12291 IRB Approval

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12291
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: 1/06/08

RTI Project/Proposal No.: 0211776

Project Title: Evaluating the Title XX Adolescent Family Life (AFL) Program
Project Manager: Olivia Ashley

Sponsor: Office of Population Affairs (OPA), Department of Health

and Human Services (DHHS)

Date Participation of Human Subjects Scheduled to Begin: 1/13/08
A.

Brief Description of Study Procedures and Participant Population:
This Office of Population Affairs (OPA) funded project involves an outcome evaluation and process evaluation. This
project included a pilot study to test outcome evaluation data collection instruments; the IRB reviewed and approved
the pilot study on May 4, 2007. IRB approval for the outcome evaluation data collection procedures and instruments
was received on July 22, 2008. This project will also involve collecting data about program implementation for the
Title XX Adolescent Family Life (AFL) Program. The AFL Program is administered by the Office of Adolescent
Pregnancy Programs (OAPP) within OPA to support Prevention demonstration projects providing abstinence
education to adolescents and Care demonstration projects providing services to pregnant and parenting
adolescents. The process evaluation will collect data on the implementation of the AFL Program through selfadministered instruments completed by AFL grantee staff. The purpose of this IRB protocol is to review the process
evaluation procedures and instruments for the pilot study.
To gather data about program implementation for the pilot study, AFL Prevention and Care demonstration project
directors will complete a self-administered instrument, which for the main process evaluation will be attached as an
enclosure to the end-of-year reporting template submitted to OPA (a copy of the instruments is attached). OPA will
solicit volunteer project directors to participate in the pilot study and supplement the list of volunteers with project
directors selected to reflect diversity in program implementation (e.g., home visiting, case management, peer
leadership, mentoring, etc.). A pre-notification memorandum will be e-mailed from OPA informing selected project
directors that OPA is conducting a process evaluation to describe the activities of Prevention and Care
demonstration projects, that a pilot study will be conducted to test the process evaluation instruments, and to alert
them to the timeline for the pilot test (a copy of the memorandum is attached.) A second memorandum will be emailed from OPA to selected project directors attaching the instrument and asking them to complete it and send it to
OPA within 3 weeks (a copy of the memorandum is attached). The sample of selected Prevention demonstration
project directors (n=9) and Care demonstration project directors (n=9) will complete the instruments electronically
using Microsoft Word or paper and pencil, whichever is easiest. Forms can be returned by project directors to OPA
electronically, by facsimile transmission, or by Federal Express. The project directors will be asked detailed
questions about the implementation of AFL demonstration projects, including the program delivery, content,
theoretical orientation, empirical basis, use of best practices, organizational context, innovation, fidelity, and
dosage. Process evaluation pilot data will be collected from January 20, 2009, to February 11, 2009. This pilot test
will also elicit comments on the availability, usefulness, and likely accuracy of the data requested; the burden
associated with providing the data; the overall instrument; and specific instrument questions. No identifying
information about adolescents or sensitive information about sexual behavior will be collected from AFL Prevention
and Care demonstration project directors for the process evaluation pilot test.

B.

Description of Physical, Psychological, Social or Legal Risks to Participants:
There are no anticipated physical, psychological, social, or legal risks for participants. There are no sensitive
questions associated with this data collection. Process evaluation data collection forms completed by Prevention
and Care demonstration project directors will address the implementation of AFL demonstration projects including
the extent to which project activities are theoretically based, whether project activities are evidence-based, the
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extent to which grantees are utilizing best practices, the organizational contexts in which project activities are
conducted, and characteristics of projects.

C1. For educational tests (cognitive, diagnostic, aptitude, achievement), survey or interview research with
adults:
1. Is information recorded in such a manner that human subjects can be identified, directly or through identifiers
linked to the subjects?
X

Yes

No

NA

If yes, explain: The instruments will include a field identifying the grantee and the person completing the
instrument.
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

X

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

X 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

X NA

If yes, explain:

D.

1

Describe other categories of exempt research1 here:

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.

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-------------------------------------------------------Space below this line for IRB use only.-----------------------------------------------------Decision of IRB Coordinator or Chair
Name of IRB Coordinator or Chair making exemption determination:

Juesta Caddell, Ph.D.

Please check appropriate answer(s):
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.
_X(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.
__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.

January 8, 2009
Date

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

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