PSY 335 Week 4 Mock IRB Proposal Worksheet

PSY 335 Entire Course Link
https://uopcourses.com/category/psy-335/

 PSY 335 Week 4 Mock IRB Proposal
Worksheet

Complete the IRB Proposal Worksheet in relation to your group
proposal.



Click the Assignment Files tab to submit your assignment. 

Institutional
Review Board Application                                        FOR
HUMAN SUBJECTS Research

 

The University of Phoenix
Institutional Review Board (IRB
) exists to ensure university compliance with
federal regulations regarding research involving human subjects.  This application is used to facilitate and
document this compliance review. 
Research projects which meet the federal definition for research and the
federal definition of human subjects must be approved by the University of Phoenix IRB
before any data collection begins.  If an
IRB application is approved by the IRB and, later, the nature of the research
design, requirements, or site locations change, a revised application
describing these changes must be submitted for reconsideration and approval by
the IRB.  This application is intended as
a stand alone document, so reference to other documents or appendices of
dissertation proposals or other research studies does not substitute for direct
provision of that information as part of this application, either as a response
within a section or as an addendum.  This
application pertains to both pilot studies and full studies.  Please note that it is the researcher’s
responsibility to give complete and accurate information about the nature of
the proposed study, particularly in terms of the effects on, and expectations
for, subject participants.  Please note
that you must document currency in CITI certification as part of this
application. 


 




Name of Researcher(s)


City, State, and Country / School or College and University


 
Affiliation
(student, faculty, or staff and id)
 


Type of Research
(research study, *funded research, or other)




 


[city/state]
[college]
University of Phoenix


 
 
IRN: LEAVE THIS BLANK


 
     
 




 
*   If research is funded, please complete the
following agency information.  Otherwise, leave blank.





agency submitted to


submission date


location of project




     
 


      
             /  /    


     




 
1.   Title of the Research Study/Dissertation:

 
 
 
 


2.    
Classification of the Study:
 
 a) Will primary data collection from human
subjects be done in this study?

 
              () Yes, original data only
is collected from human subjects and no archival data will be used.

              () Yes, both original data
from human subjects and archival data will be collected and used.   

              ()  No, only archival data will be used.            
 
 b) Are the research study results
generalizable or relevant to a larger population or only relevant to one

     
       organization or entity?

 
              () Results are
generalizable to a larger population.  

 
              () Results are relevant
only to one organization or entity.                

 




 
3.   Purpose
and Anticipated Study Goal(s) and Benefits:
   Briefly describe the
following:

 
The
purpose of the study:

 
 
The
anticipated study goal(s):

 
 
The
benefits of the study to the subjects, to the organization, and to society:

 
 
 




3.1    Data
Usage and Ownership:    If your research
involves access to, and/or use of, a pre-existing private or restricted
database (one that is not open access/publically available), please briefly
describe the type of data in the database, the organization or individual
owner or controller of the data, how the data will be accessed and how data
confidentiality will be ensured.

 
          a) 
Does this research study involve access to, or use of public, open
access databases or

               datasets,  resources, recruitment lists, contact information
for potential subjects or any other pre-

               existing public data? (Note that “open access” means free and available to the
general public without

               restriction or prior permission needed.)
                 () No                       () Yes (Please describe
here)

 
 
          b) 
Does this research study involve access to, or use of private
databases or datasets, private resources or

               recruitment lists, contact
information for potential subjects or any other pre-existing private data?

                 () No                       () Yes (Please describe
here and document permission granted for access and

                                                                     use)
 
 
          c) 
During data collection or subject recruitment, will access be needed
to any health information created,

             received or archived by health care
providers, clearinghouses, or health care plans that pertains to the

             past, present or future health conditions or
provision of health care to an individual living or deceased?

                 () Yes                       () No
 
                 () HIPAA compliance (if
health records are used, please discuss here and address HIPAA compliance)

 
 
        
 
 
         d) 
Will school or student related data be collected in this study?

                () Yes, individual student
data        (
) Yes, aggregate student
data         (
) No
 
                () FERPA compliance (if
student data is used, please explain here and address FERPA compliance)

 
 
 
 
 
 




 
 4.   Project Description:   Briefly explain and
address the following questions as indicated:

 
       a) Who are the subjects of this study
and where are they located? (for example, lawyers in private practice in the
State of Ohio) 

 
 
       b) 
What are the subjects expected to do as participants in this study and
what is the time commitment involved? Please explain. If class time is used,
please describe the activities planned for non-participants.

 
 
 
      c) Will a pilot study be conducted before the
primary data collection occurs? 
() No    ()  Yes
 
      d) What is the research method and
design? Check all that apply:

            () quantitative
analysis         (
) qualitative
analysis          (
) mixed methods
            ()  phenomenological  () case study    ()  experimental   () quasi experimental    () Delphi
            () other (specify)  ___________________________________________
           
      e)  How will data be collected? Check any that
apply:

            () face to face
interview  (
) focus group  () online survey  () mail survey  () telephone survey 
            () onsite survey  () email survey  () Skype or related
technology  

            () other (specify)
____________________________

           
   
      
      f) Where will data collection occur?
Check any that apply and specify the location(s) below.

            () organizational site  () online  () private premises   () public facility  () open access site
           () other      () not applicable
          
          
           Location
__________________________________________

 
      g)  What is the degree or magnitude of
risk/stress (physical, psychological, emotional, legal, financial) to the   

           human subjects because of their
participation in this study?  

            () minimal risk/stress, not
greater than encountered in ordinary daily life/activities or routine tests.

            () greater than minimal
risk/stress with potential for direct benefit to the individual subjects

            () greater than minimal
risk/stress with little/no potential direct benefit to individual subjects

 
      h) If greater than minimal risk/stress
to the human subject is possible, please explain how the risk/stress will be
mitigated or lessened.

 
 
       i) Are any third parties assisting
with this study that will have access to the data?

           () No   () Yes (specify)
______________________________________

 
      j) Will any aspect of the study take
place outside of the United States?

            () No   () Yes (specify where)
_______________________________________

              Note that IRB approval may be
needed in the country where research is taking place. 

 
          
PLEASE PROVIDE HERE (OR AS AN ADDENDUM TO THIS
APPLICATION) ANY ADDITIONAL INFORMATION

           OR EXPLANATION
THAT YOU THINK MAY BE HELPFUL TO THE IRB REGARDING YOUR RESEARCH STUDY

           DESIGN OR
IMPLEMENTATION.

 
 
 
 
 
 




5.  Subject
Groups:
  Will the subjects recruited to participate in this
study include any that are in protected groups identified below as specified
within the federal human subject guidelines? (The guidelines are defined at
www.citiprogram.org)   

    
      If any category
from this list is checked “yes”, please explain in the “Comments” area below
how the subjects will be protected from harm, risk, or stress as a study
participant and how stress/risk will be mitigated or lessened.

 




    a. Children/minors under age 18?


 


Yes ()


No ()




    b.
Prisoners?



 


Yes ()


No ()




   
c. Pregnant women?



 


Yes ()


No ()




   
d. Cognitively impaired or mentally

       
disabled?



 


Yes ()


No ()




   
e. Educationally or economically

       
disadvantaged?



 


Yes ()


No ()




Will the
subjects be traumatized, comatose, or terminally ill patients?



 


Yes ()


No ()




Will the subjects be elderly or aged persons?


 


Yes ()


No ()




Will the
subjects be minorities (including women)?



 


Yes ()


No ()




Will
information be withheld from subjects prior to, or during, participation?



 


Yes ()


No ()




Will the subjects be college students?


 


Yes ()


No ()




Will the subjects be
deceived, misled, or coerced in any way?



 


Yes ()


No ()




Will/might the subjects be
students of the University of Phoenix?



 


Yes ()


No ()




Will/might the subjects be
faculty or staff of the University of Phoenix?



 


Yes ()


No ()




Will information be
requested that is, or may be, personal or sensitive?



 


Yes ()


No ()




If the subjects are active
duty military, will their supervisors have influence on their participation
in this research or will participation be affected at all by the reporting
relationship(s)?



 


Yes ()


No ()




Will any aspect of this
study involve subjects from countries outside of the U.S.?  If yes, please specify in the comments
section below.



 


 
                Yes ()


 
No ()




 
Comments:
 
 
 
 
 
 
 
 
 
 
 




6.  Subject Recruitment and Selection:   Briefly explain and address the following:
 
     
a)  Which of the following will
be used to find and recruit subjects? (check all that apply and include
copies with

          
this application)

 
            ()   Flyers                                                     
(
)  Email Announcement
            ()   Events, Meetings, Conferences           ()  Area Canvassing
            ()   Phone Solicitation                                 ()  Registry
            ()   Newspaper/Radio/Television               ()  Referrals from Others
            ()   Institutional “gatekeepers”                  ()  Direct Mail
            ()   Face to Face Interaction                       ()  Internet/Websites
            ()   Bulletin Board Post                               ()  Social Media (e.g. LinkedIn, Facebook,
etc.) (please specify

            ()   Poster                                                    
                   below; documented use permission is required)

                                                                                      ()  PhoenixConnect (please note if this is
used,

                                                                                       
                 separate
prior approval through the UOPX

                                                                                                       
Committee on Research must be documented)

 
           ()   Other
(please specify)____________________________________________      

    
      
EXPLAIN AND DESCRIBE HERE IF SOCIAL MEDIA WILL BE USED
____________________________________                                                        

 
     
b)  What is the anticipated sample
size?

            () 10 or less    () 11-20     () 21-50    () 51-99     () 100-199    () 200 or more
 
      c) Will
any external parties (such as editors, translators, interpreters,
statisticians, etc.) provide assistance for

          recruitment
purposes? (This does not pertain to persons who
assist recruitment by “snowball sampling”.)

 
            () No            () Yes (please identify and explain how they will assist)
_____________________________

                                    
 
     
d)  Are any of the research  subjects students, employees, or patients
of the researcher?

            () Yes          () No
 
      e)  If any potential subjects under the
age of 18 years are not selected to participate in this study, what
activities

         
will they be doing during the time the subjects are participating in
the study so that they do not feel excluded

         
or left out? If this scenario does not pertain to the study, please
indicate “Not applicable” here.

 
 
 
     
f)  Please briefly describe the
criteria that will be used to determine the inclusion or exclusion of subjects
for

         
this study.

 
 
 
    
g)  Will any compensation or
remuneration be given to subjects for their participation in this study?

           () No            () Yes (please identify
amount and type, and the plan for dissemination.                 

 
 
        PLEASE PROVIDE HERE
(OR AS AN ADDENDUM TO THIS APPLICATION) ANY ADDITIONAL INFORMATION OR
EXPLANATION CONCERNING THE ABOVE QUESTIONS THAT YOU THINK MAY BE HELPFUL TO
THE IRB REGARDING THE RECRUITMENT OF SUBJECTS FOR YOUR RESEARCH STUDY.

 
 
 
 




7.  Informed
Consent:    Briefly explain and
address the following questions. 
 
 
     
a)  How will subjects be
informed of the study’s purpose, procedures, intent, duration of the study
and any

          
potential risks or discomforts to them?  Check all that apply:

           ()
Informed Consent form  ()
Email  ()
Letter  ()
Meeting ()
Phone Call ()
Other _______
 
      b) 
How will subjects be informed of withdrawal procedures? Check all that
apply:

           ()
Informed Consent form  ()
Email  ()
Letter  ()
Meeting ()
Phone Call ()
Other _______
 
    
c)  How will the researcher
contact information be provided to the subjects? Check all that apply:

          ()
Informed Consent form  ()
Email  ()
Letter  ()
Meeting ()
Phone Call ()
Other _______
 
    
d)  How will subjects withdraw
from the study as participants after data collection is completed?

          ()
Email the researcher    () Phone call to researcher    () Submit withdrawal form
          ()
Other (please specify)
___________________________________________________________
 
     e) 
Please explain what subjects must do to withdraw from the study after
data is collected and how subject data

          will be retrieved and handled to
ensure security and confidentiality.

 
 
 
 
    f) 
If any subjects are under the age of 18 years, parental consent is
required.  What provision is made to

        answer any questions the parents have
about this study or to address any individual concerns?  (For example,

        will there be an informational
meeting with the parents, etc.?) If this scenario does not apply to this
study,

        please indicate “Not applicable”
here.

 
 
 
 
      
PLEASE PROVIDE HERE (OR AS AN ADDENDUM TO THIS APPLICATION) ANY
ADDITIONAL INFORMATION

      
OR EXPLANATION THAT YOU THINK MAY BE HELPFUL TO THE IRB REGARDING ANY
OF THE ABOVE

      
QUESTIONS OR ABOUT THE INFORMED CONSENT FOR YOUR RESEARCH STUDY.

 
 
 
 
PLEASE READ AND CONFIRM THROUGH CHECK MARKING THE BOXES
BELOW:

          I attest that no primary data collection
from human subjects will occur  without
a prior signed Informed  

               Consent form completed for each
subject and that Informed Consent documentation will be retained

               separately from study data.
 
          I attest that a process for subject
withdrawal will be implemented whereby subjects may withdraw without

              penalty before, during and after data
collection has been completed and submitted and that the

              information
they provided will be identified, secured, withdrawn and kept confidential.

 
 




  8.  Confidentiality
and Privacy:
    Briefly explain and address how the
identity and privacy of the individual subjects will be protected.  Check any of the following that apply:

 
       a)  How will subject identity and data be
protected?

            ()   Subject names will not be used or
identified 

            ()   Pseudonyms or numbers will be used instead
of subject names

            ()   Data will be coded alphanumerically
            ()   Other (please specify) ________________________________________________
 
       b) Will any audio and/or video tape or other
recording of data be done in this study? 

            () Yes                               () No
                
       c) How
long will the study data be kept after study completion?

            ()   Three years (please note this is the
minimum required retention time)

            ()   More than three years
 
      d)
Where will the data be stored:

            ()  In an office or other location at the
researcher’s residence

            ()  At an office at the researcher’s place of
employment

            ()  At a third party facility (please specify)
________________________________

            ()  Other (please specify)
______________________________________________

 
      e)
How will data be destroyed at the appropriate time?

            ()  Shredding            ()  Burning or incineration        ()  Smashing          () File Deletion
            ()  Other (please specify)
______________________________________________

 
     
f)  How will the results of this
study be disseminated?

            () Publication            () Presentation             ()  Other _____________________________           
 
       PLEASE PROVIDE HERE
(OR AS AN ADDENDUM TO THIS APPLICATION) ANY ADDITIONAL INFORMATION OR
EXPLANATION CONCERNING THE ABOVE THAT YOU THINK MAY BE HELPFUL TO THE IRB
REGARDING CONFIDENTIALITY AND PRIVACY CONCERNS ASSOCIATED WITH YOUR RESEARCH
STUDY.

 
 
 
PLEASE READ AND CONFIRM THROUGH CHECK MARKING THE BOX
BELOW:

          I attest that the data from this research
will be kept in a secured location for at least three years following

              study
completion, and then will be permanently destroyed.

 
















 

 

 
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