Other required components of the application (submitted in addition to the research plan) are:
Letter of confirmation co-written and co-signed by the U.S. and Chinese co-investigators, and including the Authorized Organizational Representative (AOR) signature. The first section of the letter of confirmation should describe specific responsibilities of the U.S. PD/PI and Chinese partner. This letter should detail available resources, including which collaborative partner is contributing which resources, and a plan for how resources will be shared (e.g., individual contributions of specific reagents, patient samples, compounds, and access to populations for epidemiologic studies). The second part of the letter of confirmation should address the benefit of U.S.-China collaboration for this project, explaining why there is a need for international collaboration, what is the synergy between the collaborating groups, and how the project will achieve intellectual balance between the respective partners (three-page limit).
Biographical sketches for all new key personnel who are additions on the supplemental project (two-page limit for each biographical sketch).
Roles of key staff (three-page limit)
A discussion of future plans for expanding, extending, or otherwise continuing the research jointly prepared with the Chinese partner(s) (one-page limit).
Budget for the supplement with a justification that details the items requested, including personnel, travel, and Facilities and Administrative (F&A) costs. The applicant is encouraged that each application includes two budgets: one requesting NIH funding (for expenses on the U.S. side) and one budget requesting NSFC funding (for expenses on the Chinese side in Chinese currency [Renminbi]).
Human subjects/vertebrate animal documentation (if applicable).
Include a current Human Subjects/Institutional Review Board (IRB) or Vertebrate Animals/Institutional Animal Care and Use Committee (IACUC) approval letter, if available. Otherwise, this will be required at the time of funding. All appropriate IRB and IACUC approvals must be in place prior to a supplement award being made.
Any differences in the involvement or use of human subjects or specimens, or use of vertebrate animals, between the administrative supplement activity and the parent grant should be noted.
When appropriate, details should be provided on the protection of human subjects and inclusion of women, children, and minorities. Additional guidance on Human Subjects Research and Vertebrate Animals is provided under Part II of the PHS 398 instructions.
The grantee institution must show evidence of compliance with U.S. and Chinese regulations for the conduct of research involving human subjects. Additional information can be found at the HHS Office for Human Research Protections website at
http://www.hhs.gov/ohrp.
PHS 398 Checklist Form.
Selection
Administrative supplement requests will be evaluated administratively by NIH Staff. Selection factors will include the following:
Relevance of the proposed activities to the parent grant;
Adequate progress of the parent grant appropriate to the current stage of the project;
Appropriate and well-described plan to accomplish the goals within the timeframe proposed; and
Expertise of the research team proposed to conduct and achieve the goals the supplemental study.
Reviewers also will examine the appropriateness of the budgets in consideration of the study proposed and the research environment for the scientific projects.
Additional selection factors include:
Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If submitters are Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? Do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation. Does the proposed research challenge and seek to shift current understanding or clinical practice paradigms by utilizing novel theoretical concepts, approaches, or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach. Are the overall strategies, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves research in human populations, are the plans for: 1) protection of human subjects from research risks; and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Inquiries
Inquiries and discussion of plans for responding to this Notice are strongly encouraged.
For NCI:
Geraldina Dominguez, Ph.D.
Office of HIV and AIDS Malignancy
National Cancer Institute
31 Center Drive, Room 3A33, MSC 2440
Bethesda, MD 20852-2440
Telephone: (301) 496-3204
Fax: (301) 480-4137
E-mail:
domingug@mail.nih.gov
or
Julie A. Schneider, Ph.D.
Program Director, Office of China Cancer Programs
U.S. Embassy Beijing
No. 55 An Jia Lou Lu
Beijing 100600 P.R. China
Telephone: 8610-8531-3986
E-mail:
schneidj@mail.nih.gov
For NIAID:
Gayle Bernabe, M.P.H.
Regional Program Officer
Office of Global Research (OGR)
National Institute of Allergy and Infectious Diseases
National Institutes of Health
6610 Rockledge Drive, Room 5211
Bethesda, MD 20892-6613 (20817 for express delivery)
Telephone: (301) 451-1018
Fax: (301) 480-2954
E-mail:
gbernabe@niaid.nih.gov
or
Ray Chen, M.D., M.S.P.H.
Medical Officer
Office of Global Research
National Institute of Allergy and Infectious Diseases
National Institutes of Health
U.S. Embassy Beijing
No. 55 An Jia Lou Lu
Beijing 100600 P.R. China
E-mail:
rchen@niaid.nih.gov
or
Lara R. Miller, M.S.
Program Officer
Basic Immunology Branch
National Institute of Allergy and Infectious Diseases
National Institutes of Health
6610 Rockledge Drive, Room 6307, MSC 6601
Bethesda, MD 20892-6601 (20817 for express delivery)
Telephone: (301) 496-7551
Fax: (301) 480-2381
E-mail:
lrmiller@niaid.nih.gov
For applications to other NIH Institutes and Centers in the area of HIV/AIDS and its co-morbidities:
Robert W. Eisinger, Ph.D.
Director of Scientific and Program Operations
and Chair, Therapeutics Coordinating Committee
Office of AIDS Research
National Institutes of Health
5635 Fishers Lane, Room 4015, MSC 9310
Bethesda, Maryland 20892-9310
Telephone: (301)-496-0358
Fax: (301)402-8638
E-mail:
be4y@nih.gov