NIH Ebola samples and consent management A

Emmanuel Freudenthal filed this request with the National Institutes of Health of the United States of America.
Tracking #

47137

Status
Completed

Communications

From: Emmanuel Freudenthal

To Whom It May Concern:

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

I hereby request the following records:
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 NIH. 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 analysed in labs in the affected countries and in possession of the NIH. If you do not hold this document, please let me know where I can find this (institution and exact location within it)
3. A template of all of the consent forms signed by patients treated for Ebola in the US. If you do not hold this document, please let me know where I can find this (institution and exact location within it)
4. 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 NIH
5. The policies that the NIH 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.
6. the policy/document that NIH follows to manage samples such as Ebola in order to keep them linked with their consent information, including in biobanks
7. A list of the origins of the samples processed in the NIH labs in the affected countries (e.g. the Montserrado lab). 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: National Institutes of Health

Dear Mr. Freudenthal,

Attached please find our acknowledgement of your recent FOIA request (Case No. 47137).
Regards,

Lauren Bartok
Government Information Specialist
NIAID FOIA Office, OCGR, NIAID, NIH
5601 Fishers Lane, Room 6G50
Rockville, MD 20852
301-451-5109

From: National Institutes of Health

A copy of documents responsive to the request.

From: Emmanuel Freudenthal

Dear Robin,

Thanks a lot for the documents and your very effective handling of this request.

Just a quick clarification question. For item 1 and 2, you've only sent me consent forms for patients enrolled in PREVAIL studies.

I just wanted to check that my request was well understood and that the NIH does not hold consent forms for people who's samples were analysed in the affected countries, but who did not participate in PREVAIL studies. Could you confirm that?

Best,
Emmanuel

From: National Institutes of Health

Good morning Emmanuel,
Our program staff have just confirmed that your request was understood and we have provided all of the responsive documents.
Regards,

Robin

Robin L. Schofield, MPS
NIAID FOIA Coordinator

From: Emmanuel Freudenthal

Dear Robin,

Thanks for the clarification.

Best,
Emmanuel

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