Concisely describe the process for the IRB prescreening review at Chamberlain University?
Order Instructions
Week 8
After reviewing the Week 6 and 7 Let’s Check-In recordings and the DNP Practicum Form assignment from Week 7, reflect on the IRB prescreening process by answering the following questions:
Concisely describe the process for the IRB prescreening review at Chamberlain University? What barriers could you face as you progress through the IRB prescreening process?
Will you need to gain IRB approval from your organization? If so, what is the schedule for the organization’s IRB meetings? What is the process you will expect? If you do not need site IRB review, have you arranged to get a letter from your organization that confirms you do not need IRB approval? Please attach the letter to your post.
Attached for more information
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.
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 [email protected]
You may also contact the IRB administrator at:
Chad O’Lynn, Ph.D., RN, CNE, ANEF
Director of Evaluation/ IRB Administrator
Chamberlain University
Email: [email protected]
Federal Registration
The Chamberlain University IRB is registered with the Office of Human Research Protections. Registration Numbers: IRB000111037/ 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 protected].
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 [email protected] and video conferencing login information will be provided.
Handbook, Forms & Samples
Institutional Review Board Handbook
• IRB Handbook
A handbook for researchers and those who plan to submit proposals to the IRB
Institutional Review Board Forms
• Continuing Review of Study Application Form
This form is used to renew a study’s approval and provide the IRB with information on the status of the study. This form should be submitted six weeks prior to the expiration of the current IRB approval.
• Evaluation Criteria for Reviewers
This checklist is used by reviewers to evaluate submitted proposals. The checklist may be helpful for those submitting proposals to become more aware of evaluation criteria.
• IRB Application for Review Form
This is the form to submit to request the IRB to review your study proposal and information
• IRB Informed Consent Form Template
A template that can be used to develop an informed consent form
• Recruitment Template
This template can be used to draft study recruitment letters/emails.
• Reliance Agreement FAQ-April 2018
Here is an FAQ to answer some basic questions about reliance agreements with other IRBs
• Request for Chamberlain University IRB to Serve as the Relying IRB
This template is used for situations in which the researcher requests that the Chamberlain IRB defer primary review and oversight to an external IRB. Highlighted items must be completed by the researcher. Officials from the external IRB must review, sign, and submit this form to the Chamberlain IRB.
• Request for Chamberlain University IRB to Serve as the Reviewing IRB
This template is completed when the researcher requests that Chamberlain serve as the primary IRB for review and oversight. Highlighted items must be completed by the researcher. Officials from the external IRB must review, sign, and submit this form to the Chamberlain IRB.
• Study Amendment Application Form
This form is used to amend a study protocol already approved by the IRB. Changes to approved protocols must be approved by the IRB before they are implemented.
• Study Closure Form
This form is used to officially close a study with the IRB
• Unanticipated Problem/ Adverse Event Report Form
Submit this form to the IRB to report an unanticipated problem or adverse event. The report must be submitted to the IRB within 72 hours of knowledge of the problem or event.
Institutional Review Board Samples
• Sample of Adult Consent Form at 5th Grade Reading Level
Here is an example of an informed consent form for adults written at a 5th grade reading level.
• Sample of Adult Consent Form Written at a 10th Grade Reading Level
Here is an example of an adult informed consent form written at a 10th grade reading level.
Resources for Students
• Pre-Screening Form for DNP Students
Pre-screening form to determine whether DNP student scholarly projects constitute human subjects research requiring review 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 requiring review by the IRB.
• Pre-Screening Form for MSN Population Health Students
Pre-screening form to determine whether population health student projects constitute human subjects research requiring review by the IRB.
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 involving members of the Chamberlain community and/ or data collected from or about Chamberlain employees, students, or programs must first be reviewed and approved by the Office of Institutional Effectiveness & Research. Depending upon the specific study protocol and level of risk, reviews and approvals from other Chamberlain departments and teams may also be required prior to review by the Chamberlain IRB. Researchers should refer to the University’s Surveying Standard Operating Procedures for further information.
All forms and materials should be sent to [email protected]. 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” section for information regarding submission of materials after study has been approved.
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 [email protected].
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 protected].
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 at least 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 any additional study personnel who have direct contact with study participants and/or personally identifiable information/ personal health information
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” section. 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 [email protected]
Human Subjects Protections Resources
• 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.
• 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.
IRB Policies
Student Policies
• Student Conducted and Student Assisted Human Subjects Research Policy
Official university policy on human subjects research conducted by or assisted by enrolled university students
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