CFS Untied

A guest blog by Chris Douglas, 30th April 2012

In addition to taking part in the WPI’s UK study, I privately had my blood shipped to VIPdx for a HGRV/XMRV antibody test.

The following year, Dr Judy Mikovits was dismissed by the WPI. One of the bones of contention between the two parties seems to have been the scientific validity of VIPdx’s HGRV/XMRV assays and the defensibility of offering a commercial test for sale so early in the research.

These concerns were reinforced by the failure of any assays used in the US NIH’s Blood Working Group study to detect HGRV/XMRV on a fast throughput basis (i.e. outside of a research lab). These assays included those of the WPI on which VIPdx’s tests, allegedly, were based.

At the end of September 2011, UNEVX (the lab that superseded VIPdx) withdrew its HGRV/XMRV antibody test but gave scant rationale for the action. People in Europe, however, were told by their local labs that there were concerns about the test’s reliability.

On 17^th October, I emailed Annette Whittemore to request scientific validation of VIPdx’s HGRV/XMRV assays. It took a further four weeks and the intervention of Kellen Jones-Monnick (WPI Office Manager) to receive the following response from VIPdx.

STATEMENT OF VINCENT LOMBARDI, PhD
CLINICAL LAB DIRECTOR, VIP Dx

A number of recent publications and individuals have mischaracterized the nature of certain clinical laboratory results reported by VIP Dx, a CLIA certified clinical laboratory. VIP Dx has met the required CLIA Program standards and is certified to offer and perform only clinically validated laboratory tests. The “XMRV test” offered by VIP Dx is clinically validated and performed under rigorous protocols to ensure the accuracy and reliability of the test results. XMRV testing was offered based upon the existing scientific knowledge at the time. The original assays for XMRV testing were based on the 2009 Science publication. Those assays, as well as all subsequent modifications, were internally validated prior to being used to process patients’ samples. WPI’s Research Director was instrumental in the decision to make such a test available to physicians. The interpretation of the XMRV test results, as with all laboratory tests, is the responsibility of the ordering physician.

Before offering any test to the public, VIP Dx established comprehensive performance specifications including accuracy, precision, analytical sensitivity, specificity, and others required for test performance.

Further email exchanges confirmed that “…XMRV testing is for both the culture and the serology tests…” and that “…ALL of the tests we run are validated and inspected by the State of Nevada,”

I asked to see the “validation data”, requested details about “the State of Nevada” and reiterated my question about why a “clinically validated” test (or tests) was withdrawn.

VIPdx replied that “The State does not “hold” this information. It is a proprietary record of the laboratory. They inspect but do not keep our records. Our validation records and test protocols are proprietary intellectual property of the laboratory.”

Again, I requested “more tangible evidence of the scientific validity of the two XMRV tests” and an explanation of how they “…have been validated, particularly given that there was no previously established benchmark against which to compare them.”

I received no further replies from VIPdx.

Next, I contacted the State of Nevada Health Board Bureau of Health care Quality and Compliance which also handles Clinical Laboratory Improvement Amendments (CLIA).

During the ensuing correspondence, and contrary to VIPdx’s statement to me, it emerged that “Vincent Lombardi is not the laboratory director, nor has he served in that regulatory capacity” and “they took this off their website today, it is incorrect.”

[The regulatory Laboratory Director (i.e. the person who represents the lab for regulatory purposes) was/is Sanford Barsky who, in February 2012, CFS Chronicles found to be accused of scientific fraud.

http://www.cfschronicles.com/1/post/2012/02/vote-of-no-confidence.html ]

It also transpired that “Unevyx [sic] has not been approved nor have they begun to perform XMRV tests” despite offering these for sale from 13^th June 2011.

Although the State Health Board identified these two regulatory anomalies, it did not pursue an investigation into VIPdx or the scientific validity of its HGRV/XMRV tests.

Without such scientific validation, it is impossible to establish whether or not:

a) it is appropriate to take medication prescribed as a result of a positive VIPdx HGRV/XMRV test;

b) insurance company and private funds have been spent on tests that may have been invalid;

c) test results support current advocacy strategies for HGRV/XMRV-related diseases.

Given the continued absence of proof of scientific validity, I emailed VIPdx to request a refund for the test. I did this four times between 24^th February and 22^nd March but, apart from one read receipt, I have not received a reply.

In order to encourage a more forthcoming dialogue on the subject, perhaps others who have paid for a HGRV/XMRV test from VIPdx may wish to request a refund too. They also may wish to make a formal complaint to the State Health Board, particularly in light of the following statement from Dr Mikovits’ lawyer.

“Mikovits also confronted institute officials for allegedly selling blood tests through the institute’s clinic even after the tests had been invalidated, “thereby committing Medi-Care fraud,” Jones said.” Reno Gazette Journal, 23^rd April 2012.

http://www.rgj.com/article/20120423/NEWS/304230038/Fired-Whittemore-Peterson-Institute-researcher-claims-justice-system-flawed

VIPdx

Marguerite Ross, Director of Marketing and Client Relations

mross@vipdx.com

State of Nevada Health Board Bureau of Health care Quality

Vickie Estes, Supervisor, Medical Laboratory Services

vestes@health.nv.gov

According to the same article cited by Chris, http://www.rgj.com/article/20120423/NEWS/304230038/Fired-Whittemore-Peterson-Institute-researcher-claims-justice-system-flawed,

“The institute had been using federal grant money to pay a lab director, Vincent Lombardi, even though he did not work at the institute full time, Jones said.

“Jones also said Mikovits raised concerns about the alleged misuse of cells allocated for nonprofit research “to harvest supplies for the institute’s for-profit clinic.” Mikovits claimed the institute covered up the alleged misappropriation for two years.

“Mikovits also confronted institute officials for allegedly selling blood tests through the institute’s clinic even after the tests had been invalidated, “thereby committing Medi-Care fraud,” Jones said.”

Taken in combination – the concerns Chris has expressed, the statement above, and the recent article by Cort Johnson (WPI Back On Track? University Gives WPI Strong Show of Support) which documents the “strong approval” of the WPI by the University of Nevada, I have to defer to Samuel Wales’ recent cry for appropriate language to describe our paradigm. (Misopathy).

Perhaps “misapathy” would be another appropriate addition to our lexicon?

A guest blog by Chris Douglas, 16th March 2012 

Subsequent to previous blogs about the WPI losing my blood sample and consent form (see links below), I have received a further email from the National Institute of Allergy and Infectious Diseases (NIAID) which may be of interest to other participants of the UK study.

http://cfsuntied.com/blog2/2012/02/08/the-wpi-loses-uk-study-blood-sample-and-consent-form/

http://cfsuntied.com/blog2/2012/03/02/the-wpi-and-the-lost-blood-sample-communication-with-niaid/

In particular, the email states that the WPI is preparing a ‘communication plan’ to be approved by the University of Nevada, Reno, Institutional Review Board (UNR IRB). If this proceeds, it could mean that UK study participants will receive confirmation of the status of the research and whether or not further tests will be performed on (and results communicated for) the blood samples which the WPI currently holds.

This will be welcomed by many participants.

It is a shame (and sad indictment), however, that the WPI and the UNR IRB did not instigate such action either spontaneously or as a result of my direct requests for them to do so. Perhaps this was because the two bodies were working strictly (and only) within their own regulatory protocol (although this can not be clarified given the UNR IRB’s refusal to allow public access to the document in question). The issue here, though, is less about whether regulatory ethics were observed and more about the WPI and UNR IRB’s apparent inability to grasp, and operate according to, the basic tenets of professional courtesy and common decency.

I ask the following question: why would anyone with even an ounce of humility *not* take action to allay the potential fears of several hundred (some very) sick patients, many of whom have pinned their hopes on the outcome of this study and whose stress levels and relapse quotient have been reported to rise since Dr Mikovits’ departure last year? I have no satisfactory answer to this question. Perhaps the WPI and UNR IRB might have and would be prepared to enlighten us with it.

If the ‘communication plan’ does proceed, an additional outcome could be the identification of further lost blood samples and assent forms. Assuming that the WPI writes to the postal addresses on the assent forms (which might be required for ethical reasons and/or because the WPI does not have current email addresses for everyone), any participant who does not receive a letter probably has had their blood ‘mislaid’.

Other participants who face potential exclusion from the ‘communication plan’ are the ~40 housebound patients and ~10-12 in Ireland and the Scillies whose blood has yet to be drawn. According to the WPI and UNR IRB, anyone without an assent form is not a participant and so there is no regulatory obligation to communicate with these outstanding patients – the sickest of them all. At one point, it seems that the WPI did make an effort to identify these people: some known participants were asked if they could provide contact details for the outstanding patients (the participants declined). This would indicate that the WPI does not have contact details for these ~50 patients and so they may never receive direct communication about the study they still believe themselves to be enrolled in.

—– Original Message —–

From: Beisel, Christopher (NIH/NIAID) [E]

To: xxxxx

Sent: Thursday, March 15, 2012 2:45 PM

Subject: RE: R01 Grant Holder Loses Blood Sample and Consent Form

Dear xxxxx,

I’m sorry for any distress that the uncertainties regarding your consent form and personal information have caused you. We have continued to scrutinize the chain of custody of your materials, and do not have any further information concerning the whereabouts of your consent form or specimen, but will let you know immediately if further information comes to light.

I’d like to clear up some of the confusion regarding the continuation of this study following the change in Principal Investigator (PI). First, there is no change in the scientific scope of the project: the original Aims were to identify both novel viral infections and genetic susceptibility factors in European and American CFS patient cohorts. The new PI proposed no changes to these Aims and was approved to pursue them as originally stated, with incorporation of some technological advances made since the original application was written. The new PI’s training and expertise is immediately relevant to the latter objective, and he has assembled a well-qualified team of co-investigators, collaborators and consultants with the expertise and experience required to perform all the studies. Unfortunately, the Science Insider article you cite does not clearly convey this.

Second, you identify several issues with communication between the grantee (WPI) and the participants enrolled in this study, including notification of the PI change, of results that have already been obtained, and of future plans for the specimens stored at WPI. We share your concerns in this regard, and I have discussed the matter with WPI staff. They will formulate a communication plan and submit it to their IRB for approval.

Finally, you express concerns about the further use of the specimens that were collected with NIH support. For many of these, further tests will not be possible: some did not yield adequate material for further testing and some have been withdrawn from the study at the request of the donor. WPI has taken steps to ensure that they have adequate numbers of specimens to complete the studies, and has been encouraged to provide appropriate information to the present study subjects in a timely and transparent manner.

Once again, I do apologize for any distress or confusion that you’ve experienced. As I said previously, the NIH truly appreciates your interest in and commitment to the research we support on Chronic Fatigue Syndrome. Without the involvement of CFS patients like you, the scientists NIH supports would not be able to make progress in their efforts to understand and treat this disease.

Christopher E. Beisel, Ph.D.
Program Officer
Herpesvirus & Prion Research
6610 Rockledge Dr., Room 1211, Bethesda, MD 20892
Phone: 301.496.7453        FAX: 301.480.1594
NIAID, National Institutes of Health, DHHS

“You are transparent….I see many things.  I see plans within plans.”   …The Navigator, DUNE

For those of you who have not yet seen it, the WPI’s 2011 Annual Report has been published.   If you haven’t read it, it’s worth a gander.  

Much of it is interesting, some of it even more so in light of the accusations that the Whittemores are facing in legal suits.  

Some of it is interesting because of its conspicuous absence.   Dr. Daniel Peterson is pictured, and while his image is invoked, Judy Mikovits seems to have been erased from the history of the WPI.  

The “Friends” list is interesting because it seems to not reflect the current state of affairs, but that of a day gone by.

But what I find interesting enough to talk about is the appearance of Sam Shad’s name on the Board of Directors list, on page 29.

As you may recall, Sam Shad is the host of the “news” show, “Nevada Newsmakers”.  In actuality, Sam Shad Productions is a “full service advertising agency and program producer”.   The word “News” in the title of the show may be somewhat misleading.  Be that as it may, Mr. Shad has done several televised interviews with Annette Whittemore on his show, and it seems that in the interest of full disclosure and transparency, his relationship to the institute should have been made clear.   It concerns me that these programs have been regarded by us, the ME and CFS population, as news, when in fact they were nothing of the sort.  Part of the responsibility for assuming that these were legitimate interviews could possibly fall back on us.  After all, buyer beware.   But there certainly should have been some moral responsibility on the part of the WPI and its Board to clarify that these shows were orchestrated PR maneuvers.

Of particular concern to me is the October 26, 2011 post-Judy “interview”, which is transcripted here:  http://cfsuntied.com/blog2/2011/10/27/nevada-newsmakers-annette-whittemore-interviewtranscript/, …..

…..and available via video here:  http://nevadanewsmakers.com/search.asp, where a simple search of the name “Whittemore” will pull up 17 shows that revolve around either Harvey or Annette Whittemore.

It occurs to me that Mr. Shad would have a vested interest in allowing a rosy picture to be painted regarding the status of WPI, despite the turmoil that revolved (and still revolves) around the firing of their retrovirology scientist.   It further occurs to me that as much as we appreciated the media attention at the time, the “interviews” further back in time were not likely to have been much more genuinely “news interviews”.

I am not calling anyone a liar.   I AM saying that Sam Shad’s presence on the WPI Board of Directors puts a whole new restrospective spin on the WPI’s media coverage, at least for me.  

“The answer is within the problem.”…  The Navigator, DUNE

A guest blog by Chris Douglas, 2nd March 2012

In my previous guest post, I detailed how the WPI had lost my blood sample and consent form for the UK study and published a resulting letter of concern to the US National Institute of Allergy and Infectious Diseases (NIAID) which funds the research. http://cfsuntied.com/blog2/2012/02/08/the-wpi-loses-uk-study-blood-sample-and-consent-form/

In response to this letter, I have received an email from Dr Christopher Beisel who manages the NIAID grant. Dr Beisel confirms that the WPI does not have my blood sample or consent form and that it is likely neither reached the institute (either misplaced by Phlebotomy Services International, the UK-based phlebotomists or lost in transit).

He also confirms that the absence of my assent form means that I am not enrolled in the study and so I do not have to withdraw informed consent.

In light of Dr Beisel’s further commitment to continue with inquiries, the emergence of new information about the matter and, perhaps, some misunderstanding about the workings of the UK study and the reason for my initial concerns, I have replied as follows.

The Whittemore Peterson Institute is apparently attempting to sue Dr. Judy Mikovits for “all costs associated with her work”, according to today’s article at RGJ.com, including every dime of her salary since she started working there, all of her research costs while working for the Institute, and, crazily, for the $133,100 drop in donations after Mikovits left.  Here’s the article:  http://www.rgj.com/article/20120228/NEWS/120228030/Whittemore-Peterson-Institute-seek-millions-damages-from-fired-researcher

I ask you. 

On what planet is this sane?

Since when do we fire people, and then sue them for return of the salary they were paid while performing work?   And how do you even begin to justify suing someone for loss of income due to the fact that you FIRED them?  

I decided a week ago that I was tired of watching the whole trainwreck called WPI.   I stopped posting links to the ongoing saga.  It’s not productive.  But dammit, this is just continuously escalating into a nightmare for the entire community.  

Jamie Deckoff-Jones’ latest blog, Truth Is An Absolute Defense To Libel, publishes email communications from Annette Whittemore and her staff/family, in which Jamie is accused of hurting innocent people, such as Annette’s family members and people who come to work at the institute every day to “help patients like you”.   Team Whittemore wants Dr. Deckoff-Jones to issue apologies for the harm she has caused to the Whittemores, and to the Institute.

Ironic, isn’t it, considering the damage that the Institute is doing to the community?   By the time this is over, not a researcher alive will want to work in this field, and may hesitate to work in any field at all, if they have to work under the fear of their institute suing them for every penny in the event of termination.    This is ugly scrapping in the mud, a vendetta that seems based in ego, and one that has done far more harm to the patient population than any good that might come out of the science produced under the NIH grant money could ever make up for.   IMO. 

I feel that it would be ludicrous for any judge to award the WPI any money for perceived damage to their character or reputation.   The very worst damage has come from within.

A guest blog by Chris Douglas, 8th February 2012

After Judy Mikovits was dismissed by the WPI, I sought clarification from Annette Whittemore regarding the institute’s plans for the UK study so that I could decide whether or not to continue as a participant. It subsequently emerged that both my blood sample and consent form had been lost. Perhaps, predictably, the WPI blamed Dr Mikovits’ housekeeping and tried to ‘move me along’.

Let me state, at this point, that I really do not care whether Judy Mikovits, Annette Whittemore or the Easter Bunny personally lost my blood sample and consent form. What I care about is receiving a sincere apology and a credible explanation from the organisation (not an individual employee) responsible for the study I participated in.

At the risk of doing the work for the WPI, such a communication might go something like this.

Dear xxxx –

We are deeply sorry to have to inform you that we do not have your blood sample or consent form.

We have made inquiries with the phlebotomy company who drew your blood, the couriers who shipped the blood to the US and within the US, and another lab that handled the blood. We also contacted other participants who had their blood drawn on the same day as you.

Based on these findings, we believe that your blood and consent form [select option]:

(a) was not collected by the courier in the UK.

(b) was lost by the courier in international transit.

(c) was mislaid by the other US lab that received your blood.

(d) was lost in transit between the other US lab and the WPI.

(e) was lost at the WPI.

We take this matter most seriously and can assure you that the issue is being addressed with the greatest attention. We will notify you if, and when, further information comes available.

In the meantime, please find attached a blank consent form for you to sign and return. We have added a clause which refers to the lost blood sample and preceding consent form and which allows you to choose how both should be handled in the event that they are discovered (e.g. retained for study, destroyed, etc.).

We thank you for your patience and understanding in this matter and hope that you will continue to support the WPI in its future endeavours.

With kind regards,

Xxxx

Instead, after a four month email correspondence on the matter, the University of Nevada, Reno, Institutional Review Board stated simply:

“We are not at liberty to discuss with you any investigations that may have been undertaken by our office.  I can assure you, however, that we take seriously the oversight of any research studies conducted on our campus that include human participants, including those conducted at WPI. 

“Our office and the WPI have on numerous occasions answered your question about the whereabouts of your consent form and blood sample. There is no record of either.  We appreciate you contacting our office regarding this issue but we are unable to provide any further information to you.”

As a consequence, I have sent the following email to the US NIAID representatives who manage the R01 grant that funds the UK study (i.e. Dr Christopher Beisel and Dr Catherine Laughlin, Chief of the Virology Branch). I asked Khaly to publish this so that other participants of WPI studies are made aware of the issue. Thanks to her for doing so.

—– Original Message —–

From: xxxxx

To: cbeisel@niaid.nih.gov

Cc: catherine.laughlin@nih.gov

Sent: Tuesday, February 07, 2012 12:00 PM

Subject: R01 Grant Holder Loses Blood Sample and Consent Form

Confidential. Without Prejudice.

Dear Christopher

R01AI078234 Grant Holder Loses Blood Sample and Consent Form

I am a British participant in a research programme funded by NIH grant no. R01AI078234 (New Strategies to Decipher the Pathophysiology of Chronic Fatigue Syndrome). As you will be aware, this, initially, was awarded to the Whittemore Peterson Institute (WPI) at the University of Nevada, Reno (UNR), and its then Principal Investigator (PI), Dr Judy Mikovits.

In 2011, I had cause to consider whether or not to withdraw informed consent to this study and so entered into related correspondence with the WPI and the UNR’s Institutional Review Board (IRB). As a result, I discovered that the WPI had lost both my blood sample and consent form and either cannot, or will not, identify where these might be. Indeed, in the final correspondence from the UNR IRB, I was told that: “Our office and the WPI have on numerous occasions answered your question about the whereabouts of your consent form and blood sample. There is no record of either.”

That the WPI has lost my blood and consent form is alarming enough but that both they, and the UNR IRB, repeatedly respond with ‘we can not help you’ is simply deplorable.

When I asked the UNR IRB if a formal investigation had taken place that would include, for example, contacting the phlebotomists who drew the blood in the UK, the courier who shipped the blood to the US, any other labs that may have had access to the blood, other participants whose blood was drawn on the same day, etc., I was told that: “We are not at liberty to discuss with you any investigations that may have been undertaken by our office.”

In effect, both the WPI and the UNR IRB have washed their hands of me and are not honouring the ethical and legal commitment of participant protection as stated on the consent form that I signed in good faith.

This attitude is particularly contemptuous given that, not only did travel to the blood draw harm my health but, as per many participants in this British study, I donated financially to the cost of the venue hire (a curious anomaly in light of the WPI’s million dollar funding from the US NIH and, perhaps, a breach of IRB ethics in itself).

I would appreciate any advice you can offer on how to progress this matter to a more satisfactory conclusion, viz to identify the precise whereabouts of my blood sample and consent form and/or the point between Devon, UK and UNR, US at which they were lost.

I also would appreciate advice on how to withdraw consent given that the WPI and UNR IRB deny I am, or ever have been, a participant in this study.

Finally, I wish to express concern that, following a recent NIH review, the WPI has been allowed to retain the R01 funds. Having been a previous supporter of the institute, it is with great regret that I now suggest this organisation is neither capable, nor responsible, enough to manage such a large US Government grant.

A responsible organisation would have investigated thoroughly the loss of my blood sample and consent form and presented me with a credible explanation. Instead, all the WPI and UNR IRB have said is that the previous PI may have held the documents and such issues will not occur “in the future”.

This is akin to a manufacturer refusing to investigate a product complaint because the Production Director no longer works for the company. The complaint, however, remains the responsibility of the manufacturer (not its ex-employee), just as the lost blood and consent form remain the responsibility of the research institute (not its ex-PI). If the WPI can not grasp this basic rule of good conduct, how can it be trusted with over $1m of US taxpayers’ research dollars? I find this situation even more worrying given the WPI President’s current involvement in civil embezzlement litigation.

In addition, my own experience should raise concerns about other participants’ blood samples and consent forms, particularly those drawn in the UK during the last two weeks of July 2010. Regardless of assurances about blood draws “in the future”, how many samples already may have been lost or misidentified without the WPI or participants yet knowing it?

Please note that this letter will be placed in the public domain so that other participants of the WPI’s studies are made aware of the issues that I have encountered. I consider it only fair that others should have access to these facts when considering their own continued participation in such research.

Yours sincerely,

xxxxx.

Sequence of Events

26th July 2010

My blood was drawn in Ashburton, Devon, UK, by Phlebotomy Services International (PSI), a US company working on behalf of the WPI. At this time, I signed a consent form of which I have a blank copy (not a signed copy as the venue was a small hotel and did not have copying facilities).

Blood was drawn from two other participants at this venue and from additional participants on the same day at a different venue. It is my understanding that all blood samples and consent forms from these draws were collected from PSI by FedEx (for shipment to the US) later that day.

17th October 2011

I emailed the WPI’s President, Annette Whittemore, to request clarification of the status of this research but received no response other than two acknowledgements from her daughter, Andrea, on 25th October and 1st November.

15th November 2011

In the absence of a response from the WPI, I emailed the UNR IRB to ask who held consent forms for the study and whether the holder has a legal obligation to provide copies to participants.

17th and 30th November 2011

The UNR IRB acknowledged receipt of my inquiry, the latter email stating that the WPI was reviewing my request for a copy of my consent form.

16th and 22nd November 2011

I emailed Kellen Jones-Monick, the WPI’s Office Manager, to request clarification of the study’s status and, also, who holds participants’ consent forms.

22nd November 2011

Kellen confirmed that the WPI holds the consent forms and that she could provide copies upon request.

I requested a copy of my consent form from Kellen (request sent again on 27th November 2011).

5th December 2011

Kellen confirmed that both my blood sample and consent form had been lost.

“After carefully reviewing our study records, I was unable to find a consent for you.  I also checked with the lab to determine whether or not we have your blood sample and it appears we never received one.  Therefore, according to our records you are not enrolled in the R01.”

6th December 2011

I replied to Kellen with questions concerning the feasibility and ethics of identifying blood samples in the lab and forwarded the correspondence, without prejudice, to Nancy Moody, Director, Office Human Research Protection, at the UNR IRB.

15th December 2011

I prompted Kellen for a reply to my questions and she confirmed that it was not a breach of ethics for her to identify coded blood samples in the lab.

16th December 2011

I requested further clarification of Kellen’s reply and restated that I wanted to know the whereabouts of my blood and consent form.

20th December 2011

Kellen confirmed that “It is not a breach for me to access the master code and verify it against coded samples in the lab” and that “We have a meeting scheduled with an IRB representative at the end of the month regarding this matter.”

I replied to ask whether ‘this matter’ referred specifically to my case and, also, to clarify the identity of an unknown email recipient who had been copied on our correspondence without my permission.

Kellen’s response to the first query was a non-committal: “We communicate with the IRB regularly in regards to every matter concerning human subjects.” To the second query: “…Carli, our VP and legal representative.”

22nd December 2011

I asked Kellen why the WPI’s legal representative had been copied on the correspondence and without my permission.

23rd December 2011

Kellen confirmed that “Carli is in charge of compliance issues and is in continuous communication with the IRB.”

27th January 2012

I emailed Nancy Moody at the UNR IRB to ask if there had been any progress regarding my lost blood sample and consent form.

Nancy confirmed that Michelle Johnson of the UNR IRB completed a review and: “There is no blood specimen or informed consent document found in the study documentation regarding your enrollment in the study. The previous Investigator is no longer with WPI. It is unknown what the Investigator did with documentation if she was in receipt of it. Carli West Kinne of WPI has informed you of no record of your participation in this study, also. IRB has concluded our review of the study team and documents.  Administrative procedures are in place to mitigate from such poor study record keeping in the future.”

I replied that I had not been contacted by Carli or anyone else at the WPI since 23^rd December. I stated that I did not accept the WPI attributing the loss of my blood sample and consent form solely to the previous PI and so absolving itself of all responsibility. I asked if a formal investigation had included the phlebotomists, international courier, any other lab involved, other participants, etc.

Michelle Johnson replied that:

“We are not at liberty to discuss with you any investigations that may have been undertaken by our office. I can assure you, however, that we take seriously the oversight of any research studies conducted on our campus that include human participants, including those conducted at WPI. 

“Our office and the WPI have on numerous occasions answered your question about the whereabouts of your consent form and blood sample. There is no record of either. We appreciate you contacting our office regarding this issue but we are unable to provide any further information to you.”