CDC Ebola samples and consent management A

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 CDC. 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 in the affected countries , i.e. Guinea, Liberia or Sierra Leone (e.g. in Montserrado and in Bo) and in possession of the CDC. 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 CDC
5. The policies that the CDC follows to obtain the 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 CDC 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 CDC 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

Dear CDC,

Thanks for your letter in which you seek clarification for some of the words used in my FOIA request (#18-00070-FOIA). I have tried to call you (as suggested in your letter) to discuss this, but didn't get through to you.

You wrote:
- The term “inventory “as it relates to 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 CDC.
- The term “origins” of the samples processed in the CDC labs in the affected countries (e.g. the Montserrado lab), is still very broad and does not allow for a reasonable, targeted search.

Here are my clarifications:
The term "inventory" describes any document that the CDC has that lists all of the consent forms attached to the samples analysed by the CDC. I do not need multiple documents for this, just one document that contains this information. I think that this might be contained in any audit undertaken by the CDC regarding the existence and conformity of the consent process for the samples imported by the CDC to the USA. Have any such audit been conducted? Does this help refine your search?

The term "origins" is defined above, it covers any Ebola lab in the affected countries i.e. Guinea, Liberia and Sierra Leone. Based on my research, the CDC only had two such labs, one in Montserrado and one in Bo. However, please check that this is accurate. I think this request is very specific unless the CDC had many other labs that were not publicly recorded.

Please contact me as soon as possible if anything remains unclear in my request. Otherwise, I'm looking forward to receiving the documents soon.

Best,
Emmanuel

Dear CDC,

Thanks for your reply.

I'm looking forward to receiving the documents. Please feel free to send them in several batches as they become available.

Best,
Emmanuel

Dear CDC,

Thanks for your reply. Could you just confirm that this is the only document that you have out of all the following requested?

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 CDC. 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 in the affected countries , i.e. Guinea, Liberia or Sierra Leone (e.g. in Montserrado and in Bo) and in possession of the CDC. 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 CDC
5. The policies that the CDC follows to obtain the 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 CDC 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 CDC 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.

Thanks,
Emmanuel

Hi Mr Harper,

Thanks for your reply.

I'm not sure where you would find these documents at the CDC, or if they exist. It's a bit like asking me where forks are located in the CDC's kitchen. I'd be surprised you don't have forks, but I can't tell you which drawer to look in! I'll let you know if I find something more specific.

Best,
Emmanuel