Purpose

The purpose of this administrative supplement solicitation is to give NIDA-funded researchers the opportunity (1) to recruit additional study participants, or (2) to expand analyses of existing samples, which already have sufficient representation from various racial/ethnic minority populations, in order to assess patterns of drug use, effects and potential adverse behavioral, social and health consequences, or differential treatment outcomes within and across racial/ethnic groups. It is expected that recruitment of additional participants or secondary analysis of existing data sets will allow for meaningful comparisons and analyses to be made between specific racial/ethnic groups and lead to a better understanding of the racial/ethnic disparities in the prevalence, incidence, pattern and consequences, of drug abuse, and in the effectiveness of prevention and treatment approaches. It is also expected that recruitment of adequate numbers of racial/ethnic minority participants in behavioral and/or pharmacological studies will lead to the development and implementation of culturally sensitive treatment approaches. Funding will be available through administrative supplements. Existing grants eligible for supplemental support under this notice include research projects with at least one year of support remaining. Supplements may be requested for up to 2 years of support with funding beginning no later than September 30, 2002.

Research Objectives

Background

The mission of the National Institute on Drug Abuse (NIDA) is to lead the nation in bringing the power of science to bear on drug abuse and addiction by (1) providing strategic support of research across a broad range of disciplines and (2) ensuring the rapid and effective dissemination and use of the results of that research to significantly improve drug abuse and addiction prevention, treatment and policy.

In contrast with other diseases, drug addiction poses many unique challenges to health researchers, clinicians, and other providers in understanding the health consequences of drug abuse and addiction for the development of effective prevention and treatment interventions. Despite the fact that addiction is a disease, it remains a stigmatized disease, and this stigma has become associated with all aspects of drug abuse research. Stigmatization of drug abuse complicates researchers' ability to conduct research in this area. This stigma and its effects perhaps most adversely affect racial/ethnic minority populations, leading to misperceptions about drug abuse and addiction in minority communities, and affecting how prevention and treatment interventions are studied and delivered to these groups. For example, the common perception is that minority groups, particularly Blacks and Hispanics, abuse drugs more than other groups, even though epidemiologic data show little difference in overall abuse by race and ethnicity. In fact, in some instances, minority groups are less likely to abuse licit or illicit drugs. Importantly, however, differences in behavioral, social and health consequences of drug abuse do exist among racial/ethnic minorities, creating the need for research that further explores these differences. A better understanding of these disparities in health consequences will result in more effective prevention, treatment and health services in these communities.

Additional research is needed to determine (1) the effects of drugs of abuse and addiction on racial/ethnic minority populations and to determine if there is a need for more appropriate and better-targeted services, treatment and prevention interventions, (2)if there are specific, unique or unusual health, behavioral or social consequences associated with drug abuse, addiction and related diseases (e.g., depression, crime, STD's, pulmonary disease, HCV) among racial/ethnic minority populations, and (3) to better understand patterns of drug abuse and addiction in racial/ethnic minority populations and how these patterns of abuse impact health outcomes.

The NIH requires that adequate racial and ethnic minority representation must be met for all clinical studies. However, this requirement is often difficult to implement in practice. As a result, efforts to conduct a "valid analysis" (see NIH definition and related policies at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.) are often hampered, or not feasible, as population levels of racial/ethnic minorities are not of sufficient size to carry out the analysis with an appropriate amount of power.

The purpose of this administrative supplement program is to (1) allow NIDA-funded grantees the opportunity to recruit adequate numbers of volunteers into their ongoing research projects from racial/ethnic minority populations that may be currently underrepresented in their research projects. It is expected that, with additional funds, the Principal Investigator (PI) will be able to "over sample" from one or more racial/ethnic minority populations for the purpose of determining the impact of drug abuse and addiction and/or services, treatment or prevention interventions on racial/ethnic minority populations, or (2) supplemental funds could be requested to analyze existing data sets to determine patterns of abuse and the impact of drug abuse and addiction on health and behavioral outcomes on racial/ethnic minority populations.

It is further expected that the PI will disseminate the information obtained through both presentations at local and national meetings, and publications in peer reviewed journals, in a timely manner, in order to have an impact on our understanding of health disparities as they relate to drug abuse and addiction.

Supplements may be awarded for work that is within the original scope of the project, that will add value consistent with its originally approved objectives, to understand how drug abuse and addiction, and their adverse consequences, impact on services, treatment and prevention interventions within and across racial/ethnic minority populations.

Special Requirements

Budget/Administrative Issues

For FY 2002, approximately $2,500,000 will be available for the funding of administrative supplements to existing NIDA research projects. This funding is contingent upon receipt of highly meritorious applications and continued availability of funds.

Administrative supplements are provided to cover unanticipated cost increases that are associated with achieving the objectives within the original scope of a project, and include cost increases that result from making modifications in scope in order to take advantage of opportunities that would increase the value of the project consistent with its originally approved objectives and purposes. Administrative supplemental funding is generally limited to 25 percent of the Council-recommended direct costs for the current FY 2002 budget year of the project or $100,000, whichever is less. If two years of support are requested, the second year of requested support will also be limited to 25 percent of the Council-recommended direct cost for the current FY 2003 budget year or $100,000, whichever is less.

These applications undergo program, grants management, and budget review within NIDA and may be submitted through May 15, 2002. It is anticipated that all supplemental funding decisions will be completed by September 30, 2002. Under this notice, an administrative supplement is limited to two years of support and cannot exceed the stated life of the parent project.

Application Procedures

The PI should submit an application packet, which includes the following:

1. A cover page citing this NOTICE and requesting an administrative supplement, including the PI name, grant number and title, amount requested, name and title of the institutional official, and phone, email, and address information for the PI and institutional official, signed by the PI and countersigned by an authorized institutional official, which is required for issuance of an award.
   
   
2. A proposal, describing the project, should include the following:
   
   
   • An abstract
   • A brief statement indicating how what is being proposed fits within the scope of the parent grant
   • A brief description of the progress to date on the project that will provide context and show relevance as to why additional data may be meaningful
   • Budget with appropriate justifications
   • Biographical Sketch of the PI and all key personnel
   • Specific aims from the original (parent) grant
   • A plan for how the information obtained with supplemental funds will be disseminated
   • If secondary data analysis is proposed the following should be included:
     • Description of the data set
     • A hypothesis about how proposed analysis will help provide additional information about issues related to health disparities within the proposed racial/ethnic populations to be studied
     • How the analysis will help provide additional information about issues related to health disparities
   • If the proposal involves recruiting additional participants the following should be included:
     • A hypothesis about how recruitment of additional subjects from one or more racial/ethnic minority populations will help provide additional information about issues related to health disparities within the proposed racial/ethnic populations to be studied
     • Power analyses, or related analyses or justifications, to ensure adequate numbers of participants are recruited for meaningful data analysis to address issues of health disparity within and/or across racial/ethnic categories (See NIH Guidelines at http://grants.nih.gov/grants/funding/women_min/guidelinesupdate.htm.)
     • A data analysis plan that will assess effects of drug abuse and/or addiction within and across racial/ethnic groups See NIH Guidelines at http://grants.nih.gov/grants/funding/women_min/guidelinesupdate.htm.)

Send the original signed application and three photocopies in one package to:

David Shurtleff, Ph.D.
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4S-4282, MSC 9555
Bethesda, MD 20892-9555

For deliveries from non-US mail carriers, send the application to:

National Institute on Drug Abuse
6001 Executive Boulevard, Room 4S-4282,
Rockville, MD 20852

Supplement packets may be submitted at any time, but no later than May 15, 2002. If an application is received after that date, it will be returned to the applicant without review.

Review Considerations

Applications will be reviewed administratively.

Review criteria:

• Relevance of the hypothesis of the research to NIDA's health disparities program
• Adequacy of the data analysis plan to assess the effects of drug abuse and addiction, and its potential adverse health consequences and, if additional participants are to be recruited, adequacy of the number of research participants proposed
• Adequacy of the plan how data collected and/or analyzed with supplemental funds will be used to address issues of health disparities in racial/ethnic populations and how the information will be disseminated
• Expertise of the key personnel involved
• The relevance of the supplemental plan to the Specific Aims of the parent grant
• The potential impact the proposed research plan will have on future health disparities research in drug abuse and addiction

Inqiries

Inquiries concerning this notice are strongly encouraged. The opportunity to clarify any issue or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

David Shurtleff, Ph.D.
National Institute on Drug Abuse
6001 Executive Boulevard, Room
Bethesda, MD 20892-9555
Telephone: 301-443-1887
Email: dshurtle@mail.nih.gov

Direct fiscal inquiries to:

Pamela G. Fleming
Grants Management Branch
6101 Executive Boulevard
Suite 250 MSC 8403
Bethesda MD 20892-8403
Telephone: (301) 443-6710
Email: pf49e@nih.gov