Training

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 January 19, 2017]. 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.

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.

Projects conducted at MWSU fall into one of three categories. 1. EXEMPT: Exempt projects meet the requirements of Title45, §46.104.d. 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, PED450, BIO495, PSY450); theses and dissertations 2. EXPEDITED: If your research involves only minimal risk, and if it meets the conditions for expedited approval set forth in §46.110, you may be eligible 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. 3. FULL COMMITTEE REVIEW: If your project is not minimal risk, does not qualify for expedited review, or if the reviewer during expedited review requests 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 website 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.

All submissions to the MWSU CUHSR must be made via the Human Subjects Research website. There will be no exceptions. Direct any questions to the chair of the committee.

The CUHSR meets once each month while school is in session, when there are applications that meet the criteria for a full committee review. Proposals must be submitted at least 48 business hours prior to the scheduled meeting in order to be reviewed at the meeting. Contact the CUHSR chair regarding specific time and location of upcoming meetings. Meetings are open to the public.

All actions taken by the CUHSR are reported by email to the address you supply on the application. You can also use the website’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.

A two-tiered system of monitoring the use for human subjects is relied upon. In addition to the Principle Investigator, the sponsoring Department is also responsible for 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 website system.

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.

Minor changes can be made via the website. 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 project, you MUST notify the CUHSR via the website prior to implementing those changes in conducting your project.

All approved projects must submit a final status report using the website as soon as data collection is complete. For projects requiring Full Board Review, the PI must submit regular status reports (at least once per year, as determined by the CUHSR) until the participation of human subjects is complete.

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.

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.

Although there are some exceptions (see 46.117.c ), written informed consent is required for projects involving human subjects. (Informed consent must be written in a way that promotes prospective participants’ (or their legally authorized representatives’) comprehension of the project, including the key information (within the first few pages of the informed consent form) needed to help them understand reasons why a person may or may not want to participate in the research. Sufficient details about the project need to be provided in a readily understandable manner (i.e., organization, wording) for them to make a well informed decision to participate or not. Other basic elements of informed consent should include: (1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures that are experimental; (2) A description of any reasonably foreseeable risks or discomforts to the subject; (3) A description of any benefits to the subject or to others that may reasonably be expected from the research; (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; (6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained; (7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject; (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled; and, (9) One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens: (i) A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or (ii) A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

If the proposed research is to be conducted in collaboration with individuals from 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.

Refer to the Human Subject Regulations Decision Charts provided by the Office for Human Research Protections to help guide you through the application process. If your project is designated as exempt, then you need to submit an abstract of your project that fully and accurately describes your data collection procedures and exactly how and why it meets the requirements for an exempt project. The CUHSR website may classify your project as exempt, however, the chair of the CUHSR will review your abstract and has the right to reject the exempt status for 48 business 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.