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           QUANTITATIVE STUDY TEMPLATE: SCHOOL OF NURSING
  (Instructions: Adapt the information in yellow shading to your study. Please keep as
    much of the non-shaded text as possible. When you are done, remove all yellow
                                        shading.)
                                APPLICATION FORM
                            UNIVERSITY OF SAN DIEGO
                           Institutional Review Board (IRB)
All researchers are required to be familiar with:
1) The Belmont Report
(http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm), 2) 45 CFR 46 of
the code of federal regulations
(http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm)
3) Research Integrity (http://www.hhs.gov/ohrp/irb/irb_chapter4.htm)
Biomedical Researchers only must be familiar with:
Pertinent California Law for biome dical research, curre nt discussion at the Offices
of Human Research Protections (http://www.hhs.gov/ohrp/irb/irb_chapter5.htm#h1)

Please complete this application for all research, defined in 45 CFR 46.102(d)
involving human subjects, define d in 45 CFR 46.102(f) and conducted at the
University of San Diego, by or under the direction of any e mployee, agent or student
of this institution, including research conducted at or in coope ration with another
entity.
1. Title of Research: Depression and Quality of Life in Osteoporosis

2a. Principal Investigator (PI): Wilma Flintstone, RN, Doctoral Student, Nursing
                                      Please unde rline student classification and
                                      affiliation: UG, Masters, or Doctoral; College of
                                      Arts & Sciences, School of Business, School of
                                      Leadership & Education Sciences, School of
                                      Law, or School of Nursing. If not affiliated with
                                      USD, please explain:
2b. Additional Investigators: N/A
2c. Faculty Advisor (if PI is a USD student): Dr. Betty Rubble, School of Nursing
2d. USD Sponsor (if PI is not a USD employee or agent):
3. Review Category
__ __ Exempt (Complete Section A) by category _____
__X___ Expedited (Complete Section B) by category __7___
_____ Full (Complete Section C)
4. Anticipated Date on which Data Collection will begin: When approved
5. If this is a funded project, please name funding source(s). N/A
6. If this proposed research has been, or will be reviewed by an IRB elsewhe re
   please name the IRB(s). If applicable, attach a copy of each IRB's
   recommendations and findings, and dated approval.
Permission to use the Bedrock Osteoporosis Clinic to recruit participants has been
obtained (See Appendix X, Letter of Support from Dr. Petra Slate, Clinic Director.)
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You must submit this form, the attached Research Plan, and all supporting documents
in paper format. Prior to submission to the Provost’s Office, all proposals require all
signatures below as necessary. Proposals that are incomplete or lacking signatures
will be returned to the Principal Investigator or the Faculty Advisor/USD Sponsor.

______________________________               School of Nursing-today’s date
Researcher (signature)                       Department/School and Date

Wilma Flintstone_____________________(XXX) XXX-XXXwflintstone@sandiego.edu
Researcher (printed)                  Phone and email (both required)

_____________________________ ____________________________
Faculty Advisor or USD Sponsor (signature) Phone and email (both required)
(Except if P.I. is a current USD faculty member)


________________________________ ____________________________
Dean or His/Her Representative (signature) Date

________________________________ ____________________________
College or School IRB Rep. (signature) Date

________________________________ ____________________________



The project described above has been approved by the USD Institutional Review Board.




________________________________ ____________________________
Chair or Administrator to IRB (signature) Date
                                                                                               3



                          USD Institutional Review Board
                     New Application for Expedited or Full Review
                                RESEARCH PLAN

    Enter text in the space areas below each numbered heading. Expand the s ize of the
    space as needed to provide complete information.

1. PROJECT TITLE:
Depression and Quality of Life in Osteoporosis

2. SPECIFIC AIMS OF THE STUDY:

The overall purpose of the proposed study will be to examine depression and quality of
life in a group of 70 adults over age 50 diagnosed with osteoporosis of the hip or spine.

The specific aims of this study are to:

1. Describe levels of depression and quality of life in a group of 70 adults over age 50
diagnosed with osteoporosis of the hip or spine;

2. Describe relevant demographic variables, including age, gender, ethnicity, marital
status, educational level, occupational status, length of diagnosis, and treatments utilized
in this group;

3. Examine the relationships between depression, quality of life, and selected
demographic variables (age, gender, ethnicity, marital status, educational level,
occupational status, length of diagnosis, treatments utilized) in this group.

3. BACKGROUND AND SIGNIFICANCE OF THE STUDY:
PLEASE INSERT NO MORE THAN 3 PARAGRAPHS HERE REGARDING THE
BACKGROUND OF YOUR STUDY AND ITS SIGNIFICANCE. CITE RELEVANT
REFERENCES AND ATTACH A REFERENCE LIST AT THE END OF THIS FORM.

4. RESEARCH DESIGN AND METHODS :
    a. Research Design
A quantitative, descriptive, correlational study will be performed.

   b. Hypotheses or Research Questions
This study seeks to address the following research questions in a group of 70 adults
aged 50 or over who have been diagnosed with hip or spine osteoporosis?

           1) What are the levels of depression and quality of life in this group?
           2) What are relevant demographic data, including age, gender, ethnicity,
              marital status, educational level, occupational status, length of diagnosis,
              and treatments utilized, in this group?
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           3) What are the relationships between depression, quality of life, and selected
              demographic variables (age, gender, ethnicity, marital status, educational
              level, occupational status, length of diagnosis, treatments utilized) in this
              group?


   c. Definition of Variables (if quantitative)

For the purposes of this study:

1. Depression is defined as a dysphoric mood state and will be measured by the Geriatric
Depression Scale (GDS) (See Appendix X).

2. Quality of life is defined as the perceived overall satisfaction with life and will be
measured by the Missoula-Vitas Quality of Life Index (MVQOL) (See Appendix X).

3. Demographic variables are defined as age, gender, ethnicity, marital status,
educational level, occupational status, length of diagnosis, and treatments utilized for
relief of osteoporosis and will be measured by the researcher-developed Demographic
Profile Questionnaire (See Appendix X).



   d. Describe all the questionnaires and/or survey instruments you will use as well
      as the equipment with which the subject will interact. Please provide a brief
      description of all questionnaires/survey instruments (include reliability/validity
      information) and equipment, citing the source/manufacturer where applicable.
      Attach copies of each questionnaire/survey instrument as an appendix.

1. Geriatric Depression Scale (GDS) (Appendix X)

The Geriatric Depression Scale (GDS) was first developed by Yesavage et al (1983) and
has been used extensively in the older population. The GDS is a 30- item questionnaire
using a dichotomous (yes or not) response format. Its validity and reliability have been
established in a group of community dwelling elderly persons. A Cronbach’s alpha of
0.94 was derived, suggesting a high degree of internal consistency. The (GDS) was found
to have a 92% sensitivity and an 89% specificity when evaluated against diagnostic
criteria.


2. Missoula-Vitas Quality of Life Index (MVQOL) (Appendix X)

The Missoula-Vitas Quality of Life Index (MVQOLI) is a 15-item, multidimensional
instrument assessing the five dimensions of symptom, function, interpersonal
relationships, well-being, and transcendence. The item structure of the instrument and a
scoring system that allows the weighting of each dimension of quality of life by the
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respondent are unique features of the instrument. The instrument has been developed to
provide a measure of quality of life that is meaningful to patients, based on the subjective
wording of the items that allows respondents to interpret the measured elements
according to their own experiences. A person’s quality of life can range from suffering
associated with physical distress, to the experience of wellness and personal growth
arising from the completion of developmental work (Byock & Merriman, 1998). The
validity and reliability of the patient-reported survey instrument was tested with 257
patients in 10 community hospices. Cronbach’s alpha equaled 0.77 and demonstrated
internal consistency. Information from the instrument will contribute to crafting highly
specific interventions, by evaluating patient identified sources of distress, strength, and
satisfaction (Byock & Merriman, 1998).

3. Demographic Data Questionnaire (Appendix X)
The demographic profile questionnaire is a 9-question instrument developed by the
researcher. Data from the questionnaire will enable the researcher to correlate specific
demographic variables with other study variables. The questionnaire has been designed to
collect the following data: age, gender, ethnicity, marital status, educational level,
occupational status, financial ability to pay for health care, length of diagnosis, and
treatments utilized.

Equipment:

Participants will fill out pencil and paper questionnaires as listed above.

     e. Data Collection Procedures:
 In response to viewing the flier (Appendix X) posted in public places, including the
Bedrock Osteoporosis Clinic , the potential study participant will telephone the researcher
with the phone number provided on the flyer. During this initial telephone contact, the
study will be explained and any questions regarding the study will be answered. Should
the potential participant continue to express interest, a time will be arranged for the data
collection meeting, at a location convenient to the participant. It is anticipated that data
collection will occur in either the participants’ ho mes or in another neighborhood
location, such as a coffee shop, and will take approximately 60 minutes. At this data
collection meeting, written, informed. consent (Appendix X) will be obtained and the
participant will be given an opportunity to ask any questions or discuss any concerns. A
copy of the consent from will the given to the participant to keep. The researcher will
then administer the Demographic Profile Questionnaire (Appendix X), the Geriatric
Depression Scale (Appendix X), and the Missoula-Vitas Quality of Life Index (Appendix
X). The researcher will then thank the participant for their participation and give them
$10 in cash. Should the participant wish to stop the data collection meeting or withdraw
from the study for any reason, the $10 will still be given to them.


f. Data Analysis Procedures:
The Statistical Package for the Social Sciences (SPSS/11.5) will be used to perform
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the analysis of data. Descriptive statistics will be used to summarize the demographic
variables and to identify central tendency, variability and percentages of key variables.

Pearson Product-Moment Correlations will be used to examine the shape and degree of
relationships among between study variables.

5. HUMAN SUBJECTS
    a. Describe the subjects: Include the total number to be recruited and
       inclusion/exclusion criteria. If the study includes members of a vulnerable
       population (see Part Two, Section 1.D of the IRB policy available on the web at
       the following URL
       http://www.sandiego.edu/administration/academicaffairs/irb/irb_policy.php) or
       targets a particular religious, racial, ethnic, or sexual-orientation population, then
       state a justification for the choice of subject populations.

A sample of 70 adult participants over age 50 will be recruited using informational flyers.
Flyers will be posted in a variety of public places, including the Bedrock Osteoporosis
Clinics, senior centers, retirement communities, and churches in San Diego County.

The inclusion criteria are as follows: a) age 50 or over; b) have been told by a health
care professional they have osteoporosis of the hip or spine; b) able to speak and
understand English.

The exclusion criteria are as follows: a) do not meet one or more of the above inclusion
criteria.

   b. Describe the recruitment process. Attach a sample of any advertisement,
      brochure, or flyer you will use as an appendix to this application.

Flyers (see Appendix X) will be posted in a variety of public places in San Diego County,
including the Bedrock Osteoporosis Clinic, senior centers, retirement communities, and
churches. If interested, potential research participants will contact the researcher via
telephone after seeing the fliers.

   c. What steps will you take to assure that participation is voluntary? For
      example, will you provide an alternative activity in a classroom setting if a
      student chooses not to participate? Will the participant be told that refusal to
      participate or decision to withdraw will not affect his/her employment status,
      grade, or access to medical care?

   When a potential participant telephones the researcher, the purpose of the study will
   be explained and an opportunity to ask questions about the study will be provided.
   Written informed consent will be obtained prior to informant participation. The
   participants will be informed in writing in the Consent Form and verbally that their
   participation in the study is voluntary and they have the right to: (a) not answer a
   question, (b) terminate the interview, or (c) withdraw from the study at any time in
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   the process. Participants will be assured that their participation or nonparticipation or
   their refusal to answer questions will have no effect on services they receive from
   health or social services providers.

   d. What will the subjects do and/or how will you interact with the subjects?
      Include the estimated duration of subject participation.

The subjects will participate in a 60- minute data collection session consisting of the
administration of the study instruments by the researcher. The interview will be held in a
location convenient for the participant in which privacy can be maintained. Suitable
locations include the participant’s home or a neighborhood location such as a coffee
shop. After obtaining written informed consent (Appendix X), the researcher will
administer the study instruments. Following data collection, participants will be thanked
for their participation and given $10.00 in cash. The $10.00 remuneration will be made
regardless of whether all study instruments were completed or not or whether the study
participant chose to withdraw from the study completely.

   e. List any costs incurred by subjects.

The participants will incur no expenses during the study other than approximately 60
minutes of time. All participants will be compensated with $10 in cash regardless of
whether they finish the entire data collection session or not.

   f. List the location(s) where data collection will be conducted. For non-USD
      facilities, attach a signed letter on institutional letterhead to this application
      documenting the agreement of each of these facilities to participate as an
      Appendix to this application.

During initial telephone contact, the researcher and participant will mutually decide on a
date, time, and preferred setting for the data collection session. The session may
be conducted at the participant’s place of residence or other designated setting of their
choice where privacy can be maintained, such as a local coffee shop.

   g. List ALL Foreseeable Risks to Participants, including fatigue. If you are asking
      questions related to mental or physical health, include the possibility of subjects
      experiencing such emotions as anxiety or sadness. If the above does not apply,
      state: “Risks are minimal”, which means the risks are no greater than experienced
      in everyday life.

Participants will be informe d that they may be at risk for:

           1. fatigue;
           2. negative emotions as anxiety and sadness.
                                                                                            8


   h.    If applicable, include a plan for Minimization of Risks to Participants that
        includes referral to a mental health professional (e.g., the San Diego County
        Mental Health Hotline) if the participant requires further emotional support.

1. If fatigue occurs, (or for any other reason), the participant may terminate the interview
at any time to rest or re-schedule it, or may choose to not continue in the study.

2. If the participant experiences negative emotions such as anxiety or sadness, the
telephone number for the 24- hour San Diego Mental Health Hotline, 1-800-479-3339 will
be provided on the Consent Form for further emotional support if needed.

6. Statement of Risk/Benefit Ratio
Are the potential risks in this study outweighed by the potential benefits?
   State “Yes” or “No” and explain.

Yes. Given the potential benefits, including an enhanced understanding by nurses and
clinicians of depression and quality of life for men and women living daily with
osteoporosis, the potential benefits outweigh the potential risks involved in this study.

7. Protection of Confidentiality
Will all data be coded using numbers or pseudonyms?
    (circle one): Yes No

Will all data collection tools be free of any names or identifiers such as student ID
numbers?
   (circle one): Yes No

Will all data be stored in a locked file cabinet or password-protected computer file?
   (circle one): Yes No

Will only the researcher and his/her advisor (if applicable) have access to the data?
   (circle one): Yes No

Will all data be kept a minimum of 5 years before being destroyed?
     (circle one): Yes No
8. Informe d Consent/Assent
Describe the procedures you will follow to obtain informed consent and/or assent, if
applicable. Attach a copy of the consent and/or assent form(s). Consent forms must
follow the Guidelines for Consent on the IRB website at the following URL
http://www.sandiego.edu/administration/academicaffairs/pdf/irb_forms.pdf and be
written in clear language appropriate for the participant pop ulation. In certain cases such
as retrospective chart reviews, informed consent cannot be obtained. If applicable,
include a justification for waiver of informed consent. Information regarding waivers of
informed consent can be found at the following URL
http://www.hhs.gov/ohrp/humansubjects/assurance/consentckls.htm.
                                                                                          9


Prior to collecting any data, written informed consent will be obtained and the participant
 will be given a copy of the consent form (Appendix X) to keep. Each participant will be
  given the opportunity to read the consent form, discuss it, and ask the researcher any
questions. Each participant will also be provided with two contact telephone numbers for
      further information regarding the study, including that of the researcher and her
  Dissertation Chairperson, Dr. Betty Rubble, of the University of San Diego School of
                                          Nursing.
                                                                                             10


                                        Appendix X

                           Research Participant Consent Form


                      Depression and Quality of Life in Osteoporosis



Introduction

Wilma Flintstone is a doctoral student in nursing at the Hahn School of Nursing and

Health Science at the University of San Diego. You are invited to participate in a

dissertation study she is conducting for the purpose of exploring how much people with

osteoporosis feel depressed and what their quality of life is like.


Procedures

The research project will involve one meeting that will take about 60 minutes. Wilma

will ask you to fill out 3 questionnaires that will ask you information about how you are

feeling emotionally right now and what your quality of life is like. A typical question on

these questionnaires is, “Are you basically satisfied with your life?” You will also be

asked general questions about yourself such as age, occupation, and the kind of

treatments you have received for osteoporosis.


Risks

There may be a risk that you may feel tired or fatigued while filling out the

questionnaires. You can stop at any time to rest, decide not to fill out all the forms, or

withdraw from the study anytime.
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Sometimes when people are asked to think about their feelings, they feel sad or anxious.

If you would like to talk to someone about your feelings at any time, you can call toll- free

24 hours a day:


San Diego Mental Health Hotline at 1-800-479-3339


Benefits


The benefit to participating will be in knowing that you helped nurses and healthcare

providers know more about how to help people who have osteoporosis.


Participant Costs and Payment

The only cost to you is 60 minutes of your time.

You will receive $10 in cash for participating in the research project. Wilma will give
you the $10 even if you start the interview and decide not to finish it, or decide to
withdraw from the study completely.

Confidentiality

Any information provided and/or identifying records will remain confidential and

safeguarded in a locked file in Wilma Flintstone’s home for a minimum of five

years. All data collected from you will be coded with a number and not your name. The

results of the research project may be made public and information quoted in professional

journals or meetings, but information from this study will only be reported as a group,

and not individually.

Voluntary Participation and Withdrawal

Participation in the research project is entirely voluntary and you can refuse to answer

any question and/or quit at any time. Should you choose to quit, no one will be upset
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with you. Wilma will still give you the $10.00. Deciding not to participate or answer

some of the questions will have no effect on your health care or any other services you

might receive from doctors, nurses, or social services.
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More Information

If you have any additional questions about this research project, please contact Wilma
Flintstone at (XXX) XXX-XXXX. You may also contact Dr. Betty Rubble, the professor
who is supervising Wilma’s research, at the University of San Diego School of Nursing
(619) 260-XXXX for additional information.

I have read and understand this form, and consent to the research it describes to me. I
have received a copy of this consent form for my records.



Signature of Participant                                     Date




Name of Participant (Printed)




Signature of Investigator                                    Date
                                                                                   14


Code number_________:

                                      Appendix X

                         Demographic Profile Questionnaire

(Adapt as needed for your study. Note that no names or birthdates should be asked for
                on this form, as they are potential personal identifiers.)

   1. What is your age? ________

   2. What is your gender? M      F

   3. What is your race or ethnicity?___White ___African-American/Black ___

      Hispanic/Latino ____Asian ___ Native American ___ Other

   4. What is your current marital status?

          a. Currently married

          b. Divorced/Separated

          c. Widowed

          d. Single, never married

   5. How many years of schooling have you received? ____________

   6. What is your occupational status?

          a. Full- time outside the home

          b. Full time in the home

          c. Part-time outside the home

          d. Retired

          e. Student
                                                                                       15




7. How easy is it for you to afford medical treatment for your osteoporosis? (circle

   one)

       a. Very easy

       b. Somewhat easy

       c. Somewhat difficult

       d. Very difficult

8. When were you first diagnosed with osteoporosis? (month/year) ________



9. What treatments have you used for osteoporosis? (circle all that apply)

       a. medications

       b. physical therapy

       c. supportive medical device

       d. surgery
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                                APPENDIX X
                      Geriatric Depression Scale (GDS)


                               APPENDIX X
               Missoula-Vitas Quality of Life Index (MVQOL)

(Attach complete copies of all the scales/instruments you will use. Label them as
                             separate appendices.)
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                                   APPENDIX X
                                LETTER OF SUPPORT

Attach copy of a signed letter of support on institutional letterhead from agencies where
                  you will be collecting data or soliciting participation.
     It could be from anyone in a supervisory position, including an administrator.
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                                     Appendix X
                                       FLYER
Attach the actual flyer or advertisement you will be using here. It should clearly state:

    That this is a research study being conducted by a doctoral student at the
     University of San Diego;
    The type of population you are looking for (“People over age 50 who have been
     diagnosed with osteoporosis”)
    The broad, overall focus of the study in layperson’s terms; (“A study is being
     conducted to look at how people with osteoporosis cope with having it”)
    What you will ask participants to do (fill out forms, etc.) and how long it will take
     (“About 90 minutes of your time”)
    A phone number (and/or email address) where you can be reached.
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UNIVERSITY OF SAN DIEGO
          Institutional Review Board (IRB) Investigator Checklist
□ 1) Print this form.
□ 2) Become familiar with the pages of the IRB website located on the Vice President
       and Provosts area of the USD website using the left navigational links.
□ 3) Become familiar with the ethical principles of the Belmont Report by reading about
       them under the Guiding Principles page of the IRB website.
□ 4) Complete the Investigator Training, print and sign the Certificate of Comp letion at
       the end of the tutorial.
□ 5) Read the Instructions for Investigators for detailed instruction pertaining to
       determining the category of review for your proposal.
□ 6) Fill out the IRB Application using the downloadable Word document.
□ 7) Obtain all signatures on the Proposal Cover Sheet, which must be done without
       exception for all three review categories.
□ 8) Follow instructions for submitting IRB forms and proposals that are provided for
       each category of review on the Submission Procedures page of the IRB web site,
       noting the additional photocopy requirements and submission deadlines for
       proposals under the full review category.
□ 9) Read the IRB Notification Process for questions related to investigator notification
       of the proposal’s status.
□ 10) Sign this form (below) and submit one copy of it along with the signed
       Investigator Training Certificate, and completed IRB Application to:
       Hughes Administration Cente r 328, attention Ms. Lori Ermac-Nash.

_____________________________________
Investigator Signature              Date

				
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