Exempt and NHPR Information

Human Research Protections Program

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Exemption/NHPR Application Form

What are You Doing This FOR? vs. What are You DOING?

Whenever you collect or work with identifiable data from human participants, risks to participants might exist in the processes (recruitment, data collection, data storage), even if you don't intend to present or publish data results. The HRPP assesses whether activities might pose risk to individuals and determines whether such projects meet criteria as "Exempt" or "Not Human Participant Research (NHPR)."

Even though people commonly refer to "approval," such determinations mean the projects are exempt from the formal review and approval process. Thus, researchers should not state that the WWU HRPP has “reviewed and approved” an Exempt/NHPR project. (We realize people in your field might commonly do this, but it's not accurate.) Instead, state: "The WWU HRPP has determined the study to be exempt from further review in accordance with federal regulatory criteria.”

NOTE: WWU affiliates may not self-determine Exempt/NHPR status. This information is intended as guidance for submission application choice. For all Exempt/NHPR studies, you need some form of written HRPP determination before initiating any project activities, because the HRPP cannot issue retroactive determinations.

Exempt/NHPR Process

Any time you collect data through direct participant interaction, you must obtain voluntary consent from each individual. Even if you obtain oral consent, you should provide prospective participants with the following information (e.g., through email or a brief information sheet):

  • Your WWU affiliation and contact information
  • Project objectives
  • Study procedures and intentions for data use
  • Emphasis on voluntary participation
  • Explanation of potential risks, if any

You do not need to submit HRPP Modification Requests for Exempt/NHPR projects unless the nature and scope of the project significantly alters. Consult with the HRPP before taking the following steps:

  • Implementing new procedures that might heighten risk level and/or no longer fit within exemption categories.
  • Adding recruitment from vulnerable populations (e.g., minors, prisoners, individuals with cognitive impairments, etc.).
  • Transferring the role of principal investigator to another researcher.
  • Expanding plans for NHPR data use. For example, if you are conducting a program evaluation for an organization's internal use, and you wish to use that data for secondary research purposes.

Personnel Changes: Before adding new personnel who will interact directly with participants OR their identifiable data (e.g., co-investigators or research assistants), email the HRPP with their names, roles, and CITI certification, then wait for confirmation before they join the project. Personnel who will not engage with participants or identifiable data do not need to complete CITI training.

Federal Regulations 45 CFR 46.104(d) Exempt Category Descriptions with Examples

Research conducted in established or commonly accepted educational settings that specifically involves normal educational practices not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. (Includes most research on regular and special education instructional strategies, as well as assessing or comparing instructional techniques, curricula, or classroom management methods.) Participation must remain voluntary if activities are supplemental to required course activities.

What is an "established educational setting"? Anywhere educational activities typically occur—schools, colleges and universities, after-school programs, libraries, museums, training facilities, etc.

What are "normal educational practices"? Common activities in the educational setting, such as evaluating attitudes about learning, assessing classroom activities, developing new instructional methods or tests, trying out new educational tools (devices, computer software, content delivery methods, etc.) 

What about the Federal Educational Rights and Privacy Act (FERPA)? FERPA applies to all educational records containing personally identifiable information (e.g., transcripts, tests and homework assignments, interactions with online learning systems).

What are some Cat. 1 examples?

  • Evaluating a new reading curriculum in a 2nd-grade classroom through tests, student attitude surveys, and classroom observations.
  • Analyzing college students' pre-/post-assessments after implementing a new pedagogical approach in chemistry.
  • Comparing test scores between two instructors teaching the same material through different curricula. 

What would not be exempt under Cat. 1? Interviews or surveys collecting information about students' personal characteristics apart from demographics or about their beliefs/opinions (beyond thoughts about learning/curricula). Projects using an untested curriculum that might not be in the students' best interests.

Further Considerations

  • If not part of the normal curriculum, will any research activities occur during class sessions? If so, what other optional activities will be available for students who do not participate?
  • If not part of the normal curriculum, could research activities (e.g., surveys or interviews) occur after a term concludes to avoid potential undue influence to participate? Or could they take place in another instructor's class?
  • If participants will receive course credit, what equal and alternative activities are available to students to obtain the same credit without study participation?
  • For university courses, has the instructor included a syllabus statement to make students aware that their work might be used for research purposes?

Research that includes only interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior (including visual or auditory recording) if the investigator records information to protect the confidentiality of the participant; OR if disclosure of participant responses would not reasonably place individuals at risk of liability or damage their financial standing, employability, educational advancement, or reputation.

Exempt surveys/interviews must meet at least one of the following conditions:

  1. Data are collected anonymously (no identifiers can be connected to the data—even by the researcher—directly, through a combination of indirect identifiers, or through a coding system). Data involving participant audio recordings, video recordings, or photographs are not anonymous.
  2. Data includes identifiers, but the information is not sensitive. Participants would not experience negative consequences even if the data were disclosed beyond the study. Identifiable data related to illegal activities, sexual behaviors, sensitive genetic or medical information, or embarrassing behaviors in the workplace would not meet this exemption condition.
  3. Data contains direct or indirect identifiers and might involve sensitive information, and the HRPP will conduct a "Limited IRB Review" to determine whether Exempt.2.iii applies by ensuring that sufficient measures exist to protect participant privacy and data confidentiality.

What is "public behavior"? Public locations where individuals do not have reasonable expectations of privacy (e.g., a public park, public transportation, a building lobby, a coffee shop, etc.).

What about online spaces? Open forums or groups that do not require membership or a password are considered public. If you need to join a community or group via an administrator, participants have a reasonable expectation of privacy, and you may not record data without explicit permission. For more information, see Conducting Online Research.

What does "educational tests" include? Cognitive, diagnostic, aptitude, or achievement assessments.

What are some Cat. 2 examples?

  • Surveying college students about internet access and use.
  • Analyzing themes and common beliefs on a public social media group for new parents.
  • Anonymous employee satisfaction survey or anonymous survey of college seniors' sexual behavior. (Note: Responses must not link to individuals in any way.)
  • Focus groups with library patrons about what benefits they gain from reading.

What would not be exempt under Cat. 2? Non-educational survey/interview research with children. Collecting somewhat sensitive information that others outside of the research team might link to an individual respondent. Collecting very sensitive information or surveys/interviews that might prove highly distressing to participants.

Research with adult participants that collects data through benign behavioral interventions (verbal or written responses, or audiovisual recording) after the participant provides consent for the intervention and data collection. The investigator must collect data anonymously or the study cannot collect sensitive information (i.e., responses could not reasonably place individuals at personal, social, or economic risk). For projects involving sensitive and identifiable responses, the HRPP will conduct a limited review to determine whether it qualifies for Cat. 3 exemption or whether it will need an expedited submission.

What are "behavioral" interventions? Cognitive, intellectual, educational, or behavioral tasks, or manipulation of a participant's physical, sensory, social, or emotional environment.

What defines "benign"?

  1. Brief in duration
  2. Harmless
  3. Not physically invasive
  4. No reasonable risk of lasting negative effects
  5. Not offensive or embarrassing.

What are some Cat. 3 examples?

  • Cognitive tasks or online games
  • Using educational materials to alter participants' behavior (e.g., quitting smoking, engaging in exercise)
  • Exposing participants to stimuli such as color, light or sound at safe levels
  • Changing environmental conditions (e.g., noise) while participants solve puzzles

What would not be exempt under Cat. 3? Research with children, medical interventions, highly sensitive and identifiable responses.

Research involving the collection or study of existing data, documents, records, biospecimens, or diagnostic specimens if the data are 1) publicly available OR 2) the investigator records information in a way that participants cannot be identified, either directly or through a combination or indirect identifiers.

What does "publicly available" mean? Any individual in the general public can access the data without needing special qualifications, permissions, or privileges.

Do I have to obtain consent? You do not have to obtain consent to use existing data that meets the criteria above. Researchers may not contact or re-identify individuals whose data are under study.

What if I already conducted the research and now wish to use the data as an existing data set? Cat. 4 exemption applies only to data collected or that will be collected for non-research purposes or other studies not related to the proposal.

What are some Cat. 4 examples?

  • A nursing student looks at medical records to assess the impact of a certain treatment but does not record any individual identifiers
  • A sociologist visits a public, city website to analyze crime statistics that include suspect descriptions
  • An instructor reviews course papers from several years ago to compare student attitudes toward community engagement but does not use any identifiers or direct quotes

What would not be exempt under Cat. 4? Data collected as part of one's own research or data that are not publicly available.

Federally supported research and demonstration projects designed to study federal public benefit or service programs, including processes to obtain benefits, changes to the programs, or payment levels.  [Not likely relevant for any WWU researchers.]

What are some Cat. 5 examples? Internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants.

What would not be exempt under Cat. 4?  Research on state or local public benefit programs.

To meet Category 6 exemption, taste and food quality evaluation and consumer acceptance studies must involve (i) wholesome foods without additives or investigator manipulation, and/or (ii) if involving plants/animals raised for food products, it must be at or below agricultural chemical or environmental contaminants found safe by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the Dept. of Agriculture.

What are some Cat. 6 examples? 

  • A taste study comparing differences in taste between apples from different Washington state orchards
  • Impacts to taste when including an FDA-approved additive to vegetarian burgers

What would not be exempt under Cat. 6?  Foods with unsafe or unapproved additives.

Not Human Participant Research (NHPR)

Sometimes, you might wish to collect data for a project that does not meet the federal definition of research: "a systematic investigation ... designed to develop or contribute to generalizable knowledge." But through evaluating NHPR projects, the HRPP helps WWU affiliates uphold ethical principles of the Belmont Report—respect for persons, beneficence, and justice—which should still apply regardless of the reason for collecting the data.

What is QA/QI/PE?

NHPR projects often involve systematic data collection activities designed to improve benefits, outcomes, performance, services, or other aspects of organizational or program effectiveness. Such projects might be referred to as

  • Quality Assessment (QA)
  • Quality Improvement (QI) and
  • Program Evaluation (PE)

Federal regulations do not govern QA/QI/PE, but an HRPP evaluation helps to ensure that such activities meet WWU's standards for ethical data collection, especially regarding consent, privacy and confidentiality, and data security.

What's the difference between "Research" and QA/QI/PE?

  • Designed to contribute to generalizable knowledge
  • Investigator may require permission to access location and data
  • Activities usually involve direct interaction with participants (in person or online)
  • Research activities may pose risks to participants
  • Intent to prove or disprove a research question or hypothesis
  • Designed to evaluate and promptly benefit a process, program, or system
  • Investigator typically has access to location and data through institutional/organizational role
  • Activities often observational and non-obtrusive or involve minimal-risk surveys or interviews
  • Assessment activities do not pose risk to participants
  • Determines whether a program/process/system meets a set of standards
  • A Social Work student with a practicum at a community health organization examines how access to public transportation impacts unhoused individuals' use of the organization's services.
  • An Education faculty member designs and conducts a parent/guardian survey for an organization that provides tutoring services to immigrant children to determine what additional opportunities might benefit the families.
  • A university Student Wellness Program distributes surveys to first-year students about their study and sleep habits to design programming to support future first-years' transition to college.
  • May or may not benefit participants
  • Data collection, storage, and use may involve privacy and confidentiality concerns

A Sociology faculty member implements a new curricular approach and conducts pre-/post-surveys of students to assess its effectiveness. She plans to recommend updates to departmental guidelines on methodology for future courses but also hopes to generalize her findings to share at a national Sociology research conference.

Initial QI: A Communications professor recommends certain extracurricular activities to improve students' verbal interactions in professional settings. Toward the end of the term, they survey the students about their experiences and create a Tip Sheet to distribute to future classes.

Transition to Research: After two years, they decide to survey past students about whether the Tip Sheet increased confidence in public speaking, and they hope to publish the data in a professional business journal. The first activity would not need any HRPP consideration or submission, as it represents general pedagogical improvement/development. The professor would need to obtain an HRPP determination before engaging in the second activity (but its minimal risk nature would meet criteria for submitting the Application for Exemption).