Introduction

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.

Members of the Committee

IRB Member

Credentials

Role

Position at Chamberlain University

Marie Cahill

MA

Non-scientific Member

Non-Chamberlain Faculty, DeVry University

Patricia Fedorka

PhD, RNC-OB, C-EFM, CNE

Co-chair, Scientific Member

Faculty

Shakira Henderson

PhD(c), DNP, MSN, MS, MPH, RNC-NIC

Scientific Member

Faculty

Peter Horn

PhD, MA, BA

Non-scientific Member

Community Member

Chad O'Lynn

PhD, RN, CNE, ANEF

National Office representative, Scientific Member

Director of Evaluation and Innovation

Channan Pondexter

BA

Non-scientific Member

IRB Coordinator

Ellen Poole

PhD, RN, CPAN, CNE

Scientific Member

Faculty

Susan SannerPhD, APRN, FNP-BC Scientific Member Faculty 

Amy Sherer

MSN, RN

Scientific Member

Faculty

Martha Spies

PhD, MSN, RN

Co-Chair, Scientific Member

Faculty

Jill Walsh

DNP, RN

Scientific Member

Faculty

Submission Information

Submission for Initial Review

The IRB requires the submission of a research plan or protocol. It should include a clear description of the study objectives, procedures, risks and benefits, recruitment and consent processes, and procedures to maintain confidentiality and privacy.

Researchers should minimize risks to study participants by using procedures that are consistent with sound study design and professional ethical standards.

Researchers must complete the IRB Application Form when a study or project needs to be reviewed.  Researchers must obtain all necessary signatures and attach supporting documents, if necessary.

Email a copy of the completed, signed application to irb@chamberlain.edu.

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.

Amendment to Study

Researchers are responsible for ongoing requirements in the conduct of approved research.  This includes obtaining prior approval from the IRB for any modifications of the previously approved research protocol and documents before implementing any proposed modification(s). Researchers must submit an Amendment to Study Form anytime there is a modification needed in the previously approved study protocol.

NIH Training

Chamberlain College of Nursing requires all individuals involved in the conduct of human subjects research to complete human subjects protections training and to recertify every 5 years. These requirements apply to all investigators and persons with a significant role in the research.

Chamberlain faculty, staff, and students must complete the approved Chamberlain human subjects protections course provided by the National Institutes of Health (NIH). Faculty, staff, and students must login or register a new account and complete the Basic Research modules(Faculty/Staff; Student; or IRB Member).

Non-Chamberlain investigators must provide evidence of human subjects protections training. Training taken from CITI programs affiliated with the investigator’s institution or from the National Institutes of Health are acceptable; however, such training must be comparable to the training content required of Chamberlain-affiliated investigators. Training should include topics such as ethical and legal considerations of human subjects research, basic information of the IRB and IRB processes, confidentiality and privacy, conflict of interest, risks and benefits assessment, and special considerations for research involving vulnerable populations. The Chamberlain IRB will determine acceptability of investigator training.

Where can I get more information?

The IRB Handbook provides further information on IRB requirements for research at Chamberlain University. 

Researchers are also welcome to call the IRB office at: 630-353-7334.

Contact information

Chad O’Lynn, PhD, RN*, ANEF, CNE
Director of Evaluation and Innovation
Chamberlain University
Email: CO’Lynn@chamberlain.edu
Phone: 503-319-7277

CO CHAIRS:

Patricia Fedorka PhD, RNC-OB, C-EFM, CNE
Email: pfedorka@chamberlain.edu
Phone: 630-353-8823

Martha Spies PhD, MSN, RN
Email: mspies@chamberlain.edu
Phone: 314-991-6246

IRB COORDINATOR:

Channan Pondexter
Email: cpondexter@chamberlain.edu
Phone: 630-353-7334

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