The U.S. Department of Health and Human Services and 16 other federal departments and agencies have announced that the Final Revisions to the Common Rule will go into effect onJanuary 21, 2019.
All studies approved after January 21, 2019, will be required to comply with the Revised Common Rule. All studies approved prior to January 21, 2019, will continue under the previous version of the common rule.
The Revised Common Rule broadens the types of research that qualify for exemption. Exemption is defined as requiring IRB approval but not continuing review. Several exempt categories have been revised, and there are new categories of exemptions. City U policy requires all student and faculty researcher to submit their research protocols for review and approval. The Chair or Chair-designate determines whether the research is exempt, expedited or requires a full board review.
The Revised Common Rule removes the requirement for continuing review for minimal risk research and for full-board research that is in long-term follow-up or data analysis only, unless the research is FDA-regulated.
When the new rules go into effect, new minimal risk research will still require IRB approval but will not automatically undergo continuing review by the IRB unless it is FDA-regulated. The IRB may require continuing review for special circumstances such as studies involving conflict of interest, IRB reliance or prior compliance concerns.
Even when continuing review is not required, investigators remain responsible for updating the IRB about adverse events and other unanticipated problems, seeking IRB approval for changes to personnel, protocol amendments, recruitment materials, etc., and informing the IRB when the research is complete.
When the new regulations go into effect, changes will be required to the structure and content of informed consent documents. Consent forms will begin with a concise summary of "key information" that is most likely to assist a prospective subject in understanding the reasons why one might or might not want to join the research.
Revised Informed Consent Forms will be posted to the IRB web page on January 21, 2018.
City University of Seattle values the participation of students, faculty, and community members in research efforts that attempt to add to the body of knowledge in business, education, leadership and the social sciences. In so doing, the University adheres to the highest standards of integrity, accountability and responsibility. When student and/or faculty research efforts under the auspices of the University include human participants, City University of Seattle ensures adherence to the requirements of the U. S. Department of Health and Human Services regulations applicable to all human subject research. 45 CFR 46.101 et seq. Canadian students and faculty must also meet requirements for ethical review as outlined by the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans in Canada (1998, amended 2005).
City University of Seattle Institutional Review Board review is required prior to commencement of student and/or faculty research when that research meets all three of the following definitions:
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Generalizable knowledge refers to any systematically gathered data which is intended for dissemination beyond the institutional source of the data (e.g., program evaluation research for internal use does not usually need review), and which might reasonably be applicable beyond the research sample.
Human subjects are defined by HHS Regulations at 45 CFR 46.102(f) as “a living individual about whom an investigator conducting research; obtains (1) data through intervention or interaction with the individual; or 2) identifiable private information.” Intervention includes both the physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
Interaction includes communication or interpersonal contact (e.g., questionnaires, interviews) between the investigator and the subject.
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
To ensure adherence to the above Policy, all research involving human subjects must be approved by the City University of Seattle Institutional Review Board before the research is begun.
2018-2019 submission schedule
The City University of Seattle Institutional Review Board Guidelines for Submission of Ethics Review Protocols is a resource to assist you in the completion of your Ethics Review Protocol. This researcher’s manual will provide you with the description of the submission process, definition of ethical research concepts and a detailed description of the required components of each Ethics Review Protocol question.
The main role of the Institutional Review Board (IRB) is the review of all human participant research conducted at City University of Seattle to ensure that the research fulfills the requirements of the federal regulations. In the United States the regulations are under the Department of Health and Human Services, Office for Human Research Protection, Code of Federal Regulations Title 45 Part 46. In Canada the regulations are under Government of Canada, Panel on Research Ethics, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2; 2014).
City University of Seattle is committed to protecting the interests of research participants, as well as, ensuring the ethical conduct of human participant research.
As a researcher you are responsible for ensuring:
That your research participants meet selection and eligibility requirements as defined by the research study.
The research is approved by the IRB and conducted according your Ethical Review Protocol.
That no recruitment of participants or collection of data begins prior to IRB approval.
Participants' informed consent is appropriately obtained.
The study is properly designed and scientifically valid.
Your Ethical Review Protocol declares that you understand and have adhered to the core principles for responsible research involving human research participants (Belmont Report):
Respect for Persons: Informed Consent of participants
Beneficence: Minimization of risks to participants
Justice: Equitable selection of participants and distribution of benefits
Categories/Levels of Review
The IRB are faculty of City University of Seattle who are committed to providing you with expert, ongoing guidance for all ethical issues that are relevant to your research.
When you are uncertain about an ethical issue, don't hesitate to contact the IRB. If you require assistance in completion of the Ethics Review Protocol please contact the IRB (firstname.lastname@example.org) and request a consultation.
The IRB reviews research proposals according to the following criteria:
Are the risks to participants minimized?
Are the risks reasonable in relation to anticipated benefits?
Is the selection of participants equitable?
Is the study is properly designed and scientifically valid?
Your study will undergo a preliminary review which consists of the following: (1) a review of the protocol to determine if there is missing information or information that requires further clarification, (2) a review of the consent and information forms to see if they contain the required elements set forth in 45 CFR 46.116 and 117, (3) a review of the recruitment procedures, (4) determination of the appropriate approval category.
Incomplete proposals will be returned to the researcher for resubmission.
There are three levels of IRB review:
Only the IRB Chair or designated IRB member, may determine if a protocol is granted exempt status under the six categories described in 45 CFR 46.101(b). If the research fits into an exempt category and is low risk to participants, it will not need to go through expedited or full board review. The IRB Chair or designated IRB member, may determine that the research does not qualify as exempt in which case the research is forwarded for expedited or full-board review. Exempt research must be minimal risk and not expose participating participants to psychological, social or physical risks.
Exempt research does not mean that the research does not require IRB approval. It means that the research is exempt from continuing IRB review and approval. However, all modifications to a study that have been certified exempt must be submitted to the IRB for prospective review and certification of exemption prior to implementation.
Expedited research must be no more than minimal risk. As defined in the federal regulations, “minimal risk” means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45 CFR 46.102(i)). Only the IRB Chair or an IRB member may determine if a protocol is granted expedited status under seven of the nine categories as published in the federal register as 45 CFR 46.110 and 21 CFR 56.110. Categories 8 and 9 do not pertain to initial review.
Only the Chair or an IRB member can make one of the following three determinations in regard to the protocol and consent forms:
APPROVED: IRB approval indicates that the IRB reviewer(s) has concluded that the research and consent forms meet the federal criteria for approval.
MODIFICATIONS REQUIRED IN ORDER TO SECURE APPROVAL: The IRB reviewer(s) withhold approval pending submission of revisions/additional information.
FULL REVIEW REQUIRED: The IRB reviewer(s) may determine that the protocol requires full review by the IRB at a convened meeting.
Full Board Review
Proposed research that does not qualify for either exempt status or expedited review will be sent to the convened board for review.
Full Board reviews are conducted in accord with the criteria set forth in 45 CFR 46.111 and 21 CFR 56.111. The Board can make one of the following four determinations in regard to the protocol and consent forms:
APPROVED: IRB approval indicates that the Board has concluded that the research and consent forms meet the federal criteria for approval.
MODIFICATIONS REQUIRED IN ORDER TO SECURE APPROVAL: A vote for amendments required indicates the IRB has given the meeting Chair the authority to approve the minor revisions. The IRB withholds approval pending submission of minor revisions/additional information.
DEFERRED: The IRB withholds approval pending submission of major revisions / additional information. For some studies, the IRB may appoint one or more members of the IRB to discuss the reasons with the investigator. Once the revisions have been made by the researcher the revised protocol is added to the next IRB meeting agenda for review.
DISAPPROVED: Disapproval of a protocol usually occurs when the IRB determines that the risk of the procedures outweighs any benefit to be gained or if the proposed research does not meet the federal criteria for IRB approval.
The length of time a study will take to be approved and a certificate of approval issued depends on the type or level of review required.
Completeness of application
Quality of application
Timeliness of investigator response to requests for clarification and changes
Exempt Review (from date of application submission): 1 weeks Expedited Review (from date of application submission): 2 weeks Full Board Review (Ethical Review Protocols that require a full board review are reviewed at the monthly IRB meeting). Note: The outcome of the review will be sent to the researcher within a week of the IRB board meeting it was reviewed.
At any point in your research that you believe you are no longer compliant with the approved ethical requirements of your research, it is important to be proactive and contact the IRB. Your IRB is available to assist you from submission to termination of your research. The IRB’s approach to addressing such issues is a nonjudgmental one, focusing instead on finding the most effective strategy to address the issue and minimize harm to research participants.
General Submission Guidelines
Prior to submission of the Ethics Protocol the researcher is responsible (Note: that for student research submissions the student’s Faculty supervisor is responsible) to confirm to confirm that:
Submissions must be on the City University of Seattle IRB Ethical Review Protocol form and are required to be electronic, addressed to: IRB@CityU.edu.
Protocol submissions must be submitted to the IRB in a PDF file in the following format:
Title the submitted document using only the last name of the researcher (e.g., “Smith.pdf"); if the submission is a resubmission, title the document as, for example “Smith Resubmission.pdf”;
Any necessary additional documents submitted may be scanned as described below.
Student submissions must be emailed to the IRB@CityU.edu by the Faculty supervisor with copy to the student;
Faculty research submissions are emailed directly to IRB@CityU.edu by the faculty member;
Include the date that the researcher has satisfactorily completed the ethics module on the top of the Ethical Review Protocol;
To protect student and faculty confidentiality, all communication with IRB must be sent using only City University of Seattle email addresses. Protocols received from or copied to email addresses other than City University of Seattle will be returned without review;
Submit only a final Ethical Review Protocol for review, not a version showing edits;
When completing the protocol, answer fully each question; incomplete answers or incomplete or missing attachments will result in the protocol being returned for resubmission.
Your first step prior to submission of the Ethical Review Protocol is completion of the Research Ethics Training on blackboard.
Prior to submitting an Ethical Review Protocol, the student or faculty member must satisfactorily complete the City University of Seattle Ethics Module available on City University of Seattle Blackboard. Answering the module questions with a score of 70% or better constitutes “satisfactory completion”. Faculty researchers request enrollment via the IRB email (email@example.com). Faculty advisors request enrollment of their student(s) via the IRB email. Upon successful completion of the Ethics Training modules an email confirmation of completion of ethics training will be issued. Confirmation of completion of ethics training emails should be received approximately one week following completion of the ethics training modules.
Upon IRB approval of your Ethical Review Protocol you will be issued an IRB Certificate of Approval which you are required to keep for your records. Upon completion of your study you must submit the, Notice of Completion or Extension Request, on or before one year from the date of IRB approval.
NOTE: Changes to the approved protocol REQUIRE an amendment to be submitted and approved by the IRB.
The IRB Guidelines for Submission of Ethical Review Protocols will assist you in completing your Ethics Review Protocol. You will find a detailed description of the required components of each section of the Ethical Review Protocol and each question within the Ethics Review Protocol document. The IRB Guidelines for Submission of Ethical Review Protocols is available in the forms section.