IRB Approval - Abt Associates

Institutional Review Board Notice of Approval
Principal Investigator/Project Director:

Tara Earl

Project Title: Evaluation and Assessment Strategies for Enrollment (EASE) or
Behaviorally Informed Designs to Increase Enrollment in the CDC-Recognized Lifestyle
Change Program (CDC Diabetes BIA)
Sponsor Agency:
Abt IRB #:

CDC

0855

Protocol Approval Date:

November 10, 2017

Review Type:

Expedited

Type of Approval:

Full Implementation

Please note the following requirements:
Problems or adverse reactions: If any problems in treatment of human subjects or unexpected
adverse reactions occur as a result of this study, you must notify the IRB Chairperson or IRB
Administrator immediately.
Consent forms: In the event the approved study includes procedures for written informed
consent, you only may use consent forms that bear the Abt Associates Inc. (or lead/local) IRB
approval stamp.
Changes in protocol, study design, or study materials: If there are changes in procedures,
the study design, or study materials (e.g., survey instruments, consent forms), you must submit
these materials for IRB review and approval before they are implemented.
Renewal: You are required to apply for renewal of approval at least annually for as long as the
study is active. Your next review date should be on or before November 9, 2018 .
Teresa Doksum, Ph.D., M.P.H.
IRB Chair
Abt Associates Inc.
55 Wheeler Street
Cambridge, MA 02138
irb@abtassoc.com
617-349-2896
Cc: Cynthia Klein

Date: November 10, 2017