ANCILLARY STUDIES TO NIMH MULTI-SITE CLINICAL TRIALS – CLARIFICATION OF 
PROCEDURES AND RECEIPT DATES

Release Date:  November 15, 2001

NOTICE:  NOT-MH-01-005

National Institute of Mental Health
 (http://www.nimh.nih.gov/)

On May 17, 2000, the National Institute of Mental Health (NIMH) issued PAR-
00-095, "Ancillary Studies to NIMH Multi-Site Clinical Trials," located at
http://grants.nih.gov/grants/guide/pa-files/PAR-00-095.html.  This PAR 
invited applications for ancillary studies to extend the utility of multi-
site clinical trials (in schizophrenia, Alzheimer's disease, bipolar 
disorder, treatment resistant depression, and adolescent depression) 
supported by NIMH contracts.  Information about these trials is available on 
the NIMH website at http://www.nimh.nih.gov/studies/index.cfm.  At the same 
time, NIMH issued a Notice, MH-00-009, "Ancillary Studies In NIMH Multi-Site 
Clinical Trials: Career Development Awards," located at
http://grants.nih.gov/grants/guide/notice-files/NOT-MH-00-009.html, 
encouraging persons interested in Career Development Programs to consider 
ancillary studies as part of their application submitted under one of the 
Career Development announcements.  More recently, NIMH issued MH-00-012, 
"Ancillary Studies To NIMH Multi-Site Clinical Trials – Change In Receipt 
Dates," located at
http://grants.nih.gov/grants/guide/notice-files/NOT-MH-00-012.html, 
announcing that applications submitted under PAR-00-095 could be accepted on 
a monthly basis.

The purpose of this notice is to clarify procedures for PAR-00-095.  Each 
NIMH-supported trial has now established an Ancillary Study Committee (ASC) 
to review proposed projects for appropriateness and compatibility with the 
parent clinical trial.  The trials' ASC policies and procedures are available 
at http://www.catie.unc.edu/ for schizophrenia and Alzheimer's disease; 
http://www.stepbd.org/ for bipolar disorder; 
http://www.edc.gsph.pitt.edu/stard/for treatment resistant depression; and 
http://trialweb.dcri.duke.edu/tads/index.html for adolescent depression.

The trial ASC will serve as the point of initial submission for investigators 
interested in an ancillary study, and will continue to be responsible for 
processing the initial concept for an ancillary study.  However, prior to 
submitting a concept to the trial's ASC, investigators are encouraged to 
contact the NIMH program staff listed under INQUIRIES to discuss their 
proposed projects, programmatic interest, potential overlap, and other 
issues. 

An investigator will submit the concept for an ancillary study to the ASC of 
the appropriate trial.  Before the ASC reviews any concept, it submits it to 
the trial's NIMH Government Project Officer (GPO).  The NIMH GPO will consult 
with the appropriate NIMH scientific program staff to evaluate the proposed 
concept for compatibility with Institute priorities, as well as the project's 
unique contribution to and feasibility of incorporation into the trial.  
Program staff also will determine whether expedited peer review is necessary 
based on the scientific goals of the proposed concept and the parent trial. 
Once NIMH decides whether to accept the proposed concept for ASC review, the 
investigator will be notified by the ASC of this and of subsequent 
determinations.  Since the ASC review process may result in significant 
changes in the study design, the finalized ASC approved concept will be 
submitted for final approval by the ASC to the NIMH GPO, who will again 
consult with appropriate NIMH program staff.  NIMH must give its consent 
before a proposed concept for an ancillary study can be implemented within an 
NIMH supported clinical trial regardless of the funding source.  Proposed 
concepts that did not receive approval from NIMH or the ASC may be revised 
and resubmitted to the ASC.

The requirements noted above apply to all proposed ancillary studies, 
including those of contract site researchers and those projects that involve 
only one clinical site, regardless of funding source.  Grant applications 
that seek NIMH funding for ancillary studies will not be accepted for peer 
review unless accompanied by the ASC approved concept letter.

Those grant applications based on ASC-approved concepts seeking NIMH support 
and approved for expedited review by NIMH program staff should be submitted 
for the monthly receipt date (the 9th of each month) and will be reviewed by 
a Special Emphasis Panel (SEP or special review group) in an expedited 
manner.  A letter of approval for expedited review should be included in the 
application that is submitted for NIH peer review.  Those grant applications 
based on ASC-approved concepts that staff determines do not require expedited 
review should be submitted on the standard receipt dates 
(http://grants.nih.gov/grants/funding/submissionschedule.htm) and will also 
be assigned following the standard referral and review guidelines.  For those 
applications to receive funding outside the NIMH, program staff will assess 
the need for additional scientific review on a case by case basis.

SPECIFIC INFORMATION FOR GENETIC ANCILLARY STUDIES

It has become clear that many researchers are interested in ancillary genetic 
studies.  To meet this significant need and to minimize the demand on 
participants, NIMH will modify the contracts to coordinate the participant 
contacts, consent procedures, blood draws, and establishment of cell lines.  
A modification to the contracts for each of five multisite trials in 
schizophrenia (CATIE: N01 MH90001), Alzheimer's disease (CATIE: N01 MH90001), 
bipolar disorder (STEP-BD; N01 MH80001), treatment resistant depression 
(STAR*D: N01 MH90003), and adolescent depression (TADS: N01 MH80008) is 
currently being made to collect and distribute genetic materials to the 
scientific community.

Investigators are encouraged to collaborate with the contract trial staff to 
eliminate redundancies with other funded projects in their proposed ancillary 
studies and to optimize use of these anticipated shared resources.  Some 
investigators may wish to conduct ancillary genetic studies that require data 
or biomaterials not already being collected.  One such genetic study, for 
example, may require collection of DNA from relatives of trial participants. 

The approval and submission processes described above all apply to genetic 
ancillary studies, except that ancillary genetic applications seeking NIMH 
support will NOT be accepted for expedited review with monthly receipt.  The 
invesigator should submit according to standard NIH application receipt, 
referral, and review guidelines
(see http://grants.nih.gov/grants/funding/submissionschedule.htm).

A small number of concepts for ancillary genetic studies have been approved 
by one of the trial ASCs.  The ASC will now forward these concepts for 
approval to the NIMH GPO who will consult with the genetics program staff 
listed below under INQUIRIES.

INQUIRIES

Direct inquiries regarding issues related to NIMH clinical trials as well as 
scientific issues related to programs in the Division of Services and 
Interventions Research to:

John K. Hsiao, M.D.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7160, MSC 9635
Bethesda, MD  20892-9635
Telephone:  (301) 443-1185
FAX:  (301) 594-6784
Email:  jhsiao@helix.nih.gov 

Direct inquiries regarding scientific issues related to programs in the 
Division of Mental Disorders, Behavioral Research and AIDS to:

Bruce N. Cuthbert, Ph.D.
Division of Mental Disorders, Behavioral Research and AIDS 
National Institute of Mental Health
6001 Executive Boulevard, Room 6184, MSC 9625
Bethesda, MD  20892-9625
Telephone:  (301) 443-3728
FAX:  (301) 443-4611
Email:  bcuthbert@mail.nih.gov 

Direct inquiries regarding scientific issues related to non-genetic programs 
in the Division of Neuroscience and Basic Behavioral Science to:

Steven J. Zalcman, M.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7177, MSC 9639
Bethesda, MD  20892-9639
Telephone:  (301) 443-1692
FAX:  (301) 443-4822
Email:  szalcman@mail.nih.gov 

Direct inquiries regarding scientific issues related to genetics in the 
Division of Neuroscience and Basic Behavioral Science to:

Steven O. Moldin, Ph.D.
Division of Neuroscience & Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7189, MSC 9643
Bethesda, MD  20892-9643
Telephone:  (301) 443-2037
FAX:  (301) 443-9890
Email: smoldin@mail.nih.gov

Direct inquiries regarding fiscal matters to:

Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD  20892-9605
Telephone:  (301) 443-2805
FAX:  (301) 443-6885
Email:  Diana_Trunnell@nih.gov

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, RealPlayer, Video or Flash files, see Help Downloading Files.