Institutional Review Board (IRB)

COVID and Human Subjects Research Activities

Updated July 1, 2022

City University of Seattle continues to prioritize public health and the safety of faculty, staff, and students, while also maintaining our ethical obligation to protect individuals who volunteer to participate in research. It is the responsibility of Principal Investigators and student researchers and their chair to check this site regularly for updates and to be familiar with the University’s policies.

As of March 9, 2022, City University of Seattle Coronavirus Advisory:

Criteria to Resume In-Person Human Subjects Research Activities

All researchers who plan to conduct in-person human subjects research activities must ensure that their recruitment, consent and data collection procedures include health and safety measures required by City University of Seattle COVID-19 policy, specific health and safety measures (e.g., wearing a face covering/social distancing/ or other enhance safety precautions) required by local public heath and safety authorities and the State or Province where the research participant resides.

IRB Overview

What does an Institutional Review Board do?

Revisions to the Common Rule effective January 21, 2019.

Institutional Review Board Guidelines for Submission of Ethics Review Protocols.

Successfully Prepare your Ethical Review Protocol for submission.

Ethical Review Protocol PDF Download Instructions

Please follow the step-by-step instructions to download the Ethical Review Protocol PDF template. You must download the PDF to your computer before adding content.

  • Step One: Download the Ethical Review Protocol Form to your personal computer.
  • Step Two: Save the Ethical Review Protocol Form to your personal computer.
  • Step Three: Re-open the saved Ethical Review Protocol Form from your saved file on your personal computer. Enter your research content.
  • Step Four: Review IRB Ethical Review Protocol Guidelines document located below in the Ethical Review Protocol Form section of this page. This document details exactly what is required for each question of the Ethical Review Protocol.
  • Step Five: Save the completed Ethical Review Protocol to your personal computer. You will submit this saved copy of the form.

Required Documentation to be Submitted with Ethical Review Protocol Submission

Ethical Review Protocol Form

Please review the Ethical Review Protocol PDF download instructions detailed above. This process is required for the PDF to be activated with the pop-up guidance notes for each question. Please review the IRB Ethical Review Protocol Guidelines (revised 2020) document. This document details exactly what is required for each question of the Ethical Review Protocol Form.

Informed Consent Forms

Please submit the appropriate Informed Consent Form for the participants in your study. Please review the IRB Informed Consent Guide. This guide will assist you in the ethical process of informed consent.

Other Consent Forms

If you are recruiting employees as participants, you are required to submit an Organizational Consent Form. If you are employing a transcriber to transcribe your data, you are required to submit the General Statement of Confidentiality.

Amendment Process to Approved Ethical Review Protocols

Any changes to the research process in the approved Ethical Review Protocol require approval. Please submit the following document.

City University of Seattle Research Policy Manuals

The IRB Policies and Procedure Handbook will assist you in understanding the policy on research involving human participants, the code of good research practice in research, the policy governing informed consent, research misconduct and procedures for the review of research involving human participants.

Research Data Security Plan and Procedures

Federal regulations for human subject research require Institutional Review Boards (IRBs) to determine that adequate provisions to protect the privacy of subjects and the confidentiality of data are in place and that researchers include adequate provisions for monitoring the data collected to ensure the safety of subjects in their research plan.  Methods for working with research data often evolve over time given rapid changes to technology. As a result, periodic updates are required to existing IRB documents. Computer and Internet-based methods of collecting, storing, utilizing, and transmitting data in research involving human participants are developing at a rapid rate. As these new methods become more widespread in social and behavioral research, they present new challenges to the protection of research subjects.

Review the Research data Security Plan and Procedures document that includes guidance notes on best practices for data collection and storage of research data.