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Transmittal Notice

  1. Explanation of Material Transmitted: This Manual Chapter offers guidance on methods for extramural investigator to access the NIH Intramural’s special research resources. This revision reflects a title change to cover all NIH special research resources. Standard operating procedures have been removed from this revision. Biologic Products, in-kind materials/products, and radiation safety sections were added.
  2. Filing Instructions:

Remove: Manual Issuance 1366, dated 04/18/12.
Insert: Manual Issuance 1366, dated 10/21/13.

PLEASE NOTE: For information on:

The primary purpose of this chapter is to describe the policy and process to allow extramural investigators who are collaborating with an NIH intramural investigator access some of the NIH special intramural research resources. The NIH Clinical Center (CC) maintains its commitment to serve the NIH intramural research community and will facilitate the process for external access to NIH special research resources. Access for extramural investigators is based on identification of an intramural research collaborator, capacity of the CC to provide the requested resources, and an established prioritization mechanism within the CC for managing these requests. It is important that requests for access to services by extramural investigators be processed, evaluated, and prioritized in a fair and transparent manner.

The CC is the largest hospital in the world solely dedicated to clinical and translational research.  The special infrastructure and clinical staff at the CC enable the best patient care while providing an ideal environment for clinical research. Currently, this unique environment and the resources within it are available primarily for the NIH intramural community.  With multiple recent reviews highlighting the need to accelerate the pipeline of translational research, expanded use of the Clinical Center’s environment and resources in the pursuit of meaningful translational discovery is critical. Opening the NIH to extramural investigators will facilitate optimal use of its special clinical research resources. 

In December 2010, the Congressionally-mandated Scientific Management Review Board (SMRB) recognized the potential benefits of opening the Clinical Center to extramural investigators. This Board formally recommended that the role of the NIH Clinical Center “should be to serve as a state-of-the-art national resource, with resources optimally managed to enable both internal and external use.” In January 2011, the NIH Clinical Center-Extramural Collaborations Committee was formed to consider implementation of the SMRB recommendations.

As a result, in 2012 a new funding opportunity “Opportunities for Collaborative Research at the NIH Clinical Center (U01)” was announced. This funding announcement is intended to provide extramural investigators a mechanism to establish collaborations with NIH intramural investigators and to take advantage of the unique research opportunities available at the NIH Clinical Center.

C. Definitions

  1. Special Research Resources: Resources offered by NIH such as but not limited to assays/diagnostics, imaging capabilities, phenotyping, biomedical specimens, protocol support, healthy volunteers, and access to the portfolio of active rare disease protocols. Please refer to section G for a list of available resources.

  2. Extramural Investigators (EI): Extramural investigators are members of the NIH grants or contracts community who are involved with research and wish to access the resources at the NIH and its Clinical Center for a clinical research protocol.  Extramural investigator, as it is used here, refers to individuals who have or will have received NIH financial assistance support through a specific grant, contract or cooperative agreement.  In the case of NIH grants, the EI will most likely be the point-of-contact, and in the case of NIH contracts, the Contracting Officer’s Representative (COR) will most likely be the point-of-contact.  

  3. NIH Intramural Research Collaborator (IRC): 
    The NIH Intramural Research Collaborator is the NIH intramural investigator named on the grant application and with whom the Extramural Investigator will be conducting research. The IRC and their institute/center (IC) will assist the EI in navigating many of the administrative processes related to conducting research with the NIH.

  4. Consultation Letter:  A formal document akin to a Letter of Intent issued by the department offering the resource to the EI and IRC after the consultation [meeting(s), phone call(s), etc.] takes place.  The letter will include all of the following:

    1. Date(s) of the consultation

    2. Description of the requested resource(s) and estimated quantity

    3. Estimated timeframe to fill the request 

    4. Estimated cost to NIH to offer resources 

    5. Statement indicating NIH approval of appropriate use of the specified resource(s), and except for any unforeseen circumstances, agreement to implement the project (caveats include availability of appropriated funds, infeasible changes to the request since the consultation, public health emergencies, etc.)

    6. Existing licenses/patents

    7. Agreement by EI that funds will be withheld from EI’s grant for the resource, if the grant is funded and the project is implemented.  If resources are provided, the award mechanism will be changed to a cooperative agreement.  For contracts, the funding IC will agree to include an estimate for the Interagency Agreement (IAA) services in its Independent Government Cost Estimate (IGCE)

    8. Signature blocks for both NIH/CC officials, EI, and EI’s Institutional Official.

  5. Program Proposal:  A formal document that the EI and EI’s Institutional Official submit, including provision of all required documentation.  The Proposal includes all of the following:

    1. Submission of the protocol (making note of any changes since the time of consultation)

    2. Submission of the consultation letter

    3. Description of the resources requested

    4. Description of the benefits to the science or research project if granted use of the CC service

    5. Timeframe for the project (and degree of flexibility)

    6. Submission of a copy of the Notice of Grant Award or the signed face page of the NIH-funded contract

      1. If the resource is needed during the first year of the grant, the EI may not be able to provide the Notice of Grant Award in a timely manner.  Therefore, the IC may provide another form of official communication to confirm approved funding.

    7. Whether the EI or EI’s institution will provide any in-kind materials, products, patients, or services (if so, please specify)  

    8. Proof of institutional review board (IRB) approval of the protocol OR assurance the protocol will complete IRB review before the use of any funds and prior to the start of any service or enrollment of clinical research subjects in protocols

    9. If required, proof of radiation safety committee (RSC) review and approval 

    10. Proof of an investigational new drug (IND) application in “active status” or an IND Exemption Letter from the FDA.  PIs must follow the documentation guidelines in Section D.4.c. 

    11. Quantity of service requested. 

    12. Background information or supporting data.

  6. Intra-agency Agreement (IAA): A written arrangement between/among NIH components, all of which must have the statutory authority to engage in the arrangement.

  7. Project Agreement or Notice of Award (NOA): A document signifying the agreement on the terms of the project between the NIH and the extramural investigator’s institution.  For NIH grantees, the EI and institutional official from the institution (e.g. university) receiving the NIH grant, shall sign the agreement.  For NIH-funded contracts, the IAA may contain all necessary terms of the agreements and will be signed by an authorized representative of the IC.  The Project Agreement may be an attachment to the IAA or may stand alone.  This document must be signed before the project is implemented.

  8. Cooperative Agreement:  A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities. Any grant with significant involvement of the NIH will be changed to a cooperative agreement.

  1. Overview 
    The NIH CC will allow access to special research resources to extramural investigators based on: 1) whether the proposed research makes best use of the resources and is feasible for the capacity and capabilities of the CC department or other NIH entity offering the resources, 2) a collaboration with an NIH Intramural investigator and 3) whether the external entity has or will have a formal relationship with NIH (e.g. grant, contract, or cooperative agreement) involving the expected deliverable.

    Extramural investigators interested in accessing resources shall follow the procedures outlined in this chapter to obtain approval.  Extramural investigators and their institutional officials must also agree to have funds withheld from EI’s grant in order to cover CC costs incurred. For contracts, reimbursement of CC costs would be covered by the NIH Program Office via an Intra-agency Agreement (IAA).

    Once a project has been approved for access to a resource and is funded after peer review, every attempt will be made to process these requests in a timely manner without interfering with existing commitments to the NIH intramural program.

  2. Intellectual Property and Publications:
    Clinical Center staff may be involved in developing new inventions, devices, methods, applications, or other discoveries through these projects with extramural investigators gaining access to the facility.  Inventorship and ownership of any patent or intellectual property rights will be governed by United States patent law and other applicable laws, as well as applicable NIH policies.  Manuscripts, as well as other publications or presentations generated as a result of the research, will have agreed upon authorship consistent with the policies of the respective parties, including adhering to the NIH Public Access Policy for publications. Please refer to the NIH Grants Policy Statement, section 8.2.4 for more information on intellectual property and publications. A special waiver (NIH Manual 2300-308-4 Appendix 3A) has been approved by the NIH Deputy Director for Intramural Research specifically for non NIH employees participating in the “Opportunities for Collaborative Research at the NIH Clinical Center U01” to be exempt from NIH policies requiring assignment of their intellectual property rights to NIH for inventions made under the U01.

  3. NIH Appointments
    Non NIH employees such as grantees or other researchers with funding from non-IRP who are engaged in a documented research collaboration will be designated as Research Collaborators as long as all eligibility requirements are met. Please refer to NIH Manual 2300-380-4 for eligibility and policy requirements for Research Collaborators.

  4. Biologic Products
    With the use and distribution of biologic products, NIH providers must abide by the highest scientific and ethical standards to preserve the public’s trust and the substantial investment these resources represent. NIH providers who transfer or distribute materials to non-NIH researchers, including collaborators and companies, must comply with strict NIH standards to ensure that these valuable resources are adequately protected. Please visit the following link for the “Policy for the Transfer of Materials from NIH Intramural Laboratories,” http://www.ott.nih.gov/sites/default/files/documents/policy/pdfs/500-A-Policy.pdf.

  5. Providing services to Extramural Investigators:

    1. Review for Access:
      Extramural investigators (EI) are required to first have an NIH Intramural Research Collaborator and either have or be actively planning to have a formal relationship with NIH (e.g. grant, contract, or cooperative agreement). The EI will engage in a consultation with the CC department or other NIH entity offering the resource to determine the feasibility of the proposed project. A consultation letter detailing estimated cost and the requested time frame will be signed by NIH/CC officials, the EI and the IRC. The EI will subsequently submit a proposal to the CC for needed resources which will be reviewed by the respective department.

    2. In-kind Materials or Products from Extramural Investigator:

      1. If a grant: Any agreement with a drug, biotechnology, or medical device company to provide material will need to be established between the EI and the company. The EI will transfer the material to the respective department. Depending upon the request, the department may ask the EI to purchase materials or products for the project. Biomedical specimens or materials from an outside source must be collected at an accredited collection center.

      2. If a contract: The acquisition plan must clearly identify the use of a specific resource and how offerors will access resources and propose costs. Funds to cover the cost of resources will be transferred by use of an Intra-agency Agreement (IAA), and as such will be funded separately from the contract. NIH cannot enter into negotiations with companies on behalf of the EI for these resources.

    3. IRB, Radiation Safety and IND documentation:
      The CC will not manufacture, release or use products, or conduct tests for human research subjects for any project without adequate documentation of an Institutional Review Board (IRB) review and applicable Investigational New Drug (IND) paperwork as described below. A project may start production at the discretion of the respective department, but services will not be provided until necessary IRB and IND paperwork are verified. EIs must follow the following documentation rules for INDs.

      1. If an IND does not need to be filed, then provide a copy of the Food and Drug Administration (FDA) letter or email stating that an IND is not needed

      2. If an IND was filed, but determined not needed, then provide formal IND Exemption Letter to the department offering the service

      3. If an IND is in “active status,” provide FDA letter or email stating IND is in “active status” and that the study may proceed, including form 1571 with submission date and IND number; or confirm that 31 days or more have passed since date of Acknowledgement Letter without notification of a “hold” by the FDA.

      4. If an IND has been put on “hold status,” provide FDA review letter stating there is a “hold” on the IND and outlining further information needed; and subsequently provide the formal FDA letter notifying that the study may proceed and is considered “active status.”

      5. An IND Acknowledgement Letter should always be submitted if the EI has formally applied for an IND. In some cases, documentation of “active status” will not be available at the time the EI applies to use CC services. Therefore, the Acknowledgement Letter is the minimum documentation that can be provided to show the IND has been filed. At the discretion of the department offering the service, work may begin on design and development aspects of the project, but products will not be manufactured until proof of IND “active status” and proof of IRB review have been provided.

      6. An IND may change between initial discussions with department offering the resource and the approval process. The department must agree to the final IND.

      7. There may be limits on the processing and manufacturing that can be provided by department offering service. Aspects of the IND related to product manufacturing should be developed in collaboration with the respective department.

      8. Approval by both the EI’s Institutional Review Board (IRB) and an NIH Intramural IRB.

      9. Radiation Safety approval by the EI’s Radiation Safety Committee (RSC) and the NIH RSC.

      10. Investigational New Drug (IND) or NIH Radioactive Drug Research Committee (RDRC) approval if needed for the radiopharmaceutical to be used. INDs for radiopharmaceuticals provided by NIH are held by each respective department. If needed, NIH RDRC approval will be obtained collaboratively by the IRC and the NIH department.

    4. Changes to Protocol or Project by EI after Consultation:

      The CC will endeavor to implement projects approved for access once all policies and procedures outlined in this chapter have been followed by the EI and IRC. In some cases, the EI may make substantive changes to the protocol and resources requested after the consultation phase. If the protocol has changed significantly for any reason including: results of peer review or programmatic recommendations, or IND process, the respective department offering resources will re-evaluate feasibility, as well as potential timeline for implementation. In the case of significant change, the respective department may determine the project cannot be accomplished as initially intended and will engage in further discussion with EI and IRC to modify the project and/or cost estimate as appropriate, or, in the most extreme case, not undertake the project. For an NIH grant, a major change in scope of the project requires prior approval as per the NIH Grants Policy Statement. For a contract, a major change in the scope of the contract must be approved in advance, in writing, by the contracting officer.

    5. Costs for Resources:

      Cost recovery for intramural staff participation and CC resources will be provided by the IC providing the NIH funding award. Specifics of the budget will be under the discretion of the respective IC. For full information on the cost of specialized research resources provided by the NIH, please visit http://clinicalcenter.nih.gov/translational-research-resources.

  6. Requests for access to services of the CC may be categorized as follows:

    1. Extramural Project Submitted for NIH Funding: A protocol written by an EI who will be seeking NIH grant support through a grant application. Because the EI is seeking grant support, approval from an IRB and having an IND or an FDA determination that an IND is not needed. This category also applies to pre-awarded NIH contracts

    2. Extramural Grant or Cooperative Agreement previously approved for NIH Funding: A protocol written by an EI who is currently receiving an NIH grant or cooperative agreement funding. Only grants and cooperative agreements with future year commitments are eligible to utilize resources because funds cannot be transferred from the funding Institute or Center (IC) to the CC after terminal year funding of the award has been issued.

    3. NIH-Funded Contract: A contract solicited, awarded, and administered by the NIH. The Statement of Work (SOW) was developed by an NIH project officer and the contract was awarded and is administered by an NIH contracting officer. The NIH program would be responsible for the cost of resources, not the contractor. The contractor and/or the NIH contracting officer’s representative (COR) would be responsible for seeking approval from an IRB and obtaining an IND or an FDA determination that an IND is not needed.

      NOTE: Contractor use of NIH material is considered Government Furnished Materials, meaning that the Government [NIH] will make the materials available to the contractor.

E. Responsibilities

  1. CC OD coordinating team: 

    1. Responsible for receiving incoming Program Proposals and ensuring EIs have included the necessary information.

    2. Triages requests from EIs and forwards completed requests to the respective departments offering services.

    3. Maintains an online administrative site to monitor and track requests from EIs and also maintains a website http://cc.nih.gov/translational-research-resources/resources.html with the potentially available resources and their points of contact.

    4. Collaborates with CC/Office of Financial Resource Management (OFRM) to complete the IAA program and administrative requirements.

  2. CC Department offering resource:

    1. Consults with EIs who are considering use of the specific resource.

    2. Provides feedback to EIs during consultation and issues Consultation Letter to summarize the interaction.

    3. Evaluates Program Proposals and ensures that eligible projects are scheduled and implemented according to the terms of the Project Agreement or Notice of Award. 

    4. Works closely with the EI and Intramural Research Collaborator (IRC) to provide the requested resource on a mutually agreed timeframe.

    5. Tracks the outcome of each project including a summary of resources provided to the extramural investigator and other identified project metrics, using the online administrative site. 

  3. Extramural Investigator and NIH Intramural Research Collaborator:

    1. Initiates consultation with the NIH department offering resource and incorporates feedback as appropriate.

    2. Submits Program Proposal.

    3. Agrees to and signs all documentation, including the Consultation Letter and Project Agreement/Notice of Award.

    4. Works closely with a point-of-contact in department offering resource to implement the project.

  4. NIH Intramural Research Collaborator

    1. Consults with EIs who are considering use of a specialized NIH research resource

    2. Provides feedback to EIs during consultation and works with NIH department offering resources in preparation of Consultation Letter to summarize the interaction.

    3. Evaluates Program Proposals for use of NIH specialized research resources and ensures that eligible projects are implemented according to the terms of the Project Agreement or Notice of Award.

    4. Works closely with the EI and other CC and IC staff to provide the needed project support and to ensure that the overall project is conducted in collaboration with the EI on a mutually agreed timeframe.

    5. Tracks the overall outcome of each project including a summary of resources provided for the project and other identified project metrics, using the online administrative site.

  5. CC Office of Financial Resource Management (CC/OFRM):

    1. Processes the IAA between the CC and the funding IC and ensures funds are received for projects and can be fully obligated within the fiscal year of the agreement.

    2. Amends the IAA, if needed.

  6. Funding Institute/Center (IC):

    1. Receives requests from EIs, whether PIs on grants or IC staff on contracts, who intend to use the NIH specialized research resources in their research endeavor.

    2. For funded grants, agrees to withhold funds from grant or contract to reimburse CC for use of CC services.  For contracts, agrees to be responsible for the resource costs in place of the contractor.

    3. Enters into IAA with the CC to transfer funds from the funding IC to the CC.

EIs who wish to access NIH special research resources shall follow the appropriate procedures.  EIs shall engage in an initial consultation with the department offering the resource to assess the feasibility of their request.  If feasible, the CC agrees to implement the project once the EI’s grant or contract is funded by the NIH, assuming that no changes are later made to the request that would render it infeasible.  During consultation, the department offering the resource will provide estimated costs and timeframes to the EI using established templates.  Before the project is implemented, the CC and the funding IC will execute an Interagency Agreement (IAA) to transfer funds from the IC to the CC.  The amount of the transfer to the CC will be withheld from the EI’s grant.  The project is then implemented and the requested resources are provided to the EI.  Standard Operating Procedures for accessing services will be provided by the department offering the resource.

G. Available Resources

For available NIH special research resources please visit http://clinicalcenter.nih.gov/translational-research-resources/resources.html

H. Records Retention and Disposal

All records (e-mail and non-e-mail) pertaining to this chapter must be retained and disposed of under the authority of NIH Manual 1743,"Keeping and Destroying Records, Appendix 1, NIH Records Control Schedule, Appendix 1; Part 1: Administration; Section 1100 General Administration; 3000-C-10, Experiment Protocol Files; 3000-G-1, Planning and Development Records for Research Projects; 3000-G-2 Research Protocols; Solicited and Unsolicited Bids and Proposals Files; 2600-A-7 Solicited and Unsolicited Bids and Proposals Files; and 1100-M-1.

NIH e-mail messages, including attachments that are created on NIH computer systems or transmitted over NIH networks that are evidence of the activities of the agency or have informational value are considered Federal records.  These records must be maintained in accordance with current NIH Records Management guidelines. Contact your IC Records Liaison or the NIH Records Officer for additional information.

All e-mail messages are considered Government property, and, if requested for a legitimate Government purpose, must be provided to the requester, employees' supervisor, NIH staff conducting official reviews or investigations, and the Office of Inspector General who may request access to or copies of the e-mail messages.  E-mail messages must also be provided to Congressional oversight committees if requested and are subject to Freedom of Information Act requests.  Back-up files are subject to the same information requests as original messages and documents.

I. Internal Controls

The purpose of this manual issuance is to create a policy and process to allow extramural investigators to access special research resources of NIH.

  1. Office Responsible for Reviewing Internal Controls Relative to this Chapter: NIH Clinical Center, Office of the Director.

  2. Frequency of Review (in years): The Chapter will be reviewed and updated annually.

  3. Method of Review: The CC/OD coordinating team shall review the content of the Chapter to ensure it is feasible and up-to-date.  In addition, the CC/OD coordinating team will document lessons learned and process improvements. The CC/OD coordinating team will also provide data to the Clinical Center Director on the utilization of the resources, as well as data on EI, IRC, and IC compliance with policy and procedures.

  4. Review Reports are sent to: Reports shall be sent to the NIH senior official responsible for the area covered by the chapter, the Deputy Director for Extramural Research (DDER). A copy of all review reports must also be forwarded to the Deputy Director for Management.

  1. NIH Manual Chapter 1165 – Agency Agreements

  2. NIH Manual Chapter 1743 – Keeping and Destroying Records

  3. U.S. Food and Drug Administration- Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs):
    http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/Investigationa
    lNewDrugINDApplication/ucm071098.htm#form1571

  4. NIH Clinical Center, Pharmacy Department, Pharmaceutical Development Section:
    http://clinicalcenter.nih.gov/phar/index.html

  5. NIH Manual Chapter 6315-1 – Initiation, Review, Evaluation, and Award of Research & Development (R&D) Contracts

  6. Scientific Management Review Board Report on the NIH Clinical Center (December 2010):
    http://smrb.od.nih.gov/documents/reports/CC_122010.pdf

  7. NIH Grants Policy Statement:
    http://grants.nih.gov/grants/policy/policy.htm#gps

  8. NIH Public Access Policy:
    http://grants.nih.gov/grants/policy/policy.htm#gps

  9. Inventions and Patents:
    http://grants.nih.gov/grants/policy/policy.htm#gps

  10. NIH Privacy Act Systems of Record Notice 09-25-0036, Extramural Awards and Chartered Advisory Committees (IMPAC 2), 
    Contract Information (DCIS), and Cooperative Agreement Information, HHS/NIH.

    https://oma.od.nih.gov/forms/Privacy%20Documents/PAfiles/0036.htm

  11. NIH Manual Chapter 2300-308-4 -- NIH On-Site Research Collaborator Policy
     


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