to be part of the process too. Being an orphan is already a vulnerable situation and having HIV infection compounds to the vulnerability. Getting informed consent from an orphan presents an important ethical dilemma, on how can a truly informed consent be obtained. Perhaps it would have been easier to explore the possibility of obtaining intended research information from children who are not orphans first, unless it was absolutely evident that it would be impossible to obtain data from other subjects in non orphan situations.

Ethical approval obtained in 2002, however studies were already underway in 2001 which is a serious ethical misconduct.

Stolen samples – this is by any standards an offense to the orphans, the local research institution in Kenya. Legal action should come into place.

Dr Rowlands and her team talk of believing that approval for conducting the study and shipping samples abroad had been taken care of by Dr M Otsyle. It is the scientist’s responsibility to confirm that all documentation is in order, not to assume, to believe etc. In Tanzania, all international collaborators need to seek clearance to conduct research in the country, and this can not be issued without presentation of an Ethical Clearance Certificate. Is there a possibility that besides not having ethical approval, this research team from Oxford did also carry out research without Research Permits?

With evidence that a publication has been written on research data obtained from stolen samples and a study without ethical approval, the Publication should not be accepted. Perhaps with this one the evidence of misconduct had not reached the publisher..

[Elizabeth Ochola]

1.The controversies in this aspect were that Dr. sarah allegedly stole blood samples from Dr.Otsyula.oxford researchers had allegedly collected additional blood samples from the orphans without ethical approval/ permission from the Nyumbani orphanage board, in addition the Oxford researchers allegedly published 2 papers based on results derived from thedisputed blood samples

Dr sarah believed that Dr. Otsyula had ethical approval to collect blood samples and conduct the study while the oxford team allegedly had permission from Fr.Angelo to conduct research
Nyumbani home allegedly had all documents authorising collection of blood samples from orphans
It was the duty of the Nyumbani childrens home board to protect the orphans.
The risk benefit ratio should be exploited first before any research is attempted, informed consent should be sought and also the ethical approval should be sought.
_________________
Elizabeth Ochola
NTD
Schistosomiasis Project
Kisumu,
Kenya

[Tekwu]

1. Ethical issues surrounding this case study are:
- Stealing of blood samples’ by Dr Sarah Rowland-Jones, from Dr Moses Otsyula that was collected from Nyumbani orphanage, in my view this is unethical and illegal to use samples that were collected for another study on another one with different objectives (Scientific misconduct).
Another ethical issue is that Dr Moses Otsyula went to the USA just to explore potential collaboration with Harvad University so, it was not necessary for him to carry the specimen to USA. Further, he did not keep the blood samples safe and allowed them to be stolen. This is also unethical.
- The collection of additional blood samples from the orphanage without ethical approval or permission from the Nyumbani orphanage board, though father Angelo D’Agostino claimed he had all the necessary documents, the study team should have asked for these documents before proceeding.
- if it is established that additional blood samples were collected from the orphans without ethical approval or permission from the Nyumbani Orphanage board, the such action is considered to be unethical .
Ethical approval is cardinal in every research to be carried out especially where researchers are dealing with human beings.
- Publishing two papers from a disputed scientific research mean that the publisher did not ask about the ethics approval. This case study clearly calls for the urgent consideration of journals publishing research findings to be strict on ethical approval from researchers before accepting manuscripts for publication.

2. In the context of Biomedical Health Research, the protection of the welfare of the orphans who constituted a vulnerable group of research participants (because they are minors and orphans) is the responsibility of the Nyumbani Orphanage board, researchers and their assistants, and the body responsible for granting ethical approval ( ethics committees).

3. If the natural immune responses of some HIV-infected children, who happen to be orphans (institutionalized or not), could provide critical leads that could contribute towards the development of protective vaccines against HIV infection, In so far as the findings will be beneficial to mankind, research should be conducted on the orphans to investigate the potential leads but this needs special measures to be taken so that the minors are not abused.