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:
http://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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