StakeholderSurvey_IRBapproval

IRB ID Number: 12612
RESEARCH TRIANGLE INSTITUTE
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS
Request for Exemption from IRB Review
To request approval for exemption from Institutional Review Board (IRB) review, the Project Manager (includes Project
Director or Leader, Principal Investigator, or Survey Manager) must complete this form and deliver the request to an IRB
Administrator. The Project Manager will be notified if more information is necessary and the results of the determination.

Date: 4/06/10

RTI Project/Proposal No.: 0210700.001.005.001.001

Project Title: Coordinating Center for the Evaluation of the Grants for the Benefit of Homeless Individuals (GBHI)
Project Manager:

Nahama Broner, PhD

Sponsor: Substance Abuse and Mental Health Services Administration Center for Substance Abuse
Treatment (CSAT)
Date Participation of Human Subjects Scheduled to Begin: 6/1/10

A.

Brief Description of Study Procedures and Participant Population:

RTI is conducting an evaluation of the Grants for the Benefit of Homeless Individuals (GBHI) program. The
Center for Substance Abuse Treatment (CSAT) at the Substance Abuse and Mental Health Services Administration
(SAMHSA) was funded by Congress to establish the Grants for the Benefit of Homeless Individuals (GBHI) program,
sometimes also referred to as the Treatment for Homeless program, one of the grant programs in the Co-Occurring and
Homeless Activities Branch (CHAB).
Between 2001 and 2008, GBHI awarded 169 grants to provide services to the target population. Additionally, 25
new grantees were funded in 2009 (FY2010 cohort). The evaluation that RTI will be conducting will focus primarily on
this FY 2010 cohort. Additionally, to provide sufficient sample size to answer the CSAT evaluation objectives and address
the primary goal of the evaluation, the evaluation plan includes limited data collection from prior grantee cohorts funded
between 2004 and 2009.
We will use several methods to collect primary data including conference calls; site visit interviews and tours of
facilities and observation of the interventions; a Web survey of non-client partner/stakeholders, individual telephone
interviews with 2004 through 2009 grantees; web in-person focus groups of the same types of participants; interviews with
GPOs; and interviews and with TA Contractors. Below (at the end of this document) is a table that provides an overview
with regard to the purpose of each type of primary data collection, the mode of consent, the burden, the type of
respondents, the participating sites (e.g., grantee cohorts), and the schedule for data collection for the base year (e.g., Year
1) and each of the 4 option years (Years 2–5). Also attached are the related consent forms and interview/focus group
guides.
B.

Description of Physical, Psychological, Social or Legal Risks to Participants: Participation in the evaluation

will create minimal risks for participants. The questions are solely focused on aspects of their daily work or the
overall topic of needs and services for the homeless. To encourage respondents to offer candid responses, they will be
assured of the confidentiality of their responses and information gathered in the interviews will be reported only in
aggregate or synthesized form.

C1. For educational tests (cognitive, diagnostic, aptitude, achievement), survey or interview research with
adults:
1

1. Is information recorded in such a manner that human subjects can be identified, directly or through identifiers
linked to the subjects?
Yes

No

NA

If yes, explain:

2. Would any disclosure of the human subjects’ responses outside the research reasonably place the subjects at
risk of criminal or civil liability or be damaging to the subjects’ financial standing employability or reputation?
Yes

No

NA

If yes, explain:

C2. For research with existing data, documents, records, pathological or diagnostic specimens:
1. Are the sources of the data publicly available?
Yes

No

NA

If no, explain:

2. Is information recorded in such a manner that human subjects can be identified, directly or through identifiers
linked to the subjects?
Yes

No

NA

If yes, explain:

D.

Describe other categories of exempt research1 here:
Exemption Category 5(i):
This is an evaluation that is funded by and subject to the approval of the Center for Substance Abuse
Treatment (CSAT) at the Substance Abuse and Mental Health Services Administration (SAMHSA). It is
designed to evaluate the Grants for the Benefit of Homeless Individuals (GBHI) program. The
respondents are government (federal, state, county, or city) employees, local grantee evaluators,
contractors, and grantee staff and partners.

1

Note: Categories C1 and C2 above are the most common types of research conducted at RTI that may be exempt
from IRB review. For a complete list of exemption criteria, please see below.

-------------------------------------------------------Space below this line for IRB use only.-----------------------------------------------------Decision of IRB Coordinator or Chair
Name of IRB Coordinator or Chair making exemption determination:
Please check appropriate answer(s):
2

Ina Wallace

I agree that this study is exempt [45CFR46.101(b)] from IRB review based upon the information provided by the Project
Manager above. (Check applicable category below.)
__(1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research
on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques,
curricula, or classroom management methods.
__(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or
observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or
through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the
subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
__(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or
observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public
officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable
information will be maintained throughout the research and thereafter.
__(4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these
sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or
through identifiers linked to the subjects.
_X_5) Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are
designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under
those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment
for benefits or services under those programs.
__(6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is
consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant
at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety
and Inspection Service of the U.S. Department of Agriculture.

April 19, 2010
Date

Signature of IRB Coordinator or Chair named above
Version 11-30-00

3

4

Primary Data Collection: 0210700.001.005.001.001
Purpose
Site Visit Related • Prepare for site visit:
Conference Calls
logistics, agenda and
documents needed

Respondents
Project Directors
Local Evaluators
Others designated
by Grantee

Mode of Consent
•

Burden

Telephone call- •
logistics:
consent N/A—

Site Visits

• Intervention Fidelity,
adaptation and innovation
• Topics include cost,
project organization,
services, grantee & target
population characteristics,
TA, partners,
sustainability

Project Directors
Financial staff
Project staff
Stakeholders
Local Evaluators

Web Survey

•
•
•
•
•

Grantee characteristics
Population served
Service environment
Implementation
Fidelity, adaptation, and
innovation
• Sustainability
• TA
• Local evaluation

Stakeholders

• Implementation
• Service adaptation
• Lessons learned (barriers
& facilitators)

Project Directors
Local Evaluators

Telephone
Interviews
Follow-up to
Document
Exaction

• Verify or update
information from
document extraction
• Sustainability
• Lessons learned

2004 to present
Project Directors
grantees

•

Telephone,
Verbal consent

•

GPO Interviews

• TA & Grantee Support
• Monitoring
• Lessons for improvement

Current GPOs

•

In person verbal •
consent

Focus Groups

•

•

Web consent

30 minutes •

•

In person

•

Sites

2 days

25 FY10 sites

•

Web and inperson script for
consent

5

•

--Years 1–4
preceding and as
needed after 1st and
2nd site visits

25 FY10 sites --Summer 2010 Year
1–2 first site visits;
--Year 4 second site
visits

17 minutes •

25 FY10 sites --Year 2 and Year 4
pending OMB
approval
2005–2009
sites on
voluntary
basis

•

•

Schedule*

•

25 FY10
Sites
Selected
grantee 2006
to present

--Periodic in Year 1
and 2 and in Year 5

45 minutes •

2005–2009
sites on
voluntary
basis

--One time beginning
Spring 2010

45 minutes •

CHAB GPOs --Annual beginning
summer 2010

1.5 hours
•

TA Contractor
Interviews

• TA
• Grantee and GPOS
support needs
• Lesson learned

Current Contractors:
SAIS: RTI; CHAB:
JBS, AHP, & RTI

Cost Data

• Program cost and costeffectiveness

Grantees

•

•

In person and
via telephone
verbal consent

•

Part of site visit •
and calls
described above

Note: Years refer to years in the GBHI Cross-site Evaluation begun September 15, 2009.

6

45 minutes •

3 hours

•

Current SAIS --Annual beginning
and CHAB summer 2010
TA staff
25 FY10 sites --Years 1 and Year 4