Fraudulent ethics in academics

Dear Mr. Sant Rayn,

I am writing on behalf of Dr. Sudarshan and Karuna Trust – I am sorry for the delay.
Some of the areas of interest that could explored are the anemia control program under RCH I and II. We could have a broad overview of the program as well as a specific focused study at the field level.
We could study two states – Karnataka and either Arunachal Pradesh (where Karuna Trust has already started working with 9 primary health centres) or Andhra Pradesh ( if you feel that must be included as one of the areas of study). The study could include management, budgeting, implementation and administrative components of the anemia control program. NFHS data is already available but we could gather field based data after further discussions. One of our doctors is very interested in this particular area of research, and is happy to help in anyway she can.
Sickle cell anemia could also be studied in the tribal population under Karuna Trust.
If you could share your thoughts, we could together work on writing up the actual study in a formal way………..
Regards and hoping to hear from you soon,

Dr. Sylvia Selvaraj
Co-ordinator – Health and Research
Karuna Trust

________________________________________
From: santapasricha@hotmail.com
To: sakie339@hotmail.com
Subject: RE: PHFI
Date: Sat, 20 Oct 2007 14:20:37 +1000

Dear Sylvia,
thank you for your very interesting message. I am keen to explore working with the Karuna foundation next year and the opportunies you have proposed sound great.

I have a few questions I would like to ask before proceeding further, to help me ascertain what will be available and what other resources I will need to draw on.

Are there laboratory services available for the conduct of our anaemia research and epidemiologic surveys: in particular, to test samples for haemoglobin, iron, malaria and haemoglobinopathy traits eg sickle cell and thalassaemia?

Does the Karuna foundation have previous success in research of this type and supporting foreign researchers?

Where would we be likely to be based: in Karnataka or Arunachal Pradesh, or both? Which city do you envisage us being based in? I am very interested in the idea of working in Arunachal Pradesh.

Would I have a ‘supervisor’ who has experience/ interest in this type of work and who could guide me through the process? Although I have a MPH and well developed skills in clinical medicine, this will be my first ‘field work’ assignment – I believe I have the necessary skills but I will certainly need some guidance. If you have a person in mind, could you let me know their contact details? Also, could you pass on to me the contact details of the doctor you mentioned in your message who was interested in this work?

My wife, Dr Janet Harper, is an internal general medicine graduate with an interest in public health and infectious diseases. She would like to accompany me next year, and would also like to work on a project. She is particularly interested in epidemiology and public health strategies surrounding TB. Do you know of any projects she could work on simultaneously with me? I am very sorry for only introducing her late in the piece, but this is the first time we have been told of a concrete project plan for myself and thus the first time I have known where I may be based next year.

We would be able to cover our living expenses through a scholarship, but would need to apply for further funds for the conduct of the project. In ballpark terms, do you have any ideas for the expected costs we would incur to carry out the research?

I am very sorry for all these questions. As you can appreciate, it is a big decision for us to move to India for the year and we need to be aware of what to expect.

Perhaps I could give you a phone call in the next few days to discuss the project further. What would be a good time to call?

Thanks very much for your help,

Regards,
Sant-Rayn

Dear Dr. Sant-Rayn,

Thank you for your email dated 20th September 2007. With regard to your queries, please see the comments I have added, on discussion with Dr. Sudarshan.

1. Laboratory facilities
Our PHCs are equipped to do basic laboratoray tests and Sahli’s for Hemoglobin. We will have to consider upgrading if there is a requirement for more tests to be conducted at a local level. Alternately, we could identify a referral laboratory for investigations. This can be decided once the project proposal is finalised.

2. Karuna Trust has regular interaction with researchers. Currently we are involved in a study on corruption in Government Health Services with the University of Leeds. We can discuss this further if required.

3. It would be practically more convenient for you to live in Karnataka. Residence of ‘foriegners’ in Arunachal Pradesh requires special permission and may not be possible in the initial phase of the study.

4. Field based support for you will come from me and Dr. Prashanth who has a lot of field level experience and is currrently doing his MPH at Antwerp, Belgium. However the main supervision will come from Dr. Sudarshan.

5. Regarding your wife – TB is an area with a high potential for research. Karuna Trust is also involved in TB related activities. This can be further discussed to find a suitable area of interest for her.

6. Moving to a new country is definitely a big decision and requires a lot of planning. If you are here for an year, it would be good if you could rent a flat for yourselves. The minimum that you would require for rent/travel/food would work out to approximately Rs. 15,000/month for two persons.

7. PFI can support funding. This can be explored further once we have decided on the project – we can then make an estimate of available resources and what we would require.

Please do not hesitate to ask for any information that you may require. I am happy to help.

You could call me  on Wednesday 23rd October between 10.00 am and 2.00 pm Indian time.

Kind regards

Dr. Sylvia Selvaraj
Co-ordinator Health and Research,
Karuna Trust

Sent: Tuesday, December 04, 2007 4:22 PM
Subject: anaemia project proposal

Hello,
I have attached a draft copy of the project proposal to this email.
The quantitative survey comprises the most detailed component of the proposal at this stage, as Ik feel it is most important to consult with local health workers and appraise local conditions before actually designing the questionnaires.

This proposal is very open to change. I have focussed mainly on anaemia in children as this is the most urgent problem according to the NFHS 3. The other change from when we last corresponded is some focus on the effects of climate change in this region on agriculture, then on subsequent nutrition and thus anaemia. The modelling can be done in Melbourne with the collection of a small amount of data on the surveys. If there are any other ideas or methods, please let me know.

I have also included a cover letter at the start of the proposal which may be useful for generating funding. Please feel free to edit and modify.

I think we should try to gather funding with this document, whilst we continue to revise the plan as we progress.

Thanks,
Sant-Rayn

From: santapasricha@hotmail.com
To: g.brown@unimelb.edu.au; james.black@mh.org.au; meghna_9_9@yahoo.co.in; puja.thakker@phfi.org; sakie339@hotmail.com; r.moodie@unimelb.edu.au; babiggs@unimelb.edu.au; hsudarshan@vsnl.net
Subject: India Australia Council
Date: Thu, 24 Jan 2008 22:18:07 +1100

Hi All,
I think this may be one of our best chances of a big grant, although they state they rarely do much over A$15K, although I did see a few research grants at around $30K max.

Could all the collaborators please just send me their full names and qualifications for question 16, and we need a letter stating collaboration Documentary evidence concerning the type of involvement must be supplied where others have agreed to participate’ from PHFI, St John’s and Karuna Trust, to support the application.

Rob, I thought perhaps you could be the stated applicant?

I will keep writing over the weekend.
Its due late feb.
Thanks,
Sant-Rayn


 From: santapasricha@hotmail.com
To: sakie339@hotmail.com
Subject: RE: India Australia Council
Date: Fri, 8 Feb 2008 08:42:43 +1100

Hi Sylvia,
Thanks for your message – sorry for the delay in replying, we have been moving out of my house and everything has been quite chaotic.

We should reach India on 28 or 29 Feb. I am just seeing whether I will be able to attend the UN standing committee on nutrition conference in Hanoi on March 3-7 – this is a peak child and maternal nutrition group and many of the people who authored the papers in my literature search will be there, and it would be good to ask them some questions and tell them about our upcoming project: but I don’t think it will be possible to go. I will confirm early next week.

Could I ask – do you have a sense for the coverage of provision of iron supplementation to children, adolescents and women in the rural population? It will be a specific question we will address in the project, both from the perspective of the health worker and the recipients, but our sample size for this particular study is based on the estimated proportion.

Could I also ask: do the 25 PHCs organised by the Karuna Trust serve the Soliga people only, or what proportion of tribals do you think comprise the populations in this area? I understand subsidence agriculture remains the most common household income?

Thanks very much – I look forward to meeting you in a few weeks.
Sant-Rayn

Date: Wed, 5 Dec 2007 10:02:14 +0530
From: arunshet1@gmail.com
To: hsudarshan@vsnl.net
Subject: Re: anaemia project proposal
CC: santapasricha@hotmail.com; ankur.puri@phfi.org; drmeghna.82@gmail.com; meghna_9_9@yahoo.co.in; puja.thakker@phfi.org; sakie339@hotmail.com; a.street@alfred.org.au; babiggs@unimelb.edu.au; g.brown@unimelb.edu.au; james.black@mh.org.au; r.moodie@unimelb.edu.au

Sant-Rayn,

Its a good start! I actually like the idea of climatic influences. In terms of modelling, do you mean mathematical modelling. If so that would be a valuable addition. Will discuss the current draft with Dr. Sudharshan and Dr. Sylvia and get back to you with some suggestions by the end on this week.

Best wishes,
Arun

Arun Shet, M.D., AB (Hem)
Associate Professor of Medicine/Hematology
Dept of Medicine
St Johns Medical College
Associate Professor of Molecular Medicine
St Johns Research Institute
Sarjapur Road, Bangalore 560034
Phone:
Email: arunshet@iphcr.res.in
arunshet1@gmail.com

Hi Sylvia,
Hope this finds you well.
Prof Shet and I have been writing a few grant proposals. THe ones I can see being helpful are the Cooleys foundation and the Allen Foundation. We have been rejected by Nestle foundation. I will try the other two soon.

We were thinking it might be important to emphasise an intervention to optimise funding. This might also provide a valuable insight into the results. Perhaps we could look at a cluster randomised trial comparing implementation of the NNACP in one arm with nothing (control) in the other, or perhaps a newly devised strategy vs control. Then we could see what proportion of the community improves when given ther treatment. I imagine what will happen is that with iron, the prevalence of anaemia will fall eg from 70% to 30-40%, and this group will have a mixture of folate def, hb opathy, B12 etc. It is this group that will be very interesting to know more about, as they pose the limiting step to the success of any iron supplementation program. There are also quite a few interesting algorithms to determine the gold standard for fe deficiency which are dependent on response to iron, so we may be able to define the lower limit of normal ferrittin in this population.

Do you have any ideas re funding? Are there any local sources/ known donors who might be interested. You mentioned previously that PHFI could help: do you think this is still feasible?

Look forward to hearing from you soon.
it is the festive season here but I will be working each day so I’ll be contactable.

Sant-Rayn
Dear Dr. Sant Rayn,

Thank you for your email. We could do an interventional study though I doubt it would be ethical to deny IFA to those in the control group if the Hb is low, especially as it is mandatory under the National Anemia Control program. All our PHCs give both prophylactic and supplementary Iron and Folic acid especially to pregnant women.

However, under another project of ours we will be introducing one innovation each, in 7 of our PHCs, that will be scaled up to all the other PHCs (if successful).

At one of these PHCs we will be doing a targeted intervention for adolescent girls and this includes IFA supplementation. We could document the role of IFA intervention in this specific group and compare them with any of the other PHCs. For that particular area of study, there is some funding available from PFI.

With regard to funding from PHFI, Dr. Sudarshan suggested that you apply directly to them and mention Dr. Sudarshan as the referee and Karuna Trust as your geographical area of study.

I am unable to get an online version of the NNACP. Shall keep trying!!

Sylvia

Dr. Sylvia Selvaraj
Health and Research Co-ordinator
Karuna Trust
686, 16th Main, 4th ‘T’ Block,
Jayanagar
Dear Dr. Sant Rayn,

I am sure you are waiting for the outcomes of our discussion regarding the project on anemia. It was an interesting meeting in that we could share some of our experiences as well as requirements. This is tentative and will require significant inputs from you in terms of your own needs.

The resources that we already have available are
1. Field area
2. Laboratory and medical personnel resident at BR Hills
3. Records/Registers
4. There has been a previous study to document sickling in the tribal population of BR HIlls, I will get hold of that and send a copy to everyone.
5. Some subsidised facilities at St. Johns for laboratory testing, tertiary level care and laboratory staff training.

The areas that require inputs are

1. Analysis of the policy level processes of the anemia control program at all levels – this will include the administrative and implementation components. This will be a very valuable point of reference if we are to argue for any policy level changes in terms of anemia control.

2. Etiologic diagnosis. We are presuming that there will be a certain degree of iron deficient anemia. These will be documented and managed. There will also be another category who we can investigate further for sickle cell anemia, other chronic illnesses (Janet could play a big part here), genetic diseases.
Some of these will be documented at the primary care level.

The remaining group will then received further specialised investigations like Bone marrow aspirates, Breath analysis for H pylori or electrophoresis.

In effect we will be documenting the various etiology of anemia. This will then be used to influence policy.

If you could write out a project with this basic structure (We are happy to help with this) incorporating your own ideas or expectations from the project. then we can make out a formal proposal and that would help greatly to seek funding.

If you are trained in some of the basic laboratory investigations that you mentioned, it will be very useful both to train our field level staff as well as to introduce a component of standardisation for the testing.

I will also try to get you a copy of the National Anemia Control program

Regarding PHFI funding, I am copying this mail to Dr. Sudarshan. I will discuss details with him.

We also need to be clear about authorship of the subsequent article just to avoid any oversight.

Please do let me know.

Regarding Janet – we could find out if she could be involved in this project itself or work out a role in some of our other projects. I am thinking a lot about it and will write to her soon.

Kind regards

Sylvia

________________________________________
From: santapasricha@hotmail.com
To: sakie339@hotmail.com
CC: arunshet1@gmail.com; drmeghna.82@gmail.com
Subject: RE: costs for tests
Date: Thu, 15 Nov 2007 23:00:07 +1100

Dear Sylvia,
I am meeting with Prof Moodie next week to discuss costs and funding.
I remember in an earlier email it was mentioned that there might be some funding available from PHFI – do you think this is likely?
The other thing I can think of is to learn to perform some of these tests myself in the lab: I can ask the lab at my hospital to teach me to perform tests for ferritin, serology, Hb electrophoresis. Do you think this would improve costs, or is it materials rather than labour costs which add most to the cost of tests?

Also: do you have access to the National Anaemia Control Program (NCAP) protocol/ guideline? I can’t find it online. It would be great to get a copy of it somehow.

Anyway, look forward to hearing more from you and the results of your discussions.
Dr Arun – May I call you tomorrow or early next week? I am sorry to miss calling you but I was caught in the hospital in the evenings this week.

Thanks
Sant-Rayn

________________________________________
From: sakie339@hotmail.com
To: santapasricha@hotmail.com
CC: arunshet1@gmail.com; deb_tekay@yahoo.com; drmeghna.82@gmail.com; hsudarshan@vsnl.net; prashanth.ns@gmail.com
Subject: RE: costs for tests
Date: Wed, 14 Nov 2007 06:06:30 +0000

Dear Dr. Sant Rayn,

I apologise for the delay..
Today Dr. Arun Shet will be meeting with Dr. Sudarshan and me and hopefully with the details of the prior communications, we should develop a concrete protocol for the study.
I will send you the details by today.
In the meantime, if you could follow up the funding process, it will help us to make a realistic estimate of costs.

Also Dr Meghna will be involved at the field level and very interested. Unfortunately she has poor access to download research documents. It would be very useful to her if you could send her the literature that you have available till date.

Regards

Sylvia
________________________________________
From: sakie339@hotmail.com
To: santapasricha@hotmail.com
CC: arunshet1@gmail.com; hsudarshan@vsnl.net
Subject: RE: costs for tests
Date: Thu, 8 Nov 2007 09:40:51 +0000

Dear Dr. Sant Rayn,

I will discuss this with Dr. Arun Shet and Dr. Sudarshan, and get back to you probably early next week ( Everything shuts down for Diwali at this time of the year)

Sylvia

________________________________________
From: santapasricha@hotmail.com
To: sakie339@hotmail.com
Subject: RE: costs for tests
Date: Thu, 8 Nov 2007 20:43:54 +1100
Of course – I forgot the season!
Happy Diwali!
Sant-Rayn

________________________________________

From: santapasricha@hotmail.com
To: sakie339@hotmail.com
Subject: RE: costs for tests
Date: Thu, 8 Nov 2007 13:48:01 +1100

Hi Sylvia,
hope this finds you well.
I was just wondering whether you have any ideas on the approximate costs for conducting laboratory tests in Bangalore or nearby.

If we conducted an epidemiologic cross sectional survey, we would be looking at between 385 and 770 samples to be assayed for: ferritin, folate, Vit A, H pylori serology, +/- transferrin receptor and Hb electrophoresis.

The price per head of tests would determine how much money we can get and how much to ask for! And also would tell us whether we need to reduce the sample size.

Have you had any other thoughts re the project and other questions which could be asked?

Thanks for your help,
Sant-Rayn
________________________________________
From: sakie339@hotmail.com
To: santapasricha@hotmail.com; hsudarshan@vsnl.net; meghna_9_9@yahoo.co.in
Subject: Response for Janet
Date: Thu, 25 Oct 2007 06:36:01 +0100

Dear Janet,

I apologise for the delay in writing to you. I have been exploring the options available to you in terms of your specific interests. These are some of the areas you could work in.

1. Directly Observed Treatment Shortcourse (DOTS) is available in our Primary Health Centres. You could analyse the existing data and evaluate systemic issues related to drug availability/supply. Along with our study for anemia (with Dr. Sant Rayn) we could include the TB component and build up a questionnaire that will give us a good data base.

2. Merging vertical programs into comprehensive health care. There are some organizations that have worked to integrate vertical programs. We could work out a proposal to study the same in our Primary Health Centres.

3. HIV and Tuberculosis are very much of concern now especially with growing resistance to first line treatment. We could explore this further.

These are some broad areas that I have suggested. You are free to think of a project that would suit your specific needs.

Apart from all this, there is a real need for medical doctors at these remote rural areas. You could do general practice on a day to day basis.

Dr. Sudarshan suggests that both of you could stay at BR Hills, which will significantly cut down costs for you in terms of accommodation and food and you will also be available fulltime as a doctor at the centre.

Please do think about it and write to me further.
Kind regards and I apologise once again for the delay in response.

Sylvia

________________________________________
From: santapasricha@hotmail.com
To: sakie339@hotmail.com; hsudarshan@vsnl.net; meghna_9_9@yahoo.co.in
Subject: RE: PHFI
Date: Wed, 24 Oct 2007 16:21:54 +1000

Dear Dr Sylvia,
Unfortunately I was unable to connect to your phone today.
However, I am very excited about developing this project and working with your organisation to bring about some useful work.

I think we should start framing the research questions and methodology.

Are there well established anaemia control programs in place? Do you have links to those documents I could review? Are the anaemia control programs generally regarded important/ successful, or are they second tier? do they run at all your PHCs in Karnataka/ Arunachal? Is there scope to start one up and evaluate it?

Do you have any files/ papers regarding known epidemiology of anaemia in the areas under study?

I am keen to undertake research that could potentially involve several facets:
1. exploring the epidemiology of anaemia amongst tribal women and children living in Karnataka/ Arunachal Pradesh:
a) population prevalence of anaemia amongst pregnant/ non pregnant women.
b) causes of anaemia – iron deficiency, folate, sickle cell/ thalassaemia, vitamin A, malaria etc
c) causes of severe anaemia – ie what are the causes for those who have very low haemoglobins ie <7 or 8g/dL (is it iron, malaria etc).
d) causes of iron deficiency – nutrition, hookworm, even Helicobacter Pylori (this is emerging as an important, relatively unrecognised cause of iron deficiency in the west and H Pylori has been found to be common wherever people are poor and share food). This is a very exciting new area of research.
e) Interactions between anaemia/ iron deficiency and socioeconomic factors – eg crop success, wearing of shoes, diet, etc. Eventually even develop an approach for using anaemia/ iron def as an indicator of agricultural success/ marker of poverty. This would be best done in an area without an existing well implemented iron supplementation program.

2. Exploring the public health response to anaemia:
a) what are the official policies, how were they created, who wrote them, how well disseminated are they, when were they reviewed etc.
b) How is the programme implemented on the ground: do village health workers/ local health staff/ doctors understand and implement the program. (particularly antenatally, for pregnant women).
c) How do the local tribal women perceive the implementation of anaemia control projects, and do they regard them as important?
d) How well does anaemia control fit in with the Primary Health care model.
e) What is the policy towards control of haemoglobinopathies (ie sickle cell, thal) and are these implemented on the ground?

3. Clinical aspects of anaemia
a) Of recent maternal deaths, what % could be attributed to anaemia? Could anything have been done better to prevent them?
b) How do local VHWs assess for anaemia, what is the positive predictive value of their assessment, and what do they do? (eg pallor, hemoCue, Hb color scale).

I’m sure there are many other, very important questions which could be also asked and addressed, and I am very open to suggestions. It is hard for me to know exactly what questions to ask from Melbourne – your team are the experts! Please tell me what your ideas are.

Do we need to go through an ethics committee to conduct the research, and if so, how long do you expect this to take to get through the process?

Are subjects generally easily accessible for study? From the website, it seems there is a high number of patients presenting to the clinics. I expect I would need the help of a translator/ local assistant to help me on the daily work with the women: if we were conducting a large epidemiologic survey, we may even need to assemble a team for the work.

From above, you can see that it would be useful to test a few more complex lab tests:
blood: ferritin, transferrin receptor, folate, H Pylori serology, malaria, Hb gene testing/ electrophoresis
stools for hookworm

Do you think we will be able to conduct some of these tests domestically? We might need to freeze the blood if taking it a long distance but if there is a local reference lab we could do them there: do you know what costs are like so I can try to raise some funds?

Another interesting issue which I have seen on the website would be to try to look into the effects of climate change on the health of the local tribal women: perhaps exploring how crop failure, lack of water etc impacts on their health. This might be a different project all together but may be worth thinking about. My partner, Janet, is looking to work on a project – she is especially interested in control of TB (+/- multidrug resistant TB) and Leprosy – do you have any contacts she could get in touch with?

Thanks for reading this very long email!

I look forward to speaking to you soon. I’m looking forward to working with your team.
I will keep trying your number.

Regards,
Sant-Rayn
________________________________________
From: sakie339@hotmail.com
To: santapasricha@hotmail.com
CC: hsudarshan@vsnl.net; meghna_9_9@yahoo.co.in
Subject: RE: PHFI
Date: Fri, 19 Oct 2007 19:03:51 +0100
Hi all,
This paper confirms our research should be very timely.
May I email the author to introduce our project?
Thanks,
Sant-Rayn

________________________________________
Date: Fri, 11 Jan 2008 09:15:40 +0530
From: arunshet1@gmail.com
To: santapasricha@hotmail.com
Subject: Re: lit review
CC: puja.thakker@phfi.org; drmeghna.82@gmail.com; hsudarshan@vsnl.net; ankur.puri@phfi.org; james.black@mh.org.au; r.moodie@unimelb.edu.au; meghna_9_9@yahoo.co.in; sakie339@hotmail.com; babiggs@unimelb.edu.au

Hi all,
Here is the IRB application that we put in. I asssured the committee that we would get the investigator CVs and investigator signatures submitted to them in a timely manner. Please send me a copy of your CV and the signed document ASAP. If you can scan in a version of the investigators signature and send it along with your CV electronically, that would be great. Either way, I would need a hard copy of the signatures. Finally, if there are any suggestions or ammendments, let me know.

Hope to hear from you soon.

Best,
Arun
On 1/6/08, Santa Pasricha <santapasricha@hotmail.com> wrote:
Hi all,
Happy new year.
I’ve attached an outline of the literature review headings. I will start on this in the next few days. I’ve also attached an up to date endnote file with my current bibliography (around 160 refs, more to come).

I can send the set of pdfs of downloaded articles also, or I can copy them for you in a couple of months when I get to India.

I really need to get my hands on a copy of the NNACP – is there even a hard copy available which could be faxed to me?

The key interesting points to highlight are:
1. excellent RCT published in Lancet has shown that iron/folate supps for children aged 1m-30m increased death/ morbidty from malaria and should not be performed in malaria endemic regions.
2. iron supps never really gets prevalence of anaemia below 20-30% regardless of starting prevalence – interesting question is why are these leftover people anaemic?
3. No comprehensive analysis of anaemia in any Indian population
4. No analysis of hb opathies and nutritional anaemia in same population
5. Some good literature of burden of hb opathies in India, but not of their contribution to anaemia or their burden to disease/ infant mortality on the population/ village level.
6. We can request and use NHFS data in our own study – did the NHFS investigate the sites we plan to use well?

Thanks very much,
Will write again soon.
Sant-Rayn
Hi Sylvia,
Thanks for your message – sorry for the delay in replying, we have been moving out of my house and everything has been quite chaotic.

We should reach India on 28 or 29 Feb. I am just seeing whether I will be able to attend the UN standing committee on nutrition conference in Hanoi on March 3-7 – this is a peak child and maternal nutrition group and many of the people who authored the papers in my literature search will be there, and it would be good to ask them some questions and tell them about our upcoming project: but I don’t think it will be possible to go. I will confirm early next week.

Could I ask – do you have a sense for the coverage of provision of iron supplementation to children, adolescents and women in the rural population? It will be a specific question we will address in the project, both from the perspective of the health worker and the recipients, but our sample size for this particular study is based on the estimated proportion.

Could I also ask: do the 25 PHCs organised by the Karuna Trust serve the Soliga people only, or what proportion of tribals do you think comprise the populations in this area? I understand subsidence agriculture remains the most common household income?

Thanks very much – I look forward to meeting you in a few weeks.
Sant-Rayn
________________________________________
From: sakie339@hotmail.com
To: santapasricha@hotmail.com
Subject: RE: India Australia Council
Date: Mon, 4 Feb 2008 18:51:36 +0000

Dear Dr. Sant Rayn,

Could you let me know when Janet and you will be arriving – we could organise a meeting with all the others on the study to touch base..

Regards

Sylvia

________________________________________
From: santapasricha@hotmail.com
To: g.brown@unimelb.edu.au; james.black@mh.org.au; meghna_9_9@yahoo.co.in; puja.thakker@phfi.org; sakie339@hotmail.com; r.moodie@unimelb.edu.au; babiggs@unimelb.edu.au; hsudarshan@vsnl.net
Subject: India Australia Council
Date: Thu, 24 Jan 2008 22:18:07 +1100

Hi All,
I think this may be one of our best chances of a big grant, although they state they rarely do much over A$15K, although I did see a few research grants at around $30K max.

Could all the collaborators please just send me their full names and qualifications for question 16, and we need a letter stating collaboration ‘Documentary evidence concerning the type of involvement must be supplied where others have agreed to participate’ from PHFI, St John’s and Karuna Trust, to support the application.

Rob, I thought perhaps you could be the stated applicant?

I will keep writing over the weekend.
Its due late feb.
Thanks,
Sant-Rayn

From: santapasricha@hotmail.com
To: sakie339@hotmail.com; arunshet1@gmail.com; hsudarshan@vsnl.net; meghna_9_9@yahoo.co.in
CC: james.black@mh.org.au; r.moodie@unimelb.edu.au; babiggs@unimelb.edu.au
Subject: stats & ethics
Date: Wed, 20 Feb 2008 12:40:34 +1100
Hi Sylvia/ Arun,
I am meeting with a University statistician on Friday.
I’m planning to discuss nitty gritty methods of design for our study and the subsequent analysis.
In particular, I plan to clarify the required sample size and strategy for analysis.
I would appreciate your thoughts regarding the text highlighted below? Statisticians are very exact people…
What I plan to do re sampling is:
Define the total sampling population (ie children aged 1-2 years in rural Karnataka (how we define rural is another question we have to discuss) – in all regions or just those covered by a Karuna Trust PHC?), and
what do you estimate total number of children to be (ballpark, closest 10,000) eg around 20,000?

Choose a precision – are you happy with +/- 5%, 7%, 10%?
In other words, if we got an answer at the end saying, for example, the prevalence of HbS is 20%, would you be happy if the 95% confidence interval for that figure is +/- 5%, 10%, 20%, 50% etc? The standard would be 5%, but I think we would be happy with a little less (n for sample size really escalates at 5% and below).

Is there an accurate census of children available, and do we have an estimate as to its accuracy, otherwise, we can conduct a small census within selected villages, and then randomly select children from that population.

Are there some specific regions we should definitely include, and how many regions would you say are ‘distinct’ and need to be covered. For example, say there is a coastal region, mountainous region and arid region, and we wanted to ensure the random number generator didn’t accidently undersample a certain population, we can select the regions, and then based on their population, randomly select a weighted number from within each. From my out of country view, it would look like the regions we need to include would be the hills, the coast, ‘peri-Bangalore’ regions, and the northern districts.

Then we need to identify how many clusters to select (the more the better, depends on operational costs and availability of the field team) and randomly select the using the population proportional to size method. What proportion of mothers do you think will refuse to be be recruited into the study or not be available, after selection (10%, 5%?) – we need to sample (but not necessarily recruit) an extra few % to make up for this per cluster.

Roughly how many village health workers are there? We can either sample all of them if its not a huge number, or again a random sample.

Sylvia, are you aware of any recent climatic events – eg droughts or floods, in the last 5 years, in any areas of the state which will be included in our sample – we can take a second, more detailed survey here, and find out what happended to their food intake at that time.

I’ve also attached an ethics submission to this email also. The sample size calculation may change after Friday. Other than that, please feel free to modify and adjust. Perhaps the easiest thing would be to fax the last page with signatures to the Nossal Institute. I will check this and get back to you
Thanks very much.
Sant-Rayn

From: santapasricha@hotmail.com
To: arunshet1@gmail.com; hsudarshan@vsnl.net; sakie339@hotmail.com
CC: babiggs@unimelb.edu.au; drmeghna.82@gmail.com; drmgdeepak@yahoo.com; meghna_9_9@yahoo.co.in
Subject: Draft questionnaire
Date: Mon, 7 Apr 2008 18:11:04 +1000
Dear Drs Sudarshan, Shet, Selvaraj Karpagam,

Here is a first draft of a questionnaire for women/ children for the project.
Although it looks a little long, it has only about 36 questions + a 24hr food recall. Mostly there are a lot of spaces on the page!
I have tried to limit the questions to those I can forsee a useful analysis and ideally for which there is a referable precedent. Many of the questions may be too complex and require some simplification. We will also have to translate the questionnaire into local languages – for administration. Excluding the 24hr recall, there are no open questions so there should be no problem with translation/ coding.

I will produce a separate document regarding potential analysis to put the questionnaire into context in the next couple of days.
Please feel free to edit and comment as much as you like. I will take an improved draft to the field later in the week to trial it out.

Thanks
Sant-Rayn

From: sakie339@hotmail.com
To: santapasricha@hotmail.com
CC: hsudarshan@vsnl.net
Subject: RE: hi
Date: Wed, 9 Apr 2008 13:09:37 +0100

Dear Dr. Sant Rayn,

If you feel that logistically it would be difficult for you to carry out the study in three areas, then we can consider the two areas that you mentioned however if we want a representative sample, it would be a good idea to screen the three areas we mentioned earlier because north karnataka is quite different from the rest of karnataka and is important study exactly because it is so difficult to access.

However if geographic representativeness is not a focus then we can re-consider the sites of the study. We will have to decide this quickly.

When you come to BR hills we could meet up at TRC Mysore and discuss this further.

Sylvia

From: santapasricha@hotmail.com
To: sakie339@hotmail.com
CC: hsudarshan@vsnl.net; arunshet1@gmail.com
Subject: re sites
Date: Wed, 9 Apr 2008 23:33:22 +1000
Thanks Sylvia.
I am just waiting to hear back from Dr Deepak about a convenient time for me to head to BR hills and I will be coming up: I will come past the TRC on the way at a time good for you. I spoke to one of the staff there today who recommended I go up on Sunday or Monday, but I’ve left a message for Deepak to give me a call when he is free.

My feeling is that to do 3 sites could actually weaken the study not because of logistics but because of statistical power. I doubt we would be able to draw a statistically valid conclusion about the prevalence/ nature of anaemia in the whole state based on this study: it will be too small (our objective will be to explore the aetiology of anaemia within selected populations). Having 2 populations sampled with 150 each would enable us to make some comparisons between the two, as well as explore relations within the 2 groups individually, and finally to make calculations within the entire group as a whole. I don’t think 3 smaller sites will increase our validity in terms of generalisability to the rest of the state unless we have strong preexisting demographic data which calls for a need to stratify for a seperate group.

Importantly, there appears to be a a lot of malaria at Anengundi which could impact on the cause of anaemia in that population, and the potential solution: as you know, the WHO have recently recommended against blanket iron supplementation of children in malaria endemic regions unless the malaria treatment program is strong.

I would suggest we use Gumballi (incuding a tribal sample) and Anengundi. In the final prevalence estimate, we downweight the tribal sample and state the rest of the population is homogenous. We also make comparisons between the two sites.

I have attached a copy of the analysis plan to this email.
I look forward to meeting you in Mysore on the way to BR hills to discuss further.

Thanks,
Sant-Rayn

 

________________________________________
From: santapasricha@hotmail.com
To: sakie339@hotmail.com
Subject: hi
Date: Wed, 9 Apr 2008 14:01:17 +1000

Hi Sylvia,
I tried calling you today but I got your mother! I wasn’t able to reach you on the number she gave me.
Just to touch base:
– I wanted to discuss with you and Dr Sudarshan regarding doing the study at 2 or 3 of the sites. I’m starting to think we may actually get more value from doing 2 sites only, as the sample sizes at each will be somewhat larger. I would suggest the Anengundi and Gumballi sites – the rural (non tribal) region of Gumbailli being not dissimilar to the Suganahalli population. I wanted to discuss this before deciding one way or another.
– I am planning to head to BR hills in the next few days, as soon as I can let Dr Deepak know I’m coming.
– Janet is working on a proposal for her TB project out of Gumballi.

Thanks,
Sant-Rayn

From: sakie339@hotmail.com
To: santapasricha@hotmail.com
Subject: Zinc review
Date: Mon, 14 Apr 2008 12:14:45 +0530

Dear Dr. Sant Rayn,

A few articles on Zinc supplementation and a link
http://www.who.int/choice/results/u5_searb/en/index.html

Other colleagues can go through the journal articles and give their feedback/comments. What do you feel about zinc supplementation? Do you have any interesting articles that you can share?

Regards

Dr. Sylvia S Karpagam

Hi Sir, Dr Sylvia,
Hopefully will get a chance to speak to you in person tomorrow at Mysore: I’m planning to join Dr Deepak on a trip around to MM hills for a few days – he is leaving on Tuesday early am.

I have been reflecting on the major objectives of our study over the last few days.
I think we should meet an talk about these.

The major reason I say that is that designs to assess prevalence and those to assess cause can be different, as Sylvia pointed out. If we want to know prevalence, we will be able to do that with this study design: given there is only a sample frame of about 600 per site and 1200 in total, we will know the prevalence to +/-7% in each site and to 5% in the group as a whole (95% CI).

But to calculate OR for causation, we may need to think about doing something a bit different – perhaps a case control study – this could well be combined with the present study, but may require some extra features.

I have asked these questions of my epidemiologist supervisors at home who will also be able to add some ideas. But what they need to know first and foremost are our objectives.

In the meantime, the issues of logistics etc can be slowly worked through. I feel I need to spend more time in the field to get a sense of what is achievable and what the needs are, hence I will try to spend this week up in BR hills.

Thanks
Sant-Rayn

 

On 12/5/07, Dr.H.Sudarshan <hsudarshan@vsnl.net> wrote:

Dear Dr.Santa Pasricha,
Glad to receive the draft copy of the Project proposal.  Please note the correct name of our organisation is “KARUNA TRUST”  and not Karuna Foundation.  Dr. Sylvia is out of country and she will be back on 10th Dec.  We will send the feed back soon.
With regards
Sudarshan
—– Original Message —–
Sent: Tuesday, December 04, 2007 4:22 PM
Subject: anaemia project proposal

Hello,
I have attached a draft copy of the project proposal to this email.
The quantitative survey comprises the most detailed component of the proposal at this stage, as Ik feel it is most important to consult with local health workers and appraise local conditions before actually designing the questionnaires.

This proposal is very open to change. I have focussed mainly on anaemia in children as this is the most urgent problem according to the NFHS 3. The other change from when we last corresponded is some focus on the effects of climate change in this region on agriculture, then on subsequent nutrition and thus anaemia. The modelling can be done in Melbourne with the collection of a small amount of data on the surveys. If there are any other ideas or methods, please let me know.

I have also included a cover letter at the start of the proposal which may be useful for generating funding. Please feel free to edit and modify.

I think we should try to gather funding with this document, whilst we continue to revise the plan as we progress.

Thanks,
Sant-Rayn

Dear Dr. Sant Rayn,

A few articles on Zinc supplementation and a link
http://www.who.int/choice/results/u5_searb/en/index.html

Other colleagues can go through the journal articles and give their feedback/comments. What do you feel about zinc supplementation? Do you have any interesting articles that you can share?

Regards

Sylvia

 

Date: Fri, 11 Jan 2008 09:15:40 +0530
From: arunshet1@gmail.com
To: santapasricha@hotmail.com
Subject: Re: lit review
CC: puja.thakker@phfi.org; drmeghna.82@gmail.com; hsudarshan@vsnl.net; ankur.puri@phfi.org; james.black@mh.org.au; r.moodie@unimelb.edu.au; meghna_9_9@yahoo.co.in; sakie339@hotmail.com; babiggs@unimelb.edu.au

Hi all,
Here is the IRB application that we put in. I asssured the committee that we would get the investigator CVs and investigator signatures submitted to them in a timely manner. Please send me a copy of your CV and the signed document ASAP. If you can scan in a version of the investigators signature and send it along with your CV electronically, that would be great. Either way, I would need a hard copy of the signatures. Finally, if there are any suggestions or ammendments, let me know.

Hope to hear from you soon.

Best,
Arun

 

• Proposal for Karnataka Childhood Anaemia Project‏ to PHFI

27-03-2008
To hsudarshan@vsnl.net, sylvia selvaraj karpagam, ankur.puri@phfi.org, puja.thakker@phfi.org, ksrinath.reddy@phfi.org
From: Santa Pasricha (santapasricha@hotmail.com)
Sent: 27 March 2008 11:05AM
To: hsudarshan@vsnl.net (hsudarshan@vsnl.net); sylvia selvaraj (sakie339@hotmail.com); ankur.puri@phfi.org; puja.thakker@phfi.org; ksrinath.reddy@phfi.org
Karnataka Anaemia Project
Executive Summary

Partners:
o Karuna Trust:
o Dr H Surdarshan (co-investigator)
o Dr Sylvia Selvaraj Karpagam
o Dr Meghna Krishnadas
o Dr Deepak
o St John’s Research Institute:
o A/Prof Arun Shet (co-investigator)
o University of Melbourne:
o Professor Rob Moodie (co-investigator)
o A/Prof Jim Black
o A/Prof Beverley-Ann Biggs
o Dr Sant-Rayn Pasricha (field investigator, PhD student)
o Public Health Foundation of India

Background
Anaemia and undernutrition are pervasive health problems in India. The National Family Health Survey 3 (NFHS-3) found that, in rural Karnataka, anaemia affects 84.3% of children aged 6-35 months, and stunting (low height for age) affects 43%. Of women of reproductive age, 52.5% were anaemic. The high rates of anaemia and undernutrition occur despite an established National Nutritional Anaemia Prophylaxis Programme, and the presence of the National Rural Health Mission incorporating women’s and child health strategies for addressing these problems. Childhood undernutrition can result in irreversible physical and cognitive growth failure, and anaemia in women reduces work capacity and contributes to maternal mortality.

Aims
This project aims to identify the causes of anaemia and undernutrition amongst young children and their mothers living in a rural district of Karnataka, India, incorporating both proximal and distal factors. We will identify:
1. Prevalence and extent of anaemia and undernutrition in this population.
2. Biological causes of anaemia (i.e. iron deficiency, other micronutrient deficiencies, haemoglobinopathy and infection).
3. Causes of undernutrition (food security, diet, parasite infection, socio-cultural determinants).
4. Health systems delivery of anaemia prophylaxis and treatment.

Methods
1. Random sample of children aged 12-23 months, from rural and tribal populations of Chamrajnagar/ x/x district, with co-recruitment of their mother (or primary female carer), and their primary village health worker/ (AWW).
a. Questionnaire (mother):
i. Demographic and socioeconomic survey (8 questions)
ii. Food security survey (9 questions, FANTA)
iii. Dietary history for child (St John’s Research Institute, National Institute of Nutrition to assist with preparation).
iv. Maternal history (4 questions)
b. Examination (child):
i. VHW to assess for pallor.
ii. Length (cm), weight (g), Mid-arm circumference
c. Examination (mother)
i. VHW to assess for pallor.
ii. Height (cm), weight (kg) – calculation of BMI.
d. Venipuncture:
i. Mother (5mL):
1. Full blood examination
2. Ferritin
3. ESR or CRP
ii. Child (<3mL), by experienced paediatric technician
1. Full blood examination
2. ferritin
3. ESR or CRP
4. folate
5. B12
6. Serum retinol
e. Stool sample (previously prepared):
i. Hookworm eggs per gram
ii. Other parasites (ascaris)
iii. Amoebiasis
f. Village Health Worker:
i. Brief Knowledge, Attitudes and Practices Survey towards the topic of anaemia and undernutrition (8 questions).
2. Evaluation of health system delivery of iron-folate supplements:
a. Qualitative methods:
i. District Health Officer
ii.

Analyses
1. Prevalence of anaemia and undernutrition amongst rural women and children in x district of Karnataka.
2. Associations between food security and nutrition, and nutrition and anthropometry/ anaemia.
3. Associations between sociocultural factors, delivery of iron/ folate supplements and biological iron status.
4. Associations between knowledge, attitudes and practices of VHW and biologic outcomes (anthropometry, anaemia).
5. Normal distribution of haemoglobin for indian children based on individuals with normal iron status.
6. Characteristics of systemic failures in delivery of iron/ folate to rural women and children.
7. Appropriateness of current Indian policy towards addressing anaemia in women and children.

Outputs
1. Presentation of a detailed situational analysis to the directors and medical records of the Karuna Trust, and relevant local and state level health authorities, service providers and policy makers.
2. Publications for each of the analysis points as above.
a. It is anticipated that contributing partners listed above will be authors of these papers.
3. Development of a strategy to optimise the delivery of iron/ folate to the appropriate groups.
4. Implementation of a pilot project to ensure delivery of iron/ folate to women and children of this district.

Timeline
Month Task Persons Responsible
March 2008 1. Finalise study site

2. Complete ethics submission
3. ICMR form
4. AIC grant application (28th) 1. S Pasricha, S Selvaraj Karpagam, H Surdarshan
2. S Pasricha, A Shet, J Black
3. S Pasricha, A Shet, R Moodie
4. S Pasricha, R Moodie, L Duncan
April 2008 1. Develop questionnaire
2. Visit NIN Hyderabad, ?WHO Delhi, ?MI Delhi
3. Clarify laboratory techniques and sample preparation and transport requirements
4. Clarify field team personnel 1. S Pasricha, S Selvaraj Karpagam, B Biggs, A Shet, J Black
2. S Pasricha, ?others
3. S Pasricha, A Shet

4. S Pasricha, A Shet, S Selvaraj Karpagam
May 1. Identify sample frame
2. Finalise questionnaire (late)

3. Field test questionnaire (late)

4. Publicise project amongst study population 1. S Pasricha, Dr Deepak
2. S Pasricha, S Selvaraj Karpagam, B Biggs, A Shet
3. S Pasricha, S Selvaraj, Deepak
4. S Selvaraj Karpagam, Deepak
June 1. Train field team

2. Dry run
3. Perform random sample, contact VHW 1. S Pasricha, S Selvaraj Karpagam, others?
July 1. Perform field study 1. S Pasricha, study team
August 1. Perform field study S Pasricha, study team
September 1. Perform field study S Pasricha, study team
October 1. Complete field study
2. Interview of identified personnel

1. S Pasricha, H Surdarshan, S Selvaraj Karpagam
November 1. Interview of identified personnel 1. S Pasricha, H Surdarshan, S Selvaraj
December 1. Data analysis 1. S Pasricha, A Shet, J Black, S Selvaraj
January 2009 1. Data analysis
February – August 2009 1. Preparation of report and suggested interventions
2. Preparation of scientific papers All authors
August 2009 1. Submission of report to Karuna Trust and relevant stakeholders
2. Submission of papers All authors
Late 2009 Publication of scientific papers

Budget

Item Cost per unit Total
Survey Teams
Support for health workers (2) Rs 700/day x 100 days Rs 140,000
Support for medical officer (1) Rs1000 x 100 days Rs 100,000
Training expenses Rs1000 x 5 Rs5000
Transport expenses (for team, between primary health care centres) car + driver* Rs 1000 x 100 Rs 100000
Accommodation and meals for team when in field Rs500 x 5 x 100 Rs 25,000
Printing of surveys Rs 5,000 Rs 5,000
Laboratory Specimen transport costs Rs 40000
Child (300) FBE Rs 250
Ferritin Rs 110
CRP Rs 250
Folate Rs 350
B12 Rs 300
Vitamin A Rs 375
Hookworm stool examination Rs 100
Rs 75000
Rs 33000
Rs 75000
Rs 105000
Rs 90000
Rs 112500
Rs 30000

Total: 520500
Mother (300) FBE Rs 250
Ferritin Rs 110
CRP Rs 250 Rs 75000
Rs 33000
Rs 75000
Total: Rs 183000
TOTAL Rs 1118500

Arun Shet, M.D., D.M.
Associate Professor of Medicine/Hematology
Dept of Medicine
St Johns Medical College
St Johns Research Institute
Sarjapur Road, Bangalore 560034
Phone:
Email: arunshet@iphcr.res.in
arunshet1@gmail.com1

27/12/07

From
Arun Shet, M.D.
St. John’s Medical College
Bangalore – 560 034
e-mail: arunshet1@gmail.com

To
The Convenor,
Institutional Ethical Review Board
St. John’s Medical College Hospital
Bangalore – 560 034
Dear Dr. Karuna,

I am enclosing 2 copies of an application for Ethical Approval titled “Anaemia amongst tribal women and children living in rural Karnataka, India”

Consent and assent forms are also enclosed. Please do let me know if there are any issues you would like to discuss.

Please note that several collaborating investigators are not on site and their signatures will be obtained and submitted as soon as possible.

Thank you,
Yours sincerely,

Arun Shet, M.D.
Associate Professor of Medicine/Hematology
1) Title of the project:
Anaemia amongst tribal women and children living in rural Karnataka, India

2) Objective of the project

• To define the prevalence, nature and causes of anaemia amongst tribal children and their mothers living in rural regions of Karnataka, India.
• To identify the contributions towards anaemia of iron deficiency, folate deficiency, vitamin A deficiency, haemoglobinopathies
• To determine the underlying prevalence of soil-transmitted Helminths, particularly hookworm, and the prevalence of Helicobacter Pylori infection.
• To evaluating associations between these infections and haematological parameters and iron indices.
• To determine the prevalence and types of haemoglobinopathy amongst anaemic subjects.
• Define potential factors/risks for nutritional anaemia at an individual and community level.
• Demographic survey of mothers of participating children including questions about occupation pregnancies, household socioeconomics, diet, sanitation.
• Survey of village heads, community health workers and other key individuals.
• Observational study for key community factors that may relate to potential anaemia risk
• Evaluate the coverage of the National Nutritional Anaemia Control Programme (NNACP) in study villages.
• Identify specific deficiencies in the delivery of this programme.
• Predict the impact of climate change events (drought, floods) on prevalence of nutritional anaemia and malnutrition in general, amongst the study population.
• To be performed through analysis of the data collected during the survey.

3) Names of the Principal Investigator & Co-investigators with designations and qualifications.
4) Principal Investigator:
(i) Associate Professor Arun Shet
5) Co-Investigators:
(i) Dr Sant-Rayn Pasricha MBBS(Hons) MPH
Public Health Research Fellow, Public Health Foundation of India
Doctoral Student, Nossal Institute for Global Health, University of Melbourne

(ii) Dr Sylvia Selvaraj Karpagam

(iii) Dr H Sudarshan

(iv) Dr Meghna Krishnadas

(v) Professor Rob Moodie MBBS MPH FRACGP FAFPHM
Professor of Global Health, Nossal Institute for Global Health, University of Melbourne
(vi) Associate Professor Jim Black MBBS PhD FAFPHM
Epidemiologist, Nossal Institute for Global Health, University of Melbourne
(vii) Associate Professor Beverley-Ann Biggs MBBS DTM PhD FRACP FRCP FACTM, Director, International and Immigrant Health Research Group, Royal Melbourne Hospital, University of Melbourne

6) Outline of previous work in the field with relevant references
• Associate Professor Biggs is director of an iron/ folic acid supplementation project for women of reproductive age, conducted in North Western Vietnam, helping a population of more than 50,000 women.
• Dr Pasricha has analysed the data from the baseline and follow up evaluations of this project.
• Publications:
• Pasricha S-R, Caruana SR, Phuc TQ, Casey GJ, Jolley D, Kingsland S, Tien NT, MacGregor L, Montressor A, Biggs BA; Anaemia, iron deficiency, meat consumption and hookworm infection in women of reproductive age in north-west Vietnam; American Journal of Tropical Medicine and Hygeine (in press).
• Presentations:
• Pasricha S-R, Casey GJ, MacGregor L, Montresor A, Phuc TQ, Tien NT, et al. Is haemoglobin a good indicator of iron status in women of reproductive age in north-western Vietnam? Proceedings of the Haematology Society of Australia and New Zealand Annual Scientific Meeting; Gold Coast, Australia; 2007.

7) Brief description of the present work.
• Cross-sectional survey for laboratory and demographic features of anaemia.
(i) Subjects:
– Tribal children aged 6 to 59 months and their mothers
(ii) Study Design
– Cross sectional, cluster sampled survey.
– 768 randomly selected tribal children and their mothers across 20-30 clusters (villages).
– This number will enable a 95% confidence interval with precision of 5%.
(iii) Methods
– Collection of blood samples from children for analysis in laboratory.
– Minimal volume of blood required will be taken (<5mL) by venipuncture or finger prick.
– Analysis of samples for haemoglobin, mean cell volume, ferritin, zinc protoporphyrin, retinol, folate, haemoglobin electrophoresis, molecular studies for alpha thalassemia.
– Collection of specimen of stool for analysis of parasites.
– Demographic survey administered to the mothers of sampled children covering topics such as diet, birth order, age, socioeconomic status.
Mothers will also be asked to provide a small sample of blood for analysis of ferritin and haemoglobin.
o Statistical Analysis
 Prevalence of anaemia, iron deficiency, other nutritional deficiencies, malaria infection and haemoglobinopathies.
 Measurement of associations between outcomes (anaemia/ iron deficiency) and risk factors (nutrition, diet, hookworm) – regression analysis.
 Evaluation of effect of haemoglobinopathies on prevalence of anaemia.
 Development of simple statistical techniques to distinguish between iron deficiency and haemoglobinopathies as causes of microcytosis using ferritin and red cell indices.
• Survey of community leaders/ village heads for community level factors contributing towards anaemia.
o Subjects and Study Design
 Questionnaire based survey administered to local village headmen at each selected cluster.
o Methods
 Questionnaire to be administered by trained local health workers.
 To detail broad community level risk factors for anaemia eg proximity to school, types of agriculture, presence of mens’/ womens’ groups, etc.
o Statistical Methods
 Prevalence of each risk factor.
 Influences of community level risk factors on village mean biological outcomes (haemoglobin, iron, hookworm)
• Survey of health workers.
o Subjects
 Village health workers and community health workers.
o Study Design
 Comprehensive survey of all health workers working with the health care centre of the Karuna Trust.
o Methods
 Questionnaire regarding knowledge, attitudes and practices towards anaemia prevention and treatment.
 Administered by trained health workers.
o Statistical Methods
 Prevalence of accurate understanding of anaemia.
• Evaluation of the implementation of the National Nutritional Anaemia Programme at the level of the Primary Health Centre.
o Subjects
 The primary health care centres operated by the Karuna Trust.
o Study Design and Methods
 Structured, unobtrusive observation of aspects of the NNACP as delivered by the centres.
 Qualitative analysis health worker understanding of the NNACP.
 Analysis of proportion of eligible children receiving NNACP recommended supplementation.
• Evaluation of impacts of climate change on nutrition and anaemia
This will be a post hoc analyses conducted using the above data combined with climate modeling for the local area.
8) Justification for use of human volunteers/patients
– The project is intended to evaluate aspects of anaemia amongst tribal people in Karnataka, India.
– It is thus mandatory to involve human subjects for collection of samples and questionnaire data.
9) Patients-state the type of patients, who will be studies
How they will be studies? How often and how many will be studies? Which Consultant (s) are responsible for the patients?
No patients are involved in the study

10) Normal volunteers – From where will they be recruited?
Normal Subjects
• The demographic survey will recruit 768 children from tribal families of rural Karnataka, aged between 6 and 60 months.
• Selection will occur according to the population proportional to size (PSS) technique, with progressive random selection of villages, households and children.
• Mothers will be selected after the random selection of their children.
• Village headmen will be selected based on the recruitment of their village as part of a cluster.
• Health workers with the Karuna Trust will be approached to participate in the health workers survey.
11) At the time of their participation in the study, will be subjects be involved in any other experimental work? Please give details.
Subjects will not be involved in other experimental work

12) List the exact procedures how often the subjects will be submitted to such special diet, drugs administered with dose excluding Radioisotopes, etc.
Subject exposures
• Children will undergo:
o Nutritional assessment (weight, length/ height, arm circumference).
o Clinical examination (splenomegaly)
o Venipuncture/ skin prick for blood samples (sterile technique, new sharps).
o Collection of sample of stool
• Mothers will undergo:
o Questionnaire
o Venepuncture for blood samples.
• Village heads, community health workers:
o Questionnaire

13) Give details of any procedure involving radioisotopes or Irradiation.
14) State any potential or known hazards of the procedure listed in 10 above. How does the investigator intend to overcome this aspect?
Hazards of exposures
• There are few hazards from venipuncture:
o Pain – to be minimised by using well trained, experienced operators.
o Infection – preventable by using single use, sterile needles and aseptic technique.
o Haematoma – prevented by using well trained operators.

15) What is the Investigator’s personal experience with the proposed technique?
Experience with techniques:
• The investigators are experienced medical practitioners and are familiar with venipuncture. We will recruit experienced health workers to take the blood.

16) Will any sample collected from the patient be sent:
Sample use
• Samples will be analysed in India (Bangalore, Karnataka).
• No samples will be transported internationally for testing.

17) How will the informed consent be obtained any by whom?
Informed consent
• Women in households selected through the random selection process will be provided education regarding the proposed study by the study team health workers. Those interested in participating will be provided with a local language explanation of the project and the requirements of them and their children. The non compulsory nature of their enrolment will be emphasised. They will be asked to sign or otherwise indicate their permission on a consent form prior to allocation of their study number.
o Women will be asked to provide consent for their children to be enrolled and sampled in the study. Women and one randomly selected child will be enrolled as a unit.

18) Please detail whether subjects are to be reimbursed expenses incurred during participation in the study
Expenses for women
• The study team will visit the village during times when it is expected the women and their children will be in the home, thus there is minimal anticipated inconvenience or cost to the women
• We will provide enrolled women and their children with a certificate of participation and a nutritious meal.
Women and children identified to have a serious medical problem will be referred to appropriate medical services.

19) Is the form of consent with the explanatory note appended? Yes

20) Signatures of the Investigators & Co-investigators.

Principal Investigator:

Arun Shet

Co-Investigators:

Dr Sant-Rayn Pasricha
Dr Sylvia Selvaraj Karpagam
Dr H Sudarshan
Dr Meghna Krishnadas
Dr. Rob Moodie
Dr. Jim Black
Dr. Beverley-Ann Biggs

From: santapasricha@hotmail.com
To: drmgdeepak@yahoo.com; hsudarshan@vsnl.net; sakie339@hotmail.com
Subject: Revised proposal
Date: Sat, 10 May 2008 15:33:36 +1000

Hi,
I have attached a revised proposal for the project.
In particular, I have included a generous but hopefully achievable budget.
Certainly there will be more adjustments in the design and plan as time goes on, but perhaps we should forward this version once you are happy with it to the PHFI to enlist their help in grant seeking?
Thanks,
Sant-Rayn

 

From: santapasricha@hotmail.com
To: hsudarshan@vsnl.net; prashanth.ns@gmail.com; sakie339@hotmail.com
CC: vijay.bhat@manipalhealth.com; sumi.muthayya@gmail.com
Subject: PHOCON abstract
Date: Mon, 3 Nov 2008 03:23:08 +1100

Dear all,
here is a copy of an abstract describing the interim results, which we will submit to the Pediatric Haematology conference (PHOCON) in Delhi. Please let me know if there are any ammendments suggested. This abstract only covers the first 2 subcentres in each PHC, and is only an interim analysis. However, it should give us an opportunity to get some early feedback on the study.

Thanks,
Sant-rayn

The etiology of anaemia in rural children aged 12-23 months

Sant-Rayn Pasricha1 2, Jim Black2, Anita Shet1, Vijay Bhat4, Beverley-Ann Biggs2, Sylvia Selvaraj Karpagam3, Sumithra Muthayya1, Robert Moodie2, H Sudarshan3, Arun Shet1

1St John’s Research Institute, St John’s National Academy of Health Sciences, Bangalore, Karnataka, India; 2The Nossal Institute for Global Health, The University of Melbourne, Victoria, Australia; 3The Karuna Trust, BR Hills, Chamarajnagar, Karnataka, India; 4Deparment of Biochemistry, Manipal Hospital, Bangalore, Karnataka, India

Background
The prevalence of anaemia among children in India aged 12 to 24 months (< 3 years would be more specific) is above 80% (National Family Health Survey-3, 2005-06). Iron deficiency is considered the predominant cause; however contributions of vitamin B12 and folate deficiencies, inflammation and haemoglobinopathies have not been fully elucidated. We determined the etiology of anaemia among young rural children.

Methods
Children aged 12-23 months, and their mothers participated in a cross-sectional community-based study in two districts of Karnataka. Children with fever, previous history of blood transfusion, or acute illness were excluded. Venous blood was obtained for the analysis of haemoglobin, ferritin, vitamin B12, folate, C-reactive protein (CRP), haemoglobin variants, and malaria. Maternal hemoglobin was estimated by the Hemocue method using fingerprick capillary blood.
Results
Of 262 eligible children, anaemia (haemoglobin <11g/dL) was present in 195/262 children (74.4%, [95% CI 69.1, 79.8]); iron deficiency (ferritin < 15 ng/mL) in 156/258 (60.5% [95% CI 54.5, 66.5]; folate deficiency (serum folate < 3.3 ng/mL) in 5/258 (1.9% [95% CI 0.3, 3.6]), and B12 deficiency (serum B12 < 210 pg/mL) in 14/258 (5.4% [95% CI 2.6, 8.2]). Must state prevalence of IDA (those anaemic and having iron deficiency) Beta-thalassaemia trait was present in 6/262 (2.3% [95% CI 0.5, 4.1]. No cases of malaria were identified. Elevated CRP (> 5n g/mL) was found in 26/258 (10.1%, [95% CI 6.4, 13.8]). Amongst mothers, anaemia was detected in 153/235 (65.1% [95% CI 59.0, 71.2]). Multiple regression analysis revealed that haemoglobin values were positively associated with log ferritin (p<0.001) and serum folate (p<0.01), inversely associated with CRP (p<0.001), but not associated with B12 (p=0.97).
What about data on vitamin deficiencies and Hb variants in mothers? Were serum ferritin values of subjects with a high CRP excluded from the multiple regression analyses? What was the overlap in iron/vitamin B12 and folate deficiencies in this group?

Conclusion
Although iron deficiency contributes predominantly to childhood anaemia, other significant contributory factors include subclinical folate deficiency and inflammation. Data obtained in the present study compares with the National Figues. Further research on etiopathogenesis of anaemia among young children will help refine the National Anaemia Control Policy and improve the burden of childhood anaemia in India.
From: sakie339@hotmail.com

To: jfblack@unimelb.edu.au

Subject: RE: Regarding Dr. Sant Rayn Pasricha
Date: Tue, 22 Mar 2011 13:55:06 +1100

Hi,

I would like to introduce myself. I am Dr. Sylvia Selvaraj Karpagam. I was approached by Dr. Sant Rayn Pasricha, from the University of Melbourne, around August 2007 regarding a project he was planning on sickle cell anemia in a tribal area.

Since then I introduced him to Dr. Arun Shet and met several time to discuss the protocol. My name has been used on funding applications as well as IERB submission (see attached). I have helped him with literature review including access to government documents and review papers on sickle cell anemia. I have also helped him develop and pilot the questionnaire.

During the course of this I had questioned Dr. Sant Rayn Pasricha on two counts. One was the addition of friends/relatives as authors summarily without consulting others.

The other was the issue of lab reports to subjects on blank sheets without the hospital letter head and including the laboratory technician as ‘one more’ of the authors. Lab reports issued to subjects on blank sheets would have no value if taken to a hospital for further management. This was also planned to be done without the knowledge of the hospital whose resources were being used.

Since then, there has been no communication from Dr. Pasricha with me about the study and there is not even an acknowledgement in any of the published papers.

I feel that this is neither ethical nor professional. I will be writing to the journals that have published Dr. Pasricha’s articles. I thought I would inform you about this and would like your feedback or suggestions regarding the same.

Kind regards

Dr Sylvia S Karpagam

Dr. Sylvia Karpagam MD, MBBS

Community Health
________________________________

From: vijay.bhat@manipalhospitals.com
To: sakie339@hotmail.com
CC: shanmugam@manipalhospitals.com
Date: Fri, 1 Apr 2011 15:24:44 +0530
Subject: RE: Regarding reports from Manipal hospital

Dear Dr. Sylvia,
From the detailed and exhaustive details that you have provided ,it is indeed very unfortunate to know that inspite of your initial contribution in the project, you have not been given your due credit. Dr. Rayn and Dr. Arun had approached our hospital management, and as mentioned earlier, we had taken this as a purely business proposal to hospital. The tests that you have mentioned were carried out in our lab only. Out of the samples received our hospital would have received approx. 6-7 lakh rupees. All the bills(consolidated) have been submitted to St. John’s Research Institute, from where you will be able to get the details. As all the amount due was received and no pending statements were there, we will have to retrieve from our records for which you will have to officially address it.
Once again I would like to state that these were all bulk billing, and individual reports could not be given on our format. These were initially agreed upon by the investigators, and I have no role to play other than having given my technical expertise, and the SOPS were also provided for all of these parameters. St. John’s Research Institute and the Funding agency have to look into the details.
As far as the analysis is concerned we have taken utmost care and I can vouch for it.
For any further details you may contact our admin.
Regards

Dr. Vijay S. Bhat . Ph.D
Chief Biochemist

Manipal Hospital Diagnostic Services
# 98 | Manipal Hospital | HAL Airport Road | Bangalore-560017 | India
Tel : + 91 80 25023347 | Fax : + 91 80 25254563 | Cell : + 91 9945603528
Email : vijay.bhat@manipalhospitals.com | http://www.manipalhospitals.com

============================================================

From: Dr. Sylvia Karpagam [mailto:sakie339@hotmail.com]
Sent: Sunday, March 27, 2011 12:00 AM
To: Saroja Jaykumar[MHE]
Subject: Regarding reports from Manipal hospital

Dear Madam,

My name is Dr. Sylvia Karpagam. I was one of the researchers on a project to investigate anemia among children and mothers in the tribal population of BR Hills.

The guide Dr. Arun Shet had informed me that blood tests would be done in Manipal hospital laboratory by Mr. Vijay Bhat for a fee and reports would be generated on a blank sheet of paper. In return Mr Vijay Bhat would have his name on the paper (see attached).

The reports issued on a blank sheet by Manipal hospital were subsequently signed by a hematologist from St. John’s and issued to the study sample.

I had objected that this amounted to deception and misuse of the Manipal hospital laboratory as it would not be declared to the hospital authorities, but the other researchers felt that it was ethical.

I request you to let me know if the hospital was aware of blood tests done on around 400 samples of children (at the end of 2009) and if not, was it appropriate for Mr. Bhat to issue these reports.

Looking forward to your inputs.

Alternately I request you to let me know if I could contact anyone else at Manipal hospital to obtain this information.

Kind regards

Dr. Sylvia Karpagam MD, MBB

FW: Regarding reports from Manipal hospital

Vijay bhat (vijay.bhat@manipalhospitals.com)
Attachment
31-03-2011

Documents

To: sakie339@hotmail.com
Cc: Shanmugam N [MH-Bangalore]
vijay.bhat@manipalhospitals.com
Outlook.com Active View
1 attachment (267.7 KB)
Download scan0030.pdf (257.8 KB)
scan0030.pdf
View online

 

From: Shanmugam N [MH-Bangalore]
Sent: Wednesday, March 30, 2011 01:08 PM
To: Dr. Sylvia Karpagam
Cc: Vijay bhat; Dr Yamini K R.[MH-Bangalore]
Subject: RE: Regarding reports from Manipal hospital

Dear Madam,

 Reference to your mail I would like to state that we had received samples (pretreated) from St.John’s Research centre during 2008 sent by team headed by Dr.Anita shet. Details of pretreatment were not mentioned and so dept of Biochemistry undertook the analysis of all blood samples for Red cell Folate. The values were informed to Dr.Anita Shet. As per the earlier discussions it was agreed upon to pay Manipal hospital towards Red cell Folate test, at a special discounted rate(after approval from management).

 But on noticing the values which were discordant (due to improper pretreatment), the payment was kept on hold for a long time. It was only after several remainders the expense which was met for me kit, was given to Manipal hospital.

 As this was just as part of services, no hard copy of report was given, and only the equipment printout was taken by the team of Anita Shet.

 Also attached is copy of request letter from Dr.Anita Shet.

 Any further details / clarification feel free to contact me or Mr.Vijay Bhat.

 Thanks & Regards,

 N.SHANMUGAM,

OPERATIONS LEADER – SSG 1

(Lab Medicine & Cytogenetics)

Logo

Manipal Hospital

98,HAL AIRPORT ROAD,BANGALORE-560 017.

Email:shanmugam@manipalhospitals.com;Website:www.manipalhospitals.com

Mobile: +91 99456 08880; Landline: 080 2502 3399.

 

Dr. Sylvia Karpagam MD, MBBS

From: jfblack@unimelb.edu.au
To: sakie339@hotmail.com
CC: santapasricha@hotmail.com; g.brown@unimelb.edu.au; babiggs@unimelb.edu.au; r.moodie@unimelb.edu.au; arunshet1@gmail.com
Subject: RE: Regarding Dr. Sant Rayn Pasricha
Date: Tue, 22 Mar 2011 13:55:06 +1100

Dear Dr Karpagam,

I write as one of Dr Sant-Rayn Pasricha’s PhD supervisors here at the University of Melbourne.

I am sorry that you have concerns about the conduct of our research on childhood anaemia in Karnataka. I can assure you that we strive to maintain high standards of professional and ethical conduct in all our work, and take such concerns seriously. I will be happy to investigate your concerns if you can supply me with some further details.

In particular, can you explain which friends or relatives you believe were included as authors on which paper(s)? If you do you not consider their inclusion as authors justified, can you explain why? Can you explain what you mean by ‘summarily without consulting others’?

I am uncertain of the nature of your concern regarding the reporting of laboratory results. Are you referring to tests performed for research purposes or for patient management? Which laboratory technician do you mean? Was s/he involved as a collaborator in the research or simply as a paid technician?

What contribution of yours would you wish to have been acknowledged, and in which papers?

I can assure you of a prompt response if you can provide the necessary details.

Yours sincerely,

A/Prof Jim Black

Nossal Institute for Global Health

Level 4, Alan Gilbert Building

Cnr Grattan and Barry Sts

The University of Melbourne

Victoria 3010

Australia
—–Original Message—–
From: Dr. Sylvia Karpagam [mailto:sakie339@hotmail.com]
Sent: Wed 3/23/2011 2:08 PM
To: Jim Black
Cc: santapasricha@hotmail.com; Graham Brown; Beverley-ann Biggs; Rob Moodie; arunshet1@gmail.com
Subject: RE: Regarding Dr. Sant Rayn Pasricha

Dear Dr. Black,

Thank you for the prompt response and apologies for the delay in replying.

At the outset, I would like to state that my interest is not to gain academic benefit from the research study.

When Dr. Sant Rayn got in touch with me, I went out of my way to support him and his wife to identify a suitable study topic, field area and guide. I convinced Dr. Sudarshan of the need for the field study and all the other things I mentioned in my previous mail.

We met frequently to discuss several aspects of the study.

Subsequently I found Dr. Sumithra Muthaiyya’s (a colleague of Dr. Arun Shet) and Dr. Anita Shet (wife of Dr. Arun Shet) as authors.

Abstract: Sant-Rayn Pasricha, Jim Black, Anita Shet, Vijay Bhat, Beverley-Ann Biggs, Sylvia Selvaraj, Sumithra Muthayya, Robert Moodie, H Sudarshan, Shet AS. Anaemia among young children living in rural Karnataka, India: a cross sectional study, 2009

http://www.sjri.res.in/html/molecular_med_Hermato_pu.html

I had sent a mail to Dr. Sant Rayn and Dr. Arun Shet (I am not sure if the rest of you were included) asking what the basis was for the inclusion. I felt that in the interest of transparency, it was important to discuss these without unilateral decisions being made. A clear explanation of their involvement would have certainly helped. I did not get a response to this.

The second issue was that Dr. Arun Shet had come into the Karuna trust office and said that in the interest of cutting costs, lab tests would be done by a technician at Manipal hospital, without the knowledge of the hospital and therefore reports would be issued to the patients/study population, on a blank sheet of paper.

This would help the research because it still provided data, but obviously not the patient because it would not be an official report. The technician would benefit by having his name on one of the papers. This was strongly objected to by Dr. Sudarshan and me.

Since then I am unaware of what the developments were and how the reports were generated, but I was left out entirely from the communication. Considering the sequence of events, I feel that questioning these practices led to me being left out completely from the study. Most journals require a letter from each author for permission to publish. It seems to me like the best way that has been adopted to deal with a dissenting author, is to leave her out entirely.

I feel that the onus also lies on you and the rest of the team to guide Dr. Pasricha, not just on excellent technical aspects but also these issues.

India, as you may, or should be aware, is a relatively new entrant into the field of research and ethical/professional boundaries are constantly being tested and stretched. It will become a tiring exercise if we go back and forth, for lack of a better term, nit-picking. I would like my concerns to be recorded, so that it can be a frame of reference for future research.

I hope this clarifies your questions. If not I am happy to provide further clarifications.
Regards
Sylvia

Dr. Sylvia Karpagam MD, MBBS

Community Health

If you are neutral in situations of injustice, you have chosen the side of the oppressor.” – Desmond Tutu.

Date: Thu, 24 Mar 2011 09:21:47 +0530
Subject: Re: Regarding Dr. Sant Rayn Pasricha
From: arunshet1@gmail.com
To: jim.black@unimelb.edu.au
CC: santapasricha@hotmail.com; g.brown@unimelb.edu.au; babiggs@unimelb.edu.au; r.moodie@unimelb.edu.au; sakie339@hotmail.com

Dear Dr. Black,

There has been no communication from Dr. Karpagam to Dr. Pasricha or myself as she alleges.

However, here is a clarification for the issues that she raises: We included Drs. Anita Shet, Sumithra Muthayya, Savitha Nagaraj and Mr. Vijay Bhat as authors for their substantial contributions to the project. Dr. Anita Shet (pediatrician) contributed to the design and execution of the nutritional components of the study and manuscript review and her research staff were involved in training of our field workers. Dr. Sumithra Muthayya (Nutritionist) contributed vital nutritional inputs and reviewed the manuscript. Dr. Nagaraj (Microbiologist) performed the stool analysis and reviewed the manuscript. Mr Bhat (clinical biochemist) performed the laboratory analysis and helped with preanalytical variables critical to our study design.

After receiving these allegations, I had a conversation with Drs. Prashanth and H Sudarshan who represent Karuna Trust and provided me with some clarifications. As you may know, the Karuna Trust worked with us on this project as they provided the primary health care for the villages where we planned to perform these studies. Dr. Karpagam was initially involved in this project as an employee of the Karuna trust. The Karuna Trust (Drs. Prashant and Sudarshan) determined the authorship contributions from their side for the papers that we have published. Please see email from Dr. Prashant that I forwarded.

As the laboratory tests were being performed within the scope of a research study we discussed this with Dr. Sudarshan who raised concerns that official signed reports of the lab tests would not be provided. We discussed the fact that sample collection in the field results in preanalytical variables that the laboratory cannot control. Therefore, official results would not be provided by the laboratory that we were working with. Howevver, we addressed this concern by providing study participants with a summary of the laboratory data signed by a hematologist on our institution letter head. The Karuna Trust was satisfied by this plan.

In my capacity as Dr. Pasricha’s Co-Guide and corresponding author of the paper, I do not believe that he has breached any professional or ethical code. It is rather unfortunate that these unsubstantiated accusations are being made and I do hope this clarification settles the issue.

Sincerely,

Arun Shet

Hi,

I am attaching ‘some’ of my communication with Dr. Sant Rayn. Many other emails were sent through my official id and I haven’t saved my sent messages. I am sure most of you would have some of my communications in your Inbox as well.

From the attachments, it will be sure to the group (and I am sure that Dr Sant Rayn, in his heart will know) that I have genuinely given a lot of time and effort into this project.

Dr. Prashanth was not involved at all till the incident I mentioned and neither does his name figure in either the communications or proposals. However, I find his and Dr. Arun’s mail downplaying my role in Dr. Sant Rayn’s work not unexpected.

I still hold that (and I trust Dr. Sant Rayn will agree ) that my contribution to this project was not trivial.

Regarding the questions I posed, it is possible that the other authors contributed significantly – my query was what their contribution was/would be. I did not receive a communication regarding this.

Regarding my second query, Dr. Arun Shet has acknowledged that there was concern raised about the ethics of issuing reports on blank sheets for patients. If this concern had been addressed, then I am happy to hear the same.

Regards

Sylvia

——— Forwarded message ———-
From: Prashanth NS <prashanthns@iphindia.org>
Date: Tue, Mar 22, 2011 at 3:33 PM
Subject: Regarding your queries on phone about the Anaemia project
To: Arun Shet <arunshet1@gmail.com>, “Dr. H. Sudarshan” <hsudarshan@vsnl.net>

Dear Arun,

Greetings!

With reference to your phone conversation with me earlier today, you mentioned that there are questions raised about the anaemia project. I discussed this with Dr. Sudarshan on phone. I am writing to clarify the matters you raised based on my memory and the correspondence on the project.

Karuna Trust was introduced to Sant-Rayn through the Public Health Foudation of India. He had written to us asking if we would like to explore some research on anaemia with us. Subsequently we were given to understand that he would be requesting you to be his supervisor locally (KT being a service provider NGO did not have any research supervisor on board). I am copied on the original email correspondece introducing Sant-Rayn to KT from the PHFI Director.

Since I was away on study leave during the period when Sant was developing his protocol, I was not directly involved. However, on return from Antwerp since August 2008, I got directly involved in the study. Within KT, the responsibilities that we mutually discussed with you and Sant were – finalising tools, coordinating and managing field work and data collection and commenting/reviewing the manuscripts. Dr. Sudarshan, being the Secretary of KT has been involved in this project right from the very beginning and decisions on roles and responsibilities in the project were taken within KT and distributed among our staff. In course of time during the project, various people from KT were involved – am sure you remember Meghana, Deepak, Sylvia apart from Dr. Sudarshan and myself. In addition, there were also the PHC MOs and several other PHC staff involved. Many of them left KT at various points of time during the project. I have with me all the various drafts of manuscripts circulated by Sant and we were fully aware of the other authors and their contributions. But as far as KT is concerned, I do not see any scope for problems with this – KT as an institution decided on authorship for its staff based on contributions to the actual research study (protocol design, data collection, analysis and writing), in this case – both Dr. Sudarshan and me were the ones involved in these steps.

I hope this clarifies matters. I am also marking this to Dr. Sudarshan.

Regards,

Prashanth N S
Faculty, Institute of Public Health, Bangalore ( http://www.iphindia.org )
Asst. Director (Research), Karuna Trust & VGKK

web @ http://daktre.com
@prashanthns on twitter
http://en.wikipedia.org/wiki/User:Prashanthns
photos @ http://flickr.com/photos/biligiri

Hi,

With regard to Dr. Arun Shet’s clarification below, I have a few questions

As the laboratory tests were being performed within the scope of a research study we discussed this with Dr. Sudarshan who raised concerns that official signed reports of the lab tests would not be provided. We discussed the fact that sample collection in the field results in preanalytical variables that the laboratory cannot control. Therefore, official results would not be provided by the laboratory that we were working with. Howevver, we addressed this concern by providing study participants with a summary of the laboratory data signed by a hematologist on our institution letter head. The Karuna Trust was satisfied by this plan.

1. Why would lab tests done at Manipal hospital not be issued on the Manipal letter head?
2. Was the management in Manipal hospital aware of this?
3. If yes, can we have an official communication with the management if explicit permission was granted?
4. If no, does it not amount to deception and misuse of hospital equipment?
5. If lab tests were not done at St. John’s, is it right for a hematologist from St. Johns to sign for them?
6. If yes, was the management in St. Johns aware of this?
7. If yes, can we have an official letter from the management of St. Johns?
8. If no, does it not amount to misuse of the hospital letterhead for issue of tests not performed within the hospital?
9. What was the incentive paid in cash or kind to Mr. Vijay Bhat?
10. Was his organisation aware of his involvement in this project in such a manner?
11. If Dr. Sudarshan or the NGO (without research background as stated by Dr. Prashanth) say that this practice is satisfactory, does it absolve researchers of ‘stature ‘ from questioning it?

Sylvia
Dear Dr Karpagam,

As promised, I have investigated all the issues you have raised concerning the research of our team on childhood anaemia in Karnataka. We are grateful for the assistance you gave in the early phase of the project, while you were still associated with the Karuna Trust.

However, I am satisfied that no aspect of the work done during the life of this project could be considered unethical or unprofessional.

All the research work of the staff and students of the Nossal Institute for Global Health is approved and governed by the Human Research Ethics Committee (HREC) of the University of Melbourne. If you are not happy with my response you should take your concerns in writing to the HREC. We will of course abide by any decisions the HREC may make.

Other than as directed by the HREC we do not propose to engage in any further correspondence with you on this matter.

Yours sincerely,

Jim Black

A/Prof Jim Black
Associate Professor in Global Health

 

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  1. Excerpt from email by Mr. Vijay Bhat, chief Biochemist, Manipal hospital diagnostic services dated 31st March 2011 “You may kindly note that I had provided all the technical requirements and my time, towards this study. The shocking news was that inspite of all this support, BMC Public Health 2009,9:59 doi:10.1186/1471-2458-9-59 had just an acknowledgement given to me . It was only after I brought this to notice, I was included in co-authors list in a publication in Pediatrics journal.”

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