Human Subjects Research

IRB FAQ

What is the CUHSR?
All research involving human subjects is expected to conform to the principles described by the Office of Human Research Protections (OHRP). The principle investigator is morally and legally bound to ensure the ethical treatment of human subjects. In addition, Missouri Western State University requires certain research conducted with human subjects to be reviewed by the Missouri Western State University Committee on the Use of Human Subjects in Research (CUHSR). The CUHSR is sometimes referred to as the "IRB." The MWSU CUHSR was designed to meet all appropriate laws and regulations of the Federal Government for research using human subjects, and investigators are encouraged to obtain a copy of the most recent Federal publications [see the Office of Human Research Protections, Title 45; Part 46-- Protection of Human Subjects, Revised November 13, 2001; http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html]. The federal government defines research as a “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Human Subjects are living individuals from whom you collect data through intervention or interaction, or where you have identifiable private information.
Who is required to apply?
All research projects involving the collection of data from human subjects on the campus of MWSU must be reviewed by the CUHSR. In addition, research projects on human subjects conducted by faculty or staff of MWSU must be reviewed even if the data collection does not take place at MWSU. This includes but is not limited to basic research, training, demonstrations, and service projects. For example, Faculty or staff projects that involve human subjects, or utilize archived surveys, questionnaires, records, or samples from identifiable individuals living or dead Any student project that involves human subjects, or utilizes archived surveys, questionnaires, records, or samples from identifiable individuals living or dead Any classroom activity that involves human subjects, or utilizes archived surveys, questionnaires, records, or samples from identifiable individuals living or dead Student projects meeting these standards must be submitted for review whether they are initiated by the student or assigned during a class. In addition, faculty, staff, or student organizations conducting surveys or questionnaires must also have the project reviewed and approved before beginning work. Note that in many instances, you can get your project classified as exempt, and the paperwork burden involved should be minimal. Even if you believe your project is exempt, however, you must submit an application.
What kinds of review procedures are there?
Projects conducted at MWSU fall into one of three categories. 1. Exempt Exempt projects meet the requirements of Title45, §46.101.b. The following types of projects can not be classified as exempt: Research Proposals submitted to extramural funding agencies Any project that places subjects at more than minimal risk Research published in, or intended for publication in peer reviewed journals Research designed and conducted by students for a designated independent research course (e.g. independent study, PED451, BIO495, PSY480) Theses and dissertations 2. Expedited Approval If your research involves only minimal risk, and if it meets the conditions for expedited approval set forth in §46.110, you may be eleigible for expedited approval. In the MWSU CUHSR expedited approval process, you submit a full proposal to the IRB, however, the chair of the IRB or another experienced reviewer who is a member of the IRB will review your proposal and provide a response within 7 days. Expedited review can approve your proposal, or forward it for full committee review. Expedited review can not reject your proposal. All proposals that have received expedited approval are marked as such on the active proposals list. In order to receive expedited review, your proposal must be exempt from the requirements for written informed consent. 3. Full Committee Review If your project is not minimal risk, does not qualify for expedited review, or if the reviewer during expedited review requested full committee review, then your proposal will go on the agenda for the next meeting of the CUHSR. A copy of your written informed consent form must be included as a Microsoft Word attachment to your proposal, and submitted via the web site with your proposal. During the full review process each committee member, as well as any special members assigned by the chair, carefully reads and critiques the proposed research. The members meet during their regularly scheduled time and make comments regarding the protection of human subjects described. The research proposal is approved by the committee when it has received individual approval from a majority of committee members present at the meeting. A majority of committee members must be present to render a decision.
How do I submit a proposal for review?
All submissions to the MWSU CUHSR must be made via the committee website. There will be no exceptions. Go to http://www.missouriwestern.edu/orgs/human_subs and click on the "Submit A New Proposal" link. Direct any questions to the chair of the committee (cronk@missouriwestern.edu).
When does the committee meet?
The CUHSR meets at 2PM on the first Tuesday of every month, except when school is not in session. Proposals must be submitted at least 48 hours prior to the scheduled meeting in order to be guaranteed review at the meeting. CUHSR meetings occur in JGM217. Meetings are open to the public.
How will I be notified of the committee's decision?
All actions taken by the CUHSR are reported by email to the address you supply on the application. You can also use the web site's functions to check on the status of your proposal. It is your responsibility to check the status of your application. Any questions can always be directed to the chair of the committee.
Do I need the support of my department chair?
Federal regulations require at least a two-tiered system of monitoring the use for human subjects. In addition to the Principle Investigator, the sponsoring Department is also responsible ensuring that MWSU, Federal and other regulations are met. The Department Chair or his/her approved designee must approve of the use of human subjects and agree that the benefits of the study outweigh any risks to subjects. The chair or designee also verifies that adequate facilities and personnel are available for the proper use of subjects and that the Department or Division will monitor the subject use and report any perceived or potential problems immediately to CUHSR. Approval of the department chair or designee is received by email using the automated web site system.
Why do I need to be certified before I can submit a proposal?
All persons related to MWSU who conduct research on human subjects need to be aware of the MWSU CUHSR policies and procedures, and should be familiar with the legal and historical background of IRBs in general. In order to ensure that all users have read the appropriate documents, you must take and pass a brief quiz covering the material in these documents.
What if I need to change my proposal after it is approved?
Minor changes can be made via the web site. You can submit an amendment to your proposal, or request an extension of time to collect your data. If you make any changes to your proposal, you MUST notify the CUHSR via the web site.
What are the reporting requirements?
All approved projects must submit a final status report using the web site as soon as data collection is complete. If data collection takes longer than one year, the PI must submit an annual status report.
What if I experience problems during data collection?
Any adverse event must be reported to the IRB as soon as possible. You can contact the chair of the IRB, or submit an amendment to your proposal.
How long do I have to collect my data?
All projects are approved for a maximum of one year at a time. If you need longer, you will need to request an extension each year when you submit your annual status report.
What are the informed consent requirements?
If your research is classified as exempt, or receives expedited approval, then no written informed consent is required (consistent with 46.117.c). If your research does not meet the requirements of 46.117.c, then expedited approval will not be granted, and full written informed consent will be required after the CUHSR has approved your proposal and the informed consent form.

Informed consent is required if your project involves more than minimal risk, or involves an at-risk population (e.g., minors, prisoners, pregnant women). The IRB may also require that you obtain informed consent under other circumstances. Whether informed consent is required or not, all subjects must be debriefed on the purpose of the research, and provided with a means to view the results of the research when available. If informed consent is required, it must include: 1.A statement that the study involves research. 2.An explanation of the purpose of the research, an invitation to participate and explanation of why the participant was selected, and the expected duration of the participant's participation. 3.A description of procedures to be followed and identification of which procedures are investigational and which might be provided as standard care to the participant in another setting. Use of research methods such as randomization and placebo controls should be explained. 4.A description of any foreseeable risks or discomforts to the participant, an estimate of their likelihood, and a description of what steps will be taken to prevent or minimize them; as well as acknowledgment of potentially unforeseeable risks. 5.A description of any benefits to the participant or to others that may reasonably be expected from the research, and an estimate of their likelihood. 6.A disclosure of any appropriate alternative procedures or courses of treatment that might be advantageous to the participant. 7.A statement describing to what extent records will be kept confidential, including examples of who may have access to research records such as hospital personnel, the FDA, and drug sponsors. 8.For research involving more than minimal risk, an explanation and description of any compensation and any medical treatments that are available if participants are injured through participation; where further information can be obtained, and whom to contact in the event of research-related injury. 9.An explanation of whom to contact for answers to questions about the research and the research participant's rights (including the name and phone number of the Principal Investigator (PI)). 10.A statement that research is voluntary and that refusal to participate or a decision to withdraw at any time will involve no penalty or loss of benefits to which the participant is otherwise entitled. 11.A statement indicating that the participant is making a decision whether or not to participate, and that his/her signature indicates that he/she has decided to participate having read and discussed the information presented.

What if the project involves another institution?
If the proposed research involves students, clients, or employees of another organization or institution, approval for the proposed research must also be obtained from that organization. A copy of the approval should be submitted with this application. However, the committees may also choose to review the proposal jointly.
What are the components of an application?
If your project is designated as exempt, the you need to submit an abstract of your project that fully and acurately describes your data collection procedures and exactly how and why it meets the requirements for an exempt project. The web site may classify your project as exempt, however, the chair of the CUHSR will recview your abstract and has the right to reject the exempt status for 48 hours after the proposal is submitted. If your project is not exempt, you will be prompted for a full project summary. The project summary consists of: Statement of Purpose Statement of Research Methodology Statement of Research Risks and Benefits Subject Selection Procedures Confidentiality Measures