Notice Number: NOT-MD-08-002

Key Dates
Release Date: April 29, 2008

Issued by
National Center on Minority Health and Health Disparities (NCMHD) (http://www.ncmhd.nih.gov)

Purpose

The purpose of this Notice is to provide guidance and clarification to NCMHD grantees, on the policy for prior approval of subprojects and pilot projects involving human subjects or vertebrate animals.

Background

As stated in the NIH Grants Policy Statement (rev. 12/03), available at
http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600126, in general, NIH grantees are allowed a certain degree of latitude to make certain types of post-award changes. In some cases, NIH prior written approval may be required before a grantee undertakes particular activities. The grantee-initiated changes that may be made under the grantee’s authority and the changes that require NIH approval are outlined in the NIH Grants Policy Statement. When NIH approval is required, it must be requested of, and obtained from, the awarding office Grants Management Officer in advance of the change or obligation of funds.

Policy

Effective immediately, written NCMHD prior approval must be obtained before the start of any subproject or pilot project (either new or with delayed onset) involving human subjects or vertebrate animals The purpose of this policy is to ensure that there is no change in scope or aims or deviation from the award terms and conditions, and that applicable requirements have been met.   All subprojects and pilot projects must have first undergone an internal institutional scientific review and have been approved for submission to NCMHD.

Additionally, for any subproject or pilot project involving human subjects or vertebrate animals that has already commenced without the specific written prior approval of the NCMHD under an active grant, written notification must be provided to the NCMHD within 60 days of the date of this Notice. This notification must be addressed to the Chief Grants Management Officer and include a project description, a statement on relevance to minority health and/or health disparities, a research plan including the scope and aims of the project, and information pertaining to human subjects and animal welfare, in accordance with applicable regulations and policies. 

Failure to comply with the above requirements may result in suspension and/or termination of the award, withholding of support, audit disallowances, and/or other appropriate action.  A checklist of materials to accompany each request, as applicable, is provided below.
Please note that all other requirements of NCMHD grant programs remain in effect. Consultation with NCMHD Chief Grants Management Officer and the Acting Chief, Office of Scientific Programs, listed below, is encouraged.

Subproject/Pilot Project Prior Approval Checklist

• State the type of request (either new subproject or pilot project), grant number, and name of institution.
  1. Title of the project, name and biosketch of the Principal Investigator.
  2. Project Description (limit to 30 lines).
  3. Detailed budget page(s).
  4. Research Plan (not to exceed 10 pages for a pilot project or 25 pages for a full subproject).
  5. Human subject’s information in accordance with the Research Plan, Section E on Human Subjects in the PHS Form 398 (http://grants.nih.gov/grants/funding/phs398/phs398.html).
  6. Vertebrate animal information in accordance with the five items described under Section F of the PHS Form 398. 
  7. OHRP and/or OLAW-approved Institutional Assurance(s), if any.
  8. Data Safety and Monitoring Plan, if applicable.

Inquiries

Direct programmatic and scientific inquiries regarding this Notice to:

Nathan Stinson, Jr., PhD, MD, MPH
Acting Chief, Office of Scientific Programs
Division of Extramural Activities & Scientific Programs
National Center for Minority Health and Health Disparities
National Institutes of Health
6707 Democracy Blvd., Suite 800, MSC 5465
Bethesda, Maryland 20892-5465
Phone: 301-402-1366
FAX:    301-480-4049
E-mail: [email protected]

Direct administrative and management-related inquiries, and all required notifications regarding this Notice to:

Priscilla Grant, JD, CRA
Chief Grants Management Officer
Division of Extramural Activities & Scientific Programs
National Center on Minority Health & Health Disparities
National Institutes of Health
6707 Democracy Blvd., Suite 800, MSC 5465
Bethesda, MD 20892-5465
Phone: 301-402-1366
FAX:    301-480-4049
E-mail: [email protected]