[Federal Register Volume 70, Number 15 (Tuesday, January 25, 2005)]
[Notices]
[Pages 3586-3589]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-1317]



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Part II





Department of Education





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Scientifically Based Evaluation Methods; Notice

  Federal Register / Vol. 70, No. 15 / Tuesday, January 25, 2005 / 
Notices  

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DEPARTMENT OF EDUCATION

RIN 1890-ZA00


Scientifically Based Evaluation Methods

AGENCY: Department of Education.

ACTION: Notice of final priority.

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SUMMARY: The Secretary of Education announces a priority that may be 
used for any appropriate programs in the Department of Education 
(Department) in FY 2005 and in later years. We take this action to 
focus Federal financial assistance on expanding the number of programs 
and projects Department-wide that are evaluated under rigorous 
scientifically based research methods in accordance with the Elementary 
and Secondary Education Act of 1965 (ESEA), as reauthorized by the No 
Child Left Behind Act of 2001 (NCLB). The definition of scientifically 
based research in section 9201(37) of NCLB includes other research 
designs in addition to the random assignment and quasi-experimental 
designs that are the subject of this priority. However, the Secretary 
considers random assignment and quasi-experimental designs to be the 
most rigorous methods to address the question of project effectiveness. 
While this action is of particular importance for programs authorized 
by NCLB, it is also an important tool for other programs and, for this 
reason, is being established for all Department programs. Establishing 
the priority on a Department-wide basis will permit any office to use 
the priority for a program for which it is appropriate.

EFFECTIVE DATE: This priority is effective February 24, 2005.

FOR FURTHER INFORMATION CONTACT: Margo K. Anderson, U.S. Department of 
Education, 400 Maryland Avenue, SW., room 4W333, Washington, DC 20202-
5910. Telephone: (202) 205-3010.
    If you use a telecommunications device for the deaf (TDD), you may 
call the Federal Relay Service (FRS) at 1-800-877-8339.
    Individuals with disabilities may obtain this document in an 
alternative format (e.g., Braille, large print, audiotape, or computer 
diskette) on request to the contact person listed under FOR FURTHER 
INFORMATION CONTACT.

SUPPLEMENTARY INFORMATION:

General

    The ESEA as reauthorized by the NCLB uses the term scientifically 
based research more than 100 times in the context of evaluating 
programs to determine what works in education or ensuring that Federal 
funds are used to support activities and services that work. This final 
priority is intended to ensure that appropriate federally funded 
projects are evaluated using scientifically based research. 
Establishing this priority makes it possible for any office in the 
Department to encourage or to require appropriate projects to use 
scientifically based evaluation strategies to determine the 
effectiveness of a project intervention.
    We published a notice of proposed priority in the Federal Register 
on November 4, 2003 (68 FR 62445). Except for a technical change to 
correct an error in the language of the priority, one minor clarifying 
change, and the addition of a definitions section, there are no 
differences between the notice of proposed priority and this notice of 
final priority. The definitions section provides the generally accepted 
meaning for technical terms used throughout the document.

Analysis of Comments

    In response to our invitation in the notice of proposed priority, 
almost 300 parties submitted comments on the proposed priority. 
Although we received substantive comments, we determined that the 
comments did not warrant changes. However, we have reviewed the notice 
since its publication and have made a change based on that review. An 
analysis of the comments and changes is published as an appendix to 
this notice.


    Note: This notice does not solicit applications. In any year in 
which we choose to use this priority, we invite applications for new 
awards under the applicable program through a notice in the Federal 
Register. When inviting applications we designate the priority as 
absolute, competitive preference, or invitational. The effect of 
each type of priority follows:
    Absolute priority: Under an absolute priority we consider only 
applications that meet the priority (34 CFR 75.105(c)(3)).
    Competitive preference priority: Under a competitive preference 
priority we give competitive preference to an application by either 
(1) awarding additional points, depending on how well or the extent 
to which the application meets the competitive preference priority 
(34 CFR 75.105(c)(2)(i)); or (2) selecting an application that meets 
the competitive priority over an application of comparable merit 
that does not meet the priority (34 CFR 75.105(c)(2)(ii)).


    When using the priority to give competitive preference to an 
application, the Secretary will review applications using a two-stage 
process. In the first stage, the application will be reviewed without 
taking the priority into account. In the second stage of review, the 
applications rated highest in stage one will be reviewed for 
competitive preference.
    Invitational priority: Under an invitational priority we are 
particularly interested in applications that meet the invitational 
priority. However, we do not give an application that meets the 
invitational priority a competitive or absolute preference over other 
applications (34 CFR 75.105(c)(1)).

Priority

    The Secretary establishes a priority for projects proposing an 
evaluation plan that is based on rigorous scientifically based research 
methods to assess the effectiveness of a particular intervention. The 
Secretary intends that this priority will allow program participants 
and the Department to determine whether the project produces meaningful 
effects on student achievement or teacher performance.
    Evaluation methods using an experimental design are best for 
determining project effectiveness. Thus, when feasible, the project 
must use an experimental design under which participants--e.g., 
students, teachers, classrooms, or schools--are randomly assigned to 
participate in the project activities being evaluated or to a control 
group that does not participate in the project activities being 
evaluated.
    If random assignment is not feasible, the project may use a quasi-
experimental design with carefully matched comparison conditions. This 
alternative design attempts to approximate a randomly assigned control 
group by matching participants--e.g., students, teachers, classrooms, 
or schools--with non-participants having similar pre-program 
characteristics.
    In cases where random assignment is not possible and participation 
in the intervention is determined by a specified cutting point on a 
quantified continuum of scores, regression discontinuity designs may be 
employed.
    For projects that are focused on special populations in which 
sufficient numbers of participants are not available to support random 
assignment or matched comparison group designs, single-subject designs 
such as multiple baseline or treatment-reversal or interrupted time 
series that are capable of demonstrating causal relationships can be 
employed.
    Proposed evaluation strategies that use neither experimental 
designs with random assignment nor quasi-experimental designs using a 
matched comparison group nor regression discontinuity designs will not 
be considered responsive to the priority

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when sufficient numbers of participants are available to support these 
designs. Evaluation strategies that involve too small a number of 
participants to support group designs must be capable of demonstrating 
the causal effects of an intervention or program on those participants.
    The proposed evaluation plan must describe how the project 
evaluator will collect--before the project intervention commences and 
after it ends--valid and reliable data that measure the impact of 
participation in the program or in the comparison group.
    If the priority is used as a competitive preference priority, 
points awarded under this priority will be determined by the quality of 
the proposed evaluation method. In determining the quality of the 
evaluation method, we will consider the extent to which the applicant 
presents a feasible, credible plan that includes the following:
    (1) The type of design to be used (that is, random assignment or 
matched comparison). If matched comparison, include in the plan a 
discussion of why random assignment is not feasible.
    (2) Outcomes to be measured.
    (3) A discussion of how the applicant plans to assign students, 
teachers, classrooms, or schools to the project and control group or 
match them for comparison with other students, teachers, classrooms, or 
schools.
    (4) A proposed evaluator, preferably independent, with the 
necessary background and technical expertise to carry out the proposed 
evaluation. An independent evaluator does not have any authority over 
the project and is not involved in its implementation.
    In general, depending on the implemented program or project, under 
a competitive preference priority, random assignment evaluation methods 
will receive more points than matched comparison evaluation methods.

Definitions

    As used in this notice--
    Scientifically based research (section 9101(37) NCLB):
    (A) Means research that involves the application of rigorous, 
systematic, and objective procedures to obtain reliable and valid 
knowledge relevant to education activities and programs; and
    (B) Includes research that--
    (i) Employs systematic, empirical methods that draw on observation 
or experiment;
    (ii) Involves rigorous data analyses that are adequate to test the 
stated hypotheses and justify the general conclusions drawn;
    (iii) Relies on measurements or observational methods that provide 
reliable and valid data across evaluators and observers, across 
multiple measurements and observations, and across studies by the same 
or different investigators;
    (iv) Is evaluated using experimental or quasi-experimental designs 
in which individuals entities, programs, or activities are assigned to 
different conditions and with appropriate controls to evaluate the 
effects of the condition of interest, with a preference for random-
assignment experiments, or other designs to the extent that those 
designs contain within-condition or across-condition controls;
    (v) Ensures that experimental studies are presented in sufficient 
detail and clarity to allow for replication or, at a minimum, offer the 
opportunity to build systematically on their findings; and
    (vi) Has been accepted by a peer-reviewed journal or approved by a 
panel of independent experts through a comparably rigorous, objective, 
and scientific review.
    Random assignment or experimental design means random assignment of 
students, teachers, classrooms, or schools to participate in a project 
being evaluated (treatment group) or not participate in the project 
(control group). The effect of the project is the difference in 
outcomes between the treatment and control groups.
    Quasi experimental designs include several designs that attempt to 
approximate a random assignment design.
    Carefully matched comparison groups design means a quasi-
experimental design in which project participants are matched with non-
participants based on key characteristics that are thought to be 
related to the outcome.
    Regression discontinuity design means a quasi-experimental design 
that closely approximates an experimental design. In a regression 
discontinuity design, participants are assigned to a treatment or 
control group based on a numerical rating or score of a variable 
unrelated to the treatment such as the rating of an application for 
funding. Eligible students, teachers, classrooms, or schools above a 
certain score (``cut score'') are assigned to the treatment group and 
those below the score are assigned to the control group. In the case of 
the scores of applicants' proposals for funding, the ``cut score'' is 
established at the point where the program funds available are 
exhausted.
    Single subject design means a design that relies on the comparison 
of treatment effects on a single subject or group of single subjects. 
There is little confidence that findings based on this design would be 
the same for other members of the population.
    Treatment reversal design means a single subject design in which a 
pre-treatment or baseline outcome measurement is compared with a post-
treatment measure. Treatment would then be stopped for a period of 
time, a second baseline measure of the outcome would be taken, followed 
by a second application of the treatment or a different treatment. For 
example, this design might be used to evaluate a behavior modification 
program for disabled students with behavior disorders.
    Multiple baseline design means a single subject design to address 
concerns about the effects of normal development, timing of the 
treatment, and amount of the treatment with treatment-reversal designs 
by using a varying time schedule for introduction of the treatment and/
or treatments of different lengths or intensity.
    Interrupted time series design means a quasi-experimental design in 
which the outcome of interest is measured multiple times before and 
after the treatment for program participants only.

Executive Order 12866

    This notice of final priority has been reviewed in accordance with 
Executive Order 12866. Under the terms of the order, we have assessed 
the potential costs and benefits of this regulatory action.
    The potential costs associated with the notice of final priority 
are those we have determined as necessary for administering applicable 
programs effectively and efficiently.
    In assessing the potential costs and benefits--both quantitative 
and qualitative--of this notice of final priority, we have determined 
that the benefits of the final priority justify the costs.
    We have also determined that this regulatory action does not unduly 
interfere with State, local, and tribal governments in the exercise of 
their governmental functions.

Intergovernmental Review

    Some of the programs affected by this final priority are subject to 
Executive Order 12372 and the regulations in 34 CFR part 79. One of the 
objectives of the Executive order is to foster an intergovernmental 
partnership and a strengthened federalism. The Executive order relies 
on processes developed by State and local governments for coordination 
and review of proposed Federal financial assistance.

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    This document provides early notification of our specific plans and 
actions for these programs.

Electronic Access to This Document

    You may view this document, as well as all other Department of 
Education documents published in the Federal Register, in text or Adobe 
Portable Document Format (PDF) on the Internet at the following site: 
http://www.ed.gov/news/fedregister.
    To use PDF you must have Adobe Acrobat Reader, which is available 
free at this site. If you have questions about using PDF, call the U.S. 
Government Printing Office (GPO), toll free, at 1-888-293-6498; or in 
the Washington, DC, area at (202) 512-1530.


    Note: The official version of this document is the document 
published in the Federal Register. Free Internet access to the 
official edition of the Federal Register and the Code of Federal 
Regulations is available on GPO Access at: http://www.gpoaccess.gov/nara/index.html.

(Catalog of Federal Domestic Assistance Number does not apply.)

    Program Authority: ESEA, as reauthorized by the No Child Left 
Behind Act of 2001, Pub. L. 107-110, January 8, 2002.

    Dated: January 17, 2005.
Rod Paige,
Secretary of Education.

Appendix--Analysis of Comments

    Comment: Twenty-nine comments were received in support of the 
priority for random assignment studies of education policies and 
program interventions. Commenters noted that random assignment 
evaluations have been essential to understanding what works, what 
does not work, and what is harmful among interventions in many areas 
of public policy--including employment and training, welfare 
programs, health insurance, subsidies, pregnancy prevention, 
criminal justice, and substance abuse.
    Discussion: The Secretary agrees with this comment.
    Change: None.
    Comment: One hundred and eighty-three respondents commented that 
random assignment is not the only method capable of generating 
understandings of causality. They stated that the Secretary's 
proposal would elevate experimental over quasi-experimental, 
observational, single-subject, and other designs which are sometimes 
more feasible and equally valid. However, 21 respondents commented 
that the priority correctly identifies random assignment 
experimental designs as the methodological standard for what 
constitutes scientific evidence for determining whether an 
intervention produces meaningful effects. The commenters pointed out 
that attempts to draw conclusions about intervention effects based 
on other methods have often led to misleading results. They stated 
that the priority is consistent with widely recognized 
methodological standards in the social and medical sciences.
    Discussion: The Secretary agrees that a random assignment design 
is not the only method capable of providing estimates of program 
effectiveness; however, it is the most defensible method in that it 
reliably produces an unbiased estimate of effectiveness. Conclusions 
about causality based on other methods, including the quasi-
experimental designs included in this priority, have been shown to 
be misleading compared with experimental evidence. This is largely 
due to the difficulty in establishing equal treatment and comparison 
groups on all important characteristics related to the outcome 
variable with methods other than random assignment. The Secretary 
agrees with the latter commenters that random assignment is the 
standard for scientific evidence for determining the project 
effectiveness.
    Change: None.
    Comment: One hundred and seventy-three respondents commented 
that random assignment methods examine a limited number of isolated 
factors that are neither limited nor isolated in natural settings. 
These commenters stated that the complex nature of causality renders 
random assignment methods less capable of discovering causality than 
designs sensitive to local culture and conditions. Four respondents 
commented that random assignment methods estimate only the impact of 
the treatment and that the response to the treatment may vary 
according to contextual factors. These four respondents noted that 
random assignment assures that the contextual factors affecting 
outcomes are the same for the treatment and the control group and, 
therefore, the impact of the treatment is unambiguous. They noted 
further that it has not been demonstrated that evaluation methods 
``sensitive'' to local culture and conditions can provide 
unambiguous answers as to whether the treatment is the cause of the 
observed outcome.
    Discussion: The Secretary agrees with the latter comments. A 
major strength of the random assignment design is that it yields 
comparable treatment and control groups with respect to all 
characteristics and conditions, both observable and unobservable. 
When participants, e.g. students, teachers, classrooms, or schools, 
are randomly assigned to the project or to a control group, the only 
difference between the two groups is the impact of the treatment. 
While quasi-experimental designs, including carefully matched 
comparison groups, are also permitted under this priority, it is a 
practical impossibility to match on numerous characteristics and 
conditions, especially those that are unobservable or difficult to 
measure. However, case studies that collect information on local 
culture and conditions are an important complement to a random 
assignment study by providing a deeper understanding of the 
conditions that may influence the effectiveness of an intervention.
    Change: None.
    Comment: One hundred and eighty-six respondents commented that 
random assignment should sometimes be ruled out for reasons of 
ethics. For example, randomly assigning experimental subjects to 
educationally inferior treatments, or denying control groups access 
to important instructional opportunities, is not ethically 
acceptable even when the results might be enlightening. Another 13 
respondents commented that the priority recognizes that there are 
cases in which random assignment is not ethical and, in such cases, 
identifies quasi-experimental designs and single-subject designs as 
alternatives that may be justified by the circumstances of 
particular interventions.
    Discussion: The Secretary agrees with both comments. There are 
occasions when random assignment is not an acceptable or feasible 
method of evaluation. The Department will address these issues in 
deciding whether or not to apply this priority in specific program 
competitions. Also, consistent with the American Psychological 
Association ethics code and in accordance with 34 CFR part 97, the 
Department has adopted the Common Rule for protection of human 
subjects in research including Subpart D dealing with inclusion of 
children in research. Grantees submit their plans for all research 
involving human subjects to an Institutional Review Board. All 
research involving human subjects must be conducted in accordance 
with an approved research protocol. This includes obtaining informed 
consent for participation when required by the Institutional Review 
Board as a condition of approval.
    In general, random assignment does not pose ethical issues when 
employed to test the effectiveness of a new service or product that 
is believed to be beneficial and when the number of students who are 
equally eligible for and seeking that service is more than the 
number who can be served. When all applicants cannot be served, 
random assignment is fair, because it gives all participants an 
equal chance of being selected for the program.
    When a random assignment evaluation is not ethical or not 
feasible, this priority includes quasi-experimental designs such as 
carefully matched comparison groups, regression discontinuity 
designs, single-subject designs, and interrupted time series that 
are capable of estimating program impacts. However, quasi-
experimental designs do not provide the level of confidence in 
causal relationships that random assignment designs provide.
    Change: None.
    Comment: One hundred and seventy-four respondents commented that 
although it may be important to examine causality prior to wide 
implementation, pilot or exploratory programs are often too small in 
scale to provide reliable conclusions.
    Discussion: The priority recognizes that for projects that are 
focused on special populations in which sufficient numbers of 
participants are not available to support random assignment or 
matched comparison group designs, single-subject designs such as 
multiple baseline or treatment-reversal or interrupted time series 
that are capable of demonstrating causal relationships can be 
employed. These small-scale or efficacy studies should lead to 
large-scale or effectiveness studies. Further, this priority is only 
relevant to programs for which demonstrations of effectiveness are

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reasonable and relevant. The priority would generally not be applied 
in competitions to fund pilot or exploratory programs.
    Change: None.
    Comment: Two hundred and forty-two respondents commented that 
the choice of a research method must be determined by the goal or 
question being asked. They stated that alternative and mixed methods 
are rigorous and scientific and are important in knowing how well a 
program was implemented and what is ``inside the box.'' Another 
group of 14 respondents commented that the priority does not 
preclude non-experimental designs, but gives clear priority to 
experimental designs for determining project effectiveness. These 
commenters noted that there may be areas in which an experimental 
design may not be feasible and non-experimental methods, including 
observational studies, may provide information on how to move 
research forward.
    Discussion: The Secretary agrees with these comments. There are 
many research questions other than effectiveness that can be 
pursued. For these questions, research designs other than 
experimental and quasi-experimental would be appropriate. This 
priority is to be applied only when the question to be addressed is 
program effectiveness. The priority would be inappropriate if it 
were applied, for example, to applications in which the primary 
question is the fidelity of program implementation.
    Change: None.
    Comment: Twenty respondents expressed concern that the 
Department will make the priority a requirement for all grant 
competitions regardless of the intervention.
    Discussion: The Secretary does not intend to make random 
assignment a requirement for all of the Department's grant 
competitions. The priority is intended for use only with 
discretionary grant programs in which grantees may use their funds 
to implement clearly specified interventions, and when the 
Department desires to obtain evidence of the impact of those 
interventions on relevant outcomes.
    Change: None.
    Comment: One hundred and sixty-eight respondents disagreed with 
the Department's statement in the notice of proposed priority that 
``this regulatory action does not unduly interfere with State, 
local, and tribal governments in the exercise of their governmental 
functions.'' They took the position that as provision and support of 
programs are governmental functions so, too, is determining program 
effectiveness.
    Discussion: As indicated above, the priority is for use only 
with discretionary grant programs in which awards are made on the 
basis of competition. The Secretary often establishes priorities for 
such programs and does not agree that supporting projects that would 
use scientific methods to evaluate the effectiveness of the 
interventions being implemented with grant funds would interfere 
with State, local, and tribal governments in the exercise of their 
governmental functions.
    Change: None.
    Comment: Six respondents expressed concern that the priority 
might limit what is studied or result in poorer quality programs 
being funded because of the additional points given to the 
evaluation priority.
    Discussion: When using the priority to give competitive 
preference to an application, the Secretary intends to review 
applications using a two-stage process. The first stage would review 
the application without taking the priority into account. In the 
second stage of review, the applications rated highest in stage one 
would be reviewed for competitive preference. This will ensure that 
applications of lower program quality will not be funded as a result 
of additional points for the evaluation priority.
    Change: Although no change has been made in the priority, the 
description of the competitive preference is clarified to include a 
two-stage review.
    Comment: Nine respondents recommended that the Department 
continue to recognize the importance of independent evaluators.
    Discussion: The priority gives preference to independent 
evaluators who have no authority over the project and are not 
involved in its implementation. Thus the importance of independent 
evaluators is recognized.
    Change: None.
    Comment: Twenty-three respondents expressed concern that there 
would be inadequate financial and technical resources in small 
programs and in rural areas to carry out a random assignment study 
and may prevent congressionally-intended beneficiary communities 
from receiving federal assistance.
    Discussion: The priority provides for the use of alternate 
designs where insufficient numbers of participants are available to 
support random assignment or matched comparison group designs. The 
Secretary believes that investing in projects that generate evidence 
regarding the effectiveness of specified interventions would provide 
benefits beyond the individual grantee, and thus would represent a 
wise use of program dollars.
    Change: None.
    Comment: None.
    Discussion: In order to make this priority more understandable 
to the general public, the Secretary believes that the priority 
would be improved by adding generally accepted definitions for 
technical terms used throughout the document. This may be helpful to 
practitioners and others who are interested in strengthening the 
evaluations of proposed projects but who may not be familiar with 
the specific types of evaluation described in this notice.
    Change: The Secretary has added a definitions section to provide 
generally-accepted definitions of terms used throughout the 
document.

[FR Doc. 05-1317 Filed 1-24-05; 8:45 am]
BILLING CODE 4000-01-P