C. IRB Approval

Institutional Review Board Notice of Approval

Principal Investigator/Project Director: Jane Fox
Project Title:

Chart Abstraction of Ryan White HIV/AIDS Program (RWHAP) Recipient
Data (Chart Abstraction)

Sponsor Agency: DHHS/HRSA
Abt IRB #:

2004

Protocol Approval Date:

4/22/2019

Review Type:

Expedited per 45CFR46.110 (Category 5)

Type of Approval:

Full Implementation

The Abt IRB approved a waiver of consent per 45CFR46.116(f) and has determined that the
waiver of HIPAA authorization satisfies the three criteria in the Privacy Rule per
45CFR164.512(i):
(A) The use or disclosure of protected health information involves no more than a minimal risk to
the privacy of individuals, based on, at least, the presence of the following elements;
(1) An adequate plan to protect the identifiers from improper use and disclosure;
(2) An adequate plan to destroy the identifiers at the earliest opportunity consistent with
conduct of the research, unless there is a health or research justification for retaining the
identifiers or such retention is otherwise required by law; and
(3) Adequate written assurances that the protected health information will not be reused
or disclosed to any other person or entity, except as required by law, for authorized
oversight of the research study, or for other research for which the use or disclosure of
protected health information would be permitted by this subpart;
(B) The research could not practicably be conducted without the waiver or alteration; and
(C) The research could not practicably be conducted without access to and use of the protected
health information described in the protocol including: medical chart data of Ryan White HIV/AIDS
Program (RWHAP) clients

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.
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 4/21/2020.

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: Katie Speanburg, IRB Administrator

Date:

4/22/2019

Institutional Review Board Notice of Approval

Principal Investigator/Project Director:

Jane Fox

Project Title: Chart Abstraction of Ryan White HIV/AIDS Program (RWHAP) Recipient Data
(Chart Abstraction)
Sponsor Agency:
Abt IRB #:

HRSA

2004

Review Type:

Expedited

Approval Date

September 16, 2019

Type of Approval:

Study Modification

Modification Number:

Submitted 9/10/2019 re: expanding eligibility criteria

Please note the following requirements:

The Board’s approval of this modification does not alter your responsibilities for the project’s
continuing review.
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 local) IRB approval stamp.
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 April 21, 2020.
IRB Chair
Teresa Doksum
Abt Associates Inc.
10 Fawcett Street
Cambridge, MA 02138
617-349-2896
irb@abtassoc.com
Cc:

Cicely Wanska

Date
October 9, 2019