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.
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 email@example.com for any questions.
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 firstname.lastname@example.org
You may also contact the IRB administrator at:
Chad O'Lynn, Ph.D., RN, CNE, ANEF
Director of Evaluation/ IRB Administrator
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 email@example.com.
Institutional Review Board Committee Members
Role (as Defined by OHRP)
Interim Administrator; Scientific Member
Non-affiliated Member; Non-scientific Member
Non-affiliated Member; Non-scientific Member
DNP, MSN/ED, RN
PhD, RN, CPAN, CNE
PhD, JD, MBA, MSW, LCSW
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 firstname.lastname@example.org and video conferencing login information will be provided.
Handbook, Forms & Samples
Institutional Review Board Handbook
- 2019-2020 IRB Handbook
A handbook for researchers and those who plan to submit proposals to the IRB
Institutional Review Board Forms
Institutional Review Board Samples
Resources for Students
- Pre-Screening Form for DNP Stuidents
Use this form to provide information about your proposed scholarly project and whether or not it must be reviewed by the IRB
- Pre-Screening Form for MSN-ST/AT Students
Pre-screening form to determine whether MSN-ST/AT student projects constitute human subjects research
- Pre-Screening Form for MSN Population Health Students
Pre-screening form to determine whether population health student projects constitute human subjects research.
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 email@example.com. 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.
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 firstname.lastname@example.org.
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 email@example.com.
Required Human Subjects Protections Training
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 firstname.lastname@example.org
- Adtalem's FERPA Policy
Adtalem Global Education policy on FERPA dated 8-24-17
- Adtalem FERPA Records FAQs
A resource provided by Adtalem Global Education of frequently asked questions about FERPA policies and procedures
- The Belmont Report
Here is a copy of the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, adopted in 1979.
- Common Rule 1991 and Updated 2009
Here is a copy of 45 CFR 46, otherwise known as the "Common Rule" drafted in 1991 and updated in 2009. Please note: A new revision of the Common Rule will take effect in January 2018!
- Declaration of Helsinki
Here is a copy of the Declaration of Helsinki: Principles for Medical Research Involving Human Subjects, originally drafted in 1964 and updated in 2013.
- FERPA 2009
Here is the Family Education Rights and Privacy Act Regulations (FERPA) as updated in 2009. These regulations may apply to some types of educational research.
- How to the Lower Reading Level of Informed Consent Documents
Here is one source describing how to lower the reading level of informed consent documents. This source comes from the Centers of Disease Control's website.
- Informed Consent Laws by State 2017
This resource describes state laws applicable to informed consent processes and documents above and beyond Federal requirements.
- Instructions for Enrolling in CITI Human Subjects Research Course
Instructions on how to access and enroll in CITI courses.
- Joint Guidelines on e-Informed Consent from OHRP/FDA
These guidelines on e-Informed Consent (or eIC) were published in December 2016. The guidelines were issued jointly by the Office of Human Research Protections and the Food & Drug Administration.
- Revised 2018 Common Rule as Published in January 2017
This is a copy of the revisions to 45 CFR 46 ("Common Rule") as published in the Federal Register January 19, 2017. The revisions will take effect, by in large, on January 19, 2018.
- Student Conducted and Student Assisted Human Subjects Research Policy
Official university policy on human subjects research conducted by or assisted by enrolled university students