Getting Started

First, please be aware of the most important aspect of human subjects research: Under no circumstances may research begin until your proposal has been reviewed and verification of validation or approval has been secured from the IRB.

Second, it will be helpful for you to understand the terminology that is used. Research protocols submitted to the IRB are classified under one of three categories: Exempt, Expedited and Full. A brief description of each follows:

Exempt Research:
Use the newly developed Exempt Form for submission of protocols.  Exempt categories are determined by federal regulatory agencies and include research of less than minimal or no risk in the following situations:

• Study of some educational practices
• Survey interview of adult subjects or public figures (non-sensitive topic areas only)
• Observation of non-institutionalized adults
• Archival or secondary use of data or specimens with no identifiable information

To determine if your study meets the criteria for exempt status, please see our Exempt Research Help. Please note that special subject populations (such as minors, elderly, etc.) do not qualify for this category.

Expedited Review:
This category includes research activities involving no more than "minimal risk" to subjects such as moderate exercise by normal volunteers or study of group behavior where behavior is not manipulated nor subjects exposed to stressful situations. The only involvement of human subjects (special subject populations do not qualify) will be found in one or more of the categories in the Expedited and Full Committee Review Research packet . This document should be completed only if the study is believed to qualify for expedited review.

Full Review:
If the study does not qualify for exempt or expedited review, full review by the convened IRB is required. See the Expedited and Full Committee Review Research packet. All required documents must be submitted to the Office of Research Compliance,223 Brackett Hall, not later than 12:00 NOON on the specified deadline date (15 working days prior to the meeting). The IRB usually meets on the first Thursday of each month.

Now that you understand how protocols are classified, you can begin the submission process. A brief overview is provided here:

1. Ensure that you have allowed appropriate time for obtaining verification of validation or approval prior to beginning the human subjects research portion of your study. Timely submission is critical to timely processing of all proposals. Please ensure that you have carefully completed all of the necessary documents and submitted them to this office in a timely fashion.
2. Approximate time lines can be given for each status, but these estimates are contingent upon several factors including reviewer availability, complexity of research, number of protocols received, current office workload, current staffing, etc. The estimates are: Exempt - 7 to 10 business days, Expedited - 3 to 4 weeks, Full - 1 to 2 months after a convened meeting.
   
   EXEMPT:
   Upon receipt, this protocol is pre-reviewed and circulated to the Chair of the IRB or designee. It typically takes seven to ten business days for this review to be completed and for a response to be given to the investigator. The response will either be a request for modifications/additional information or an email notification of validation. If a request for modifications/additional information is made, these must be submitted and re-reviewed. Validation that study qualifies as Exempt from continuing review will be granted once all modifications/additional information were found to be acceptable.
   
   EXPEDITED:
   Upon receipt, this protocol is processed and circulated to two IRB members for review. This processing typically takes three to five days, depending on the current staffing and workload. The reviewers, upon receipt, have 7 business days in which to review the submission and make comments. It may take longer depending on the workload of the reviewer and the complexity of the research. Typically, within two weeks of the reviewers receiving the materials, the Principal Investigator (PI) may be contacted with a request for modification(s) or additional information. If a request for modification(s) or additional information is made, these changes must be submitted and re-reviewed. Once the changes are approved, then written approval is granted.
   
   FULL:
   This protocol must be received by the established deadline date. Please see our Calendar & Deadlines page. Upon receipt, the protocol is processed, assigned to primary and secondary reviewers, and circulated to all IRB members for review. This processing typically takes three to five days, depending on the current staffing and workload. At the meeting, the primary reviewer will present the study to the committee for review and discussion. At the conclusion of the discussion, a vote is taken. The decision will be communicated to the PI. Typically, the results are either a request for modification(s) to the proposal, a request for additional information, or approval. If modifications are requested, a determination is made if the revisions must again come before a full committee. The primary and secondary reviewers may approve any minor changes in order to expedite this part of the process.
   
3. Read through the entire packet and determine under what status your protocol should be submitted.
4. Prior to submitting the actual documents, please make sure that all documents are neatly typed and written in non-technical language. Please be aware that incomplete applications will not be reviewed by the IRB. Make sure all the sections are completed. Only faculty or staff members of the University may be a study PI. Students may be co-investigators.
5. Please review your application using the checklist(s) provided. This refers to the exempt and expedited checklists for determining the category, as well as the checklist for the elements of an informed consent document.
6. If there is an associated grant application with the IRB protocol, the same title must be used on both documents. If you have more than one IRB protocol associated with the same grant, please add a colon after the grant title and follow it with a subtitle that is specific to this particular protocol. This will assist you and our office in easily locating the research protocol. If you are submitting the grant for funding, a copy of the grant application must be sent to the IRB with your Expedited or Full application.
7. If your study utilizes a consent form, prior to submission to the IRB for approval, it will be pre-screened by the Office of Research Compliance. There may be additional changes later required, but this pre-screening process will identify any omissions and help streamline the review process. If you are submitting under FULL committee review, you must have the informed consent in the office by the designated deadline date. Refer to the Informed Consent section for further information.
8. For FULL committee review, the PI will receive notification of the results of the proposal review approximately one week after the IRB meeting.
9. Once you have completed the paperwork, please submit the entire packet to the IRB Administrator. You may submit the form in one of two ways:
   Electronic: You may e-mail the entire IRB application packet to the coordinator as an attachment. You will have to then print off and submit a signature page with all required original signatures. For Exempt protocols, a signed copy is not required.
   Hard Copy: You may print off the entire proposal and mail or bring a signed, hard copy to the Office of Research Compliance in 223 Brackett Hall. For Expedited and Full protocols, the complete application must still be submitted electronically for routing to reviewers.
10. It is important for the investigator to KEEP A COPY of every document related to the research study that is submitted to the IRB. The Office of Research Compliance will not be responsible for duplicating any information submitted to the IRB.

Biomedical or Clinical Research: Clemson University (CU) has an Institutional Authorization Agreement with Greenville Hospital System (GHS) for it to be the IRB of Record for biomedical and clinical research conducted by Clemson University faculty, staff, and students. The term biomedical research is not easily defined, but refers to laboratory-based and clinical research which is aimed to define, treat, and/or prevent human diseases or conditions. It may include human participation, records-based studies, clinical samples, or technology development for clinical trials. It is important to note the Clemson University’s IRB will still review some health-related research protocols that are mainly in the area of social and behavioral sciences. Principal Investigators should contact the Office of Research Compliance at 864-656-6460 and read the guidance document at http://www.clemson.edu/research/orcSite/IRBforms/GHS_SubmittingResearchProtocols.doc for more specific guidance.

For additional information and instructions, please contact the Office of Research Compliance at 864-656-6460.