Human Subjects Review Program

Frequently Asked Questions

What is a "human subjects research review"?

How do I know if my research project requires institutional (i.e. HSRC) review?

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." Your responses on the logic-based form will determine which questions you need to answer.

Do student research projects require institutional review and approval?

Any student research project with human participants conducted 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.

Student research projects conducted as a recognized part of an undergraduate or graduate class assignment (e.g., research methods course) are frequently exempt from HSRC review. For further guidance, contact the Research Compliance Administrator.

I am on a tight timeline to get my research done.  How long does the HSRC review process take?

The amount of time required for the HSRC to review your study and notify you of the status of your proposal varies depending upon the type of review required, the clarity and completeness of the application, and the number of reviews being conducted by the HSRC at the same time.  If your proposal is truly exempt from formal HSRC review and your application is complete, you will likely receive written notification from the human protection administrator within three weeks. Alternatively, if your research proposal meets the criteria for a "minimal risk review" by a subcommittee of the HSRC, the review and notification process may take up to 6 weeks.  Additional time may be required for clarifications and/or revisions. Finally, should the nature of your planned research require formal review at a convened meeting of the HSRC, the approval process time could take up to eight weeks. Please note that the review and approval process may take longer when proposals are submitted near the end of a quarter, during quarter breaks, or in cases where an investigator's application materials are incomplete.

Whom should I contact for more information about the HSRC review and approval process?

The CWU Research Compliance Administrator (RCA) coordinates the day-to-day activities of the Human Subjects Review Council (HSRC). Contact the RCA who is available for individual consultation with researchers preparing the HSRC application for review.

How do I begin the HSRC review process?

Once you have determined how you will use human participants in your research, you should:

• become familiar with the HSRC review process and continue to read the Frequently Asked Questions page;
• determine if your research may be exempt from federal regulations;
• complete the CITI program training designed for "researchers/investigators;"
• complete the HSRC Application form in IRBManager, the electronic application submission system;
• Call the administrator if you have any questions at 509-963-3115 or email at hsrc@cwu.edu.

What factors do HSRC members consider when reviewing my research proposal?

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

• how participants are approached (i.e., recruited) to be in the study;
• what procedures are used to obtain consent from prospective participants or their legally authorized representatives;
• the type of compensation, if any, offered to participants;
• the safeguards in place to protect participants who may be vulnerable to coercion or undue influence;
• the procedures used to protect participants' privacy; and
• the nature of the physical and psychosocial risks, stresses, and discomforts participants will be asked to endure.

Is it possible that the HSRC will deny approval of my research proposal?

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.

Once I have received HSRC approval, how long is it valid?

In keeping with federal regulations, HSRC approval of reviewed research is valid for no more than one year. (On rare occasions, the HSRC may determine that a study requires continuing review more frequently than every 12 months.) A few weeks before your study's approval expires, you will receive an email from the human protection administrator with a link to the original study. 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 four weeks prior to your study's expiration date.

If your initial application for HSRC approval was determined "Exempt" from formal HSRC review, institutional approval of your study is granted for a period of three years after which time if you want to continue your study you must submit a new application.

If I am collecting data online (using the Internet), what additional information should I submit?

Data collection using the Internet (e-mail, web-based surveys, chat rooms, 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 Survey Research Requirements. For other Internet data collection, it is advisable to call the HSRC office for guidance.

If I am collecting data off-campus, do I need to get permission or approval from anyone other than the HSRC?

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.

If I am using copyrighted materials or other instruments not authored by me, what must I do?

It is the usual practice of the HSRC to ask investigators to document the sources of instruments they are using. 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.

Is a consent form always required when collecting data from human participants?

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 human protection administrator prior to submitting your application for HSRC review.

What exactly should be included in the informed consent form?

Great question! The Office for Human Research Protections (OHRP) offers very helpful guidance concerning the content of informed consent documents. In addition, a consent form checklist has also been developed to assist investigators in evaluating their consent forms prior to HSRC review.

Investigators planning research with minors (i.e., children) should also consider developmentally-appropriate procedures for gaining the assent of these study participants in addition to acquiring the informed consent of their parent or legal guardian. Sample consent, assent, and parental permission forms are available on the Forms and Templates page. 

What if I want to change some of my study procedures after the HSRC has already approved my research?

You must notify the HSRC if you intend to make changes to your research protocol. You can make minor and administrative changes (e.g., add investigators, change in location, change in recruitment procedures, minor change in design) by completing a modification request form. However, if you intend to make substantial changes in the purpose, design, procedures, or participants of your research, you may be required to submit a new HSRC application form. Please contact the human protection administrator if you have questions about the types of protocol changes that will require the submission of a new application rather than a modification request form.