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Application Process for the Institutional Review Board (IRB)

Human Subjects Research


 

I. Introduction

     To assure the protection of human subjects and to comply with Federal law, t​he University of Mount Olive requires that prior to contacting potential study participants; all research projects involving human subjects must be reviewed and approved by the Institutional Review Board for Human Subjects Research (IRB). The IRB has the responsibility for protecting the rights and welfare of human subjects in research.

     The University of Mount Olive has an Insititutional Review Board Organization (IORG)​ with the Office for Human Research Protections (OHRP) in the Department of Health and Human Services. This agreement will assure that all human subjects research conducted under the auspices of the University of Mount Olive will comply with Title 45, Code 46 (Common Rule) of the federal regulations. The University of Mount Olive IRB also adheres to other federal, state, local and institutional guidelines as applicable on the responsible conduct of research.

University of Mount Olive​ 

IORG#00005659 

IRB#00006813

Expires 05/16/2017 (copy provided in document section)

Institutional Review Board (IRB)

​​     The Institutional Review Board for (IRB) for the University of Mount Olive has the responsibility to oversee procedures for carrying out the University's commitment to protect human subjects in research. This oversight includes both internal and externally funded research. The IRB is authorized to approve, require modifications in (to secure approval), or disapprove all research activities using human subjects.​

II. How do I submit a research proposal to the IRB?

A. Complete the NIH Online Human Subject Participant Training 

All researchers who interact with human subjects to collect data must complete the NIH online educational program on ethics and procedures for the use of human subjects in research prior to submitting a proposal to the IRB for review.


     The free NIH Human Subject Research Participant online training course must be completed by the principal investigator (PI), co-principal investigators, and other key personnel who are responsible for the design and/or conduct of the study.

Visit https://phrp.nihtraining.com/users/login.php

      Research assistants, including students, who are collecting data from human subjects including providing explanations or answering questions about the research or data gathering instruments are also required to complete the training program.

     Individuals providing technical services only such as setting up a room, handing out and collecting survey instruments without providing explanations or answering questions about the research or data-gathering instruments, typing data into a data base, transcribing audiotapes, or reviewing videotapes to code behavior, are not required to complete the online training; however, should receive instruction on maintaining privacy and confidentiality of data, and sign a contract with the PI stating such. Docmentation of these privacy contracts must be provided with the IRB application.

B. Submit an IRB Application for Review

     Submit your IRB application (See documents section), and all supporting documentation (i.e., consent forms, participation recruitment flyers, emails, presentations, survey tools, appropriate permissions for sites, participants or research tools, privacy statements for research personnel or transcriptionists, demographic collection tools, etc.) to the IRB Chair in electronic format through UMO email.​​ All students submitting an IRB application must copy their faculty advisor in all communication with the IRB. Applications must be approved prior to any subject recruitment or contact with subjects.
     The objective of IRB committee review is to ensure that the rights and welfare of the subjects are adequately protected and that all activities involving human subjects are in compliance with University policies and Federal regulations to assure that:

    1. The selection of research subjects is equitable
    2. Informed consent is obtained and documented where appropriate
    3. The risk to subjects is minimized
    4. The risks to subjects are reasonable in relation to anticipated benefits to subjects and others
    5. Privacy and confidentiality are protected
    6. Data handling and safety monitoring provisions are adequate
    7. V​ulnerable subjects are provided special safeguards against undue influence or coercion to participate in the research.

III.  Types of Protocol Review

A. New Protocol Review - All new research projects involving human subjects.

     Submit an IRB application and supporting materials as specified on the application form to the IRB Chair for full protocol review or  expedited review. Note the deadlines for submissions below. The researcher may be contacted by the IRB Chair to submit additional information and/or make changes. Exceptions to these deadlines are approved by IRB committee vote and administered by the IRB Chair (i.e., MSN students in their first semester of their research sequence are a planned exception to these deadlines, etc.).

  • Applications for expedited review must be submitted 10 working days prior to the second Monday of the month.
  • Applications for full-protocol review must be sumbitted 10 working days prior to the third Monday of the month in August, November, February, and May. Note that the IRB meets only four times per year for full-protocol review.

B. Revisions to an Approved Protocol - Any changes in an approved protocol.

     Researchers are required to report any changes in an approved protocol to the IRB Chair, including subject population, study location, procedures, or project personnel for review prior to initiating the changes. Researchers shall submit a description of the proposed changes, and the revised protocol that incorporates the proposed changes.

C. Continuing Project Review

     All research involving human subjects must be re-reviewed every twelve months or more frequently if specified in the original approval notification. This applies to studies for which data are continuing to be collected.

     For review of continuing projects, researchers shall submit a status report and supporting materials to the IRB Chair. Research projects are not eligible for continuing review if the project’s approval has expired. A new protocol application needs to be filed in this situation.

IV. Researchers’ Responsibilities for Responsible Conduct of Research

     Researchers shall obtain approval for proposed human subjects research prior to recruiting subjects or collecting data from subjects. This applies to preliminary and pilot studies which are developing or testing instruments and procedures, as well as the full study.

     Researchers shall explain to subjects, prior to their decision about whether or not to participate, the objectives of the research, the procedures to be followed and the potential risks and benefits. Researchers shall not use individuals as subjects unless satisfied that they, and/or others legally responsible for their well-being, fully understand the consequence of participation and freely consent to participate in the research. The IRB may waive these requirements for written informed consent only when persuaded that the research cannot otherwise be done, that its potential value outweighs the indignity to the subject, and that the subject runs no further risk or harm in participating. Researchers shall seek consent from subjects to participate only under circumstances that provide the prospective subject sufficient opportunity to consider and decide freely whether or not to participate. Subjects shall be given a copy of the informed consent materials to keep.

     Researchers shall make clear to subjects that participation is voluntary and that they are free to withdraw from active participation in the research at any time. Subjects who indicate a desire to withdraw shall be allowed to do so promptly and without penalty or loss of benefits to which the subject is otherwise entitled.

     Any payment to subjects must be reasonable and prorated with partial payment in the event subjects discontinue participation during the course of the study.

     Researchers shall respect the privacy of subjects. They shall protect confidential information given them, advising subjects in advance of any limits upon their ability to ensure that the information will remain confidential.

     Researchers shall obtain approval from the IRB prior to making any changes in the research procedures. This approval shall be done in a timely manner (within 10 business days).


V.  Student Research Projects

A. Student Research Projects designed to add to generalizable knowledge through dissemination of results in publications or presentations beyond the classroom. 

     Such student projects are research and must have IRB approval. Faculty members who assign or supervise research conducted by students are responsible for ensuring that the proposed research is reviewed and approved by the IRB, conducted in accordance with University policy. The faculty supervisor is also responsible for ensuring that the student is qualified to adequately safeguard the well-being of all subjects and confidentiality of all data.

B. Class Projects designed to provide hands-on experience or research training.

     Such projects are not treated as research projects and do not require formal IRB review. Projects in this category are expected to be confined to the specific class and end at the termination of that class. If it is anticipated that the research project will be used in other classes, published, or presented beyond the classroom, the project is required to be submitted to the IRB for review. Faculty members who assign research learning experiences are responsible for assuring that people used in such projects are treated ethically. Faculty members must provide information to students on University policies and guidelines on human subjects research and develop class procedures in a manner that protects the privacy, dignity, and welfare of participants.


 

 

 

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Institutional Review Board (IRB) Members 

 ​​

Chair

Dr. Joy Kieffer

(2013 to present)​​​

Division​ Chair & Assoc. Professor ​of Nursing

jkieffer@UMO.edu

Institutional Officer

Dr. Julie Santiago

(2014 to present)

Director of Institutional Research & Planning

jsantiago@UMO​.edu

Full Members

Vice Chair

Ms. Jackie Hill 

(Non-Scientist)

(2011 to present)​

Librarian

jhill@UMO.edu

Ms. Ginny Renkienwicz

(2016 to present)

Instructor of
 Healthcare Mangement

grenkiewicz@UMO.edu


Dr. Ivan Danchev

(2013 to present)

Asst. Professor of Physics

idanchev@UMO.edu

Dr. Sandra Ixa Plata-Potter

(2016 to present)

Asst. Professor of Early Childhood Education

splata-potter@UMO.edu

Dr. Leem Shim

(2014 to present)

Assoc. Professor of Computer Information Systems

lshim@UMO.edu

Dr. Ron Stevens

(2016 to present)

Director of Assessment Services

rstevens@UMO.edu

Dr. Jennifer Sugg

(2016 to present)

Asst. Professor of Nursing

jsugg@UMO.edu


Dr. Stephen Edwards

(2016 to present)

Asst. Professor for Agriculture Education

sedwards@UMO.edu

Dr. Tony Franklin

(2016 to present)

Asst. Professor of Sports Management

afranklin@UMO.edu


Dr. Roselie McDevitt

(2016 to present)

Professor of
 Accounting

rmcdevitt@UMO.edu

Dr. Guy Bradbury

(2016 to present)

Asst. Professor of
 Mangement

gbradbury@UMO.edu

Mr. Michael "Todd" Hatley

(2016 to present)

Instructor of Healthcare Mangement

mhatley@UMO.edu



​Community Members

 Ms. Tammy Keel

(2013 to present)​

Principal – Mount Olive Middle School

tammykeel@wcps.org      

Ms. Denise Brigham

(2013 to present)​

UMO Division of Nursing Adjunct Faculty​​​

Denise.Brigham@UMO.edu
  
  
IRBReviewerTemplate08-2016.pdf
  
UMO IRB Expiration 05132019.pdf
  
UMOExpeditedvsExempt.pdf
  
UMOIRBApplication2016.docx
  
UMOIRBConsentTemplate06-2016.doc
  
UMOIRBInformedConsentChecklist06-2016.pdf
  
UMOIRBManualv05-12-2016.pdf