Getting Started

  • New to human subjects research? Find answers to common questions to help you get started below.
  • Want more? Review HSD’s IRB 101 Online Tutorial for an in-depth overview on working with the UW IRB.
  • Still have questions? HSD staff can also provide guidance and answer questions at hsdinfo@uw.edu.

Common Questions

What is an IRB and what does it do?

An institutional review board is a group registered with the federal government that is formally designated to review and monitor research involving human subjects. The purpose of the reviews is to protect the safety, rights, and welfare of research participants and to ensure institutional compliance with federal and state regulations and University policies. The Human Subjects Division manages the three Institutional Review Boards (IRBs) that review and oversee UW human subjects research.

Do I need to submit an IRB application?

Human subjects research requires IRB approval or a determination that the research is “exempt” from the federal regulations. Depending on the particulars of your project, you may not need to submit an IRB application at all! Whether or not IRB review is required is determined by going through a few key questions based on some regulatory definitions.

Researchers may self-determine that their project does not meet the definition of “human subjects research” using the Human Subjects Research Determination worksheet. Even if you determine that your project does not meet the definition, you may still wish to submit an application to request a formal determination letter, for example to obtain or access data from a source or if you have a complicated project. For more information:

Determinations that the human subjects research is “exempt” from the federal regulations must be made by HSD. If you believe your research may qualify for exempt status, submit an application and do not include consent materials.  For more information:

Visit Do I Need IRB Review to go through the steps in order to determine if you need to submit an application for your project.

Should my IRB application go to the UW IRB or a non-UW IRB?

Is your study eligible for UW IRB review? If your research is happening at UW, then it’s UW research, right? It’s not that simple, and whether a project is considered “UW” research has nothing to do with physical location. It depends on whether the UW is considered “engaged” in the research through direct federal funding or human subjects activities. For more information: 

Is the UW IRB the right IRB? While the UW IRB is usually the right choice for most UW research in which UW is conducting all or most of the research activities, there are many circumstances in which an external, or non-UW, IRB must review UW research instead of the UW IRB. HSD’s Reliance Team must authorize the use of a non-UW IRB in advance. For more information:

Contact HSD’s Reliance team at hsdrely@uw.edu

What training should I take?

Human Subjects Protections Training: The UW and HSD do not currently require that researchers complete training or submit documentation of training as part of the application review process except for student and medical resident researchers as explained below. However, HSD recommends that all researchers who are new to research involving human subjects complete training in the basic ethical principles for working with human research subjects. Additionally, many funding organizations and collaborating institutions require human subjects protections training.

IRB 101 Online Tutorial: The IRB 101 tutorial is required for student and medical resident principal investigators and recommended for everyone new to working with the UW IRB. The tutorial walks you through the questions to ask to determine if you need IRB review and provides important practical information about navigating the IRB process at UW.

Good Clinical Practice Training: Researchers working in behavioral or biomedical clinical research must sometimes complete training in Good Clinical Practice (GCP) to meet the requirements of the organizations they are affiliated with, funding agencies, or study sponsors. GCP training educates researchers on the fundamental principles of conducting high quality clinical trials.

How long does IRB review take?

Human subjects research must be reviewed and approved in advance. Review times can vary widely depending on the type of review that is needed. Applications that require review by the full convened IRB generally take the longest. Situations that typically require longer review times include:

  • Involvement of federally protected or especially vulnerable populations, such as prisoners
  • Complex studies involving many different study procedures
  • The UW IRB reviewing for multiple institutions

Median Turnaround Times (TAT) for New Applications

 

Review Type Median Turnaround
Determination: a formal determination that a project does not require IRB review because:

·    It is not considered to be research

·    It does not involve human subjects

·    It is not considered to be UW research

Note: Researchers may also self-determine that a study falls into one of these categories using the human subjects research determination worksheet.

 3.75 days
Exemption: a determination that the human subjects research fits into one or more exempt categories that do not require IRB review or require only limited IRB review. 4.25 days
Expedited: IRB review conducted by a designated voting member rather than by the convened committee. It is used for minimal risk research that fits into one or more of the permitted expedited review categories. 12.75 days
Full Board: IRB review by the convened committee at a scheduled meeting. This is required for research that is not eligible for exemption or expedited review. 67.25 days
Authorization to use a non-UW IRB: Reliance requests for IRB review by a non-UW IRB instead of the UW IRB. 4.5 days
RNI Determination: A formal regulatory definition made by the Regulatory Affairs team for Reportable New Information. 7 days

What are the additional requirements for student and resident researchers?

Student and medical resident principal investigators for UW IRB applications must meet the following 2 requirements:

  1. IRB 101 Training Requirement: Complete UW’s IRB 101 Online Tutorial and make sure to save your training certificate. When you fill out your Zipline application, upload your training certificate to the Local Site Documents page. Review the IRB 101 landing page for more information about this requirement.
  2. Faculty Advisor Review Requirement: You must have a faculty advisor sign off on your project.
    1. List your faculty advisor by name in the IRB protocol form.
    2. Before submitting your application to HSD, complete the Manage Ancillary Review activity to send the application to your advisor for review. Refer to Add Faculty Advisor Review for more information. If you can’t find your faculty advisor in Zipline, they must create a Zipline account.
    3. Your faculty advisor will receive a notification that your study is ready for review once you’ve added the faculty advisor review and submitted the study to HSD. Instructions on completing faculty advisor review are available in the Faculty Advisor Guide.
    4. Once your faculty advisor has provided sign-off, the review will show as “Accepted” in the Reviews tab for your study.

What do I need to know about obtaining informed consent?

  1. Obtaining informed consent from research participants is one of the key criteria for IRB approval. Informed consent must include:
    • Key information that the specific subject population would need to make an informed decision about participation;
    • Presentation that aids comprehension of the information and allows for dialogue; and
    • Voluntary participation without coercion or undue influence.
  1. HSD provides extensive guidance on informed consent, including:
  1. If IRB review is required for your study, you must include consent materials in your IRB application unless the consent requirement is waived. For example, the informed consent requirement is commonly waived for records review studies that do not involve contacting subjects.

How do I submit an IRB application?

All applications must be submitted via Zipline, UW’s eIRB system.  Zipline applications include:

  • Web-based forms with basic questions; and
  • Uploaded attachments that contain most of the information about the study, such as the HSD application form and any consent materials.

All applications must include one of the following application forms. HSD recommends completing the required documents before creating your study in Zipline. 

  • IRB Protocol Form: Standard application form used to request review from HSD or the UW IRB. (Review IRB Protocol Tips for additional information.)
  • IRB Protocol Form, No Contact: Shortened version of the standard IRB application form that may be used for studies that do not involve interaction of any kind (in person, email, internet, social media, etc.) with subjects. (Review IRB Protocol Tips for additional information.)
  • External IRB Review Request Form: Use this form to request authorization to obtain IRB review from a non-UW (“external”) IRB instead of the UW IRB.

Tips to Ensure a Smooth and Timely Review:

  • Plan ahead. Review times vary depending upon the type of review, complexity of the study, HSD staffing shortages, submission volumes etc. Be sure to allow enough time for review.
  • Check for completeness. Carefully read all instructions. Be sure that you have provided thorough answers to relevant questions and uploaded necessary documents before submitting your application.
  • Satisfy requirements for student research (if applicable).
  • Click the “submit” button. The application can only be submitted by the PI or assigned PI Proxy. If you are preparing the application for the PI, email the PI a link to the study by copying and pasting the URL. The PI can then:
    • Log in and submit the application by clicking on Submit and then OK, OR
    • Assign the PI Proxy so the PI Proxy can submit.
  • Respond to requests for more information or changes promptly. The PI, PI proxies, and primary contact receive an email notification if more information or changes are needed to complete the review. Review cannot move forward in Zipline until the PI or PI proxy submits a response.

HSD has many resources to help you submit IRB applications. For help, review:

How do I respond to the IRB if they request more information or changes to my application?

The review process in Zipline resembles a tennis match. When the application is pushed to you, HSD is not able to move forward with the review process until you respond. Similarly, once you respond to HSD, you are no longer able to make changes to the application. There can be as many rounds of back and forth as needed.

If HSD pushes the application to you, you will receive an email notification and the study will appear in your My Inbox. The application state will show as one of the following:

  • Clarifications Requested
  • Modifications Required to Secure Approval
  • Deferred

The general process you should follow to respond is the same:

  1. If you received a formal letter, you’ll need to prepare a response letter by embedding your responses in the letter that you received.
  2. You may be asked to make edits to the attached study documents. Edited documents such as the IRB protocol form must be uploaded to the appropriate section of the online application form (called the SmartForm) rather than simply attaching the revised document to your reply.
  3. The principal investigator listed on the application or a designated PI proxy will need to push the application back to HSD using the Submit Response activity. The only document that should be uploaded to the Submit Response activity is your response letter.

Tips to avoid errors that may delay your review:

  • Use the most recent version of the document that was provided to HSD when editing documents. Tracking your changes also helps streamline our review process.
  • Upload your revised study documents to the correct location in the study SmartForm. Do not include them in the Submit Response activity.
  • Do not use the Add Comments activity to respond to HSD- this does not push the application back to HSD so staff are unable to move the review forward.

Review Respond to HSD in the Zipline Online Help Library for step by step instructions with screenshots.

How do I manage my study after I receive IRB approval?

Manage Study Access:

There are many different user roles in Zipline, and each provides a different level of access to the study. Review the Managing Study Access table for a summary of the different user roles and step by step directions on making the changes in Zipline.

Make Changes to Your Study:

Exempt Research: Some changes always require HSD to review a modification and make re-determination of exempt status. Many other changes do not. Review the exempt research guidance for more information.

IRB Reviewed Research: Submit a modification to your application. The modification must be approved by the IRB before you make the change. There are two types of modifications in Zipline:

  • Administrative changes to update study team members who have access to the Zipline access; and
  • All other changes to the study.

Zipline does not allow more than one open modification of each type at a time. Review the resources below for more information.

Resources:

Report to the IRB:

Regulations require certain information to be reported to the IRB, including information about new or increased risk to subjects and problems that have occurred, such as data breaches resulting from a stolen laptop.

Consult HSD’s Report Safety/Compliance Information for more information about what needs to be reported, the timeline for reporting, and how to report.

Send an email to hsdreprt@uw.edu if you have questions or need help.

Renew IRB Approval (if required):

Your IRB approval letter will tell you if an annual re-review, called continuing review, is required for your study.  Most expedited studies do not require continuing review, while studies reviewed by the full board are more likely to require continuing review.

Review Renew Your IRB Approval for more information.

Close IRB Application:

Submit a continuing review to close your IRB application when your human subjects research is complete. Applications may be closed when:

  • All subjects have completed all study-related interventions and procedures, including any follow-up.
  • You have obtained all private identifiable data and/or specimens from all subjects.
  • You have completed your analysis of all private identifiable data and specimens, as described in your IRB application.