- What is "human subjects research review"?
- How do I know if my research project requires institutional review (i.e., HSRC) approval?
- Do student research projects require institutional review and approval?
- I am on a tight timeline to get my research done. How long does the HSRC review process take?
- Whom should I contact for more information about the HSRC review and approval process?
- How do I begin the HSRC review process?
- Which forms do I use when submitting my research proposal for HSRC review and approval?
- Why are there so many different forms for HSRC approval?
- What factors do HSRC members consider when reviewing a research proposal?
- Is it possible that the HSRC will deny approval of my research proposal?
- Once I have received HSRC approval, how long is it valid?
- If I am collecting data on-line (using the Internet), what additional information should I submit?
- If I am collecting data off-campus, do I need to get permission or approval from anyone other than the HSRC?
- If I am using copyright materials or other instruments not authored by me, what must I do?
- Is a consent form always required when collecting data from human participants?
- Speaking of consent forms, what exactly should be included in the informed consent form?
Changing an Approved Study
- What if I want to change some of my study procedures after the HSRC has already approved my research?
- What if I need to add other investigators or research assistants after the HSRC has already approved my study?
Federal and state regulations, as well as CWU policy, require that any use of human participants in research be reviewed and approved 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 Human Protections Administrator coordinates the work of the HSRC and is located in Black Hall 225-17 (963-3115).
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 refer to " Archival Data Checklist" for further guidance.
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, refer to the "CWU Guidelines for Student Research and Class Projects."
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 Protections Administrator within two weeks. Alternately, if your research proposal meets the criteria for a "minimal risk review" by a subcommittee of the HSRC, the review and notification process will usually take four to six 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.
The CWU Human Protections Administrator, job-shared by Sandy Martinez and Ruth Ann Stacy, coordinates the day-to-day activities of the Human Subjects Review Council (HSRC). Either Sandy or Ruth Ann are available for individual consultation with researchers who are preparing either requests for exemptions or applications for HSRC review and approval. Please click here for HSRC contact information.
Once you have determined how you will use human participants in your research, you should:
- become familiar with the HSRC review process by continuing to read this Frequently Asked Questions webpage;
- determine if you will be using already existing data collected for purposes other than this research and, if so, complete the " Archival Data Checklist" to determine your next step;
- determine if your research may possibly be exempt from federal regulations by consulting with the Human Protections Administrator at 963-3115 and/or referring to "the federal code 45CFR46.101";
- complete either the "Request for Exemption" or "HSRC Application" form;
- attach all relevant information (e.g., grant proposal, consent forms, questionnaires, recruitment flyers and scripts, debriefing statements) to your application; and
- submit these materials to the Human Protections Administrator (Black Hall, Room 225-17; Mailstop 7401).
- You will also need to complete either an on-line tutorial or campus workshop on the responsible conduct of research prior to submitting your HSRC application or exemption request.
Initially, when you submit your research proposal for HSRC review, you should select one of two options. After carefully reviewing the criteria for exemption from formal HSRC review (see above) and/or consulting with the HSRC office, if you believe your research qualifies for exemption, you should submit the "Request for Exemption" form to the Human Protections Administrator. If your study does not meet one or more of the exemption criteria, you should submit the full "Human Subjects Review Committee Application" form. Even if you believe your study is exempt from formal HSRC review, you must submit an exemption request form and receive the Human Protections Administrator's certification of your exemption prior to initiating your research.
The most common error made by investigators is failure to download the most recent version of the needed form from the HSRC Forms web page. Cutting and pasting on a previously used application form (or within the Application Help Manual) may delay review of your application.
Good question! Federal regulations concerning the conduct of research with human participants require that institutions not only review and approve an investigator's initial study proposal, but they also require that research protocols be reviewed on a continuing basis. Furthermore, if an investigator wants to make changes in previously approved study procedures, these modifications are also subject to HSRC review and approval. Finally, there may be occasions in which unanticipated problems occur during the course of a study; in all cases, these events must be reported to the HSRC in keeping with the federal requirements for human research. HSRC provides a form for each of these occasions.
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.
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 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 the 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 a "Status Report" form from the Human Protections Administrator. You should use this form to notify the HSRC of the current status of your research project. If the approved investigation has been completed, the HSRC should also be notified of its completion; however, if you intend to continue recruiting participants or collecting data, a "Request for Continuing Approval" form should be submitted 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 between one to five years so long as your approved study procedures are not modified in any way.
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 " Internet Research Issues " 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 page of HSRC website. No participants may be recruited from these agencies or institutions until these organizations and the CWU 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), as well as HSRC, approval of the research protocol.
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 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 Human Protections Administrator prior to submitting your application for HSRC review.
Great question! The DHHS 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 page of HSRC website.
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 in your research protocol. You can make minor and administrative changes (e.g., change in location, change in recruitment procedures, minor change in design) by submitting a "Project Modification Request Form" to the HSRC. 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 Protections Administrator if you have questions about the types of protocol changes that will require submission of a new application rather than a "Project Modification Request Form."
What if I need to add other investigators or research assistants after the HSRC has already approved my study?
Generally speaking, this is an administrative change that can be handled by submitting a "Project Modification Request Form" to the Human Protections Administrator.