March 17, 2022

From: Paul Connett <pconnett@gmail.com>
Date: Thu, Mar 17, 2022 at 7:57 AM
Subject: Concern on “waterBEST” study proposal

To: John Roberts OHRE Director’s Office <>, Louise Winstanly IRB B Chair <>, Robert Matthews IRB D Chair <>, IRB Compliance Office <>

Cc: Michael Connett <>

We understand that the “waterBEST” study proposal is being reviewed by either the IRB B or IRB D panels.  We are including the Chairs of both panels in this communication and request that the Chair of the appropriate panel forward this message and the attached letter of concern to each of the members of their panel.

Please acknowledge receipt of this letter.

I look forward to a prompt response to this serious matter.

Paul Connett, PhD

Executive Director, American Environmental Health Studies Project (AEHSP) and Fluoride Action Network (FAN)

Attachment of letter

April 1, 2022

From: Paul Connett <pconnett@gmail.com>
Date:  April 1, 2022 at 12:50 AM
Subject: Your URGENT attention required

To: John Roberts OHRE Director’s Office <>, Louise Winstanly IRB B Chair <>, Robert Matthews IRB D Chair <>, IRB Compliance Office <>, “Cc: Michael Connett” <>

Dear Mr Roberts, Ms Winstanly, Dr Matthews, and IRB Compliance Office,

Two weeks ago I sent you a letter expressing serious concerns about the safety of a human research study being reviewed by your IRB.  The letter outlined in detail the reasons we believe the study poses a substantial risk to the young children who are the proposed participants that substantially outweighs any expected benefits.  The letter also describes other serious ethical concerns about the study.

I requested that you acknowledge receipt of the letter and that you provide a prompt response to the substantive concerns that have been raised.

I have not received any acknowledgment of receipt of the letter or any response to the substance of the letter.

I’ve again attached the letter to this email, along with a copy of my original email to each of you.

Please acknowledge receipt of the letter and this message by Monday, April 4th.

My understanding is that the study was planning to begin recruitment this month, so we consider this an urgent matter.  I hope you will treat this as seriously as we believe is warranted.  Please let me know what you have done so far to respond, and give us your plan moving forward, and expected schedule.  We request you distribute this message and the attached letter to all the IRB members.

Sincerely,

Paul Connett, PhD

Executive Director, American Environmental Health Studies Project (AEHSP) and Fluoride Action Network (FAN)

April 7, 2022

From: Paul Connett <pconnett@gmail.com>
Date: Thu, April 7, 2022 at 10:08 AM
Subject: Your URGENT attention required on the “waterBEST” study

To: John Roberts OHRE Director’s Office <>, Louise Winstanly IRB B Chair <>, Robert Matthews IRB D Chair <>, IRB Compliance Office <>

Cc: Michael Connett <>

Dear Mr Johns, Ms Winstanly, Dr Matthews, and IRB Compliance Office,

Thank you for letting me know the cause of the delay in responding to our concerns about the WaterBEST study being reviewed by your IRB.  We have six specific questions:

1.)  Will you be able to provide us a response to the serious concerns we raised in the letter by next week?

2.)  Please let us know which of the seven UNC IRBs has been reviewing the WaterBEST study.  We have included the Chairs of IRB B and IRB D since dental studies are apparently assigned to one of these two IRBs, but we do not wish to burden the IRB that is not handling this study with our communications.

3.)  Please let us know whether you have forwarded our letter of concern to the individual IRB members of the relevant IRB, as was requested.

4.)  Will the study recruitment be put on hold?

5.)  Can you describe the process you have for reviewing this issue?

6.)  In the interests of resolving this issue expeditiously, we request a meeting with you and the IRB Chair at your earliest opportunity.

I look forward to hearing from you soon on this matter.

Sincerely,

Paul Connett, PhD

Executive Director, American Environmental Health Studies Project (AEHSP) and Fluoride Action Network (FAN)

April 14, 2022

From: Paul Connett <pconnett@gmail.com>
To: Louise Winstanly IRB B Chair <>, Robert Matthews IRB D Chair <>, IRB Compliance Office <>,
Andy <> IRB B <>
CC:
IRB B <>, IRB B <>,
IRB B <>, IRB B <>,
IRB B <>, IRB B <>,
IRB B <>, IRB B <>,
IRB B <>, IRB B <>,
IRB B <>, IRB D <>,
IRB D <>, IRB D <>,
IRB D <>, IRB D <>,
IRB D <>, IRB D <>,
IRB D <>, IRB D <>,
IRB D <>

Dear Mr Johns, Ms Winstanly, Dr Matthews, and IRB Compliance Office, and members of IRBs B and D,

It has now been almost a month since we first contacted you with our serious concerns about the safety and ethics of a human research study that you have been reviewing.  I am disappointed in the lack of responsiveness. This is the fourth email I’ve sent and we have yet to receive any substantive response, or even acknowledgement of receipt of the email I sent last week.

Checking the clinicaltrials.org website shows that the listing for the study was updated on March 31, 2022 and the study start date is given as April 2022, so recruitment may have already begun.  We finally obtained a copy of the Informed Consent Form and were dismayed to find that it gives absolutely no mention to the serious risks this study poses to child participants.  In fact, it does not mention any health risks at all besides the meaningless statement that there may be the risk of “too much” exposure, but without an inkling of what that could produce in terms of adverse health effects.

We respectfully ask any of you who have not read our original letter of concern to read it now.  It is attached below as a PDF file.  It provides detailed evidence for why we believe this study violates multiple NIH Guidelines for ethics and safety. In short, it explains that a prominent researcher at your institution is recruiting unsuspecting parents (with inducements) in the community to engage in a  human experiment with which NIH-funded studies indicate has the potential to damage their children’s mental development – with no warning that this real possibility exists. It is hard to believe that anyone would sanction such risks for a dental experiment, let alone people like yourselves who have an important oversight role in issues like this.

In my last email of April 7, I requested responses to several questions, which are available below in the copy of that email.  We ask for a response to these questions by next Monday, April 18.

Sincerely,

Paul Connett, PhD

Executive Director, American Environmental Health Studies Project (AEHSP) and Fluoride Action Network (FAN)

copies of previous three emails sent on March 17, April 1, and April 7, 2022:

Print PDF