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INSTITUTIONAL
REVIEW BOARD

Chamberlain University: Institutional Review Board

Welcome

An Institutional Review Board (IRB) is a committee established to review, approve, and oversee research involving human subjects. The purpose of the IRB is to ensure that all human subjects research is conducted in accordance with all federal, institutional, and ethical guidelines.
The Chamberlain IRB strives to create a supportive, collaborative environment for members of the Chamberlain community so that the design and implementation of research studies take place in a culture of ethical conduct. Nonetheless, the responsibility of the IRB is limited to review and oversight of applicable research studies for compliance with ethical standards, federal rules, and other applicable laws. The IRB does not provide advisement or mentoring on study design nor does it create required documents, such as recruitment flyers or consent forms, as a service to faculty and students.
The Chamberlain IRB is registered with the Office for Human Research Protections of the U.S. Department of Health and Human Services, The IRB typically meets monthly, though urgent matters may prompt additional meetings.

New Human Subjects Protections Training Now Available through CITI

The human subjects protections training course offered by the NIH is no longer available. Consequently, Chamberlain University has reactivated its subscription with the Collaborative Institutional Training Initiative (CITI) to provide this training. Students and colleagues affiliated with Chamberlain University can complete this training course at no charge. Instructions on how to access and enroll in the course are provided in a handout located under the "Human Subjects Protections Resources" tab on the left side of the screen. Once the CITI site is accessed, investigators will be asked to select either the "Biomedical Research" or "Social & Behavioral Research" course. The type of study the investigator will propose to the IRB should guide the investigator as to which course to select. (Investigators may choose, if they wish, to enroll in both courses by adding the other course after enrollment.) Investigators must successfully complete all modules within the course to earn a completion certificate.

The IRB accepts any comparable training for up to five years; there is no need to complete the new CITI course unless prior coursework has expired.

Please note: Although the courses available are complimentary, investigators may request from CITI continuing education credits for completed coursework. Investigators will be billed by CITI for continuing education credits.

Please contact the IRB at irb@chamberlain.edu for any questions.
 

Where can I get more information?

The IRB Handbook, provides further information on Institutional Review Board requirements and processes at Chamberlain University. The general contact email for the Institutional Review Board at Chamberlain University is irb@chamberlain.edu

You may also contact the IRB administrator at:

Chad O'Lynn, Ph.D., RN, CNE, ANEF
Director of Evaluation/ IRB Administrator
Chamberlain University
Email: colynn@chamberlain.edu

Federal Registration

The Chamberlain University IRB is registered with the Office of Human Research Protections. Registration Numbers: IRB00009799/ IORG0008174.

The IRB also carries a Federal Wide Assurance, Registration Number: FWA00021986.

For more information about the Chamberlain University IRB, please contact the IRB directly at irb@chamberlain.edu.

Committee Information

Institutional Review Board Committee Members 

Name Credentials Role (as Defined by OHRP)

Chad O'Lynn

PhD, RN

Interim Administrator; Scientific Member

Belquis Ahmadi

LL.M

Non-affiliated Member; Non-scientific Member

Peter Horn

PhD

Non-affiliated Member; Non-scientific Member

Michael Kozloski

PhD

Scientific Member

Patrick LaRose

DNP, MSN/ED, RN

Scientific Member

Ellen Poole

PhD, RN, CPAN, CNE

Scientific Member

Gilbert Singletary

PhD, JD, MBA, MSW, LCSW

Non-Scientific Member

Martha Spies

PhD, RN

Scientific Member

Institutional Review Board Committee Meetings

The IRB meets via video conferencing on the 3rd Friday of every month at 2 pm Central. Faculty, students, and members of the general public are welcome to join the meetings as guests, though they may be excused if the committee needs to go into executive session.
To join an IRB meeting, contact the IRB at irb@chamberlain.edu and video conferencing login information will be provided.

Handbook, Forms & Samples 

Institutional Review Board Handbook 

Institutional Review Board Forms 

Institutional Review Board Samples 

Resources for Students

Submission Information

Submission for Initial Review 

For the initial review of a proposed study, researchers must complete and submit an IRB Application Form. The application form will solicit information about the study's objectives and procedures, risks and benefits, subject recruitment, data collection methods and tools, informed consent procedures, and how researchers will ensure privacy of subjects and confidentiality of data, as well as other information.

When appropriate, researchers must include the following along with the application form:

  • Informed Consent Materials and Forms

  • Written Information Sheets Provided to Study Subjects

  • Parental Consent and/ or Assent Forms

  • Recruitment letters, notices, emails, or other materials

  • Letters of Support

  • Study Protocol

  • Questionnaires/ surveys/ interview questions/ tools

  • Copies of approval letters from other institutional review boards

  • Study Budgets

  • Approval Notice from the Chamberlain University Office of Institutional Effectiveness & Research

  • Approval Notice from the Chamberlain University Marketing/ Regulatory Compliance departments

  • Reliance agreements with/ from external IRBs

Please note: All studies collecting data from Chamberlain University students and colleagues must first be reviewed and approved by the Office of Institutional Effectiveness & Research. For studies involving contact and interaction with Chamberlain University students, recruitment flyers and surveys must be reviewed and approved by Marketing/ Regulatory Compliance prior to submission to the IRB. Researchers should refer to the University's Surveying Standard Operating Procedures for further information.

All forms and materials should be sent to irb@chamberlain.edu. The IRB will record the date of receipt and review the submission for completeness. For initial reviews, the IRB will make every effort to provide researchers an initial review response within 14 days after receiving all required forms and materials. Materials received just before a holiday or a session break may result in a response delay.

Please refer to the "Continuing Review and Amendments to Studies" tab for information regarding submission materials after the initial review.
 

Reporting Unanticipated Problems, Adverse Events, Non-Compliance, Amendments & Continuing Review

Reporting Unanticipated Problems

An unanticipated problem is an occurrence that is a) unexpected in terms of nature, severity, or frequency based on the IRB approved study protocol and the subject population being studied; b) is related or possibly related to participation in the research study; and c) suggests that subjects or others are at a greater risk of harm (including physical, psychological, economic, or social) than was previously known or recognized. All three conditions must be met in order for an occurrence to be considered an unanticipated problem. Simply put, an unanticipated problem results in an increased risk of harm to study participants, whether or not any participants actually experience harm as a result.

Researchers must report all unanticipated problems to the IRB as soon as possible by submitting an Unanticipated Problem / Adverse Event Report form. This form is available under the "IRB Forms" tab of this website. The IRB will review the occurrence within one week and determine appropriate action. All unanticipated problems will be reported to the Provost within five (5) days following the IRB review and to any relevant Federal, state, or regulatory agencies within thirty (30) days.
 

Reporting Adverse Events 

An adverse event is an unfavorable medical occurrence (psychological or physical harm), including a sign, symptom, or disease, temporally associated with participation in the research, whether or not it might be related to a subject’s participation in the research study. Adverse events result in actual harm to individual participants. If an adverse event meets the criteria of an unanticipated problem, then the event must also be reported to the IRB as noted above. 

It is important to note that not all adverse events are unanticipated problems. In fact, adverse events in research are often anticipated, such as harm that occurs as an expected risk of participation. Adverse events may also encompass harm that is unrelated to study participation, such as disease progression in subjects with baseline health conditions. Adverse events that are anticipated or unrelated to study participation typically do not need to be reported to the IRB; however, if the adverse event suggests that study participants may be at greater risk for harm than previously expected or if the adverse event is serious and related to study participation, then the adverse event must be reported to the IRB.

Reporting Non-Compliance 

Non-compliance is any deviation from the IRB approved study protocol, IRB policies or requirements, or any laws or regulations. If non-compliance compromises the rights and welfare of study participants or compromises the integrity or interpretability of the data collected from them, then the non-compliance is considered promptly reportable non-compliance (PRNC) and must be reported to the IRB as soon as possible.

Examples of PRNC include, but are not limited to, the following:

  • Enrollment of subjects before IRB approval has occurred and/or after IRB approval has lapsed

  • Continued treatment of subjects after IRB approval has lapsed without first obtaining permission from the IRB

  • Principal Investigator enrolls a subject into a study who does not meet all of the inclusion/exclusion criteria resulting in placing the subject at risk of harm

  • Enrollment of children, prisoners, pregnant women and fetuses, without prior IRB approval

  • Use of an unapproved consent form

  • Change in study protocol without IRB approval except in cases of potential immediate harm to participants

  • A breach of confidentiality

  • Unresolved complaint from any study participant

Upon notification, the IRB will review the PRNC within one week and determine appropriate action. Such action may lead up to suspension or revocation of study approval. If the PRNC constitutes an unanticipated problem, the IRB will follow the procedures noted above. If the PRNC is particularly serious, suggests a pattern of non-compliance, or results in suspension or revocation of study approval, the IRB is required to notify all relevant Federal and state agencies.
Researchers are encouraged to contact the IRB for any questions related to unanticipated problems, adverse events, or non-compliance, or if assistance with reporting is needed.
 

Reporting Amendments to Study

Researchers must inform the IRB for any of the following changes by submitting a Study Amendment Application Form:

  • Study title

  • Contact information of the principal investigator

  • Previously approved study protocol

  • Previously approved recruitment or informed consent materials

Proposed changes must be approved by the IRB before they may be implemented by the investigators unless there is a possibility of immediate harm to study subjects. In the latter case, the change will be temporary pending IRB approval. Submit the completed Study Amendment Application Form to irb@chamberlain.edu.

Reporting Continuing Review 

Continuing Review is a reevaluation of an approved study conducted at least once a year, as mandated by federal regulations. Continuing review is required so long as the study is ongoing, that is, until research-related interactions and interventions with human subjects or the obtaining and analysis of identifiable private information described in the IRB-approved research plan have been completed.

This review allows the IRB to monitor the progress of the study and ensure that it continues to meet the requirements for approval.

Researchers must provide the following information in the continuing review process:

  • A status report on the progress of the research
  • Any adverse events, unanticipated problems involving risks to subjects or others, any withdrawal of subjects from the research, and any complaints about the research since the last IRB review
  • A summary of any relevant recent literature, interim findings, and amendments or modifications to the research since the last review
  • Any relevant multi-center trial reports
  • Any other relevant information, especially new information about risks associated with the research
  • A clean copy of the current date-stamped consent document;
  • A clean copy of any newly proposed consent documents
  • A clean copy of the current recruiting materials.

Email a copy of the completed, signed Continuing Review Form to irb@chamberlain.edu.

Required Human Subjects Protections Training 

Training Requirements 

The Chamberlain University IRB requires all individuals involved in the conduct of human subjects research to complete human subjects protections training and to renew this training every 5 years. Evidence of completion of this training is required with the initial submission of each study to the IRB. These requirements apply to all investigators and persons with a significant role in the research study.

Chamberlain University readily accepts training certificates provided by the Collaborative Institute Training Initiative (CITI). Students and colleagues affiliated with Chamberlain University can complete CITI courses specifically prepared for Chamberlain University at no charge. Instructions on how to access and enroll in the course are provided in a handout located under the "Human Subjects Protections Resources" tab on the left side of the screen. Once the CITI site is accessed, investigators will be asked to select either the "Biomedical Research" or "Social & Behavioral Research" course. The type of study the investigator will propose to the IRB should guide the investigator as to which course to select. (Investigators may choose, if they wish, to enroll in both courses by adding the other course after enrollment.) Investigators must successfully complete all modules within the course to earn a completion certificate. Evidence of completion of other types of training may be accepted on a case-by-case basis. 

Courses provided from other providers may also be accepted by the IRB. Regardless of the provider of these courses, courses must cover the following areas of content:

  • History of human subjects protections
  • Ethical codes and regulations governing the protection of human subjects
  • Basic definitions of human subjects protection terminology, including human subjects, research, informed consent, assent, identifiable private information, vulnerable populations, and minimal risk
  • Evaluation of risks to human subjects and how to minimize risks
  • Procedures to obtain and ensure informed consent
  • The role and responsibilities of institutional review boards (IRBs)
  • Oversight of the conduct of human subjects research

Any questions about this requirement should be directed to the IRB at irb@chamberlain.edu

Human Subjects Protections Resources

IRB Policies

Student Policies