Fillable Application For IRB Review - 09-11-2017

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Application For IRB Review - 09-11-2017

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Dickinson State University
Institutional Review Board (IRB) for the Protection of Human Subjects in Research
All research with human subjects conducted at DSU must be approved by the IRB. If you believe your research is exempt
from IRB approval, please review and complete the exemption form.
I. THE RESEARCH TEAM
A. Principal Investigator/Researcher
The Principal Investigator/s (PI) conducts and directs the study. S/he acts as the main contact person for the IRB, and
carries full responsibility for the study and must provide documentation of completed Human Subject training.
Name:
Title:
Department:
Email:
Address:
Phone:
Yes
No
B. Co-Investigators
Co-investigators are those other than the Principal Investigator who conduct, direct, and are responsible for the
study. Co-Investigators must provide documentation of completed Human Subject training. If more than one co-
investigator is involved in the study, please list them in “Other,” below.
______ I have co-investigators for this project. ______ I have no co-investigators for this project.
Name:
Title:
Department:
Email:
Address:
Phone:
Other co-
investigators:
Is documentation of Human Subjects training attached for each individual?
Yes
No
C. Other personnel
Other personnel include all team members other than the principal investigator and co-investigator/s who assist in
the execution of the study. This may include students. Please indicate in “Role” if this person is a student, employee,
or has another relationship with the campus.
______ I have other personnel for this project. ______ I have no other personnel for this project.
Name:
Role:
Name:
Role:
Name:
Role:
Others:
Is documentation of Human Subjects training attached for each individual?
Yes
No
II. THE RESEARCH PROJECT
A. Project Title:
B. Objectives:
List your research objectives, including the purpose of the study and research questions or hypotheses.
C. Procedure:
Provide a detailed description of the research design including (a) a step-by-step description of what will
happen to the subjects, (b) a timeline for the project, (c) and a description of the materials used.
D. Subjects:
Provide a detailed description of the desired subjects including (a) the population of interest, (b) the
number of subjects that will be used to represent that population, and (c) a description of the desired
demographic of the subject pool including age, sex, race, or any other specific characteristics.
E. Special Populations: Please check all of the following that apply and complete the appropriate Section if indicated.
Adults, Non-students
(No additional forms) Minors under 18 (Complete Section D
DSU students
(Complete Section B) Cognitively Impaired (Complete Section E)
Prisoners
(Complete Section C) Other (Please explain below)
F. Recruitment:
Provide a detailed description of (a) all sources of potential subjects, (b) all the mechanisms through which
subjects will be recruited, (c) the exclusion and inclusion criteria. All recruitment documents must be
included as attachments.
G. Risks:
Provide a detailed description of (a) any potential risks to subjects even if minimal, (b) procedures that will
be used to minimize the risks, and (c) procedures that will be followed if any harm comes to a subject.
Every study has some potential risk, so “no potential risk” is not an acceptable statement.
H. Benefits:
Provide a detailed description of (a) any benefits to the subjects themselves for participating in the
research, including compensation of any sort, (b) benefits to the researchers, if any, and (c) benefits to the
greater knowledge base.
I. Confidentiality
Provide a detailed description of (a) how confidentiality of subjects will be protected during data
collection, (c) how confidentiality of subjects will be protected during data analysis, (c) how data will be
safeguarded and stored after the study is complete, (d) how and when data will be destroyed or archived,
and (e) who will have access to the data at each stage of the study.
FUNDING
Does this project have an outside funding source?
Yes*
No
*If you answered “Yes” to the question above, you must complete Section A – Funding Source
III. INFORMED CONSENT
Unless waived by the IRB, informed consent is necessary for all research involving human subjects and must be
documented in some manner. The investigator may determine which method would best serve the interest of the subject
population, but the IRB reserves the right to require alternative or more stringent means of securing consent. Use of subjects unable
to give personal consent for reasons of age, mental state, legal or other such status requires that consent be secured from parents
or a legal guardian.
The traditional informed consent process may be waived under particular conditions. Please review the conditions at this
link http://answers.hhs.gov/ohrp/questions/7268
if you believe your project qualifies for waiver of informed consent. If you would
like to apply for a waiver of Informed Consent, please complete the waiver form in Section F.
______ Waiver of consent is requested. If checked, please complete the waiver form in Section F
______ Waiver of consent is NOT requested. If checked, please continue below.
INFORMED CONSENT FOR ADULT SUBJECTS
This section is for competent adult subjects only. If you plan to work with minors or with another special population,
please complete the appropriate form in Section C through E.
1. Process:
Please describe the procedures used to obtain informed consent including (a) how informed consent
will be obtained, (b) where consent will be obtained, and (c) who will obtain the consent.
2. Understanding:
Please describe how you will ensure that the subjects understand the information presented. If
English is not the native language, how will translation be provided?
3. Competence:
Will all adult subjects be competent to give consent? If not, how will competency be assessed and
how will proxy consent be obtained?
4. Documentation:
Please indicate all of the ways in which informed consent will be documented. A copy of the
consent form must be attached to this document.
IV. ASSURANCES AND RESPONSIBILITIES
As principal investigator(s)/researcher(s), I hereby offer assurance of each of the following:
_____ I will follow procedures to safeguard and protect the rights and welfare of the subjects of my research.
_____ I will not begin data collection until I receive a written approval from the IRB.
_____ I will use a third party to solicit participation, administer the study, and collect data when subjects are either students in a
course for which I am the instructor or under my direct supervision.
_____ I acknowledge responsibility for each of the following:
_____ Protecting the rights and welfare of human subjects
_____ Complying with all applicable federal and IRB regulations
_____ Conducting the research according to the IRB expedited or full board protocol
_____ Reporting any changes in previously approved protocols to the IRB prior to implementation
_____ Reporting unanticipated injuries or problems involving risks to human subjects to the IRB
_____ Maintaining all approved protocol documents and notifications for three years after completion of the protocol
_____ Supervising all research conducted by students
_____ Obtaining approval for continuation protocols.
Checklist: For each of the following, please indicate whether the forms are attached or not applicable.
• Section A – Funding Source _____ Attached _____ Not Applicable
• Section B – DSU Students as Subjects _____ Attached _____ Not Applicable
• Section C – Prisoners as Subjects _____ Attached _____ Not Applicable
• Section D – Minors Under 18 as Subjects _____ Attached _____ Not Applicable
• Section E – Cognitively Impaired People as Subjects _____ Attached _____ Not Applicable
• Section F – Consent Waiver Form _____ Attached _____ Not Applicable
• Informed Consent Form _____ Attached _____ Not Applicable
• Child Assent Form _____ Attached _____ Not Applicable
• Materials to be used in the study such as surveys, questionnaire, tests, etc. _____ Attached _____ Not Applicable
• Recruitment materials _____ Attached _____ Not Applicable
• Documentation of Human Subjects Training for all Researchers _____ Attached _____ Not Applicable
Please submit the completed IRB Form as signed and scanned PDF attachments or as paper copies to the chair of the IRB. Contact
information for the chair may be found at
http://www.dickinsonstate.edu/academics/academic_resources/academic_affairs/forms/irbforms.aspx
As principal investigator, I agree with all of the researcher assurances and responsibilities above.
________________________________________________ ____________________
Signature of Principal Investigator/Researcher Date
As faculty advisor, I hereby accept responsibility for the conduct of this project.
________________________________________________ ____________________
Signature of Faculty Advisor if a student is the principal investigator Date
************************************************************************************************************
Date received: _____________________________ Protocol Review Number: ________________________
Review completed: _____________________________ Notification sent: ________________________
IRB members present to review the application:
________________________________________________ ____________________
Signature of Chair of IRB committee Date
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Application For IRB Review - 09-11-2017

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Completed 15 November 2019

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