From: Francis Pomeroy <francispomeroy@hotmail.com> Sent: Monday, September 05, 2011 7:38 AM To: wbrown3@uw.

edu Subject: Hello, I would like to alert you to a clinical trial being conducted by a UW researcher that may not have IRB approval. Stephan Guyenet, Ph.D., appears to be a co-investigator. Please see this link: http://wholehealthsource.blogspot.com/2011/09/food-reward-hypothesis-lets-test-it.html There is no mention of human subjects protections in this advertisement, although I realize that this does not necessarily mean that it does not have IRB approval. Thank you. Francis Pomeroy

From: Wendy S. Brown Sent: Tuesday, September 06, 2011 12:49 PM To: 'Francis Pomeroy' <francispomeroy@hotmail.com> Subject: RE: Dear Francis, I received your inquiry, am looking into this concern and will get back to you no later than 9/13 about my findings. I also want to confirm that you are correct that recruitment websites like this are not required to reference IRB approval so it is possible that this project has IRB approval after all. Thank you for bringing this to my attention and for your patience while I investigate this issue. Wendy S. Brown, RN Assistant Director, Quality & Compliance University of Washington, Human Subjects Division Box 359470, wbrown3@uw.edu Office: 206-543-5602 Fax: 206-543-9218 Please note we cannot guarantee the confidentiality of email communication.

On Tue, 6 Sep 2011, Wendy S. Brown wrote: Dear Stephan, I am the Assistant Director for Quality and Compliance for the UW Human Subjects Division. One of my responsibilities is to investigate and respond to concerns about human subject research conducted by UW researchers. Over the weekend, I received an email about what appears to be human subject research that you are conducting. The email said the information posted about a "trial" you are conducting didn't mention having IRB approval. While citing IRB approval is not a requirement for recruiting material, I did a check of the HSD research database and could not locate any approved study with your name or Chris Kessler as the lead researcher(s) or with a title like "Food Reward." That said, I admit our database is limited in search capability so if you are not the lead researcher or the title of the study does not contain words like "food reward," I would not be able to identify this study using my somewhat limited search function. In order to respond to the inquiry, I need your help to understand if this project has IRB approval and if yes under which IRB. If you have received IRB approval from one of the UW IRB's please let me know the correct title of the project and HSD #. If you have received IRB approval from a non-UWIRB, please let me know which IRB and under what Principal Investigator and study title. Below is the link I was provided to the study in question. http://wholehealthsource.blogspot.com/2011/09/food-reward-hypothesis-lets-test-it.html I would appreciate a response to this inquiry as soon as possible. Thank you so much for your help in resolving this. Best Regards, Wendy S. Brown, RN Assistant Director, Quality & Compliance University of Washington, Human Subjects Division Box 359470, wbrown3@uw.edu Office: 206-543-5602 Fax: 206-543-9218
Please note we cannot guarantee the confidentiality of email communication.

From: guyenet@u.washington.edu Sent: Tuesday, September 06, 2011 1:18 PM To: Wendy S. Brown Subject: Re: Food Reward Trial Dear Ms. Brown, Thank you for your message. This trial is not connected with my work at the University of Washington in any way. It is something I am organizing in my spare time, in collaboration with volunteers I have located using my blog. This will not make use of any grant funding, nor my work time here at UW. Please let me know if this will present any problems. Sincerely, Stephan Guyenet -----------------------------------------------------------Stephan J. Guyenet, Ph.D. Senior fellow University of Washington Division of Metabolism, Endocrinology and Nutrition Laboratory of Dr. Michael W. Schwartz Lab phone: (206) 897-5286

From: Wendy S. Brown Sent: Tuesday, September 06, 2011 1:38 PM To: Noella A. Rawlings Subject: FW: Food Reward Trial Hi Noella, Please see messages below. I need your guidance about an individual (Stephen Guyenet) whose UW directory listing shows him as a "UW Senior Fellow in Medicine" and who is conducting what appears to be human subjects research without IRB approval.Below is the link to his blog and information about the "study." http://wholehealthsource.blogspot.com/2011/09/food-reward-hypothesis-lets-test-it.html My questions are: 1) If he is truly conducting this research outside of his association with the UW, is he required to obtain UW IRB approval? 2) Can you confirm his association with the UW: the UW directory describes him as "Senior Fellow, Medicine." Is that still correct? Thanks for any help you can give me!! Wendy S. Brown, RN Assistant Director, Quality & Compliance University of Washington, Human Subjects Division Box 359470, wbrown3@uw.edu Office: 206-543-5602 Fax: 206-543-9218
Please note we cannot guarantee the confidentiality of email communication.

From: Noella A. Rawlings Sent: Tuesday, September 06, 2011 1:59 PM To: Wendy S. Brown Subject: RE: Food Reward Trial Thanks, Wendy, I got your voice mail and will look into this and get back to you, Noella

On Tue, 6 Sep 2011, Wendy S. Brown wrote: Dear Stephan, Thanks for the prompt reply, I really appreciate it. If you can tell me what your current association with the UW is, that would be helpful in understanding what your responsibilities for IRB review may or may not be. For example, are you employed by and receive a paycheck from the UW and if yes, for what types of work? Are you a student? Do you hold a faculty appointment and if yes, please describe. Last, did you seek IRB approval for your current "trial" and if yes, from which IRB? Wendy S. Brown, RN Assistant Director, Quality & Compliance University of Washington, Human Subjects Division Box 359470, wbrown3@uw.edu Office: 206-543-5602 Fax: 206-543-9218
Please note we cannot guarantee the confidentiality of email communication.

From: guyenet@u.washington.edu Sent: Tuesday, September 06, 2011 3:52 PM To: Wendy S. Brown Subject: RE: Food Reward Trial Hi Wendy, I am a postdoctoral fellow in the department of Medicine. I am employed by and receive a paycheck from the UW, but I do not have a faculty appointment. I work with rodents studying the mechanisms of diet-induced obesity. I am a PhD scientist and I do not work with patients. I did not seek IRB approval for this study. My understanding was that this is required for work that is associated with the University. Please correct me if I am wrong. The study was designed in collaboration with a licensed medical practitioner who is assuming liability through his medical insurance. The study has not begun at this point, so if this presents a problem I can still postpone it or call it off. Thanks for your help, Stephan -------------------------------------------------Stephan J. Guyenet, Ph.D. Senior fellow University of Washington Division of Metabolism, Endocrinology and Nutrition Laboratory of Dr. Michael W. Schwartz Lab phone: (206) 897-5286

From: Wendy S. Brown Sent: Thursday, September 08, 2011 11:08 AM To: Stephan J. Guyenet Cc: Noella A. Rawlings Subject: RE: Food Reward Trial Hello again Stephan, I spoke to the UW SOM Director of Compliance this morning who said that after speaking with your supervisor, Michael Schwartz, it was agreed your participation in this "study" must have IRB review in order for you to take part. The reason for this is due to your position as a "UW Senior Fellow," which obligates people in such a position to obtain IRB review. If you want to continue with your participation in this study, you must submit an IRB application to the Human Subjects Division which is found at this link: http://www.washington.edU/research/hsd/docs/3 I am sorry if this is disappointing information but I wanted to be certain you did not proceed with this study without the required approvals. Please don't hesitate to contact me if you have any questions. Best Regards, Wendy S. Brown, RN Assistant Director, Quality & Compliance University of Washington, Human Subjects Division Box 359470, wbrown3@uw.edu Office: 206-543-5602 Fax 206-543-9218 Please note we cannot guarantee the confidentiality of email communication.

From: Noella A. Rawlings Sent: Thursday, September 08, 2011 11:12 AM To: Wendy S. Brown Subject: RE: Food Reward Trial Dr. Schwartz informed me that Dr. Gueynet would terminate his participation in the study. Dr. Schwartz and I discussed the need for IRB review - I don't know if he told Dr. Guyenet he needed IRB review. Sorry for the misunderstanding. Noella From: Wendy S. Brown Sent: Thursday, September 08, 2011 11:21 AM To: Noella A. Rawlings Subject: RE: Food Reward Trial I don't think my telling Stephan ahead of Dr. Schwartz talking with him about IRB review is a problem...at least I hope not! Wendy S. Brown, RN Assistant Director, Quality & Compliance University of Washington, Human Subjects Division Box 359470, wbrown3@uw.edu Office: 206-543-5602 Fax: 206-543-9218
Please note we cannot guarantee the confidentiality of email communication.

From: Noella A. Rawlings Sent: Thursday, September 08, 2011 11:23 AM To: Wendy S. Brown Subject: RE: Food Reward Trial No - not a problem - I hope Dr. Schwartz told him that. I spoke with Dr. Guyenet and he had questions about outside work so I sent him the policies and forms he would need to fill out. Noella From: guyenet@u.washington.edu Sent: Thursday, September 08, 2011 11:29 AM To: Wendy S. Brown Cc: Noella A. Rawlings Subject: RE: Food Reward Trial Hi Wendy, Thanks for your message. I have decided to end my participation in this study and advise my collaborators not to undertake it. There is no way for me to obtain IRB approval without my mentor, who understandably is not interested in doing this study. In retrospect, there are a number of problems with this idea that I didn't understand at the time. As I said before, I am 100% committed to upholding my responsibilities to the UW and to the NIH. I appreciate you helping me with this. Sincerely, Stephan ----------------------------------------------------Stephan J. Guyenet, Ph.D. Senior fellow University of Washington Division of Metabolism, Endocrinology and Nutrition Laboratory of Dr. Michael W. Schwartz Lab phone: (206) 897-5286

Date: Thu, 8 Sep 201118:32:15 +0000 From: Wendy S. Brown <wbrown3@u.Washington.edu> To: Stephan J. Guyenet <guyenet@u.Washington.edu> Subject: RE: Food Reward Trial Dear Stephan, Thank you for understanding that I really don't like to deliver disappointing news! However as we discussed when we spoke on Tuesday, my job is to protect both UW researchers (like you!) and UW research. To have advised you incorrectly could have had some negative impacts on your position which I wanted to be sure did not happen to the extent that I could control. I wish you the best in your position and with your future research! Wendy S. Brown, RN Assistant Director, Quality & Compliance University of Washington, Human Subjects Division Box 359470, wbrown3@u.Washington.edu Office: 206-543-5602 Fax: 206-543-9218
Please note we cannot guarantee the confidentiality of email communication.

From: Wendy S. Brown Sent: Thursday, September 08, 2011 11:19 AM To: 'Francis Pomeroy' <francispomeroy@hotmail.com> Subject: RE: Dear Francis, As promised, I reviewed this situation and discussed it with Stephan Guyenet and others. Mr. Guyenet has been informed that if he wishes to continue his part in this study, IRB review will be required. It is my understanding that at this time, Mr. Guyenet plans to withdraw from his participation in this "study." If you are interested in participating, you may still contact Chris Kresser, Thank you for sharing your concerns about this project and for giving my office the opportunity to investigate this. Kind Regards, Wendy S. Brown, RN Assistant Director, Quality & Compliance University of Washington, Human Subjects Division Box 359470, wbrown3@uw.edu Office: 206-543-5602 Fax: 206-543-9218
Please note we cannot guarantee the confidentiality of email communication.