Apply for Initial Review

Studies that are determined as not human subjects research (NHSR) are not subject to the same federal requirements for research involving human subjects as non-exempt studies. However, investigators will retain the responsibility to protect the rights and welfare of their subjects, adhere to WSU policies, and conduct their research in accordance with the ethical principles of Justice, Beneficence, and Respect for Persons as described in the Belmont Report.

The investigators are responsible for initial determination of whether an activity constitutes human subject research and upholding all ethical best practices. However, since Washington State University will hold them responsible if the determination is not correct, investigators who believe their research may qualify as NHSR are urged to request confirmation and documentation of this agreement from the HRPP Office.

To be eligible as NHSR at least one of the following criteria must be met:

1. The study does not meet the federal definition of  “human subject,” meaning the investigator does not interact, intervene, or collect identifiable data from living humans.

2. The study does not meet the federal definition of “research,” meaning the project is not systematic in design or is not intended to be generalizable. It is important to note that pursuit of publication is not indicative of being generalizable.

To request a NHSR determination on letterhead form our office, please download and complete the Not Human Subjects Research (NHSR) Determination application.

Studies that qualify for exempt certification are not subject to the same federal requirements for research involving human subjects as non-exempt studies. However, investigators will retain the responsibility to protect the rights and welfare of their subjects, adhere to WSU policies, and conduct their research in accordance with the ethical principles of Justice, Beneficence, and Respect for Persons as described in the Belmont Report. Research  involving both identifiable and sensitive data may require limited IRB review* under expedited review procedures to ensure adequate protections for human subject participants (45 CRF 46.109(a)).

To be eligible for exempt certification review, all of the following criteria must be met:

1. The study meets the federal definition of both  “human subject” and “research.”

2. The study meets the specific conditions under one or more of the following exempt categories and subcategories:

• Exemption 45 CFR 46.104(d)(1): Research conducted in established or commonly accepted educational settings, involving normal education practices.
• Exemption 45 CFR 46.104(d)(2):Research only including interactions involving educational tests, survey procedures, interview procedures, or observation of public behavior. *Limited IRB review may apply.
• Exemption 45 CFR 46.104(d)(3): Research involving benign behavioral interventions and collection of information from adults with their agreement.*Limited IRB review may apply.
• Exemption 45 CFR 46.104(d)(4): Secondary research use of identifiable private information or identifiable biospecimens.
• Exemption 45 CFR 46.104(d)(5): Research studying, evaluating, or examining public benefit or service programs.
• Exemption 45 CFR 46.104(d)(6): Research involving taste and food quality evaluation of consumer acceptance studies.

Please be aware that the following limitations and restrictions apply:

• Children: Exemptions 2(i) and 2(ii) does not apply to research with children as participants, except for research involving observations of public behavior when the investigator does not participate in the activities being observed. Exemption 2(iii) does not apply to research with children as participants. Exemption 3 does not apply to research with children as participants (45 CFR 46.401(b)).
• Prisoners: Research involving prisoners does not qualify for exemptions except for when research is aimed at involving a broader subject population that only incidentally includes prisoners (45 CFR 46.104(b)).

To apply for exempt certification/limited IRB approval please download and complete the “Human Subjects Research Exempt Certification Application.”

Studies that qualify for expedited review are subject to the full scope of federal requirements as outlined in 45 CFR 46 for research involving human subjects. In addition to these federal requirements, investigators will retain the responsibility to protect the rights and welfare of their subjects, adhere to WSU policies, and conduct their research in accordance with the ethical principles of Justice, Beneficence, and Respect for Persons as described in the Belmont Report. Expedited review procedures may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal. Additionally, expedited review procedures may not be used for classified research involving human subjects.

To be eligible for exempt certification review, all of the following criteria must be met:

1. The study meets the federal definition of both  “human subject” and “research.”

2. The research activities that present no more than minimal risk to human subjects.

3. The study meets the specific conditions under one or more of the following expedited categories:

• Expedited 1: Clinical studies of drugs and medical devices .
• Expedited 2: Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
• Expedited 3: Prospective collection of biological specimens for research purposes by noninvasive means.
• Expedited 4: Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves.
• Expedited 5: Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis).
• Expedited 6: Collection of data from voice, video, digital, or image recordings made for research purposes.
• Expedited 7: Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

To apply for expedited approval, please download and complete the “Non-Exempt Application.”

Projects not eligible under exempt or expedited review undergo review by a convened board. The IRB usually meets at least once per month during the academic year and summer. For the current dates and deadlines for convened full board meetings, please reference the full board schedule.

To apply for approval, please download and complete the “Non-Exempt Application.”