Do I need IRB review?
Review processes safeguard human subjects
According to WSU policy, all research conducted by any agent acting on behalf of WSU (faculty, staff, student or volunteer) that involves human participants must adhere to regulations, rules, policies, and guidelines regardless of the funding source. Federal, state, local, and institutional guidelines exist to protect human research participants. Human Subjects Research is determined by the definitions of “human subject” and “research” under Health and Human Services (HHS) and Food and Drug Administration (FDA) regulations.
Get IRB approval before starting research
The WSU Institutional Review Board (IRB) must review and approve research involving human participants prior to recruitment and data collection. If you conduct research involving human participants without prior IRB approval, the data you collect may not be usable. Refer to our Step-by-Step Submission Guidance page before submitting research for IRB approval. If you fail to obtain required IRB approval before starting research, be aware of the following:
- The IRB cannot provide retroactive approval. This is not allowed under the regulations.
- You will not be able to use data that you gathered for your presentation, publication, or graduation.
If you have collected data from human research participants or generated data through interaction with a person’s private identifiable information or identifiable biospecimens without IRB review, email a description of the research that was conducted and the reason you did not apply for IRB approval to email@example.com. IRB staff members will assist in determining the appropriate course of action
Use these three questions to determine the need for IRB review
WSU Institutional Review Board (IRB) review and approval is required if all 3 of the following are true. Researchers should submit the Human Subjects Research Determination Form (docx) to receive confirmation from the HRPP regarding the required level of review for each unique project.
1. Is your activity research?
A research activity is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. The WSU IRB recognizes activities that meet this definition as research, regardless of whether they are conducted or supported under a program that is considered research for other purposes. For example, some demonstrations and service programs may include research activities. A sampling of research methods can include but is not limited to the following:
- Accessing private records
- Taste testing
- Clinical trials
- Therapeutic evaluations
- Experimental treatments
- Bodily fluids or tissues
- Residual diagnostic specimens
- Cell lines with an identifiable donor
2. Does your activity involve human subjects?
A human subject is a living individual about whom an investigator (whether professional or student) conducting research does either of the following:
- Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens
FDA Definition of Human Subjects Research
The Food and Drug Administration has its own definition of what activities constitute “human subject research.” 21 CFR 50.3 If you are planning to conduct a clinical investigation or trial, please contact the IRB office: firstname.lastname@example.org
3. Are you a WSU researcher?
This can include, but is not limited to, faculty, staff, students, and volunteers. You must seek WSU IRB review regardless of your location or position if you are conducting WSU research.
WSU research involving other institutions
If you are conducting research involving Non-WSU researchers, there may need to be additional agreements or reviews. Please see our “External Collaborations” page for more information.
WSU student research (graduate/undergraduate honors theses or dissertations)
If you are a WSU student using/collecting data from human participants for a thesis or dissertation, it is critical that you obtain WSU IRB determination/approval prior to beginning your research. Without IRB review or determination, and, if necessary, the IRB’s approval, your program will be unable to accept your work and this may delay degree attainment. Honors Theses may not require IRB review as they often not considered “generalizable” under the federal definition of “research.” Please use our Human Subjects Research Determination Form (docx) and submit it to us to determine your need for review.
Guidelines for clinical investigators
Anticipate special requirements for IRB review when conducting research with Spokane hospitals or industry-sponsored clinical trials. The NIH definition of Clinical Trial differs from the FDA definition of Clinical Investigation. The NIH has a guidance page clarifying the difference between these two agencies.
When IRB review may be unnecessary
Some research activities fall outside the IRB’s authority
Examples of activities that do not require review might include a nursing practicum, certain classroom activities, or work related to a master’s in teaching program. To help determine whether your activity requires IRB review, use the Human Subjects Research Determination Form (docx) If you are still uncertain, contact the IRB: email@example.com
Other committee approvals and approval by Non-WSU entities
WSU IRB approval does not constitute approval received by other committees or entities. You are responsible for securing all other required approvals, which may include:
- Biosafety (IBC)
- Animal Welfare Program (IACUC)
- Radiation Safety (RSC)
- Departmental/Institutional approval (for researchers who are not normally eligible to act as Principal Investigators)
- Conflict of Interest (COI or FCOI)
- School Districts or other Non-WSU Locations
- IRBs of Collaborating Institutions
Contact the Office of Research Assurances for details.
Class projects and activities
The WSU IRB does not oversee class projects and activities that do not meet the definitions of “research” and/or “human subjects” above. Faculty and the academic department are responsible for all of the following:
- Deciding whether class projects and student activities involve human participants and meet the definition of research
- Overseeing these activities
- Ensuring that students adhere to ethical principles (e.g. Belmont Principles) in the conduct of these activities
- Obtaining departmental approval if required
Issues that faculty and departments should address
When conducting activities involving human participants, faculty and academic departments should address the following:
- Rights of the participants:
- Participants should be asked to participate and receive an explanation of what the activity is about
- Participants should understand that their participation is voluntary
Adherence to policies, local laws, and regulations:
- WSU ethical guidelines and policies
- State and federal regulations such as the Family Education Rights and Privacy Act (FERPA)
Adherence to the following principles of the Belmont report (which establishes the ethical foundation for conducting research with human subjects):
- Respect for persons: Requires recognition of the personal dignity and autonomy of individuals, and special protection of those persons with diminished autonomy. In order to ensure respect for persons, participation in research must be informed and voluntary (e.g. an informed consent process must still be included).
- Beneficence: Entails an obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm.
- Justice: Requires that the benefits and burdens of research be distributed equitably. Those who are most likely to benefit from the potential outcomes of the research should equally share the burden of participation