Required Changes to Research Protocols in Response to COVID-19
City University of Seattle is committed to protecting the rights and welfare of all individuals who participate as subjects in research, as well as, researchers. Please find here the mandatory changes in research protocols due to COVID-19 related risks.
Use of Email for Transmitting and Receiving Research Documents
Given the current restrictions on face to face contact with research participants, correspondence with research participants can be conducted via email and/or video interviews. Please refer to the IRB Informed Consent Guide in the related files section of this page (below) and adhere to the following process to ensure participants’ privacy and confidentiality:
- All correspondence with research participants and transmission of research documents between the researcher and the participant is required to be conducted via City U email and all documents (Informed Consent Forms, research data collection instruments) must be encrypted/password protected. The email to research participants that contains encrypted/password protected research documents is required to contain directions to the participant describing the process of returning signed encrypted/password protected documents.
- Informed consent can be obtained verbally by recording at the onset of the video interview the researcher reviewing the informed consent form, having the participant acknowledge that they understand what has been read to them and that they verbally state their consent to participate.
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.
- IRB Informed Consent Guide
- Informed Consent Form: Research Participant
- Informed Consent Form: Parent/Legal Guardian
- Informed Consent Form: Internet Survey Data Collection
- Informed Consent Form: Autoethnographic Research
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.