Tips for a Successful Submission
Human Research Protections Program
Submission and Other Resources
Researchers and Advisors
The Protocol "Recipe"
We know you want your HRPP/IRB experience to be as smooth and streamlined as possible. These tips will help you write a strong application that will need fewer revisions and receive a faster determination/approval.
Imagine that you will give your application to a cousin who knows nothing about research or that you might ask another researcher unfamiliar with your study to assist you. Would your cousin understand your materials? Could the other researcher conduct study activities on their own? In other words, have you provided enough clear and accurate detail that someone else could follow your protocol “recipe”? (Remember, IRB members come from different disciplines and might not know the specialized vocabulary of your field, but we need to understand all aspects of your study to effectively evaluate your submission.)
Keep this perspective in mind when creating your submission materials and strive to be as clear, complete, and accurate as possible.
First Steps
Start early!
Carefully read the Review Categories to determine which application form you should use. Contact the HRPP, if you’re not sure.
Read approximate Review Timelines (and deadlines for Full Board studies) and work backward in planning your protocol submission. We process all applications by submission order (except for rare cases) and can’t give priority because someone didn’t submit in a timely manner. The earlier you submit, the better!
Students: Work closely with your faculty/staff advisor throughout this process—from study design to submission.
Always use the most recent HRPP forms on the website. Please don’t reuse previously approved protocol forms.
Use HRPP templates (e.g., consent, confidentiality agreements) to ensure you have included all necessary information in an appropriate format. Don't forget: Remove any instructions (usually italicized) to you the researcher that the participant should not see. Also, update language and remove any parts that aren't applicable to your particular study.
All study team members (and your faculty advisor, if applicable) must have current CITI Social Behavioral training: within the past 5 years or for federally funded studies, within the past 3 years. NOTE: The HRPP does not require Responsible Conduct of Research (RCR) CITI training. Please do not submit RCR certificates.
If you are collaborating with a researcher at another institution, read guidance on Ceding or Obtaining HRPP/IRB Oversight to understand process requirements and potential timeline implications.
Pre-K-12 students: Even if working in your own classroom or school, you need to include written site permission from the district or principal with your initial submission. If the district requires HRPP documentation first, please explain that in your application, and we can issue conditional approval. (You may not begin any part of your project, including recruitment, with conditional approval; you will need to wait for final, written HRPP approval.)
Tribal nations, individuals, organizations, or Tribal-related knowledge: You might need prior approval from another person, people, or ethics committee. You will need some type of existing relationship or understanding with whatever group your study involves before you submit an application. Contact us early in the process if you need guidance. (We're developing specific guidance for research involving American Indian/Alaska Native populations or topics. If you have relevant insights or experience and would like to assist us, we welcome your help.)
Individuals of culturally diverse backgrounds and/or non-English language speakers: Be mindful of different (from your own) values, motivations, communication practices and expectations, areas for potential misunderstanding, systems or procedures, etc. Your protocol application should demonstrate your cultural competence and sensitivity in conducting research with this population.
Multilingual populations: Translate all participant materials into their preferred language (and submit these with your protocol application).
Incarcerated individuals (anyone under judicial supervision, on parole, etc.) or Pregnant Individuals (when specifically recruiting this population): Research with these populations always requires Full Board review because they need special protections. Plan accordingly and contact the HRPP with questions.
Video recording: Visual data involves highly identifiable information and might not be eligible for Exemption, especially if involving one of the populations above. Contact us for further guidance.
Preparing the Application
Answer only the questions asked in each section: the recruitment section should not include methodology, the benefits section should not discuss incentives, etc.
Please don't cut and paste from a grant application, usually written in more technical language for experts in your field. The HRPP needs different information about protections for participants and clarifying how potential benefits outweigh any risks.
Study Goals and Statement of Significance: Be clear in these sections, because reviewers need to fully understand why you wish to do this study, as well as how your project will be different from research that already exists on the topic.
Research Activities: Provide detailed steps so that we know exactly what you plan to do. Explain methods in chronological order and describe all aspects of the participant’s experience, including environment and setting, if applicable. Write tasks in present tense. If you use past tense, reviewers might think you’ve already conducted parts of your study without an HRPP/IRB determination or approval. (An exception would be if you refer to one of your previous studies.)
Consent Process: Provide a clear description of all steps, not simply “I will obtain consent.” For studies with more complex procedures or higher risks, explain a plan to give participants time to review the information and consider whether to participate before you obtain consent. See Informed Consent Guidance for more information.
Participant Risks: Don't under- or overstate risks. You may say “This study has no known risks” (if true), but you can’t say “This study has no risks.” For more information, see Reducing Study and Participant Risk.
Anonymous vs. Confidential: Be careful not to confuse these terms. "Anonymous" means even you don’t know who participants are and wouldn't be able to identify anyone from the data you collect! Read guidance on Anonymity, Confidentiality, and Privacy, and use the correct terms in your application and in recruitment and consent materials.
Confidentiality and Privacy: This section of the application and consent materials typically require the most revisions. Be specific and consistent about your plans for data collection, storage, and maintenance.
Participant-Related Materials
Ads or flyers (or an included link or QR code) should contain the following information:
- that the project is research
- your name and Western Washington University
- purpose of the research
- inclusion or exclusion criteria
- brief explanation of tasks
- time commitment, incentive (if any)
- research location
- WWU email or contact number
Please do not say only “email the researcher with questions.” People need enough information beforehand to decide whether they want to contact you and express interest in the study. Also, please do not add bold, underline, or highlights to any incentive or compensation information.
Remember that if using a snowball technique, individuals may share study information with others, but no one should provide you with someone else’s contact information without explicit permission.
When recruiting in person, be aware of potential privacy issues. If your study involves potentially sensitive or private information (e.g., religious or political affiliation, sexual orientation, employee satisfaction), make sure individuals have an option to express interest or enroll in the study without others knowing.
Consent information should include the same information as the recruitment points above, as well as additional information about benefits and risks, confidentiality, data storage, voluntary withdrawal, etc. Online consent (e.g., online surveys) should use appropriate language for transferring data through the internet.
Regulations specify consent language must be "understandable to the participant," which mean different levels will be appropriate for different groups. With general populations for whom you might not their reading capabilities, use simple, lay (common) language (typically an 8th-grade reading level) so that those from all backgrounds will understand what the study involves and what you are asking them to do. Adjust language levels for minors of younger ages. But if recruiting highly educated individuals or those with specific expertise, use language that they would expect and be comfortable with.
Ask a friend or family member to read any materials that potential participants will see—do they easily understand them? For minors, write assent forms at grade level or one level below their current reading level.
All risks you describe in the protocol should be included in the consent materials, as well as steps you’re taking to reduce them.
See Informed Consent Guidance for more information. Please use only HRPP consent templates to ensure you include all necessary parts with correct language.
For all participant-related materials (recruitment, consent, instruments, other communication): proofread carefully to avoid typos or grammatical errors.
You want the people you're trying to recruit and those you've enrolled in the study to have trust in your capabilities. You don't want them to make incorrect assumptions about your competence due to easily avoidable errors.
Pre-Submission Checklist
Be sure your application is complete. Missing information or missing parts (e.g., CITI certification, surveys, recruitment materials) is the primary reason we return applications without processing them.
Check for consistency throughout your materials re: number of participants, what type of research activities and how long each will take, etc. What you describe in the application, recruitment materials, and consent form should all be the same. We need a correct application on file, and lack of consistency is another main reason we return protocols for revision.
Run all your materials—including the application—through spelling and grammar check. We don’t review the application form itself for punctuation and grammar, but clean materials show your professionalism and attention to detail. (In contrast, sloppy materials might raise questions about your ability to effectively manage the proposed study.)
Right before you submit, review the section on Anticipated Start Date and the date accompanying your Submission Signature. These dates should be appropriate and accurate.
For example, if you will end up submitting your protocol on October 10, you shouldn’t list a September 12 anticipated start date or final signature date. Also, if it’s October 28, you shouldn't list an October 30 anticipated start date.
Again, consult the approximate HRPP Review Timelines and please be realistic and respectful of our processes. Everyone wishes to get started on their projects, and yours is only one submission among many. We promise we're doing our best to assist everyone.
Follow application instructions for correctly naming your supplemental files. We need to know what each file is when we conduct the review without first having to open documents to determine their purpose.
Attach all parts to your submission email as individual files (not shared links or OneDrive files). The HRPP will not click through or access linked documents or folders. (Tip: In Outlook, when you click the paper clip to attach a file, a pop-up message should ask whether you wish to share a link or attach a separate copy. Choose the separate copy.)
Use only your WWU email address to submit all materials to the HRPP. (Non-WWU emails often divert to the Junk or Clutter folder, where we might not see them.)
Include your last name in the email Subject line.
Always include message text in your submission email. Outlook sometimes interprets messages without message text as Spam and diverts them to the Clutter or Junk folder. (Besides, an email with an appropriate greeting, message body, and closing reflects best practices in professional communication etiquette.)
Managing Revision Feedback
If you don’t understand some of the feedback you receive, please ask for clarification(s). We’re asking for revisions for a reason, and it’s important that you understand the reasons and how you should address them.
If you disagree with any revision requests, please contact us to discuss it/them. It’s possible we didn’t correctly understand something in your original submission, and a conversation will help solve a misunderstanding. If we did understand and still require a revision, keep in mind that we're trying to fulfill our obligations to ensure the highest participant protections and best ethical research practices.
Pay close attention to all revision requests and what you need to resubmit.
If you were asked to make changes to the protocol application, please do not respond to those revisions in an email. On the other hand, if you were asked only to revise the informed consent or other specific materials, you do not need to resubmit the entire protocol. Or, if we said to answer questions in a response email, that’s fine.
Please try to respond promptly. You don’t need to rush, but you must resubmit required revisions within 60 days of receipt.
Otherwise, your application will be administratively closed, and you will have to submit a new application that will return to the processing queue.
We adhere to this resubmission time limit so that we can effectively monitor outstanding studies without undue administrative burden.
Last but Not Least ....
Students: Be sure your faculty/staff advisor carefully reads all your final submission materials and checks thoroughly for the tips outlined on this page before you submit. (And as an emerging growing researcher, you should do your best to follow these guidelines, so that your advisor recognizes your commitment to professionalism, to the research process, and to your research participants.)
Everyone: When in doubt, email the HRPP or schedule a consultation.