Fillable IRBFORMA-2015-2016 Southern Adventist University – Institutional Review Board

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IRBFORMA-2015-2016 Southern Adventist University – Institutional Review Board

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The IRBFORMA-2015-2016 Southern Adventist University – Institutional Review Board form is 7 pages long and contains:

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1
FORM A
Not required for a literature review/academic exercise.
RESEARCH APPROVAL
Title of Research Project:
Resear
ch Request: _____Exempt _____Expedited _____Full Review _____Other (Animal/Plant)
Principal Investigator:
E-mail Address:
Phone #:
Co-Investigator:
E-mail Address:
Phone #
Co-Investigator:
E-mail Address:
Phone #:
Co-Investigator
E-mail Address:
Phone #:
Department:
Faculty Supervisor:
Starting Date:
Estimated Completion Date:
Information About Cooperating Institutions: Is this research being done with any institutions, individuals or
organizations not affiliated with SAU? If yes, please provide the names and contact information of
authorized officials below.
Name of Institution
Address:
Contact Name:
Phone #:
Contact E-mail:
External Funding Agency:
Identification # ( if applicable)
Grant Submission Deadline (if any)
Please attach all of the following items, making sure the entire application is completely filled out (where
applicable) before submitting the application:
• Any research instruments (tests, surveys, questionnaires, protocols, or any form else used to collect data)
• All informed consent documents
• Permission from applicable authorities (principals of schools, teachers of classrooms, etc.) to conduct
your research at their facilities on their School Letterhead.
• Students need signatures from their faculty advisor.
This box is for Southern – IRB Office Use Only
IRB
Tracking #
Date Received
Exempt Expe
dited Full Review Animal/Plant
1) IRB B
oard Approver __________________________ _______________________ ______________
Name Title Date
2) IRB Board Approver __________________________ _______________________ ______________
Name Title Date
Date Approval Sent____________
2
All student applications must be signed by the faculty advisor then scanned and submitted
electronically, or submitted directly by the faculty advisor. All applications should be submitted by
email to irb@southern.edu.
Please be aware you cannot begin your research until it has been officially approved by the IRB.
Type of Research- Check all areas that apply
Dissertation/Thesis
Background and Rationale for the Study: (This section should present the context of the work by explaining
the relation of the proposed research to previous investigations in the field. Include citations for relevant
research.)
Applying for ARC Funding
Funded Faculty Research
General Faculty Research
Student Research
Animal/Plant
3
Purpose/Objectives of the Research: (Briefly state, in non-technical language, the purpose of the research
and the problem to be investigated. When possible, state specific hypotheses to be tested or specific research
questions to be answered. For pilot or exploratory studies, discuss the way in which the information obtained
will be used in future studies so that the long-term benefits can be assessed.)
4
Methods and/or Procedures:(Briefly discuss, in non-technical language, the research
methods which directly
involve use of human subjects. Discuss how the methods employed will allow the investigator to address his/her
hypotheses and/or research question(s).)
5
Description of Research Sample: If human subjects are involved, please check all that apply:
Minors (if minors are involved please attach a Childs Assent Form)
Prison Inmates
Mentally Impaired
Physically Disabled
Institutionalized Residents
Anyone unable to make informed decisions about participation
Vulnerable or at-risk groups, e.g. poverty, pregnant women, substance abuse population
Health Care Data Information -be sure to attach any necessary HIPAA forms if this line is checked
Animals or plants will be used
Other: please describe:
Approximate Number of Subjects:
Participant Recruitment: Describe how participant recruitment will be performed. Include how potential
participants are introduced to the study. Attach any recruiting materials you plan to use and the text of E-mail
or Web-based solicitations you will use at the end of the documment.
Content Sensitivity:
Does your research address culturally or morally sensitive issues?
If yes, please describe:
Privacy and Confidentiality:
Efforts will be made to keep personal information confidential.We cannot guarantee absolute confidentiality.
Personal information may be disclosed if required by law. Identities will be help in confidence in reports in
which the study may be published and databases in which results may be stored.
Will personal identifiers be collected?
Will identifiers be translated to a code?
Will recordings be made (audio, video)
If yes, please describe.
Is Funding being soug
ht to support this research?
Indicate if the funding is:
Is there a funding risk?
Who will keep the financial records?
Who will have access to data (survey, questionnaires, recordings, interview records, etc.)? Please list below.
6
Participant Compensation and Costs
Are participants to be compensated for the study? If yes, what is the amount, type and source of
funds:
Amount $
Type:
Source:
Will participants who are students be offered class credit?
Are other inducements planned to recruit participants?
I
f yes, please describe:
Are there any costs to participants? If yes, please explain
Other: Animals/Plants
Are the animals/plants being studied on the endangered list?
Are Scientific Collection Permits required, i.e. Tennessee Wildlife Resources Agency?
Have the animal(s) utilized in this study already been used in a previous study (non-naïve animals)?
Will the animal(s) used in this study be used in a future study?
Where will the animals be housed?
Will the rodents (if applicable) be housed in wire bottom cages?
Will plants be used for instructional purposes as part of teaching a course?
Are there any risks involved with this study?
Are there any potential damage or adverse consequences to researcher, participants, or environment? These
might include physical, psychological, social, or spiritual risks whether as part of the protocol or a remote
possibility. Please indicate all that apply.
Physical Risk: May include pain injury, and impairment of a sense such as touch or sight. These risks
may be brief or extended, temporary or permanent, occur during participation in the research or arise
after.
Psychological Risk: Can include anxiety, sadness, regret and emotional distress, among others.
Psychological risks exist in many different types of research in addition to behavioral studies.
Social Risk: Can exist whenever there is the possibility that participating in research or the revelation
of data collected by investigators in the course of the research, if disclosed to individuals or entities
outside of the research, could negatively impact others’ perceptions of the participant. Social risks can
range from jeopardizing the individual’s reputation and social standing, to placing the individual at-risk
of political or social reprisals.
Legal Risk: Include the exposure of activities of a research subject “that could reasonable place the
subjects at risk of criminal or civil liability”.
Economic Risk: May exist if knowledge of one’s participation in research, for example, could make it
difficult for a research participant to retain a job or find a job, or if insurance premiums increase or loss
of insurance is a result of the disclosure of research data.
Spiritual Risk: May exist if knowledge of one’s spiritual beliefs or lack of, could be exposed which in
turn could invoke an economic, social and or psychological risk.
No
7
Risks: In your opinion, do bene
fits outweigh risks?
Results:
The results will be disseminated as :
Class
work only
Published article
Student conf
erence Professional conference
Other If other, please specify:
Signatures: If submitted by the faculty advisor's email address, electronic (typed) signatures are acceptable
for both faculty advior and student. Only PDF files and Word documents are acceptable submissions.
Principal Investigator (PI) or Student Date
___________________________________ ___________________
Faculty Advisor (for student applications) Date
All student applications must be signed by the faculty advisor and submitted electronically via
email by the faculty advisor. All applications should be submitted by faculty advisor to:
irb@southern.edu
Additional Special Requirements or Attachments to the Application
Approvals from other IRBs
Cooperative research projects involve research that involves more than one institution. In these instances,
federal law holds each institution responsible for safeguarding the rights and welfare of human subjects and for
complying with federal policy; therefore, SAU IRB applications must be made even if there is another
institution conducting a review of the same research project. When a study is being carried out at a non-USA
site, and approval from other institutional review boards at the foreign site must be sought. The IRB
recommends that a copy of each IRB approval be submitted.
Questionnaires/Other Instruments
Any questionnaires, tests, survey instruments or data collections sheets which are not standard and well known
must be submitted as part of the application. Structured interview questions and outlines for unstructured
interviews also must be included.
Advertisements/Notices/Recruitment Flyers
The text of any advertisement, video display, notice, sign, brochure or flyer used to recruit subjects either
should be included as an attachment.
Please explain how you plan to minimize the risks identified above:
No
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IRBFORMA-2015-2016 Southern Adventist University Institutional Review Board

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Completed 10 February 2020

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