Sponsored Projects
Researcher's Guide for Conducting Human Subjects Research
For detailed information on human subjects research, please see the Policy and Procedure for Human Subjects Manual.
Prior to Submission of Your Research Materials
Before you submit your research materials make sure you have the following documents included for Institutional Review Board (IRB) review:
- Adequate training of research team (CITI training certificates)
- *NIH no longer offers their Human Subjects training. As of September 27, 2018 all researchers are required to complete the CITI training basic course for Social Behavioral or Biomedical research.Ìý
- Complete IRB protocol
- Informed consent/assent/parental permission document(s)
- Recruitment materials
- Letter(s) of support
- Any requests for waivers (if applicable)
Complete the appropriate protocol form, including all necessary materials for IRB review .
Complete protocols should be electronically submitted by the Primary Investigator to:
Compliance Specialist
°ÄÃÅÁùºÏ²ÊÀúÊ·¼Ç¼
Office of Sponsored Projects
irb@wiu.edu
While department or college level reviews are not required, researchers are strongly encouraged to have their protocolsÌýcheckedÌýby colleagues, faculty mentors, or IRB staff prior to submission to the University IRB.
Note: Adequate time is a necessity for the IRB to review protocols. A full IRB review may take a minimum of one month to complete. Protocols must be received in the Office of Sponsored Projects at least two weeks prior to the next scheduled meeting. IRB meeting dates and deadlines are available by visiting our Membership and Meeting Info page , sending an e-mail to the Compliance Specialist at IRB@wiu.edu, or calling the Office of Sponsored Projects at (309) 298-1191.
Research conducted in cooperation with other agencies or organizations, e.g., University of Illinois, Illinois State University, Bridgeway, etc., may require review by those organizations’ IRBs and a letter of approval from the °ÄÃÅÁùºÏ²ÊÀúÊ·¼Ç¼ IRB. For advice in such situations, please contactÌýthe Compliance Specialist at IRB@wiu.edu.
IRB Forms
Any research that involves human subjects, whether funded or not, that is undertaken by a °ÄÃÅÁùºÏ²ÊÀúÊ·¼Ç¼ faculty, academic staff or student or supported by °ÄÃÅÁùºÏ²ÊÀúÊ·¼Ç¼, must be reviewed by the Institutional Review Board (IRB). Approval must be granted by the IRB prior to collecting data from any human subjects for research purposes or soliciting subjects for a research study. For detailed information on human subjects research, please see theÌý Policy and Procedure for Human Subjects manualÌý.
It is the policy of °ÄÃÅÁùºÏ²ÊÀúÊ·¼Ç¼ that all individuals engaged in research involving human participants must complete an educational program related to the responsible conduct of research prior to initiation of a research project. For detailed information on research training, please seeÌý Procedures for Submitting ProtocolsÌý.
IRB protocols that do not require full board review may be submitted at anytime. Protocols for full review by the convened IRB must be received in the Office of Sponsored Projects no later than 4:30 p.m. two weeks before the meeting date. For more information about °ÄÃÅÁùºÏ²ÊÀúÊ·¼Ç¼’s Institutional Review Board and meeting times, pleaseÌýsee theÌýMembership and Meeting InfoÌýpageÌý. For further instructions on how to complete the °ÄÃÅÁùºÏ²ÊÀúÊ·¼Ç¼ IRB form, please seeÌýReview of Research InstructionsÌý.
°ÄÃÅÁùºÏ²ÊÀúÊ·¼Ç¼ IRB Forms | |
Initial Review |
|
Review and Monitoring |
The °ÄÃÅÁùºÏ²ÊÀúÊ·¼Ç¼ IRB approves human subject research at the following review levels:
- Exempt Review - To qualify, research must fall into one of six federally-defined exempt categories.Ìý These categories present the lowest amount of risk to potential subjects because they involve either collection of anonymous or publicly-available data, or conduct of the least potentially-harmful research experiments.
- Expedited Review - To qualify for an expedited review, research must fall into one of nine federally-defined expedited categories.Ìý These categories involve collection of samples and data in a manner that is not anonymous and that involves no more than minimal risk to subjects.Ìý Research projects that qualify for expedited review must include participant informed consent.
- Full Review - A project that involves greater than minimal risk requires approval by the Institutional Review Board Committee.Ìý Research that requires full committee review can include:Ìý Non-exempt research that involves children or other vulnerable populations, research that involves experimental drugs or devices, research that involves invasive procedures, or survey research that involves sensitive questions or information about sexual practice or illegal behavior.ÌýÌýÌýÌýÌýÌýÌýÌý
- Review and MonitoringÌý– This form has a three-fold purpose:
- continuation on a protocol that has been submitted and approved by the IRB,
- modification on a protocol that has been submitted and approved the IRB,
- conclusion or closing of a protocol that has been submitted and approved by the IRB.
If you have questions please contact:
Compliance Specialist
Office of Sponsored Projects
Sherman Hall 320
1 University Circle
Macomb, IL 61455
irb@wiu.edu
(309)298-1191
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