RFA AMMENDMENT: Revised Review Criteria for Ancillary Studies in Immunomodulation Clinical Trials (RFA–AI-08-011)

Notice Number: NOT-AI-09-054

Key Dates
Release Date: September 16, 2009

Issued by
National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (http://www.niams.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov)

Purpose

The purpose of this notice is to clarify that the criteria below will be used for review of applications submitted in response to RFA-AI-08-011 which was extended for a final receipt date of January 9, 2010 (NOT-AI-09-044):

Overall Impact. Reviewers will provide an overall priority/impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed). 

Core Review Criteria.  Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each.  An application does not need to be strong in all categories to be judged likely to have major scientific impact.  For example, a project that by its nature is not innovative may be essential to advance a field.

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 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)?  If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation.  Does the application challenge and seek to shift current research 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 strategy, 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 clinical research, 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? Is there a high likelihood that the samples needed for the proposed studies will become available?

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? 

Additional Review Criteria. As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Inquiries

Inquiries and discussion of plans for responding to RFA–AI-08-011 are strongly encouraged. Interested parties may contact:

1. Scientific/Research Contact(s):

Annette L. Rothermel, Ph.D.
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
6610 Rockledge Drive
Room 6617, MSC-6601
Bethesda, MD 20892- 6601
Telephone: (301) 496-7104
Fax: (301) 480-1450
Email: arothermel@niaid.nih.gov  

Yan Wang, M.D., Ph.D.
Division of Skin and Rheumatic Diseases, Extramural Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institute of Health, DHHS
One Democracy Plaza, Suite 800
6701 Democracy Blvd, MSC 4872
Bethesda, MD 20892
Phone: 301-594-5032
Fax: 301-480-1284
Email: wangy1@mail.nih.gov

Ursula Utz, Ph.D.
Program Director
National Institute of Neurological Disorders and Stroke
Room 2134
6001 Executive Boulevard
Bethesda, MD 20892-9521
Phone: 301-496-1431
FAX: 301-402-1501
Email: utzu@mail.nih.gov

Beena Akolkar, Ph.D.
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Room 6105
6707 Democracy Boulevard
Bethesda, MD 20892-5460
Phone: 301-594-8812
FAX: 301-480-3503
Email: akolkarb@niddk.nih.gov

2. Peer Review Contact(s):

Paul Amstad, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3121, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817 (for express mail)
Telephone: (301) 402-7098
Fax: (301) 480-2408
Email: pamstad@niaid.nih.gov


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