Frequently Asked Questions

Whenever you collect data directly from individuals or access their personal information, you need to follow ethical processes and practices. The HRPP assesses potential risks and helps you mitigate them. Not all projects meet criteria as "research," as defined by federal regulations, and some will not need HRPP consideration. For more information about different levels of review and when you should submit, see Review Categories and Timelines, and click on the "Learn More" links for expanded explanations.

Using the term "participants" demonstrates respect for those who choose to take part in a research study because it reflects a mutual endeavor between a researcher and an informed, active participant. In contrast, "subjects" implies a hierarchy where an investigator conducts research on and to a passive participant. These vocabulary choices align with the Belmont Report's principle of respect for persons.

We understand people have "IRB" stuck in their default vocabulary, and that's fine. But a significant difference exists between the Human Research Protections Program (HRPP) and the Institutional Review Board (IRB).

As part of the Office of Research Integrity and Compliance, the HRPP, under the Vice Provost for Research, serves as the formal WWU office supporting human participant research and other activities involving data collection from individuals, and promoting ethical research practices. The HRPP Administrator reviews protocol submissions and develops and updates policies/processes based on current regulations and best practices in ethical human participant research (in consultation with the IRB Chair and Board members); conducts educational outreach on HRPP processes and general research integrity for the campus community; collaborates with staff of other institutions when supporting collaborative research between WWU researchers and non-WWU affiliates; attends professional conferences to remain abreast of regulatory updates and field standards; and manages all office processing.

As a body within the HRPP, the Institutional Review Board (IRB) has 11 appointed members from multiple WWU disciplines. IRB members review certain expedited submissions, convene to review full-board protocols needing higher-level risk assessment and mitigation, and provide input on HRPP policies and procedures. IRB members also serve as liaisons to the campus community for questions about human participant research ethics in their fields and about HRPP/IRB processes.

For more information, see What is the HRPP/IRB?

Yes. If you're collecting individual responses from people, you will need to submit at least the Application for Exemption, so that the HRPP can determine that few or no risks exist to participants and that you have some type of consent process, even if informal or oral. For more information about different levels of review, see Review Categories and Timelines

Yes, if your project involves active data collection from individuals. Your project needs to be reviewed if it involves any intervention or interaction directly human participants or their identifiable data. Despite what people think, data are rarely anonymous. Often, a few pieces of demographic information can result in a person's reidentification, and thus appropriate protections are necessary. For more information, review the guidance on Anonymity, Confidentiality, and Privacy.

If you will analyze existing data with no linked direct or indirect identifiers, you might not need to submit an application. Email the HRPP with a brief description of your project for guidance.

You may not "self-determine" Exempt status. Even though your study might meet one or more categories of Exempt research or meet criteria as Not Huma, Participant Research (NHPR), you still need to submit an application to the HRPP, along with relevant study-related materials (e.g., CITI training, consent forms, surveys, etc.), Only HRPP staff issue an Exemption or NHPR determination after assessing your project. See Exempt/NHPR Information for more details.

If a project represents a course assignment to teach research methods (i.e., the purpose of the activity is a class requirement to demonstrate learning a particular method or methods), it might not need review. But if a project does not have an HRPP determination (Exempt/Not Human Participant Research) or approval, the data may not be used at any point during or after the conclusion of the course for publication, presentation, or other research purposes. Sometimes, students will complete a project "only for a course" that they later wish to present in a conference or symposium setting or submit to a University student publication. Without an HRPP determination, that's not permitted, and the HRPP can never issue a retroactive determination, even for Exempt or NHPR projects. Students should discuss these limitations with their instructor or faculty advisor to consider whether HRPP review would be the best option.

If you have any questions, contact the HRPP right away, so that you don't run into time constraints due to the short nature of the 10-week term!

NOTE: All undergraduate and graduate theses and dissertations are considered research and require HRPP review prior to any human participant data collection.

Studies that meet criteria as Exempt and Not Human Participant Research (NHPR) receive an HRPP determination, not "approval," because those projects do not go through the formal review and approval process. Expedited and Full-Board studies receive HRPP or IRB approval because they have been reviewed by one or more IRB members or the convened Board.

For Exempt/NHPR projects don't state that the WWU HRPP or IRB has “reviewed and approved” your study. (We realize people in your field might commonly do this, but it's not accurate!) Instead, say, "The WWU HRPP has determined the study to be exempt from further review in accordance with federal regulatory criteria.”

If you're planning a collaborative research project with co-investigators at another institution, you might find navigating multiple HRPPs or IRBs confusing. Whether you go through the WWU HRPP or the other institution's HRPP/IRB depends on multiple factors, including that institution's requirements. Read detailed information about the process for ceding WWU HRPP oversight to another institution or for the WWU HRPP to assume oversight for non-WWU researchers.

Review the policies of all HRPP/IRB offices as soon as possible to ensure the smoothest process for starting research. Remember: WWU affiliates may not join a research project under another institution's oversight without obtaining WWU HRPP authorization first.

We're so happy to have you join our WWU community and want to support all your research endeavors. Read the HRPP guidance for transferring protocols to WWU HRPP oversight to ensure you remain in compliance with your previous institution's and WWU's policies and procedures. And please feel free to contact the HRPP at any time with your questions.

You don't need to submit an application for a pilot study if all three statements are true:

1. Your only goal with this pilot study is to assess the feasibility of a larger study. The pilot will be exploratory to help refine data collection processes, instruments, research design, etc.
2. You don't intend to publish or disseminate the pilot study outcomes as research data.
3. You'll limit the pilot study to a small scale (~10 or fewer participants).

Note that you may not use any pilot study data for research purposes unless you previously submitted an application to the HRPP and received a determination or approval before initiating the study. Even for a pilot study, however, you need to demonstrate best practices in collecting human participant data, which includes some form of consent and appropriate data security and management procedures.

Activities to assess, analyze, critique, and improve processes or aspects of an organization, where the data will be used for internal purposes, are not considered "research," but still need to follow ethical principles for collecting and working with data from individuals. See further information and guidance on "Not Human Participant Research" projects. 

Your project might need HRPP review if you will use multiple case studies to draw generalizable conclusions or address a hypothesis. But we can't provide set guidance for all possible variations and need to consider this question on a case-by-case basis. Contact the HRPP for individual guidance. 

Journalism projects usually don't meet the definition of research and don't require any HRPP consideration when interviewing individuals to report on current events, trends, newsworthy issues, or stories about people or events. But if you intend to draw generalizable conclusions and present the data in a context other than media, you might need HRPP consideration. If you aren't sure whether your project falls into this latter scope, contact the HRPP for guidance. 

Some participant populations or settings require a letter of permission from an appropriate person in the organization/group. Read the information on Recruitment and Site Permissions for guidance.

Not if you collected the data for any research purposes. Federal regulations and WWU HRPP policies prohibit retroactive approval for previously conducted research. Even for studies that would have been Exempt, the HRPP cannot provide a retroactive determination.

However, if you or another entity collected data for exclusively non-research purposes (e.g., program evaluation, curriculum assessment, medical information), you may apply for an Exemption determination to use that data for research purposes as secondary-data analysis.

First, read about Review Categories and Timelines to better understand the different levels of review and what your project might require. Then review the Submission Process guidelines. For guidance on ensuring that your consent materials include all the necessary parts and will give your participants the information they need to make an informed choice, look at the Informed Consent templates and select the one that best aligns with your study methods. Finally, carefully review Tips for a Successful Protocol Submission to help the review process go more smoothly with fewer necessary revisions. And if you still have questions after reading these materials, we're happy to meet with you for a one-on-one consultation about your project or protocol submission.

We need to keep submission materials confidential, and it would be challenging to design a hypothetical study that might effectively guide someone else. But we encourage you to look at the Recognition of WWU Human Participant Research page to see the nature of the unique, important projects of our WWU community.

You might find someone with similar interests or engaged in projects that resonate with you, in which case you can reach out directly to those individuals to talk about their HRPP process (or maybe even future collaborations!).

First, the HRPP/IRB respects that you are the discipline expert seeking to conduct a research project important to you. We don't seek to meddle with your methodology or impose unreasonable expectations or demands. We trust that WWU researchers want and intend to conduct rigorous, ethical research, and our goal is to partner with you to make sure it provides the highest protections to the participants you hope to enroll. 

Before the review process begins, the HRPP assesses whether a submission is complete, accurate, and ready for review. If parts are missing, if you didn't follow instructions, or if the application contains too many errors so that it doesn't reflect reasonable expectations for professionalism, we will return the application and request resubmission.

If your application is ready for review, we evaluate the entire protocol according to federal regulations and the ethical principles of the Belmont Report. In other words, we assess whether the project poses any risks to participants, whether you have managed these risks sufficiently, and whether we can offer other ways to mitigate risks. We also determine whether potential participants will be adequately informed about the research project, any potential risks, and their rights as a research participant. We will draw on the collective expertise of HRPP staff and trained IRB members to ensure that we review your project appropriately; if we encounter limitations to our knowledge, we'll seek input from a specialist, if necessary, to respect the unique nature of your discipline.

Finally, we look for consistency and accuracy, because we need the protocol on file to precisely represent the project you'll conduct. (For example, if the application says you will survey 10-15 individuals in one place but then mentions 20-30 participants elsewhere, or it specifies surveys but then mentions interviews or focus groups, we will require revisions for consistency to know exactly what you plan to do.)

Review Tips for a Successful Protocol Submission for further guidance.

We've tried to provide as much helpful information as possible under our Topics Based Guidance page. But if you still have questions or don't see the information you're looking for, please contact the HRPP for assistance.

Yes. Every HRPP protocol submission must include current (within 5 years) CITI Social and Behavioral Research -- Basic/Refresher Course (#60805473) certification for all researchers and key personnel, including faculty/staff advisers of student research projects. (Individuals who will not interact directly with participants or have access to identifiable data do not need to complete CITI training.)

For more details about training requirements, see HRPP Required Training.

Note: The HRPP does not require Responsible Conduct of Research training. But federal funding agencies and some other external agencies require RCR certification and 3-year CITI certification. Contact Research and Sponsored Programs for more information.

The HRPP site navigation page provides every link throughout the HRPP website on one page grouped by topic. Look carefully to see whether the information you're seeking could be in one of those links.

Please let us know! If you're looking for specific information and don't see it on our website, we'll be glad to assist: Contact the HRPP with your questions and suggestions.

We view this website as organic, and we're always updating it based on your needs!