Human Subjects Review Council

Federal regulations and state laws, as well as CWU policy, require that the use of human participants, or their data, in research, be reviewed and approved/certified by an institutional review board (IRB). The Human Subjects Review Council (HSRC) serves as the institutional review board for Central Washington University. The university's Research Compliance Administrator coordinates the work of the HSRC. The office is located in Barge Hall 102.

Any CWU faculty member, staff member, or student whose investigation involves either the collection of data from human participants or the use of personal records must submit a research proposal for HSRC review.

If you are using already existing data in your research, please complete the HSRC application through IRBManager. Indicate the level of review (last question on the first page) as 'Determination of HSRC Oversight."

If you are teaching a research methods classes where human subject research will be a part of the coursework, then you must submit a "Course Project Exemption" application in IRBManager.

This application is open to faculty ONLY.

For further guidance or questions, contact the Research Compliance Administrator.

If you are a student conducting a student research project with human participants as part of an independent study course, undergraduate honors thesis, undergraduate directed research (e.g., SOURCE), or master's thesis/project must be submitted for HSRC review and approval.

The amount of time required for the HSRC to review your study will vary depending on:

• The type of review required
• The clarity and completeness of the application
• The number of reviews being conducted by the HSRC at the same time
• Quarter breaks and closures
• Exempt and complete protocols can anticipate receiving approval within 3 weeks.

Minimal risk protocols will be subject to a review by a subcommittee of the HSRC and the review process may take up to 6 weeks.

Full board protocols will require a formal review at a convened meeting of the HSRC and the review process may take up to 8 weeks.

Once you have determined that you will be using human subjects in your research, you should:

• Review the FAQs page and become familiar with the HSRC review process;
• Determine if your research may be exempt from federal regulations;
• Complete the Researcher/Investigator CITI training course;
• Submit a HSRC application through IRBManager, the electronic research portal;
• Contact the administrator at 509-963-3115 or hsrc@cwu.edu if you have any questions.

The HSRC reviews the proposed propose(s), procedures, and participant populations to be used in order to determine whether the benefits of the research activities outweigh the anticipated risks to subjects. Among the issues to be considered are:

• How participants are recruited;
• The procedures to obtain consent from prospective subjects or their legally authorized representatives;
• The type of compensations (if any) being offered to participants;
• The safeguards in place to project subjects who may be vulnerable to coercion or undue influence;
• The procedures used to project subjects' privacy;
• The nature of the physical and psychosocial risks, stresses, and discomforts subjects will be asked to endure.

On occasion, the HSRC may decide there is insufficient information to approve or disapprove a human subjects research application. In such a case, the HSRC will defer consideration of the proposal and, instead, will ask the researcher to clarify or provide additional information. When the HSRC receives this additional information from the investigator, the application is reconsidered for approval.

In very rare instances, an institutional review board (IRB) like the CWU Human Subjects Review Council may determine that the risks of a proposed study outweigh the anticipated benefits and will consequently withhold council approval of the investigation. Should the researcher disagree with the HSRC's disapproval of the study, the decision may be appealed using procedures specified by the institution.

However, the more typical case is that the investigator and the HSRC will choose to work together to modify study-related procedures in order to reduce the risks to participants, and in turn, gain council approval to commence with the research.

In keeping with federal regulations, HSRC approval of reviewed research is valid for no more than 1 year. (On rare occasions, the HSRC may determine that a study requires continuing review more frequently than every 12 months). If the approved investigation has been completed, you should complete a termination report form; however, if you intend to continue recruiting participants or collecting data, you must complete continuing review form at least 4 weeks prior to your study's expiration date

Institutional approval of Exempt research is granted for a period of 3 years after which time if you want to continue your study you must submit a new application.

Data collection using the Internet (e.g., email, web-based surveys, chatrooms, etc..) presents unique issues of security, privacy, and the informed consent process that are not easily resolved.

If using a web-based survey, refer to the Survey Research Requirements page. For other Internet data collection, please contact the HSRC office.

Researchers seeking access to participants through other agencies or institutions should fully inform these organizations about the purposes and procedures of the planned research. Official approval from a designated representative of the organization must be obtained and included with the materials you submit for HSRC review and approval. A sample letter of cooperation is available on the Forms and Templates page. No participants may be recruited from these agencies or institutions until these organizations and the HSRC have approved your research proposal.

Investigators who wish to conduct research in other countries should consult with the HSRC regarding specific procedures for obtaining local (i.e., host community, country), approval of the research protocol.

For each instrument not authored by the investigator, include evidence that permission has been granted from the author to use this instrument in its original or modified form. This may take the form of copies of correspondence (letters or emails) with an author which clearly states that the investigator has permission to use or modify the instrument before using it in this research.

With respect to copyright or licensed materials, it is expected that CWU investigators will purchase these materials in sufficient quantities appropriate to their study sample size and will not photocopy them for use by subjects. Include with your application a statement or receipt for the purchase of copyrighted or licensed materials.

Please note: If more than one purchased instrument is submitted to the HSRC in the review/approval process, the extras will be returned to the investigator at the conclusion of the review.

Federal regulations governing human subjects research allow for circumstances in which the requirements for written documentation of informed consent may be waived by the institutional review board (i.e., the CWU Human Subjects Review Council).

In addition to reviewing these regulations, you may find it helpful to consult with the research compliance administrator prior to submitting your application for HSRC review.

Please check out the informed consent page for more details.

You must notify the HSRC if you intend to make changes to your research protocol. You can make minor or administrative changes (e.g., add investigators, change in location, recruitment procedure changes, or minor design changes) by submitting a modification request form.

If you intent on making substantial changes in the purpose, design, procedures, or subject population, you may be required a new HSRC application.

Please contact the research compliance administrator if you have questions about the type of protocol changes that will require a new application rather than a modification.