HomeResearchIntramural ResearchClinical Research NHGRI Institutional Review Board (IRB)

NHGRI Institutional Review Board

	Overview
	IRB News and Updates
	NHGRI IRB Membership
	NHGRI Forms
	NIH Forms
	Contact

Overview

The NHGRI Institutional Review Board (IRB) is one of several IRBs that reviews research conducted in the NIH Intramural Research Program. The IRB's mission is to protect the rights and welfare of individual subjects and to ensure programmatic compliance with Federal, State and Institutional regulations. The IRB carries out its mission by reviewing, approving and monitoring all human subjects' research within our Institutes' Intramural Research Programs.

The NHGRI IRB was established and functions in accord with the NIH Federal-wide Assurance, FWA00005897 [ohsr.od.nih.gov]. It is guided by the NIH OHSR IRB standard operating procedures [ohsr.od.nih.gov].

Top of page

IRB News and Updates

The latest news, guidelines and official information from NHGRI's Institutional Review Board.

June 12, 2008 Update

• Genetic Information Nondiscrimination Act (GINA) signed into law on May 21, 2008.
• Quick guide to GINA
• IRB currently evaluating the impact of GINA.

May 28, 2008 Update

Please note that implementation of the new policy regarding "Reimbursement of Travel and Subsistence Expenses for NIH Clinical Research Protocol Participants" is being delayed per Dr. John Gallin, Director of the Clinical Center. The Clinical Center will follow the current process for patient travel until a number of issues are resolved. No actions pertaining to this new policy need to be taken by investigators until further notice.

April 15, 2008 Update

• New Travel Reimbursement Policy for Research Subjects
• Updated Conflict-of-Interest Guide, Ethics Clearance and Consent Statements
• Transition to electronic Web-based Protocol Tracking and Management System

August 15, 2007 Update

• New IRB coordinator and updated IRB forms

March 6, 2007 Update

• Final Conflict of Interest Policy

November 1, 2006 Update

• New 1195 and 1195-1 Forms

June 26, 2006 Update

• Use of short written consent forms with oral consent

June 21, 2006 Update

• Updated forms and guidelines regarding stored human samples, specimens or data

Top of page

NHGRI IRB Membership

• IRB Membership Roster
  As of December 2007

Top of page

NHGRI Forms

• Scientific Review Committee (SRC) and IRB Submission Calendar
• NHGRI IRB Protocol Checklists: All forms are in except where indicated.
  • SRC Review
  • New Protocols
  • Continuing Review of Protocols (Full IRB Review)
  • Triennial Review of Protocols (Full IRB Review)
  • Expedited Continuing or Triennial Review of Protocols
  • Termination of Protocols
• Response to Stipulations for Conditionally Approved Protocols
• Protocol Amendments or Adverse Events
• NHGRI Human Subjects Research Protocol Template
• Targeted/Planned Enrollment Table
• NHGRI Ongoing Research Participant Enrollment Form
• Watermarked Standard Consent Form Template
  
• Watermarked Consent Form Template w/ HIV Testing Page
• Watermarked Assent Form Template
• Previously Collected Human Biological Materials/Data Amendment Form
• Examples of Protocol Deviations and Violations
• Template Memo for Reporting Protocol Deviations and Violations to the NHGRI IRB

Top of page

NIH Forms

All forms are in except where indicated.

• Clinical Research Protocol: Initial Review Application Form NIH-1195
• Clinical Research Protocol: Continuing Review Application Form NIH-1195-1
• Exemption Form: Request for Review of Research Activity Involving Human Subjects [ohsr.od.nih.gov]
• Guide to Preventing Conflicts of Interest
• Serious Adverse Event Report Form
• Clearance of NIH Investigator Personal Financial Holdings by IC Ethics Office
• Guidelines for Completing the Clearance of NIH Personal Investigator Financial Holdings

To view the files on this page, you will need Adobe Acrobat Reader.

To view the files on this page, you will need MS Word. A copy of the latest version of Word Viewer can be downloaded for free.

Top of page

Contact

Victoria Willits
IRB Coordinator
Building 10, CRC/6-3340
Phone: (301) 496-1906
E-mail: vwillits@mail.nih.gov

Sara Hull, Ph.D.
IRB Administrator
Phone: (301) 435-8712
E-mail: shull@mail.nih.gov

Directions to the IRB Office

Top of page

Last Updated: September 2, 2008