When to ask?

All research involving the use of human subjects subject to the Marshall University Human Research Protection Program MUST be submitted to an Institutional Review Board (IRB) designated by Marshall University for review and approval PRIOR to initiation of the project.

When there is any doubt as to whether or not a study could qualify as human subject research, you should submit an abstract to ORI for an IRB Chair to review and make a determination.  This abstract must be written in lay terms, should be 500 words or less and include the following information:

• The Purpose of the Research:

• The Scientific or Scholarly Rationale:

• The Procedures to be Performed:

• A Description of What Procedures Were Being Performed Already for Diagnostic or Treatment Purposes:

• The Risks and Potential Benefits of the Research:

• Complete Inclusion/Exclusion Criteria

The abstract can be mailed, hand delivered or emailed to the respective IRB Coordinator.  The contact information for the IRB Coordinators:

   IRB#1 (Medical), Trula Stanley, (304) 696-7320, stanley@marshall.edu

   IRB#2 (Social/Behavioral), Bruce Day, (304) 696-4303, day50@marshall.edu

Once the IRB Chair has made a determination, the respective IRB Coordinator will contact you to communicate the decision.

Thesis Abstracts may be submitted to the Director, Office of Research Integrity for a determination as to whether or not it is human subject research.  If the thesis is deemed to be human subject research then you will be directed to the appropriate IRB Coordinator for assistance.  If the thesis is deemed not to be human subject research then you will be provided a letter stating that determination.

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What is Human Subject Research?

Activities are human subject research under DHHS regulations when they meet the DHHS definition of “research” (45 CFR §46.102(d)) and involve a “subject” as defined in DHHS regulations (45 CFR §46.102(f)).

Activities are human subject research under FDA regulations when they meet the FDA definition of “research” (21 CFR §50.3(c), 21 CFR §56.103(c), 21 CFR §312.3(b), or 21 CFR §812.3(h)) and involve a “subject” as defined in FDA regulations (21 CFR §50.3(g), 21 CFR §56.103(e), 21 CFR §312.3(b), or 21 CFR §812.3(p))

Research:

Under DHHS regulations (45 CFR §46.102(d)) is defined as:  A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Under FDA regulations (21 CFR §50.3(c) is defined as:  Any experiment that involves a test article and one or more human subjects, and that either is subject to requirements for prior submission to the Food and Drug Administration.

Human Subject:

Under DHHS Regulations (45 CFR §46.102(f)) is defined as:  Living individual(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information. 

Under FDA regulations (21 CFR §50.3(g) a human subject is defined as:

• An individual who is or becomes a participant in research, either as a recipient of the test article or as a control.  A participant may be either a healthy human or a patient.

• Or in the case of a medical device: A human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control.  A participant may be in normal health or may have a medical condition or disease.

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What is NOT Human Subject Research?

Data collection for internal departmental, school, or other institutional administrative purposes. (i.e. teaching evaluations, customer service surveys)

Information-gathering interviews where questions focus on things, products, or policies rather than about people or their thoughts. (i.e. canvassing librarians about inter-library loan policies or rising journal costs)

Publicly available data does not require IRB approval.  (i.e. for internal departmental, school, or other institutional administrative purposes. (i.e. teaching evaluations, customer service surveys)

Coded data that were not collected for the currently proposed projects as long as the investigator receiving the data cannot link the data back to the individual.

Case Studies which are published and/or presented at national or regional meetings are often not considered human subject research if the case is limited to a description of the clinical features and/or outcome of a single patient and do not contribute to generalizable knowledge.  (for example: the comparison of case studies would qualify as human subject research)

Note:  When there is any doubt as to whether or not a study could qualify as human subject research, you should submit an abstract to ORI for an IRB Chair to review and make a determination.

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What information to submit?

All human subject research is submitted via the IRBNet online submission program.  The study should be submitted to the appropriate IRB:

• Applications for medical/biological research should be submitted to IRB #1

• Applications for social/behavioral research should be submitted to IRB #2

• Applications for studies that have been approved under the National Cancer Institutes Central IRB should be submitted to the MU CIRB.

The following must be submitted with the Protocol Application Form:

• Protocol

• Abstract (Lay summary)

• CITI Educational Course Certificate

• Curriculum Vitae and/or Resume for each Investigator

• Informed Consent(s)

• Child Assent (If Applicable)

• Waiver of Informed Consent/HIPAA Waiver (If Applicable)

• Survey/Interview Questions (If Applicable)

• Recruitment Materials (If Applicable)

• Initial Protocol Assessment Form (For Full Board Initial Studies Only)

• Expedited Protocol Assessment Form (For Expedited Studies)

• Permission Letter(s) From Schools or Businesses (If Applicable)

If you are not sure if a study qualifies as human subject research then you should submit an abstract to the Office of Research Integrity for a determination.   

If a research study abstract is submitted for determination of human subject research, then the IRB coordinator will notify you of  the IRB chair's determination.  If the study is deemed to be human subject research then you will receive assistance on the process of application submission. If the study is deemed not to be human subject research then you will receive a letter to that effect. 

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Who has the authority to make a determination?

Each IRB Chair has the authority to determine if a study qualifies as human subject research and the subsequent category in which it may qualify.  Thesis determinations as to whether or not it is human subject research may be made by the Director, Office of Research Integrity or an IRB Chair. 

Case Studies/Presentations - Case studies/presentations with literature review but without further analysis have been regarded as a medical education activity, not research at all.  In this situation, no IRB notification or classification should be required since it is not human subject research for IRB purposes.  Of course, if an investigator is unsure whether an activity is human research or not, he/she should contact the Office of Research Integrity (304) 696-7320 and submit an abstract for a judgment on that point.

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Who will communicate the decisions to you?

The IRB coordinator will relay all communications between the IRB and the investigator via email and correspondence.  This may include:

• Need of additional information

• Missing documents

Once an application has been reviewed and a determination made then the IRB coordinator will notify you via email and written notification of the decision of the Chair or convened board. 

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