DARPA Restoring Active Memory (RAM) Project Voluntary Human Test Subject Informed Consent (National Institutes of Health)

Karl Pensworth filed this request with the National Institutes of Health of the United States of America.
Tracking #

52977

Multi Request DARPA Restoring Active Memory (RAM) Project Voluntary Human Test Subject Informed Consent
Status
Completed

Communications

From: Karl Pensworth


To Whom It May Concern:

Pursuant to the Freedom of Information Act, I hereby request the following records:

Any and all available records pertaining to the DARPA Restoring Active Memory (RAM) program, co-operative agreement: N66001-14-2-4032 and/or any, all, or any combination of the following National Institute of Health and National Science Foundation grant codes:

NIH R01 NS099348
NSF BCS-1441502
NSF BCS-1631550

In particular, please provide:

1) The Statement of Work/Scope on each sub-program or full contract with each contract-awardee or winning offeror company or institution, and the full Statement of Work included with each contract;
2) Complete Documentation of Informed Consent from all human subjects utilized by or involved with this program in any way, including:
2. a) The FWA (Federal Wide Assurance) signed off by the Office of Human Research Protections, Department of Health and Human Services.
2. b) Detailed Informed Consent documents including lists of consenting human subjects, specific information provided to human subjects, and signed documents from human subjects attesting to Informed Consent.
2. c) Any additional internal CIA document assuring compliance with the Common Rule signed off by the Institutional Review Board involved.
2. d) All affirmations of Compliance Oversight from the Office of Human Subject Research Protections.
2. e) All Waivers of Consent from the Secretary of Defense or any other federal agency, as applicable, including the full reasons for these waivers.
3) Complete Documentation with precise details on Location and Field of Operation where scientific instruments and/or weapons are being utilized or tested, "wittingly" or "unwittingly," overtly or covertly, on human beings--namely US immigrants, citizens or any individuals present in the USA whether temporarily or permanently, currently or formerly.

The requested documents will be made available to the general public, and this request is not being made for commercial purposes.

In the event that there are fees, I would be grateful if you would inform me of the total charges in advance of fulfilling my request. I would prefer the request filled electronically, by e-mail attachment if available or CD-ROM if not.

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.

Sincerely,

Karl Pensworth

From: National Institutes of Health

Hello Mr. Pensworth,
Attached is the interim letter to your NINDS FOIA request. It has been assigned case # 52977.

Please let me know if you have any questions.

Thank you,

Robert L. Wymer

Government Information Specialist

Freedom of Information and Privacy Act Branch

National Heart, Lung, and Blood Institute National Institutes of Health

301-496-9737 FOIA line

301-827-6256 direct line

301-402-3604 fax

From: National Institutes of Health

Hello Mr. Pensworth,
My office is reviewing the responsive records to your FOIA request related to NIH R01NS099348 and wanted to clarify a few items in regards to your request.

1. The Statement of Work/Scope on each sub-program or full contract with each contract-awardee or winning offeror company or institution, and the full Statement of Work included with each contract;

* NIH R01NS099348 is a grant and not a contract, so it would not have a Statement of Work/Scope. Would you be willing to exclude Item 1 from your request?

1. Complete Documentation of Informed Consent from all human subjects utilized by or involved with this program in any way, including:
2. a) The FWA (Federal Wide Assurance) signed off by the Office of Human Research Protections, Department of Health and Human Services.
2. b) Detailed Informed consent documents including lists of consenting human subjects, specific information provided to human subjects, and signed documents from human subjects attesting to Informed Consent.
2. c) Any additional internal CIA document assuring compliance with the Common Rule signed off by the Institutional Review Board involved.
2. d) All affirmations of Compliance Oversight from the Office of Human Subject Research Protections.
2. e) All Waivers of Consent from the Secretary of Defense or any other federal agency, as applicable, including the full reasons for these waivers.

1. Complete documentation with precise details on Location and Field of Operation where scientific instruments and/or weapons are being utilized or tested, "wittingly" or "unwittingly," overtly or covertly, on human beings--namely US immigrants, citizens or any individuals present in the USA whether temporarily or permanently, currently or formerly.

* The only documents that are responsive to this request would be the IRB approval letters and blank informed consent forms. The other documents listed are not provided to us. Are you willing to amend your request to receive the IRB approval letters and informed consent forms that we do possess?

Also, are you willing to exclude personal information from the requested records?

Please let me know and I will process your request accordingly.

Thank you again,

Robert L. Wymer

Government Information Specialist

Freedom of Information and Privacy Act Branch

National Heart, Lung, and Blood Institute National Institutes of Health

301-496-9737 FOIA line

301-827-6256 direct line

301-402-3604 fax

From: National Institutes of Health

Hello Mr. Pensworth,
The final letter for your NINDS FOIA Request 52977 is attached.

Thank you and have a good weekend,

Robert L. Wymer

Government Information Specialist

Freedom of Information and Privacy Act Branch

National Heart, Lung, and Blood Institute National Institutes of Health

301-496-9737 FOIA line

301-402-3604 fax

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