RFA AMMENDMENT: Revised Review Criteria Ancillary Studies Immunomodulation Clinical Trials RFAAI-08-011) Notice Number: NOT-AI-09-054 Key Dates Release Date: September 16, 2009 Issued National Institute Allergy Infectious Diseases NIAID)
http://www.niaid.nih.gov) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS)
http://www.niams.nih.gov) National Institute Neurological Disorders Stroke NINDS)
http://www.ninds.nih.gov) National Institute Diabetes Digestive Kidney Diseases NIDDK)
http://www.niddk.nih.gov) Purpose purpose this notice to clarify the criteria below be used review applications submitted response RFA-AI-08-011 was extended a final receipt date January 9, 2010 NOT-AI-09-044): Overall Impact. Reviewers provide overall priority/impact score reflect assessment the likelihood the project exert sustained, powerful influence the research field(s) involved, consideration the following five core review criteria, additional review criteria applicable the project proposed). Core Review Criteria. Reviewers consider of five review criteria below the determination scientific technical merit, give separate score each. application does need be strong all categories be judged likely have major scientific impact. example, project by nature not innovative be essential advance field. Significance. Does project address important problem a critical barrier progress the field? the aims the project achieved, will scientific knowledge, technical capability, and/or clinical practice improved? will successful completion the aims change concepts, methods, technologies, treatments, services, preventative interventions drive field? Investigator(s). the PD/PIs, collaborators, other researchers well suited the project? Early Stage Investigators New Investigators, they appropriate experience training? established, they demonstrated ongoing record accomplishments have advanced field(s)? the project collaborative multi-PD/PI, the investigators complementary integrated expertise; their leadership approach, governance organizational structure appropriate the project? Innovation. Does application challenge seek shift current research clinical practice paradigms utilizing novel theoretical concepts, approaches methodologies, instrumentation, interventions? the concepts, approaches methodologies, instrumentation, interventions novel one field research novel a broad sense? a refinement, improvement, new application theoretical concepts, approaches methodologies, instrumentation, interventions proposed? Approach. the overall strategy, methodology, analyses well-reasoned appropriate accomplish specific aims the project? potential problems, alternative strategies, benchmarks success presented? the project in early stages development, the strategy establish feasibility will particularly risky aspects managed? the project involves clinical research, the plans 1) protection human subjects research risks, 2) inclusion minorities members both sexes/genders, well the inclusion children, justified terms the scientific goals research strategy proposed? there high likelihood the samples needed the proposed studies become available? Environment. the scientific environment which work be done contribute the probability success? the institutional support, equipment other physical resources available the investigators adequate the project proposed? the project benefit unique features the scientific environment, subject populations, collaborative arrangements? Additional Review Criteria. applicable the project proposed, reviewers consider following additional items the determination scientific technical merit, will give separate scores these items. Protections Human Subjects. research involves human subjects does involve of six categories research are exempt under 45 CFR Part 46, committee evaluate justification involvement human subjects the proposed protections research risk relating their participation according the following five review criteria: 1) risk subjects, 2) adequacy protection against risks, 3) potential benefits the subjects others, 4) importance the knowledge be gained, 5) data safety monitoring clinical trials. research involves human subjects meets criteria one more the six categories research are exempt under 45 CFR Part 46, committee evaluate: 1) justification the exemption, 2) human subjects involvement characteristics, 3) sources materials. Inclusion Women, Minorities, Children. the proposed project involves clinical research, committee evaluate proposed plans inclusion minorities members both genders, well the inclusion children. Vertebrate Animals. committee evaluate involvement live vertebrate animals part the scientific assessment according the following five points: 1) proposed of animals, species, strains, ages, sex, numbers be used; 2) justifications the of animals for appropriateness the species numbers proposed; 3) adequacy veterinary care; 4) procedures limiting discomfort, distress, pain injury that is unavoidable the conduct scientifically sound research including use analgesic, anesthetic, tranquilizing drugs and/or comfortable restraining devices; 5) methods euthanasia reason selection not consistent the AVMA Guidelines Euthanasia. Biohazards. Reviewers assess whether materials procedures proposed potentially hazardous research personnel and/or environment, if needed, determine whether adequate protection proposed. Inquiries Inquiries discussion plans responding RFAAI-08-011 strongly encouraged. Interested parties contact: 1. Scientific/Research Contact(s): Annette L. Rothermel, Ph.D. Division Allergy, Immunology Transplantation National Institute Allergy 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 Skin Rheumatic Diseases, Extramural Program National Institute Arthritis Musculoskeletal Skin Diseases National Institute Health, DHHS 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 Neurological Disorders 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 Diabetes, Endocrinology, Metabolic Diseases National Institute Diabetes Digestive 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 Extramural Activities National Institute Allergy Infectious Diseases Room 3121, MSC-7616 6700B Rockledge Drive Bethesda, MD 20892-7616 Bethesda, MD 20817 express mail) Telephone: 301) 402-7098 Fax: 301) 480-2408 Email:
pamstad@niaid.nih.gov