approval letter

April 4, 2017
Heather Nelson, PhD, MPH
Health Resources in Action
95 Berkeley Street
Boston, MA 02116, United States
IRB#: 120170022
Sponsor Protocol Number: HHSP233201500040C
Study Title: Assessment of the Impact of Energy Development on Women’s Behavioral Health in Eastern Montana and
Western North Dakota

Notification of Approval
This is to inform you that New England Independent Review Board (NEIRB) has approved the following for
the above referenced research.
Date of Review: 04/03/2017
Action Date (first day of study approval period): 04/03/2017
End Approval Date (last day that the study is approved): 04/02/2018

Approval Includes:
Investigator
Protocol (03-24-2017)
Consent Form NEIRB 1.0
Informed Consent Script - As Submitted #67728.0 - As Submitted
Intro letter for Key Informant Interviews - As Submitted #67726.0 - As Submitted
Stipend Receipt Form - As Submitted #67554.0 - As Submitted
Survey Instrument - #67727.0 - As Submitted

NEIRB’s approval includes the following condition: The IRBs representing two tribal nations involved in the evaluation
(Fort Peck and Fort Berthold) will also review this research and will have jurisdiction over participant recruitment,
informed consent, data collection, and analysis components that will involve members of the tribal nations.
NEIRB has approved the following locations to be used in the research:
• Health Resources in Action, 95 Berkeley Street, Boston, Massachusetts 02116

197 First Avenue . Suite 250 . Needham, MA 02494 Phone: 617-243-3924 . Fax: 617-969-1310

www.neirb.com

Continued approval is conditional upon your compliance with the following requirements:
• Compliance with all aspects of NEIRB’s Investigator Responsibilities (available at www.neirb.com).
• The study cannot continue after the End Approval Date unless re-approved by NEIRB. A Study Continuing
Review Report must be completed and returned to NEIRB prior to the study end date of the approval period.
• Compliance with all federal, state and local laws pertaining to this research.
• Any and all necessary FDA approvals must be received prior to your initiation of the trial.
Please contact NEIRB with any questions about this determination.
Copy:
NEIRB study file
Enclosures

197 First Avenue . Suite 250 . Needham, MA 02494 Phone: 617-243-3924 . Fax: 617-969-1310

www.neirb.com