Subject: NIH Guide 08/24/90
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Thu, 23 Aug 90 07:40 EST

Good Morning,
   This is the first of several articles re: NIH Guide 8/24/90.
Please post this one to the NIH listserver as:
    NIHGUIDE.082490
   Thanks.
          Dottie
 ---------------------------- Text of forwarded message -----------------------
 
X-comment: NIH Guide (including TOC) contained 20 pages (1600 lines)
X-comment: RFAs described:  HL-90-15-B, HL-90-14-B, RR-90-03, DC-90-02
     other well-supported justification must be provided.  The IRG/TEG
     will be instructed to evaluate the merit of such justifications.
     Appropriate justification will not adversely affect the assigned
     score.  The NIH/ADAMHA will not fund such applications/proposals
     unless the justification provided is compelling.
 
  3) If the gender composition of the study population is not described,
     BUT the study otherwise has the potential to answer the scientific
     question(s) posed and translate the findings to all persons at risk
     of the disease, the omission will be documented by the Executive
     Secretary of the IRG/TEG in an administrative note, and will not
     adversely affect the scientific assessment and the assigned score.
     If there is inadequate information on the study population to allow
     evaluation of the scientific question(s), the review may be
     deferred.  The NIH/ADAMHA funding components will not fund/award
     grants or contracts until the applicant provides sufficient
     information on the study population to assure compliance with the
     NIH/ADAMHA policy on inclusion of women in study populations.

            NIH GUIDE - Vol. 19, No. 31, August 24, 1990 - Page 18
     Since the need to modify sample design could delay award and affect
     the costs of the study, applicants are strongly advised to address
     this issue in the initial submission.  If costs or study designs
     are significantly affected by such modification, submission of an
     amended application/proposal for IRG/TEG review and/or
     reconsideration by the appropriate National Advisory Council or
     Board may be necessary.
 
Whenever there are scientific reasons to anticipate differences between men
and women with regard to the hypothesis under investigation, applicants should
consider the inclusion of an evaluation of gender differences in the proposed
study.  However, if men and women are enrolled in numbers that reflect the
gender proportion of the disease under study, it is not an automatic
requirement for the study design to include statistical power for men and
women separately.
 
It is important to note that regardless of the program relevance of the
proposed research, the NIH/ADAMHA funding components will not fund/award
grants or contracts that do not comply with this policy.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
            NIH GUIDE - Vol. 19, No. 31, August 24, 1990 - Page 19