This document discusses research analyzing the use of exercise programs to treat depression in Hispanic seniors. It describes plans to recruit 30 Hispanic seniors aged 50-69 to participate in a study evaluating the effects of a prescribed and monitored exercise program on depression. Participants will complete consent forms, questionnaires on depression and physical readiness, and will then participate in an exercise program while being monitored. They will complete post-program depression questionnaires to determine if symptoms decreased. The research aims to add to evidence that exercise can be an effective treatment for depression in older Hispanic adults.
A Review Committee S Guide For Evaluating Qualitative ProposalsAndrea Porter
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A Multidisciplinary Analysis of Research and Performance Synthesis Utilized in Criminal Justice Program and Educational Program Evaluation
1. 1
A Multidisciplinary Analysis of Research and Performance Synthesis Utilized in
Criminal Justice Program and Educational Program Evaluation
Dr. Robelyn A. Garcia
Criminal Justice Planning and Program Evaluation
Arizona State University
A. An Institutional Review Board (IRB) is not necessarily required for a Program
Evaluation. Moreover, there are many Research Situations where it would be
Appropriate to convene an IRB prior to conducting a Program Evaluation.
An Institutional Review Board (IRB) also known as an independent ethics
committee (IEC) or ethical review board (ERB) is a committee that approves, monitors,
and reviews biomedical and behavioral research involving human subjects (Posavac,
2011). All human subjects research and program evaluation that involves human subject
research requires an Institutional Review Board to convene prior to conducting the
evaluation. Even program evaluations that involve partial human subjects research, must
be reviewed and approved by the Institutional Review Board, regardless of sponsorship.
If a researcher were going to evaluate the Arizona State University Employee
Wellness Program, this would be considered research involving human subjects;
therefore it would be appropriate to convene an IRB prior to conducting the program
evaluation. I have had to complete several Institutional Review Board human subjects
research applications for exempt research; I have completed two at Arizona State
University so far in my academic career. One of my research studies evaluated the
effects of an exercise program as improving or eliminating depression in Hispanic senior
human subjects. My second applied analysis evaluated a prescribed and monitored
exercise program administered via the Internet for senior adults with depression.
2. 2
Both of the aforementioned studies involved human subject research, therefore I
needed an IRB. I have included the Institutional Review Board human subjects research
applications for exempt research in the Appendix for the reader’s review.
B. When Planning an Evaluation, there is a Multitude of Steps an Evaluator must take.
One Final Step in the Preparation Planning Process is to Present a Written Proposal.
Preparing and presenting a written proposal is an extremely important skill for a
researcher and evaluator. Much of the success of the evaluation will be determined by
how well you write and present a proposal. You must convince others in writing that the
evaluation research that you plan to complete is worth completing and that you as a
researcher have the ability to accomplish the evaluation.
The written proposal should describe the specific goals, objectives and purpose of
the evaluation. The proposal should also describe the evaluation design, support for the
chosen design, methodology, hypotheses and proposed analyses. It is of import to also
present a detailed work plan and evaluation budget in writing so you will be able to
reference this if needed in the future. Preparing this written proposal completes the
preparation phase of the program evaluation (Posavac, 2011). The written proposal is
important in developing a concrete strategy for identifying evaluation goals, meeting
these goals and verifying that the proposed evaluation actually matches the finished
evaluation. Written proposals also give evaluators a better focus on the program they
intend to evaluate. Proposals and presentations of the proposal help to organize the
research and serve as a preview of the research and direction of the evaluation. In
addition, the written proposal will provide an important reference for the finished
evaluation.
3. 3
C. After Evaluators and Stakeholders have agreed on Criteria that Would Indicate
Successful Implementation and Outcome, Researchers Face the Task of Developing
Valid and Reliable Methods to Measure those Criteria.
Reliability and validity are both very important concepts when performing an
evaluation. Different sources and different methods need to be recognized and utilized
to strengthen the reliability and validity of the findings of evaluation research (Posavac &
Carey, 2010). Reliability refers to the consistent stability of measurement scores from
the evaluation, whereas validity refers to the accuracy of the interpretations of the
measurement scores.
It is possible to improve the reliability and validity of measures in a study,
however the evaluator will not be able to improve the validity of the research without
sufficient reliability (Posavac & Carey, 2010). Both of these different concepts are
important and many times thought to be synonymous. Moreover, it is important to note
that there can be reliability in a study without validity, but to obtain validity in a study
you must have reliability. Therefore, reliability must be one of the first characteristics to
look for when selecting a measurement. Reliability is easier to determine, since you are
only concerned with the consistency of the measurement. Finding a valid and reliable
instrument is of utmost concern when planning an evaluation. Posavac and Carey state
that the easiest way to minimize threats to validity is to use an experiment based on
observations of randomly assigned study groups and control groups (2010).
4. 4
D. Utilizing Closed-ended and Open-ended Questions when Conducting a Qualitative
Interview for Research Analysis and Program Evaluation.
The philosophical roots of a qualitative interview lead to a highly subjective
outcome reflective of the evaluator’s philosophical underpinnings. The conclusions
drawn from qualitative interview open-ended and closed-ended questions will only be as
strong as the quality of the evaluation of the researcher. Qualitative interviews are
deductive in nature and this requires a large amount of subjective analysis and a large
amount of labor by the evaluator. The observation and data interpretation of this large
amount of data may not necessarily be utilized to make assumptions beyond the specific
group of research participants (Posavac, 2011).
In qualitative interviews, open-ended questions require a thought out response
that individuals give spontaneously. These types of questions are broad and often require
more than a one or two word response. Open-ended questions provide the evaluator with
direct quotes to be used as raw data. These direct quotes reveal the participants emotions
in the way in which they have organized their thoughts about their experiences and
perceptions of the world around them (Patton, 1990). Answering close-ended questions
requires different types of mental processing than answering open-ended questions.
Participants need to think systematically to accurately express their thoughts using closeended questions. A close-ended question is answered finitely and can be a yes or no
question, a one-word fact response question, or a multiple choice question. When used in
a qualitative interview these types of questions are more restrictive for the participant
because there are suggested responses from which the participant must select.
5. 5
E. Experimental and Quasi-Experimental Designs in Research and Program Evaluation
with a Focus on the Assignment of Participants to Experimentation Groups.
Even after carefully designing quasi-experimental evaluations, concerns still
linger that effects other than the program direct effects that were evaluated could have
caused changes in participants or even masked the true program effect (Posavac & Carey,
2010). In order to minimize these unintended effects the evaluator must try to anticipate
and/or prevent threats to validity. As long as the disadvantages of quasi-experimental
design are recognized, this type of evaluation can be a powerful research tool. Quasiexperimental evaluations are especially effective in situations where experimental
evaluations are not possible.
Experimental research design in evaluation is a method of research used to search
for a specific program effect observed under strictly controlled conditions. Participants
are randomly assigned in the evaluation to either the experimental group or the control
group. Quasi-experimental design differs from experimental design significantly when
selecting groups for program evaluation. The quasi- experiment involves testing a
variable by selecting groups without any random pre-selection process. This type of
design has a control group, however the external variables that affect the implementation
of the experiment cannot be fully controlled. Posavac and Carey stress the importance of
working with all groups affected and evaluated by the program (Posavac & Carey, 2010).
‘True’ experimental designs and quasi-experimental designs are both useful and effective
measurement tools in program evaluation.
6. 6
F. The Strengths of utilizing a Balanced Scorecard Approach Lie Within the Four
Perspectives of the Balanced Scorecard. A Multi-Indicator Analysis Provided by the
Four Perspectives Reaches Beyond Data from Financial Measures.
A Balanced Scorecard approach is used as a strategy in evaluation research that
includes evaluating more than just the finances of an organization. Posavac and Carey
stress the importance of using a Balanced Scorecard approach in any and all disciplines
because it gives the evaluation a perspective from all areas and more indicators than just
the bottom line (2010). The Balance Scorecard is a modern approach to performance
evaluation methodology utilizing a systemic measurement model. Stakeholders, clients,
customers and staff must be part of an evaluation to ensure that their unique perspectives
are addressed and understood (Posavac, 2011). A Balanced Scorecard’s four
perspectives addresses each of these organization’s viewpoints and develops metrics,
collects data and analyzes data in relation to each of these perspectives. An evaluation
can use the Balance Scorecard approach and adjust the perspectives to the needs of each
organization.
The four baseline perspectives used in a Balance Scorecard are the financial
perspective, the customer perspective, the organization and business process perspective,
and the innovation learning and growth perspective. The financial perspective represents
how the firm looks to the shareholder; the customer perspective represents how the
customers and clients view the organization; the internal organization and business
process perspective represents how well the organization manages it’s operational
processes; the innovation learning and growth perspective represents if the organization
can continue to improve and create value. Developing multiple indicators from the four
perspectives for the evaluation is the strength of a using a Balance Scorecard approach
(Posavac & Carey, 2010).
7. 7
Appendices
Appendix A
Arizona State University
Research Compliance Office
P.O. Box 871103
Tempe, AZ 85287-1103
Phone: 480-965-6788
Fax: (480) 965-7772
For Office Use Only:
Date Received:
___________
HS Number:
____________
ARIZONA STATE UNIVERSITY
APPLICATION FOR EXEMPT RESEARCH
PROTOCOL TITLE:
An Analysis of a Prescribed and Monitored Exercise Program for
Hispanic Seniors with Depression
PRINCIPAL INVESTIGATOR:
DEPARTMENT/CENTER:
Dr. Robelyn Garcia
4455 E. Paradise Village Pkwy
Townhouse
Paradise Valley, AZ 85032
CAMPUS ADDRESS:
Department of Human Services,
Aging and Lifespan Development
Department of Student Recreation
Department of Student Health
PHONE:
Mail Code: 0180, 4230
DATE OF REQUEST:
3/23/2008
UNIVERSITY AFFILIATION:
Professor
Associate Professor
X Visiting Professor
Instructor
X Post Doc Fellow
X Graduate Student
X Staff
480-221-0597
E-MAIL:
DrRGarcia@asu.edu
CO-INVESTIGATOR:
DEPARTMENT/CENTER:
CAMPUS ADDRESS:
(include campus mail code)
PHONE:
EMAIL:
UNIVERSITY AFFILIATION:
Professor
Associate Professor
Assistant Professor
Instructor
Other: Please specify.
8. 8
STUDY OVERVIEW
1. Provide a brief description of the background, purpose, and design of your research. Avoid using technical
terms and jargon. Be sure to list all of the means you will use to collect data (e.g. tests, surveys, interviews,
observations, existing data). Provide a short description of the tests, instruments, or measures and attach copies of
all instruments and cover letters for review:
The current research project investigates the effectiveness of a prescribed and monitored exercise
program for the treatment of depression in Hispanic Older Adults. The Dependent Variable for the study is
Depression. The Independent Variable for the study is the Effects of Exercise and the population is older Hispanic
adults. This study will analyze the effect of a monitored exercise program on Hispanic Seniors to show that
exercise is an effective treatment for Depression. The design of the research is a systematic review and analysis
of controlled trials.
Many studies have been conducted showing that exercise is an effective treatment for depression in adults.
However, there is limited research using Hispanic seniors as the population. This study is devoted to the goal of
providing empirical support for the notion that an exercise program is a feasible and effective treatment for
depression in older Hispanic adults.
The following instruments (attached in Appendices) will be used for the study: 1) ASU IRB Consent
Form for Minimal Risk, 2) Physical Activity Readiness Questionnaire (PAR Q) which includes Personal
Information and Waiver Liability Section, 3) The Merck Manual of Geriatrics Geriatric Depression Scale (GDS),
and 4) The Merck Manual Geriatric Depression Scoring Table. Study participants will join a study involving
research of the effects of a monitored exercise program on Hispanic Seniors to show that exercise is an effective
treatment for Depression.
All participants will complete a IRB ASU Consent Form, Physical Activity Readiness Questionnaire and
Geriatric Depression Scale Questionnaire. All subjects will then be monitored in a prescribed exercise program
to help them decrease and/or eliminate the magnitude of their depression symptoms. At the end of the study,
participants will then repeat the Geriatric Depression Scale Questionnaire to determine if the are less depressed.
RECRUITMENT
2. Describe how you will recruit participants (attach a copy of recruitment materials).
Participants will be recruited through the ASU Lifelong Learning Institute by offering free of charge exercise
testing, exercise prescription, and exercise monitoring program. Senior participants will also be recruited from
local agencies which serve depressed patients.
PROJECT FUNDING
3. How is the research project funded? (A copy of the grant application(s) must be provided prior to IRB
approval)
(Go to question 4)__Funding decision is pending
X Research is funded
a) What is the source of funding or potential funding? (Check all that apply)
____ Federal
_____ Private Foundation
_____ Department Funds
X
$25 Hourly Subcontract X
$55,000 Fellowship
_____ Other _________
b) Please list the name(s) of the sponsor(s):
9. 9
c) What is the Project grant number and title (for example NIH grant number)?
d) What is the ASU account number/project number? 1000860
e) Identify the institution(s) administering the grant(s):
STUDY POPULATION- If you are doing data analysis only, please write DA.
4.Indicate the total number of participants
Indicate the age range of the participants
that you plan to include or enroll in your
that you plan to enroll in your study
30
study.
50 to 69
SUPPLEMENTAL MATERIALS
5. Attach a copy of the following items as applicable to your study (Please check the ones that are attached):
__Research Methods (Research design, Data Source, Sampling strategy, etc )
X Any Letters (cover letters or information letters), Recruitment Materials, Questionnaires, etc. which will be
distributed
to participants
__If the research is conducted off-site, provide a permission letter where applicable
__If the research is part of a proposal submitted for external funding, submit a copy of the FULL proposal
Note: The information should be in sufficient detail so IRB can determine if the study can be classified as
EXEMPT under Federal Regulations 45CFR46.101(b).
DATA USE
6. How will the data be used? (Check all that apply)
Dissertation
X Publication/journal article
Thesis
Undergraduate honors project
X Results released to participants/parents
Results released to employer or school
Results released to agency or organization
Conferences/presentations
X Other: Post Doc Graduate Class Project, SWG/GRN 598 Research in Aging- Ethno-Gerontology
EXEMPT STATUS
7. Identify which of the 6 federal exemption categories below applies to your research proposal and explain
why the proposed research meets the category. Federal law 45 CFR 46.101(b) identifies the following EXEMPT
categories. Check all that apply to your research and provide comments as to how your research falls into the
category.
1. SPECIAL NOTE: The exemptions at 45 CFR 46.101(b) do not apply to research involving prisoners.
The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or
observation of public behavior, does not apply to research with children, except for research
involving observations of public behavior when the investigator(s) do not participate in the
activities being observed.
2.
na
10. 10
3. X
(7.1) 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.
4. na
5. Study
will analyze the effectiveness of teaching depressed Hispanic Seniors to use exercise as a tool to
help reduce and / or eliminate depression symptoms.
6.
7. ____(7.2)
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.
8. ____(7.3)
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:
9. (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.
10.
Please provide an explanation as to how your research falls into this category:
11.
12.
13.
14.
15.
____7.4) 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.
Note-Please review the OHRP Guidance on Research Involving Coded Private Information or
Biological Specimens:
http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf
X (7.5) 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. (Generally does not apply to the university setting)
16.
continued
Study will analyze the effectiveness of teaching depressed Hispanic Seniors to use exercise as a
tool to help reduce and / or eliminate depression symptoms. This procedure will be beneficial to
all mental health agencies servicing adults with Depression.
11. 11
17.
18.
____(7.6) 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.
Please provide an explanation as to how your research falls into this category:
PPRINCIPAL INVESTIGATOR
In making this application, I certify that I have read and understand the ASU Procedures for the Review of
Human Subjects Research and that I intend to comply with the letter and spirit of the University Policy. I may
begin research when the Institutional Review Board gives notice of its approval. I must inform the IRB of ANY
changes in method or procedure that may conceivably alter the exempt status of the project. I also agree and
understand that records of the participants will be kept for at least three (3) years after the completion of the
research
Name (first, middle initial, last):
Dr Robelyn A. Garcia
Signature:
X
Date:
FOR OFFICE
USE:
This application has been reviewed by the Arizona State University
IRB:
Exempt Category/Categories: __________
Approved
Deferred to other review
Recommended that investigator submit for
expedited or Full Board review.
Authorizing Signature:
X
Date:
12. 12
Appendix B
Human Subjects Research
Arizona State University
Research Compliance Office
P.O. Box 871103
Tempe, AZ 85287-1103
Phone: 480-965-6788
Fax: (480) 965-7772
For Office Use Only:
Date Received:
___________
HS Number:
____________
ARIZONA STATE UNIVERSITY
APPLICATION FOR EXEMPT RESEARCH
PROTOCOL TITLE:
An Analysis of a Prescribed and Monitored Exercise Program
administered via the Internet for Seniors with Depression
PRINCIPAL INVESTIGATOR:
DEPARTMENT/CENTER:
Dr. Robelyn Garcia
4455 E. Paradise Village Pkwy
Townhouse
Paradise Valley, AZ 85032
Department of Human Services,
Aging and Lifespan
Development
Department of Student
Recreation
Department of Student Health
PHONE:
CAMPUS ADDRESS:
Mail Code: 0000, 4240
DATE OF REQUEST:
8/01/2010
UNIVERSITY AFFILIATION:
Professor
Associate Professor
X Adjunct Professor
Instructor
X Post Doc Fellow
X Graduate Student
X Staff
480-323-8147
E-MAIL:
DrRGarcia@asu.edu
CO-INVESTIGATOR:
DEPARTMENT/CENTER:
CAMPUS ADDRESS:
(include campus mail code)
PHONE:
EMAIL:
STUDY OVERVIEW
UNIVERSITY AFFILIATION:
Professor
Associate Professor
Assistant Professor
Instructor
Other: Please specify.
13. 13
1. Provide a brief description of the background, purpose, and design of your research. Avoid using
technical terms and jargon. Be sure to list all of the means you will use to collect data (e.g. tests,
surveys, interviews, observations, existing data). Provide a short description of the tests, instruments,
or measures and attach copies of all instruments and cover letters for review:
The current research project investigates the effectiveness of a prescribed and monitored
exercise program, administered via the Internet, for the treatment of depression in Older Adults. The
Dependent Variable for the study is Depression. The Independent Variable for the study is the Effects
of Exercise and the population is older adults. This study will analyze the effect of a monitored exercise
program on Seniors to show that exercise is an effective treatment for Depression. The design of the
research is a systematic review and analysis of controlled trials.
Many studies have been conducted showing that exercise is an effective treatment for
depression in adults. However, there is limited research using the internet as the modality. This study
is devoted to the goal of providing empirical support for the notion that an exercise program,
administered via the Internet, is a feasible and effective treatment for depression in Senior adults.
The following instruments (attached in Appendices) will be used for the study: 1) ASU IRB
Consent Form for Minimal Risk, 2) Physical Activity Readiness Questionnaire (PAR Q) which includes
Personal Information and Waiver Liability Section, 3) The Merck Manual of Geriatrics Geriatric
Depression Scale (GDS), and 4) The Merck Manual Geriatric Depression Scoring Table. Study
participants will join a study involving research of the effects of a monitored online exercise program on
Seniors to show that exercise is an effective treatment for Depression.
All participants will complete a IRB ASU Consent Form, Physical Activity Readiness
Questionnaire and Geriatric Depression Scale Questionnaire. All subjects will then be monitored in a
prescribed exercise program to help them decrease and/or eliminate the magnitude of their depression
symptoms. At the end of the study, participants will then repeat the Geriatric Depression Scale
Questionnaire to determine if the are less depressed.
RECRUITMENT
2. Describe how you will recruit participants (attach a copy of recruitment materials).
Participants will be recruited through Senior University by offering free of charge Geriatric Depression
testing, exercise prescription, and exercise monitoring program. Senior participants will also be
recruited from local agencies (Minderful Center, DUET) which serve depressed elder patients.
PROJECT FUNDING
3. How is the research project funded? (A copy of the grant application(s) must be provided prior to IRB
approval)
X Research is not funded (Go to question
4 )__Funding decision is pending
X Research is private funded
a) What is the source of funding or potential funding? (Check all that apply)
____ Federal
_____ Private Foundation
X
Department Funds
_____ Subcontract
_____ Fellowship
X
Other $15,000
b) Please list the name(s) of the sponsor(s):
c) What is the Project grant number and title (for example NIH grant number)?
d) What is the ASU account number/project number?
e) Identify the institution(s) administering the grant(s):
14. 14
STUDY POPULATION- If you are doing data analysis only, please write DA.
4.Indicate the total number of
Indicate the age range of the
participants that you plan to include
participants that you plan to enroll in
30
or enroll in your study.
your study
50 to 80
SUPPLEMENTAL MATERIALS
5. Attach a copy of the following items as applicable to your study (Please check the ones that are
attached):
II
__Research Methods (Research design, Data Source, Sampling strategy, etc )
X Any Letters (cover letters or information letters), Recruitment Materials, Questionnaires, etc.
which will be distributed to participants
__If the research is conducted off-site, provide a permission letter where applicable
__If the research is part of a proposal submitted for external funding, submit a copy of the FULL
proposal
Note: The information should be in sufficient detail so IRB can determine if the study can be classified
as EXEMPT under Federal Regulations 45CFR46.101(b).
DATA USE
6. How will the data be used? (Check all that apply)
Dissertation
X Publication/journal article
Thesis
Undergraduate honors project
X Results released to participants/parents
Results released to employer or school
Results released to agency or organization
Conferences/presentations
X Other: Graduate Applied Project, ALD 593 Research
EXEMPT STATUS
7. Identify which of the 6 federal exemption categories below applies to your research proposal;explain
why the proposed research meets the category. Federal law 45 CFR 46.101(b) identifies the following
EXEMPT categories. Check all that apply to your research and provide comments as to how your
research falls into the category.
1. SPECIAL NOTE: The exemptions at 45 CFR 46.101(b) do not apply to research involving
prisoners. The exemption at 45 CFR 46.101(b)(2), for research involving survey or
interview procedures or observation of public behavior, does not apply to research with
children, except for research involving observations of public behavior when the
investigator(s) do not participate in the activities being observed.
2.
3. X
(7.1) 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.
4.
5. Study
will analyze the effectiveness of teaching depressed Hispanic Seniors to use exercise
as a tool to help reduce and / or eliminate depression symptoms.
6.
7. ____(7.2)
Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures or observation of public behavior,
15. 15
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.
8. ____(7.3)
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:
9. (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.
10.
Please provide an explanation as to how your research falls into this category:
11.
____7.4) 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.
12.
Note-Please review the OHRP Guidance on Research Involving Coded Private
Information or Biological Specimens:
13.
http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf
X (7.5) 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. (Generally
does not apply to the university setting)
14.
Study will analyze the effectiveness of teaching depressed Seniors to use
exercise as a tool to help reduce and / or eliminate depression symptoms. This
procedure will be beneficial to all mental health agencies servicing adults
with Depression.
15.
____(7.6) 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.
Please provide an explanation as to how your research falls into this category:
16.
PPRINCIPAL INVESTIGATOR
In making this application, I certify that I have read and understand the ASU Procedures for the Review of Human Subjects
Research and that I intend to comply with the letter and spirit of the University Policy. I may begin research when the
Institutional Review Board gives notice of its approval. I must inform the IRB of ANY changes in method or procedure that
may conceivably alter the exempt status of the project. I also agree and understand that records of the participants will be
kept for at least three (3) years after the completion of the research
Name (first, middle initial, last):
16. 16
Robelyn A. Garcia
Signature:
X
Date:
FOR OFFICE
USE:
This application has been reviewed by the Arizona State
University IRB:
Exempt Category/Categories: __________
Approved
Deferred to other review
Recommended that investigator submit for
expedited or Full Board review.
Authorizing Signature:
X
Date:
References
Alkin, M. (1986). A Guide for Evaluation Decision Makers. Thousand Oaks: Sage
Publications.
Charrier, K. (2004). Strategic Management in Policing: The Role of the Strategic
Manager. The Police Chief, vol. 71, no. 6, June 2004. Alexandria, VA.
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