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 the Office of Research Integrity for an IRB chairman or the director to review and make a determination. This abstract must be written in lay terms, should be 1-2 pages max, and should 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 (if applicable);
- The risks and potential benefits of the research; and
- Complete inclusion/exclusion criteria (this can be submitted separately if extensive).
The abstract can be mailed, hand delivered or e-mailed to the Office of Research Integrity (ORI). The ORI contact information is:
Office of Research Integrity
Weisburg Applied Engineering Building – Rm 4211
304-696-4303
Once a determination has been made, the ORI will contact you to communicate the decision.
Thesis/Dissertation Abstracts may be submitted to the Director of the 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.
Activities are human subject research under DHHS regulations when they meet the DHHS definition of “research” (45 CFR §46.102(l)) and involve a “human subject” as defined in DHHS regulations (45 CFR §46.102(e)).
Activities are human subject research under FDA regulations when they meet the FDA definition of “research/investigation” (21 CFR §50.3(c), 21 CFR §56.102(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 §56.102(e), 21 CFR §312.3(b), or 21 CFR §812.3(p))
Research:
Under DHHS regulations (45 CFR §46.102(l)) 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(e)) is defined as: A living individual about whom an investigator (whether professional or student) conducting research:
(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
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 subject may be either a healthy human or a patient.
Definition of Engaged in Research:
A person is considered engaged in a particular non-exempt human subject research project when he/she for the purposes of the research project obtains: (1) data or biospecimens related to the subjects of the research through intervention or interaction with them; (2) identifiable private information or identifiable biospecimens related to the subjects of the research; or (3) the informed consent of human subjects for the 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., internet data, census data, labor statistics, public records).
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 the Office of Research Integrity for an IRB chairman or the director to review and make a determination.
All human subject research is submitted via the IRBNet online submission program. The study should be submitted to the appropriate Institutional Review Board (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 medical/biological studies that have been approved under a central IRB should be submitted to IRB #1 (see Standard Operating Procedures Manual, chapter five).
The IRB #1 and IRB #2 submission lists can be found in the IRBNet Library. The submit list is the first document in each library.
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.
The IRB coordinator will relay all communications between the IRB and the investigator via e-mail and other correspondence.
These communications may include:
- Need for additional information
- Missing documents
- Other communications
Once an application has been reviewed and a determination is made, the IRB coordinator will notify you via e-mail regarding the decision of the chairman or the convened board.