NOVEL HIV THERAPIES: INTEGRATED PRECLINICAL/CLINICAL PROGRAM - REMINDER AND
UPDATE

Release Date:  September 16, 1998

PA NUMBER:  PAR-97-080

P.T.

National Institute of Allergy and Infectious Diseases
National Institute of Mental Health

Application Receipt Date:  November 12

PAR-97-080, which describes the research objectives, application procedures,
review considerations, and award criteria for this solicitation, was published
in NIH Guide for Grants and Contracts, Vol. 26, No. 24, July 25, 1997.  The PA
can be found at the following URL:
https://grants.nih.gov/grants/guide/pa-files/PAR-97-080.html

Program Project (P01) applications in response to this Program Announcement are
due November 12, 1998.

NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN
RESEARCH INVOLVING HUMAN SUBJECTS (added)

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

APPLICATION INSTRUCTIONS (Modified)

Applicants must follow the instructions in the September 1997 edition of the
NIAID Multiproject Instructions Brochure which is available via the WWW at URL:
http://www.niaid.nih.gov/ncn/tools/multibron.htm 

REVIEW CRITERIA (modified to address inclusion of children)

The initial review group will also examine:  the appropriateness of proposed
project budget and duration; the adequacy of plans to include both genders and
minorities and their subgroups as appropriate for the scientific goals of the
research and plans for the recruitment and retention of subjects; adequacy of
plans for including children as appropriate for the scientific goals of the
research; the provisions for the protection of human and animal subjects; and the
safety of the research environment.

INQUIRIES

The PA and the NIH policy and guidelines on the inclusion of children in clinical
studies may also be obtained by mail or e-mail from Dr. Nava Sarver.  Dr. Sarver
may also provide additional information concerning the PA and the NIH policy on
the inclusion of children cited herein.

Nava Sarver, Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 2C01
Bethesda, MD  20892
Telephone:  (301) 496-2970
FAX:  (301) 402-3211
Email:  [email protected]

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