We report. You decide.
We learned last October, that the University of Rochester has been conducting the same sort of air pollution experiments on human subjects as EPA researchers. Based on documents we obtained through the Freedom of Information Act, we determined that the EPA-conducted experiments were flagrantly illegal.
Suspecting that the University of Rochester experiments were similarly illegal we wrote the University of Rochester general counsel:
Ms. Sue S. Stewart
Senior Vice President and General Counsel
University of Rochester
500 Joseph C. Wilson Blvd.
Rochester, NY 14627
Re: Illegal Human Experimentation at the University of Rochester
I am writing to request that all human clinical research funded by the U.S. Environmental Protection Agency (EPA) and conducted at the University of Rochester be suspended immediately pending an investigation.
There is strong reason to believe that this research is being conducted in an illegal manner that endangers the health and safety of the human subjects, violates federal regulations, and exposes the University and its employees to civil and possibly criminal liabilities.
Specifically, the University is involved in experiments during which human subjects were (are) exposed to exceedingly toxic substances (e.g., airborne particulate matter and diesel exhaust), and misinformed about the dangers of those substances. A summary of the experiments is [here].
Moreover, it is likely that the University’s institutional review board (IRB) was misinformed about the dangers —otherwise, it could never have approved the experiments in the first place.
All the aforementioned conduct is in gross violation of The Common Rule, which is meant to protect the public and institutions from rogue researchers.
In addition to this suspension request, I am asking for copies of the IRB applications and study subject consent forms so that we may conduct a preliminary review to see what, if any, further action is required.
Thank you for your prompt attention to this matter of public safety.
The University of Rochester promptly responded:
October 19, 2012
Dear Mr. Milloy,
Thank you for your letter of October 16th (below.) The University’s Research Subjects Review Board (RSRB), whose purpose is to protect the rights and welfare of human research subjects at the University of Rochester is our Institutional Review Board (IRB). Our RSRB did review and approve the research you referenced. The RSRB will review it again, including research subject safety and relevant IRB applications and study subject consent forms.
The University of Rochester is committed to protecting study subjects and operating in compliance with federal regulations and guidelines.
A month later, we received this communication:
Dear Mr. Milloy –
This email is in response to your request for a status update. Working with our RSRB we have determined that there is only one study at the UR currently enrolling patients that would arguably fall within the scope of your concerns. We are undertaking a thorough re-review of that study, including obtaining comment from an independent consultant from outside the institution. The RSRB is proceeding expeditiously, but a good review will still take some time to complete.
In the interim, I want to let you know that University of Rochester excluded from eligibility for this research any people who because of pre-existing conditions might be vulnerable to research related injury.
On January 9, 2013, I submitted a FOIA request to the University asking for documents describing the experiments and disclosures made to the study subjects, which instantly drew this response:
The Freedom of Information Act does not apply to the University of Rochester because it is not a public or governmental institution.
As of January 1, 2013, I am no longer the General Counsel. I have retired. In the future, please direct your questions and comments to Christine Burke, who is copied on my email. Ms. Burke is the General Counsel for the University’s Medical Center. Gail Norris, also copied, is the new General Counsel of the University.
The attached URochester memo would seem to indicate that the information I am seeking is FOIA-able.
If you differ, please advise and explain.
My FOIA request was again refused on January 23, with the University saying that the request would have to be made to EPA:
Dear Mr. Milloy,
This is in follow up to your email renewing your request, pursuant to FOIA, for copies of the consent form and IRB applications in connection with UR’s particulate research. To clarify, Congress through OMB A-110 requires funding agencies – not private universities – to make certain research data available through Freedom of Information. Upon a funding agency’s receipt of an FOI request, the agency will notify researchers of the request for their data. The funding agency, in this case EPA, is responsible for determining whether to release the data. I believe the disclosure requirement is limited to research data and is not applicable to consent forms and IRB applications. In any event, I recommend that you direct your FOI request to the EPA.
I thought it would be helpful to give you an update on our review. First, I would like to clarify the focus of the only University of Rochester air pollution study currently enrolling subjects (as this doesn’t appear to be clear from previous emails between you and Ms. Stewart). The only air pollution research currently enrolling subjects is an ozone study. Your questions, of course, pertain to diesel and particulate studies. We are not currently enrolling any subjects in those types of studies.
With respect to the particulate studies, the University remains committed to responding to the concerns you’ve raised by taking a fresh look at the two, closed, particulate studies which are the basis of your inquiry. As a reminder, we are engaging independent experts to review the studies. This decision was approved by our institutional review board and we have identified appropriate outside experts to undertake the review. We have become aware of the EPA Inspector General’s intent to review air pollution studies. While we will keep our review moving forward, we are tracking the results of the EPA investigation and reserve the right to take the EPA findings into account. Our review will take time to complete. We hope you will understand that it is necessary to be thorough and deliberate in order to ensure the credibility of our review.
We had asked for the documents from EPA in October 2012. EPA responded saying that they would cost an unaffordable $6,231.00.
So the effort to get copies of the documents describing the experiments stalled.
Finally on May 14, 2013, we received this letter from the University of Rochester:
Dear Mr. Milloy –
This is to provide you with the final results of our review in response to the concerns you brought to our attention regarding air pollution research conducted at the University of Rochester. Christine Burke, Medical Center General Counsel, asked me to communicate this information to you in her absence.
As you know, in order to reassess the propriety of the research at issue and to ensure objectivity we requested outside reviews by two independent experts unaffiliated with the University. The two experts are both board certified pulmonologists associated with major academic medical centers. They thoroughly reviewed the initial applications to the RSRB for approval of the research and the consent forms. They also consulted the applicable literature and relied upon their own knowledge and expertise in order to quantify the clinical risks involved in the research. Both experts concluded that the subjects were not exposed to undue risk, that the risks were appropriately disclosed, and that the research was appropriate. We now consider this matter closed, although we do reserve the right to consider the conclusions of the EPA regarding the studies at issue when they are available. Thank you for bringing your concerns to our attention.
Spencer L. Studwell, Esq.
Associate Vice President for Risk Management.
Sr. Associate General Counsel
We responded today (May 15) as follows:
Dear Mr. Spencer,
Thank you for your note, however, without seeing the documents that I have previously requested, your conclusion has no demonstrable basis in fact and, so, this matter is hardly “closed.”
Aside from the black box/secret nature of the review, the unidentified board certified pulmonologists cannot be presumed to have any expertise or knowledge whatsoever with the current EPA-determined science of PM2.5 and/or diesel exhaust.
So the review you claim to have occurred appears to be nothing more than whitewash.
At this point, there can be no doubt that the EPA-funded PM2.5 human clinical research URochester has conducted flatly violates the Common Rule as well as the Nuremberg Code.
Consequently, the physicians conducting the experiments have likely violated New York state law by committing batteries on the study subjects.
Keep in mind that one student has already died from URochester negligence in conducting an air pollution clinical study.
I renew my request for copies of the relevant IRB applications and consent forms. I can assure you that they will not remain secret in perpetuity and I caution you against destroying them.