U01 Implementing a Collaboration

Yes. If you have a grant or contract and a written agreement covering collaboration with an NIH intramural investigator at the Clinical Center and you would like to conduct research at the NIH, you will first need to be appointed as an on-site Research Collaborator (RC), clinical or non-clinical.

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 appointment process.  For more information on the RC appointment, see the table below.

No, you do not need an appointment but there should be a collaboration agreement.

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.

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 Education and Collaboration Outreach 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.

Yes, all persons who wish to provide patient care services at the Clinical Center can exercise only those clinical privileges recommended by their collaborating Institute/Center and granted by the Chief Executive Officer, 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.

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 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.) The length of time for the credentialing 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.

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.

When you conduct research at the NIH, you will need an NIH appointment as a Research Collaborator (RC), which will require compliance with particular ethical standards and financial conflict of interest policies.

• If appointed as a Research Collaborator (RC), usually you will be required to be in compliance with the recently issued NIH Financial Conflict of Interest regulation applicable to investigators and their institutions (see: http://grants.nih.gov/grants/policy/coi/coi_faqs.htm).
• RCs who are detailed or appointed under the Intergovernmental Personnel Act (IPA) are subject to Federal statutes and regulations on conflict of interest and ethical conduct. RCs who are IPA appointees are also subject to the HHS NIH-specific ethical conduct requirements.
• 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.

The Financial Conflict of Interest regulation in 42 CFR 50.603 does not apply to federal agencies. Thus, the Clinical Center is not required to have a financial conflict of interest policy compliant with 42 CFR Part 50. As is explained in the preamble to the final rule addressing that section (http://grants.nih.gov/grants/policy/coi/fcoi_final_rule.pdf  at 53261): "Federal agencies and their employees are subject to conflicts of interest requirements, including disclosure by employees and review by agencies, pursuant to Federal criminal statutes, the Ethics in Government Act as amended, and supplemental agency regulations.

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  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/sourcebook/ethical-conduct. These resources assist intramural clinical researchers and will influence collaborative protocol efforts on new grants.

The investigators may consult with the NIH Office of Human Subjects Research at (301) 402-3444 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.

Both situations are possible, depending on the specifics of the protocol. To discuss these possibilities, please contact the NIH Office of Human Subjects Research at (301) 402-3444.  Ideally, a plan should be made during protocol development.

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.

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 the Office of Human Subjects Research at (301) 402-3444. NIH IRBs may require additional training.

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 (https://www.cc.nih.gov/participate).

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.

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.

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.

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 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.

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.

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.

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.

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). 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/forms-model-agreements#MTACTA. 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.

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 a 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, International Society for Biological and Environmental Repositories.

Please visit the Policy for the Transfer of Materials from NIH Intramural Laboratories  and Guidelines for Human Biospecimen Storage and Tracking within the NIH Intramural Research Program  for additional information on biospecimen tracking and custodianship.

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.

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 are available.

Yes, you may bring data with you to the Clinical Center if permitted by your home institution. Records you bring to the Clinical Center that are owned by your home institution should be marked, kept separate from NIH records and kept under your control. If data you bring includes personally identifiable information, patient privacy and security must be protected through locked and secured systems.

Outside data sets are not routinely included in the Clinical Center medical record. But, if the data you bring includes personably identifiable information related to care and treatment of NIH patients, then the information will need to be incorporated into the NIH Clinical Center medical record as part of ordinary medical practice. NIH medical records are subject to the federal Privacy Act as well as federal standards for the storage and use of personally identifiable data. Data with personally identifiable information that is a federal record, e.g., information stored on NIH computers or in NIH records that is under the control of NIH, must comply with applicable federal laws, which may include the Privacy Act as well as federal standards for the storage and use of personally identifiable data. For more information see: http://csrc.nist.gov/publications/nistpubs/800-122/sp800-122.pdf  (defining PII), http://www.hhs.gov/foia/privacy/ (Privacy Act), and http://csrc.nist.gov/groups/SMA/fisma/index.html (storage standards).

Yes, data collected as part of the collaboration may be retained and released to you for future research activities consistent with applicable laws, like the HHS human subjects' protections regulations found at 45 CFR 46, and the participant's informed consent. Future studies with identifiable information may require IRB approval or an exemption determination. Specific policies for sharing data after the end of the collaboration and for future research activities are maintained by the NIH Office of Human Subjects Research Protections (OHSRP), see: http://ohsr.od.nih.gov/.

Yes, data collected as part of the collaboration may be retained and released to you for future research activities consistent with applicable laws, like the HHS human subjects' protections regulations found at 45 CFR 46, and the participant's informed consent. Future studies with non-identifiable information may not require IRB approval or exemption. Specific policies for sharing data after the end of the collaboration and for future research activities are maintained by the NIH Office of Human Subjects Research Protections (OHSRP), see: http://ohsr.od.nih.gov/.

Maybe. Individual patient medical records may be viewed in the NIH's Clinical Research Information System (CRIS), the Clinical Center electronic medical record, for certain approved research purposes, consistent with applicable laws, like the HHS human subjects' protections regulations found at 45 CFR 46, and the participant's informed consent. Future studies with identifiable information may require IRB approval or an exemption determination at your home institution. Remote access to CRIS requires an active NIH appointment, an active CRIS account, and an NIH PIV card or RSA token to allow access via the NIH Virtual Private Network (VPN). If you are obtaining another appointment at NIH after your collaboration ends, then, you may be able to access or obtain data for approved future studies.

Identifiable images of patients enrolled in specified clinical research protocols may be viewed in the Clinical Center Research Picture Archival Systems (PACS). Approved PACS users are only given authorization to see exams related to their protocol(s). Remote access to PACS requires an active appointment to NIH staff and an NIH PIV card or RSA token to allow access via the NIH Virtual Private Network (VPN).

Clinical research data is contained in Clinical Center systems of records and Institute/Center systems of records record systems. In contrast, generally, the Clinical Center's patient medical record consists of: (1) the Clinical Research Information System (the Clinical Center electronic medical record), which processes and stores orders, test results and other clinical documentation for in-patient and out-patient visits; and (2) the Radiology Information System and the Picture Archiving and Communication System (PACS), which manage images and tests available through the Radiology and Imaging Services Department. Study-specific research data generated in the different Institute-based laboratories are stored separately in Institute/Center record systems.

Additionally, the NIH's Biomedical Translational Research Information System (BTRIS) collects and stores individual medical record and research data from multiple sources for existing and future research purposes. Data from the Clinical Center medical record systems and from some Institute/Center systems (e.g., text and images) are deposited daily into BTRIS. For more information on BTRIS see http://btris.nih.gov/.

Maybe, depending upon whether you retain an appointment at NIH, e.g., as a Guest Researcher. 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).

NIH supports the broad sharing of research data. It is particularly important for unique data that cannot be readily replicated. Data sharing allows scientists to expedite the translation of research results into knowledge, products, and procedures to improve human health. Sharing data reinforces open scientific inquiry, encourages diversity of analysis and opinion, promotes new research, makes possible the testing of new or alternative hypotheses and methods of analysis, supports studies on data collection methods and measurement, facilitates the education of new researchers, enables the exploration of topics not envisioned by the initial investigators, and permits the creation of new datasets when data from multiple sources are combined. In NIH's view, all data should be considered for data sharing. Data should be made as widely and freely available as possible while safeguarding the privacy of participants, and protecting confidential and proprietary data.

Towards this end, the NIH intramural program promotes data sharing consistent with policies applicable to NIH extramural research. For example, under the 2014 GDS Policy for genomic data, intramural research data will be shared through NIH-approved repositories. See: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html. Moreover, at the Clinical Center, all clinical trials are registered in the ClinicalTrials.gov system managed by the National Library of Medicine and summary results are distributed through ClinicalTrials.gov for many of these trials.