INNOVATIVE DRUG DISCOVERY RESEARCH IN AIDS OPPORTUNISTIC INFECTIONS - ADDENDUM Release Date: April 30, 1998 PA NUMBER: PA-96-068 P.T. National Institute of Allergy and Infectious Disease Application Receipt Dates: January 2, March 1, September 1 This notice is an addendum to expand the areas of study that are responsive to PA-96-068, "Innovative Drug Discovery Research in AIDS Opportunistic Infections," which was published in the NIH Guide for Grants and Contracts, Vol. 25, No. 26, August 2, 1996. This addendum also includes NIH Policy and Guidelines on the Inclusion of Children As Participants in Research Involving Human Subjects, and the revised Review Criteria. Additions to RESEARCH OBJECTIVES Background Although introduction of potent antiretroviral therapy has improved and prolonged the lives of people living with AIDS, the management of patients who develop OIs remains complex. Issues such as toxicity of therapeutic agents, drug resistance, relapses, drug-drug interactions, and/or lack or approved standard treatments for certain OIs (e.g., JC virus, C. parvum, E. bieneusi) persist. Research Objectives and Experimental Approaches Research responsive to this PA includes studies to identify therapies and evaluation strategies for the following infectious agents: human cytomegalovirus (HCMV), JC virus, Mycobacterium tuberculosis, Mycobacterium avium, Pneumocystis carinii, Cryptosporidium parvum, Toxoplasma gondii, the Microsporida, azole- resistant Candida albicans, and Cryptococcus neoformans. The following areas of study are added: o discovery and evaluation of novel chemical entities generated by combinatorial and gene cluster methodologies; o identification of specific immune defects leading to development of opportunistic infections; o understanding the role of infectious agents as cofactors in HIV proliferation. NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: https://grants.nih.gov/grants/guide/notice-files/not98-024.html Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written review, comments on the following aspects of the application will be made in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in the assignment of the overall score. 1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? 2. Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation. Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. Investigator. Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? 5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition, the adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research will be reviewed. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research. INQUIRIES Direct inquires regarding programmatic issues to: Chris Lambros, Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 2C40, MSC 7620 Bethesda, MD 20892-7620 Telephone: (301) 402-2304 FAX: (301) 402-3171 Email: Direct inquiries regarding fiscal and administrative matters to: Ms. Jane W. Unsworth Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4B25, MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 402-6824 FAX: (301) 480-3780 Email:
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