These frequently asked questions (FAQs) are designed to assist investigators in learning more about establishing partnerships with NIH intramural investigators and accessing special NIH research resources. The FAQs provide general information about potentially available resources and partnerships, applying for access to research resources and logistics of utilizing resources and/or implementing a partnership. These FAQs are illustrative of general concepts only; sometimes the answer to a question may differ due to the facts of the situation. Each collaboration with NIH will be controlled by its corresponding written and executed agreement.
If you need more information, please contact ClinicalCtrPartner@mail.nih.gov.
Resources
Collaborations
NIH Appointments for Extramural Investigators
Credentialing for Extramural Investigators
Conflict of Interest
Clinical Protocols
Building a Budget for the U01 Funding Opportunity
Applying for the U01 Funding Opportunity
Patients
Intellectual Property
Biospecimens
Workspace and Lodging for Extramural Partners
Data
Resources
What resources are available?
You can search the Resources on the Collaborating with NIH Intramural Investigators at the Clinical Center website, which lists research services, clinical support services, equipment, technology, patient cohorts, and specimens potentially available at the Clinical Center ("resources").
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How can I access resources?
Currently, an external investigator may access resources only via a formal funding relationship with the NIH (contract, grant, or cooperative agreement). In most situations, a documented research collaboration with an NIH investigator is required. This research collaboration may be documented by the following: Cooperative Research and Development Agreement, Memorandum of Understanding, Clinical Trial Agreement, or Intergovernmental Personnel Act agreement or other appropriate written agreement.
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Are specific funding opportunities available for partnering with NIH collaborators and accessing NIH resources?
Yes. Two specific opportunities are available.
You may also be able to utilize other NIH grants, cooperative agreements, and contracts as a vehicle for accessing Clinical Center resources under certain conditions. For more information please contact ClinicalCtrPartner@mail.nih.gov.
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How do I contact the Clinical Center department or institute-based program that provides the resource I would like to use?
The Resources page on the Collaborating with NIH Intramural Investigators at the Clinical Center website provides name and contact information of the NIH investigators (NIH employees) who serve as the contact for a collaboration resource offered by the Clinical Center or other NIH Institutes or Centers. Prospective users are encouraged to communicate directly with these NIH investigators about potential resources and collaborations.
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How long will it take to get access to the resource I am interested in using?
After the grant or contract is approved and funded, the request will be entered into a queue for prioritization based on both scientific merit and availability of the resource. The department that provides or oversees the resource will provide an approximate timeline.
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What are the costs for each resource?
Clinical Center costs vary depending on the services required to support specific research projects. Please contact ClinicalCtrPartner@mail.nih.gov with questions related to costs for specific resources.
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What if I cannot find a specific resource in which I am interested?
Please contact the Clinical Center Service Office and your request for access to a specific resource will be considered. Not all resources will be offered for collaboration and some may have limited availability.
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Where can I learn about current clinical protocols?
You can search the Search the Studies website for an up-to-date list of current protocols.
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Collaborations
How can I contact NIH investigators?
You will find contact information for NIH investigators on the NIH Directory or the Search the Studies website.
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How can I identify NIH investigators interested in my area of research?
You can search the Database of NIH Intramural Research Reports, the Intramural Principal Investigator Directory, and the Search the Studies website. By entering key words, such as a disease, a therapy, etc. you may be able to identify a potential collaborator.
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I am interested in collaborating with an NIH investigator. How might the collaboration be structured?
A collaboration between an extramural investigator and an intramural investigator must be documented in writing. A research collaboration may be documented by the following: Cooperative Research and Development Agreement, Memorandum of Understanding, Clinical Trial Agreement, Intergovernmental Personnel Act agreement or other appropriate written agreement. In any collaboration, the intramural and extramural investigators can interact in several ways. Below are a few examples of potential collaboration models:
- An intramural Investigator conducts specific studies at the Clinical Center and an extramural investigator conducts their collaborative studies at their home institution
- A trainee/Junior Faculty member comes to the Clinical Center to manage/conduct collaborative project
- An extramural Investigator takes a sabbatical to conduct joint studies at the Clinical Center
Please note: For the extramural investigator to gain research or clinical privileges at the NIH Clinical Center, he or she must obtain the appropriate NIH appointment and credentialing.
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In the absence of a formal scientific collaboration, can I still access resources?
In limited circumstances access to resources in the absence of a formal scientific collaboration may be possible with a written agreement. Please contact ClinicalCtrPartner@mail.nih.gov for further guidance.
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NIH Appointments for Extramural Investigators
If I want to come to the NIH to conduct research, do I need an NIH appointment prior to starting?
Yes. If you have a grant or contract and a written agreement covering collaboration with an NIH intramural investigator at the NIH Clinical Center and you would like to conduct research at the NIH, you will first need to obtain the appropriate appointment. The specific appointment you need is determined by the type of research you plan to undertake. You will work with your intramural collaborator to facilitate the actual appointment process.
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If I want to visit the NIH for a brief time and do not plan to conduct research on the campus (i.e., to conduct planning meetings with an intramural collaborator), do I need an NIH appointment?
No. If you are visiting the NIH for a short time and are not planning to conduct research on the government property, e.g. NIH campus, you do not need an appointment but there should be a collaboration agreement.
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How long does it take to gain the appropriate NIH appointment to work on the collaborative project?
The time to receive an NIH appointment will depend on the type of appointment and the NIH institute with which you will be collaborating. The average timeframe is between 30 and 90 days. Your NIH intramural collaborator and intramural collaborator's Institute/Center will assist you with and facilitate the appointment process.
Appointments for non-immigrant foreign nationals, working at domestic institutions collaborating with NIH intramural investigators, will take longer to process.
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Can my medical students accompany me for short visits to launch and sustain a project, and if so do they have to be credentialed at NIH? How about fellows?
Medical students may come to the NIH to conduct research and function under the preceptorship and direct supervision of a Senior Medical Staff member, who is responsible for their behavior and performance. They will not have any responsibility for the direct care and management of patients. Medical students who want to have patient contact must be registered by the Clinical Center's Office of Clinical Research Training and Medical Education. There must be a written training agreement and the home institution or student must provide evidence of professional liability coverage.
Fellows may also come to the NIH to conduct research. Research must be conducted under direct supervision of a Senior Medical Staff member. Fellows will not have any responsibility for direct patient care and management of patients. Fellows who wish to have patient contact must be approved for medical staff membership and go through the appropriate appointment and credentialing processes as other investigators. There must be a written training agreement and the home institution or student must provide evidence of professional liability coverage.
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Credentialing for Extramural Investigators
If I come to NIH to provide direct patient care, do I need to get credentialed?
Yes, all persons who wish to provide patient care services at the NIH Clinical Center can exercise only those clinical privileges recommended by their collaborating Institute/Center and granted by the Director, Clinical Center. These privileges may only be issued to individuals if their application for membership on the Active Medical Staff has been approved. An individual is not entitled to carry out any clinical activities based solely on a prior, current, or pending affiliation with the NIH or other health care institution. Your intramural collaborator's Institute/Center will facilitate the credentialing process.
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What do I need to do to be credentialed at the Clinical Center?
Doctors of medicine, osteopathy, dentistry, and podiatry are eligible for membership on the Active Medical Staff. Only individuals providing direct, including incidental, patient care services are required to apply for medical staff membership. All applicants seeking appointment to the active staff must be recommended and sponsored by one of the NIH Institutes/Centers and complete an initial credentialing application package, which is available through the Credentialing Services Office of the NIH Clinical Center. You may work with your intramural partner to facilitate this process. Credentialing will occur after the appropriate appointment mechanism is in place (for more information, see "NIH Appointments for Extramural Investigators" section above.)
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How long does the credentialing process take?
Credentialing usually occurs after the appointment is confirmed. The length of time for this process will depend upon several factors, including the candidate's employment history. In general, clinical credentialing applications should be submitted at least two months in advance of the proposed clinical start date.
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Once I receive the appropriate NIH appointment and am credentialed to work at NIH, will I have access to systems needed to conduct clinical research?
Medical staff applicants can request full access to the Clinical Research Information System via the initial credentialing process, including rights to view patient information and to enter clinical documentation and medical orders. Once their credentialing application is submitted they will receive an email with instructions on how to complete the necessary online training. Clinical Research Information System access codes will not be issued until medical staff membership is approved. Individuals who are not appointed to the Clinical Center medical staff may request view-only Clinical Research Information System access. Instructions can be found at http://cris.cc.nih.gov/accounts/index.html.
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Conflict of Interest
If I want to conduct research at the NIH Clinical Center, do I have to comply with the NIH employee financial conflict of interest policies? What ethical policies and guidelines would I need to follow?
When you conduct research at the NIH, you will need an NIH appointment, which will require compliance with particular ethical standards and financial conflict of interest policies. The requirements of each appointment will vary. You will be assisted by your intramural partner and the Deputy Ethics Coordinator in your intramural collaborator's Institute/Center as to how to comply with the relevant requirements.
If you are conducting research at your home institution, you must follow standard NIH grant requirements and your home institution's policies. See http://grants.nih.gov/grants/funding/welcomewagon.htm#fcoi
Your home institutions' standards of conduct, which must be consistent with State and local laws and cover, at a minimum, expected conduct in certain specified areas. See the NIH Grants Policy Statement, Section 4.1.29, "Standards of Conduct" for more information.
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Clinical Protocols
What resources does the NIH provide to assist with developing and conducting clinical protocols?
Comprehensive policies, procedures, and standards are available to guide protocol planning, development and implementation in the intramural program at NIH. The Standards for Clinical Research Within the NIH Intramural Research Program 
(115 KB) complements the Guidelines for the Conduct of Research in the Intramural Research Program at NIH and A Guide to Training and Mentoring in the Intramural Research Program at NIH both available at http://sourcebook.od.nih.gov/ethic-conduct/ethical-conduct-toc.htm. These statements encompass the NIH standards of training, ethics, and conduct for scientists http://sourcebook.od.nih.gov/ethic-conduct/COI_Guide_110316.pdf (45 KB). These resources assist intramural clinical researchers and will influence collaborative protocol efforts on new grants.
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How do I handle the IRB review of my protocol(s), especially if the protocol will take place at multiple sites, including the NIH campus?
The investigators may consult with Charlotte Holden in the NIH Office of Human Subjects Research (Charlotte.Holden@nih.gov) regarding this question. IRB review may occur at each site, or alternatively, it may be possible to enter into an Authorization Agreement (also known as a "reliance agreement"). This is an agreement between NIH and one or more institutions involved in the same cooperative research that assigns regulatory responsibilities to specific IRBs.
A multi-site protocol may have two Principal Investigators, with one for each institution.
IRB approval is not required before grant submission, but it is required before the grant is awarded.
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Do I need to write a new protocol to do a clinical project at the Clinical Center, or can I use a protocol reviewed and approved by the IRB of my home institution?
Both situations are possible, depending on the specifics of the protocol. To discuss these possibilities, please contact Charlotte Holden in the NIH Office of Human Subjects Research (Charlotte.Holden@nih.gov). Ideally, a plan should be made during protocol development.
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Can an extramural investigator be a Protocol Principal Investigator on an NIH protocol?
The extramural and intramural investigators will both be co-Principal Investigators on the grant. The protocol Principal Investigator is a separate designation.
Typically, non-NIH non-Federal employees cannot be protocol principal investigators for protocols carried out at the Clinical Center, though they can be Adjunct Principal Investigators.
In some cases, an extramural investigator whose appointment is through a temporary detail via the Intergovernmental Personnel Act may be able to serve as the protocol PI. The decision to name an extramural PI as the protocol Principal Investigator should be carefully considered, due to the protocol Principal Investigator's need for familiarity with NIH policies, including protocol implementation and human subjects requirements.
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Will I have to complete NIH-specific training or education prior to being a Principal Investigator or Adjunct Principal Investigator on a protocol carried out at the Clinical Center?
Yes. NIH has specific education requirements for Principal Investigators and others engaged in human subjects research under an NIH appointment. NIH requires all investigators, regardless of their role on the protocol, to complete the following web-based training course, Clinical Center Clinical Research Training online course for Investigators: http://clinicalcenter.nih.gov/training/training/crt.html. This course addresses the essential standards for training and education approved by the NIH for performing clinical research in the Intramural Research Program. All NIH intramural clinical investigators are required to take the course and successfully complete the exam. Additionally, investigators engaged in FDA-regulated research will need to provide proof of, or take Good Clinical Practice training. Investigators engaged in Social Behavioral Research will need to provide proof of, or take Social Behavioral Research training. In some situations, previous training taken may fulfill these requirements. For more information, consult with Heather Bridge (Heather.Bridge@nih.gov) in the Office of Human Subjects Research. NIH IRBs may require additional training.
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Building a Budget for the U01 Funding Opportunity
How will the project budget be formulated?
General budget instructions can be found in the Funding Opportunity Announcement in Section IV. Application and Submission Information. The project budget should not exceed $500,000 a year in direct costs, for a period of no more than three years. Funds should support the project costs of the extramural principal investigator, the intramural principal investigator / co-investigator, and the Clinical Center.
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How are Clinical Center costs determined?
For specific information on determining Clinical Center costs, please see the U01 Budget Instructions page.
Extramural Collaborations budget templates 
(58 KB) of the project activities are provided by the Clinical Center and should be completed by the intramural principal investigator/co-investigator. Once completed, these templates should be returned to the Clinical Center Partner team, who will work with the intramural investigator to project Clinical Center costs.
Please contact ClinicalCtrPartner@mail.nih.gov with questions.
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What kinds of costs can an intramural investigator include in the project budget?
In general, the budget request will be limited to the costs required for carrying out the proposed work if those costs can be specifically identified with the project. These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses.
Restrictions: Budget requests from federal agencies, including the NIH intramural program, may not include any salary and related fringe benefits for career, career conditional or other federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative costs).
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Who is responsible for the intramural budget?
The intramural co-investigator on the project is responsible for his or her own intramural budget. The intramural investigator will develop a sub-award budget for submission with the grant. The intramural investigator is also responsible for coordination with the Clinical Center to assure that all NIH Clinical Center related costs are clearly identified as a separate sub-award budget. The NIH Clinical Center and the intramural investigator costs associated with the research project will not be paid to the grantee, but instead will be supported directly by the awarding NIH Institute/Center.
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Applying for the U01 Funding Opportunity
What kind of information should be included in the required Collaboration Plan?
As noted in the Funding Opportunity Announcement (PAR-13-029) the goal of this program is to support collaborative translational research by promoting partnerships between intramural and extramural investigators. The required Collaboration Plan should describe how the proposed collaboration will be maintained throughout the duration of the award. The Collaboration Plan should focus on how the science will move forward; it should be prepared to align with the review criterion of Approach, which includes the following questions:
- Is the Collaboration Plan well defined with identifiable responsibilities for the NIH intramural investigator and the extramural applicant?
- Is a plan for management of the collaboration presented, as well as descriptions of what each participant proposes to provide to the collaborative partnership?
The following areas should be addressed in the Collaboration Plan:
- Organizational structure
- Management plan detailing how existing resources, including unique resources available through the NIH Clinical Center, will be utilized
- Planned interaction and responsibilities of key personnel
- Description of how research teams will communicate (e.g., videocast, web meeting, etc.)
- Available resources and details of how these resources will be shared
The Collaboration Plan should be included as an attachment to the SF424 (R&R) Research and Related Other Project Information component under "Other Attachments". The filename "Collaboration Plan.pdf" should be used and will be reflected in the final image bookmarking for easy access by reviewers. The Collaboration Plan is NOT included in the page limit of the Research Strategy.
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What is the difference between the Collaboration Plan and the Multiple PD/PI Leadership Plan, and are both plans required?
All applications submitted in response to PAR-13-029 must include a Collaboration Plan. A Leadership Plan is required for any application submitted using the Multiple PD/PI option. Although there will likely be some overlap or redundancy, both plans are required if the Multiple PD/PI option is used.
The Multiple PD/PI Leadership Plan should address the following administrative processes and PI responsibilities:
- Roles/areas of responsibility of the PIs
- Fiscal and management coordination
- Process for making decisions on scientific direction and allocation of resources
- Data sharing and communication among investigators
- Publication and intellectual property (if needed) policies
- Procedures for resolving conflicts
The Multiple PD/PI Leadership Plan should be included as an attachment to the SF424 (R&R) Research and Related Other Project Information component under "Other Research Plan Sections".
Examples of leadership plans are available on the Multiple PI website at http://grants.nih.gov/grants/multi_pi/index.htm.
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I am an investigator and am interested in applying as a principal investigator for the U01. If awarded, would the grant be counted as an extramural NIH award for me such that I would lose New Investigator status if I were to apply for an R01 as an extramural NIH investigator in the future?
Yes, if you are serving as a PI (either intramural or extramural) on a Multiple PD/PI application that is selected for an award, you will lose your New Investigator (NI) status. However, if you apply as a co-investigator, your NIH status would be preserved (see: http://grants.nih.gov/grants/multi_pi/faq.htm). Additional information about New Investigators and Early Stage Investigators may be found at http://grants.nih.gov/grants/new_investigators/.
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Patients
Can I bring patients to the Clinical Center?
Yes, as long as patients will be enrolled in an existing intramural NIH protocol with a responsible NIH physician, they may access all resources available at the Clinical Center (http://clinicalcenter.nih.gov/participate.shtml).
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Who is responsible for the care of patients I may bring to the Clinical Center?
While the Principal Investigator on the protocol is ultimately responsible for the care of patients on a given study, a cadre of skilled personnel is required to support the Principal Investigator and provide oversight of clinical trials. The appropriate organization of a clinical trial team may differ depending on program objectives, but the Principal Investigator will be responsible for ensuring that the appropriate mix of individuals and skills is represented.
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Will patients have to pay to travel to the NIH?
Reimbursement for patient travel is variable across NIH institutes and protocols. All NIH protocols are required to establish a protocol-specific reimbursement rate for travel (i.e., local and long-distance transportation) and subsistence (i.e., meals and lodging). Clinical research protocol participants are to be reimbursed in accordance with these protocol-specific reimbursement rates. NIH will make every effort to assure fairness in reimbursing clinical research protocol participants for travel and subsistence by taking into account the scientific needs of the studies and the financial and/or medical needs of individual participants. Participants needing additional financial assistance will be able to receive supplemental reimbursement based upon need. Requests for supplemental reimbursement will be evaluated on a case-by-case basis for valid financial and/or medical need through a standardized process.
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If patients are outpatients will they have to pay for housing and food while at NIH?
Reimbursement for housing and food may be available for outpatients who live greater than 50 miles from NIH, depending on the protocol reimbursement.
Lodging: Participants will be provided reimbursement for lodging expenses in accordance with the protocol-specific reimbursement rate for participants living greater than 50 miles from the NIH clinical research site. If the hotel cost is less than the protocol-specific reimbursement rate, NIH will only reimburse for the actual cost of the lodging.
Meals: Protocol participants who live greater than 50 miles from the NIH clinical research site are eligible for reimbursement in accordance with the protocol-specific reimbursement rate for meals at a daily rate. Nutritional supplements are provided routinely to outpatients during clinic visits as requested.
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Can parents or guardians accompany minor patients coming to the NIH?
Yes, parents or guardians may accompany minors enrolled in clinical trials at the Clinical Center. Depending on the protocol reimbursement, the travel of a parent or guardian may be covered. Subject to availability, a wide range of resources and services are available for young patients, their families and guardians. The NIH Children's Inn [disclaimer] is a hospital hospitality house that offers a variety of services while also providing mutual support to families during their time of need. The NIH Children's School has educated school age patients of the Clinical Center. The school is subsidized by the Federal government and is available free of charge to Clinical Center patients. The Edmond J. Safra Family Lodge at NIH offers a home-like place of respite for families and loved ones of adult patients who are receiving care at the NIH Clinical Center.
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Intellectual Property
How are ownership rights determined for inventions developed jointly by an intramural NIH investigator and an NIH extramurally funded investigator not working at NIH?
Ordinarily, invention rights attributed solely to the extramural investigator will be owned by the extramural investigator's institution. Invention rights attributed solely to the intramural NIH investigator will belong to the U.S. Government. Joint inventions will be owned by both the investigator's home institution and the U.S. Government. For the NIH, the Office of Technology Transfer would seek to enter into an Inter-institutional Agreement for joint inventions with an extramural institution to identify which party will take the lead on the management of patenting and licensing.
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How are ownership rights determined for extramural investigators working at the NIH?
For this grant program, extramural investigators are not required to assign their intellectual property rights to NIH for inventions made under the U01 funded on-campus collaborations. Invention rights attributed solely to the extramural investigator will be owned by the extramural investigator's institution. Invention rights attributed solely to the intramural NIH investigator will belong to the U.S. Government. Joint inventions will be owned by both the investigator's home institution and the U.S. Government. For the NIH, the Office of Technology Transfer may seek to enter into an Inter-institutional Agreement for joint inventions with an extramural institution to identify which party will take the lead on the management of patenting and licensing.
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What policies apply to an extramural investigator working at the NIH regarding publications and copyrighting?
For work solely at their home institutions, grantees are governed by the policies of their home institution and any applicable grant conditions and policies. Grantees may assert copyright in works developed under an NIH grant provided a royalty-free, nonexclusive, and irrevocable license for the Federal government to reproduce, publish, or otherwise use the material and authorize others to do so for Federal purposes is provided. U.S. copyright cannot be asserted in works by NIH employees or joint works with extramural investigators to the extent the Federal employee's contribution is not a separable part of the work. Extramural investigators working under appointments at NIH need to follow applicable NIH policy governing the review and approval of scientific, technical or other professional information to be published based on work conducted at NIH. NIH encourages public dissemination of scientific research and other information on public health matters by its employees and staff.
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Biospecimens
What guidelines should I follow in sharing biospecimens between sites?
NIH providers who intend to transfer or distribute human biospecimens to non-NIH researchers, including collaborators and companies, must comply with the Policy for the Transfer of Materials from NIH Intramural Laboratories, NIH's Policy for the Transfer of Materials and Biospecimen Guidelines Document and must follow strict NIH standards to ensure that these valuable resources are adequately protected.
NIH researchers must utilize written agreements to document shipping and sharing of human biospecimens with outside organizations for research purposes (see Policy for the Transfer of Materials from NIH Intramural Laboratories (49 KB)). Various types of agreements can be used depending on the circumstances. NIH's Model Human Material Transfer Agreement can be found at http://www.ott.nih.gov/model_agreements. Biospecimens should be coded. Personally identified biospecimens may only be shipped if an appropriate agreement has been used and the appropriate high level NIH employee has agreed to such transfer.
Packaging and shipping of human biospecimens must conform to all applicable regulations and standards, including the U.S. Department of Transportation and International Air Transport Association standards.
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What guidelines should I follow for collecting and storing biospecimens at the NIH?
Human biospecimens should be collected consistent with 45 CFR 46, Protection of Human Subjects, and using procedures appropriate for the type of specimen being collected and its intended uses, and must be handled in accordance with the U.S. Occupational Safety and Health Administration's Bloodborne Pathogens Standard.
Human biospecimens must have an individual computer-generated label or electronic tracking device with a system-unique identifier. The identifier must enable the investigator to link to the protocol and informed consent (or waiver) under which the specimen was collected, as well as an NIH Clinical Center central biomedical and translational research information system patient identification number, as appropriate. The label must be able to withstand all potential storage conditions.
All repositories, whether large or represented by individual freezers in laboratories, should follow best practices for specimen storage and retrieval. For more guidance, see Best Practices for Repositories section: Collection, Storage and Retrieval of Human Biological Materials for Research (290 KB) [disclaimer], International Society for Biological and Environmental Repositories.
Please visit the Policy for the Transfer of Materials from NIH Intramural Laboratories (49 KB) and Guidelines for Human Biospecimen Storage and Tracking within the NIH Intramural Research Program (544 KB) for additional information on biospecimen tracking and custodianship.
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Workspace and Lodging for Extramural Partners
Will office space be available for me to use while I am at NIH?
Every effort will be made to accommodate space needs for extramural investigators collaborating on research projects. Requests for space will be made by the intramural collaborator through her/his IC Director, Scientific Director, or Executive Officer to the NIH Office of Research Facilities.
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Are housing accommodations available on the NIH campus or locally for extended visits to Bethesda?
On-campus housing is not currently available for visiting researchers. Five local hotels in Bethesda offer shuttles to the NIH campus: American Inn of Bethesda; Bethesda Court Hotel; Doubletree Hotel Bethesda; Marriott Residence Inn; Hyatt Regency Bethesda. There are many other hotel/motel options available in the immediate area. In addition, there may be private individuals who provide rooms in their homes which can be rented by short-term visitors (researchers) at NIH. There are also lists of apartments which can be made available.
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Data
When data are generated during the course of a research study at the Clinical Center, where are they stored?
Clinical research data is contained in Clinical Center systems of records and Institute/Center record systems. The Clinical Research Information System (the Clinical Center electronic record) processes and stores orders, test results and other clinical documentation for in-patient and out-patient visits. The Radiology Information System and the Picture Archiving and Communication System (PACS) manage images and tests available through the Radiology and Imaging Services Department.
Data generated by these systems are considered to be part of the official NIH Clinical Center medical record. Study-specific research data generated in the different institute based laboratories are stored separately in Institute/Center record systems. Data from Clinical Center record systems and from Institute/Center systems (data, text and images) are deposited daily into the NIH Biomedical Translational Research Information System (BTRIS). BTRIS integrates the medical record and research data from multiple sources as identified data for active protocols to protocol investigators and as de-identified data for hypothesis testing.
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When my collaboration at the Clinical Center is complete, what happens to the data?
Data collected as part of a clinical research study at the Clinical Center is the property of the NIH systems and is maintained according to applicable record schedules.
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Will I have access to NIH data systems when I return to my home institution?
Access to NIH intramural data systems requires an active NIH appointment. Some systems also require a two-factor authentication personal identity verification (PIV) card. NIH PIV cards are available to those with an active appointment to NIH staff and allow access to systems from remote locations via the NIH Virtual Private Network (VPN).
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Can I bring data with me to the NIH Clinical Center?
You may bring data sets with you to the NIH Clinical Center based on the policies and procedures of your home institution. If these data contain personally identifiable information and are to be stored on NIH computers or in NIH records, then these data sets must comply with the federal Privacy Act as well as federal standards for the storage and use of personally identifiable data. You will need to assure that you have the permission to bring these records to NIH and that after you depart from NIH, the records will remain for NIH’s future use. Outside data sets are not routinely included in the NIH Clinical Center Medical Record. If data sets are not a system of records (a group of any records under the control of NIH from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual) and do not contain personally identifiable information, they are not subject to the Privacy Act but should be maintained in a secure, encrypted computer system or locked file cabinet, etc.
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What are the NIH rules for data sharing?
NIH supports the sharing of research data supported by federal funds. All clinical trials conducted at the NIH Clinical Center are required to file study outcomes through the ClinicalTrials.gov system managed by the National Library of Medicine.
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Can I take the data from my collaboration back to my home institution for use in future studies?
Data collected while at the NIH are the property of NIH; copies of data you generate may generally be brought back to your home institution for future research, with some limitations and conditions.
- Human subjects data are subject to policies of the NIH Office of Human Subjects Research Protections (OHSRP), the relevant NIH Institutional Review Board (IRB) and the protections of the Federal Privacy Act. Future use is limited to those circumstances described in the consent forms for your study. In general, as with all patient records, copies of data that contain personally identifiable information (PII) cannot be removed from the NIH nor used by you at NIH after termination of the study, while copies of de-identified data you generate may be removed in compliance with applicable laws and NIH, OHSRP and IRB policies.
- A data transfer agreement will be needed to clarify the terms of data sharing; investigators should check with the relevant NIH institute's Technology Development Coordinator for more information.
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