Ebola samples and consent management

Emmanuel Freudenthal filed this request with the Fort Bragg - Administrative Services Division of the United States of America.
Tracking #

FA-18-0196

Status
Completed
Tags

Communications

From: Emmanuel Freudenthal

To Whom It May Concern:

This is a request under the Freedom of Information Act, covering the time period December 1st 2013 to now.

I hereby request the following records from the 1st Area Medical Laboratory (AML) at Fort Bragg:
1. A template of the consent forms signed by patients enrolled in Ebola vaccines and therapies clinical trials in the affected countries (i.e. Guinea, Liberia and Sierra Leone) and in possession of the AML. If you do not hold this document, please let me know where I can find this (institution and exact location within it)
2. A template of the consent form signed by the Ebola patients whose samples have been analyzed in labs in the affected countries (e.g. in Nimba, Sinoe and Grand Gedeh) and in possession of the AML. If you do not hold this document, please let me know where I can find this (institution and exact location within it)
3. the inventory of all the consent forms that have been signed, both for sample extraction and vaccine and therapies clinical trials, in the affected countries and in possession of the AML
4. The policies that the AML follows to obtain consent of patients in the extraction of blood and other samples for medicinal or research purposes - both in the US and abroad.
5. the policy/document that AML follows to manage samples such as Ebola in order to keep them linked with their consent information, including in biobanks
6. A list of the origins of the samples processed in the AML labs in the affected countries (e.g. in Nimba, Sinoe and Grand Gedeh). Or if that does not exist, the documents that came with each of the samples.

This request should be properly classified as a media request. I am a freelance investigative reporter covering covering East and Central Africa, with a particular focus on business, corruption, natural resources, land and social issues. I have a strong likelihood of publishing news articles based on information released in response to this request. I have previously been published in Le Monde Afrique, IRIN News, Sydney Morning Herald, African Arguments and others. If you have questions about my media classification, please let me know and I'm happy to address them.

In the event that fees cannot be waived, I would be grateful if you would inform me of the total charges in advance of fulfilling my request. I would prefer the request filed electronically, by e-mail attachment if available or CD-ROM if not, and I would like text-searchable documents.

Thank you in advance for your anticipated cooperation in this matter. I look forward to receiving your response to this request within 20 business days, as the statute requires.

Best regards,
Emmanuel Freudenthal

From: Emmanuel Freudenthal

Dear Fort Bragg,

Could you confirm that you've received my FOI request?

Thanks,
Emmanuel

From: Beryl Lipton

To Whom It May Concern:

This is an appeal under the Freedom of Information Act.

On October 29, 2017, I submitted the attached request under the Freedom of Information Act to the Department of the Army, U.S. Army Garrison Ft. Bragg. I have yet to receive an acknowledgement.

Far more than twenty working days have elapsed without a substantive determination. I am appealing the constructive denial of my request. I ask for a determination requiring that the agency respond to my request, provide the documents, or outline reasons that they are exempt.

Thank you for your time and help with this issue.

Best,

Emmanuel Freudenthal

From: Fort Bragg - Administrative Services Division

Sir,

After receiving your letter stating your request has not been answered I having checking to see what happen and found out this request was sent to the 1st Area Medical Laboratory (AML) which does not have a FOIA Officer. So I have tracked the correct office and spoke with the person that will be handling your request, and will be contacting your office asap. Please see the attached documents.

v/r

DOUGLAS E. MOORE
FOIA/PA Officer
Admin Svcs Div, DHR
Fort Bragg, NC 28310-5000
Office: (910) 907-3642, DSN: 337-3642
Fax: (910) 432-0808
Email: douglas.e.moore.civ@mail.mil

"We're only as good as our customers say we are"
Say it on ICE:
https://icemgr.disa.mil/admin/service_providers/cards/index.cfm?fa=question_list&service_provider_id=96682&card_id=51808

From: Emmanuel Freudenthal

Thanks. I'm looking forward to a response.

Best,
Emmanuel

From: Fort Bragg - Administrative Services Division

This case was referred back on March 6, 2020, please see the Attached Memo. I am sending an email to the 20th CBRNE Command to find out what happen.

v/r

DOUGLAS E. MOORE
FOIA/PA Officer
Admin Svcs Div, DHR
Fort Bragg, NC 28310-5000
Office: (910) 907-3642, DSN: 337-3642
Fax: (910) 432-0808
Email: douglas.e.moore.civ@mail.mil

"We're only as good as our customers say we are"
Say it on ICE:
https://icemgr.disa.mil/admin/service_providers/cards/index.cfm?fa=question_list&service_provider_id=96682&card_id=51808

From: Fort Bragg - Administrative Services Division

Sir,

I received this email again yesterday can you please respond to the requester.

v/r

DOUGLAS E. MOORE
FOIA/PA Officer
Admin Svcs Div, DHR
Fort Bragg, NC 28310-5000
Office: (910) 907-3642, DSN: 337-3642
Fax: (910) 432-0808
Email: douglas.e.moore.civ@mail.mil

"We're only as good as our customers say we are"
Say it on ICE:
https://icemgr.disa.mil/admin/service_providers/cards/index.cfm?fa=question_list&service_provider_id=96682&card_id=51808

From: Emmanuel Freudenthal

Thanks, I would really appreciate a response. It's been 3 years already, which is quite a while...

From: Fort Bragg - Administrative Services Division

CLASSIFICATION: UNCLASSIFIED

Gentlemen -

Acknowledge receipt of your emails.

When this request originally came in, I notified the 1st AML, however, this data didn't exist and then they were tasked to support COVID-19 operations throughout the DoD.

I am no longer with the 20th CBRNE Command, however the new Records Manager and FOIA officer is Mr. John Spillman.

I would also recommend submitting the request through the 44th Medical Brigade at Fort Bragg who is the parent unit for the 1st AML, with the 20th having Training and Readiness Authority over the unit.

Thank you.

Charles Musante

CHARLES A. MUSANTE
Secretary of the General Staff
U.S. Army Combat Capabilities Development Command
6662 Gunner Circle, Bldg 3071, Room 216
Aberdeen Proving Ground, MD 21005-5201
Commercial: 410-278-2189

From: Fort Bragg - Administrative Services Division

This is a update to your request:

Subject: Re: [Non-DoD Source] RE: Freedom of Information Act Request #FA-18-0196 (UNCLASSIFIED//FOUO PROTECTED BY PRIVACY ACT/REL TO US DOD)

I think it is probably ours, I have the original FOIA request in my email from earlier in the year. I believe it just fell by the wayside when 1AML scattered in support of COVID. Our FOIA officer is working on the response now, I'll reach out if we need anything!

Amy L. Snyder
Deputy Command Judge Advocate
20th CBRNE Command
Aberdeen Proving Ground, MD

v/r

DOUGLAS E. MOORE
FOIA/PA Officer
Admin Svcs Div, DHR
Fort Bragg, NC 28310-5000
Office: (910) 907-3642, DSN: 337-3642
Fax: (910) 432-0808
Email: douglas.e.moore.civ@mail.mil

"We're only as good as our customers say we are"
Say it on ICE:
https://icemgr.disa.mil/admin/service_providers/cards/index.cfm?fa=question_list&service_provider_id=96682&card_id=51808

From: Fort Bragg - Administrative Services Division

CLASSIFICATION: UNCLASSIFIED

This is a update to your request:

Subject: Re: [Non-DoD Source] RE: Freedom of Information Act Request #FA-18-0196 (UNCLASSIFIED//FOUO PROTECTED BY PRIVACY ACT/REL TO US DOD)

I think it is probably ours, I have the original FOIA request in my email from earlier in the year. I believe it just fell by the wayside when 1AML scattered in support of COVID. Our FOIA officer is working on the response now, I'll reach out if we need anything!

Amy L. Snyder

Deputy Command Judge Advocate

20th CBRNE Command

Aberdeen Proving Ground, MD

v/r

DOUGLAS E. MOORE

FOIA/PA Officer

Admin Svcs Div, DHR

Fort Bragg, NC 28310-5000

Office: (910) 907-3642, DSN: 337-3642

Fax: (910) 432-0808

Email: douglas.e.moore.civ@mail.mil

"We're only as good as our customers say we are"

Say it on ICE:

https://icemgr.disa.mil/admin/service_providers/cards/index.cfm?fa=question_list&service_provider_id=96682&card_id=51808

From: Fort Bragg - Administrative Services Division

CLASSIFICATION: UNCLASSIFIED

Please call me

v/r

DOUGLAS E. MOORE

FOIA/PA Officer

Admin Svcs Div, DHR

Fort Bragg, NC 28310-5000

Office: (910) 907-3642, DSN: 337-3642

Fax: (910) 432-0808

Email: douglas.e.moore.civ@mail.mil

"We're only as good as our customers say we are"

Say it on ICE:

https://icemgr.disa.mil/admin/service_providers/cards/index.cfm?fa=question_list&service_provider_id=96682&card_id=51808

From: Emmanuel Freudenthal

Dear Mr Moore,

Apologies for not redirecting the request, which I'll do following our phone conversation.

The request was originally intended to inform an article which I published here: https://www.telegraph.co.uk/global-health/science-and-disease/ebolas-lost-blood-row-samples-flown-africa-big-pharma-set-cash/

I hope that I'll be able to receive the documents requested from your colleague.

Best,
Emmanuel

From: Fort Bragg - Administrative Services Division

CLASSIFICATION: UNCLASSIFIED

Dear Emanuel Freudenthal,

I was cc'd for the first time about your request on 16 September 2020, below is the email traffic beginning with your request until aforementioned date. Upon receiving I inquired about the request to ensure we had the information you requested. What I found was that the 44th Medical Brigade (Fort Bragg), MAJ Roan (cc' line), had open and was tracking this FOIA Request. Therefore, I treated the request based on my findings and the response below from the former 20th CBRNE Command FOIA Officer (Mr. Musante) as an inquiry to whether we had the information you requested.

The response below is from the former 1st AML Commander, COL Carder:

After searching our records here I find no evidence the AML participated in any vaccine trials while in Liberia.

One of our former officers who was assigned to USAMRIID was in Liberia during that time frame and said NIH-IRF ran a study.
Recommend directing request there.
https://nems.nih.gov/NEMS-locations/Pages/Integrated_Research_Facility_at_Fort_Detrick_Maryland.aspx

1AML participated in Operation United Assistance and was tasked to support USAFRICOM's support to USAID in West Africa in order to assist in the overall U.S. Government Foreign Humanitarian Assistance/Disaster Relief (FHA/DR) and Cooperative Threat Reduction (CTD) efforts to contain the spread and reduce the threat of EVD.

See attached OPORD for more information and Unit history for overview of unit operations.
1 excel file contains sample results by location for question 6 and the other lists POCs for reference.

FOIA Request responses:

1. A template of the consent forms signed by patients enrolled in Ebola vaccines and therapies clinical trials in the affected countries (i.e. Guinea, Liberia and Sierra Leone) and in possession of the AML. If you do not hold this document, please let me know where I can find this (institution and exact location within it)
Answer 1. 1AML does not possess any consent forms.

2. A template of the consent form signed by the Ebola patients whose samples have been analyzed in labs in the affected countries (e.g. in Nimba, Sinoe and Grand Gedeh) and in possession of the AML. If you do not hold this document, please let me know where I can find this (institution and exact location within it)
Answer 2. 1AML does not hold any documents of this type and does not know who has the requested documents.

3. the inventory of all the consent forms that have been signed, both for sample extraction and vaccine and therapies clinical trials, in the affected countries and in possession of the AML
Answer 3. 1AML does not possess any consent forms.

4. The policies that the AML follows to obtain consent of patients in the extraction of blood and other samples for medicinal or research purposes - both in the US and abroad.
Answer 4. 1AML does not possess any consent forms. 1AML received samples from other medical facilities and conducted tests to determine the presence or absence of the Ebola virus in the submitted sample. There was no patient contact with 1AML.

5. the policy/document that AML follows to manage samples such as Ebola in order to keep them linked with their consent information, including in biobanks.
Answer 5. 1AML does not possess any forms linking patient to sample or any type of personally identifiable information.

6. A list of the origins of the samples processed in the AML labs in the affected countries (e.g. in Nimba, Sinoe and Grand Gedeh). Or if that does not exist, the documents that came with each of the samples.
Answer 6. The excel file attached shows locations and the number of samples from those locations. There are no supporting documents for the codes used in the excel file. 1AML does not possess any documents that accompanied any samples received.

If you require any additional information, please contact me at your convenience. Thank you.

Very Respectfully,

JOHN G. SPILLMAN
Records Manager//FOIA/PA Officer
20TH CBRNE Command, G6
6544 Havre de Grace Street, Building 5016
Aberdeen Proving Ground, MD 21005
Office: 410-306-4862
Primary Email: john.g.spillman.civ@mail.mil
Secondary Email: john.g.spillman.civ@army.mil

Controlled by: (AFCB-IM) Records Information Management Office, G6
CUI Category: PRVCY
Distributuion/Dissemination Controls: FEDCON
POC: John G. Spillman, 410-306-4862

From: Fort Bragg - Administrative Services Division

CLASSIFICATION: UNCLASSIFIED

Dear Mr. Emmanuel Freudenthal,

Attached is the missing document referenced in previous email message. Thank you.

Very Respectfully,

JOHN G. SPILLMAN

Records Manager//FOIA/PA Officer

20TH CBRNE Command, G6

6544 Havre de Grace Street, Building 5016

Aberdeen Proving Ground, MD 21005

Office: 410-306-4862

Primary Email: john.g.spillman.civ@mail.mil

Secondary Email: john.g.spillman.civ@army.mil

Controlled by: (AFCB-IM) Records Information Management Office, G6

CUI Category: PRVCY

Distributuion/Dissemination Controls: FEDCON

POC: John G. Spillman, 410-306-4862

"Maintaining Federal Records is Everyone's Responsibility."

"When records are well managed, agencies can use them to assess the impact of programs, to reduce redundant efforts, to save money, and to share knowledge within and across their organizations."

* Predident Barack Obama, November 28, 2011

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