Student Spotlight

Katie Rose-Borcherding, OMS II

Class of 2018

  • Hometown: Colorado Springs, CO
  • Undergraduate Studies: Physiology (Seattle Pacific University)
  • Clubs and Activities: Pediatrics Club, Osteopathic Club, and Global Medicine Honors Track

Why did you choose RVU? After my interview day at RVU, I knew that if I was accepted I would choose RVU over any other school....
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Faculty Spotlight

Christopher Unrein, DO, FACOI, FACP, CMD

 

Professor of Internal Medicine, Chief Academic Officer of Rocky Mountain OPTI, Medical Director of Rocky Vista Health Center

  • Hometown: Denver, CO, born and raised - a rare find of a nearly extinct species: a native Coloradoan!
  • Undergraduate Studies: Bachelors of Arts in Biology (University of Colorado Denver)
  • Graduate Studies: Des Moines University College of Osteopathic Medicine and Surgery; Internal Medicine residency at Mountainside Hospital (Montclair, NJ)

What class do you teach? I teach some cardiovascular disease and EKG interpretations, hepatitis and infectious diarrhea, genitourinary infections,...
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IRB Compliance

Role of the Institutional Review Board (IRB) 

Mission: The mission of the RVU Institutional Review Board (IRB) is to assure adequate protections of the rights and welfare of human subjects research. To achieve this, the RVU IRB advises investigators in designing research projects in a manner to minimize potential harm to human subjects, review all planned research involving human subjects prior to initiation of the research, approve research that meets established criteria for protection of human subjects, and monitor approved research to ascertain that human subjects are indeed protected.

Function: The RVU Institutional Review Board (IRB) reviews all research protocols, submitted by students, faculty and/or staff involving human subjects.  The IRB has the authority to approve, require modification, or to disapprove any research project, in accordance with standards set by the U.S. Department of Health and Human Services (HHS).

For additional information about the IRB’s constitution, see the IRB Constitution document.

 

Research and IRB Review Categories

If you are conducting research that involves human subjects, you must determine which research application to submit. The IRB reviews and approves research under three distinctive categories, specified by federal regulations: Exempt, Expedited, and Full IRB Research Review.

Certain research is exempt from the requirements of the HHS regulations. Nevertheless, a determination that research is exempt does not imply that investigators have no ethical responsibilities to subjects in such research.  Rather, it means that the regulatory requirements related to IRB review, informed consent, and assurance of compliance do not apply to the research.

At RVU the IRB is responsible for determining whether proposed research is exempt from HHS regulations for the protection of human subjects. To determine if your prospective project may qualify as Exempt, please review the Exemption from IRB Review Document and the Research and IRB Review Process Decision Tree.

If the project meets the description of an Exempt project, please click here: “Request for Review – EXEMPT Research (PDF)” and complete the form.

An Expedited review procedure consists of a review of research involving human subjects by the IRB Chairperson, or by one or more experienced reviewers designated by the Chairperson from among members of the IRB, in accordance with the requirements set forth in 45 CFR 46.110.

HHS regulations allow some categories of minimal risk research to be reviewed by the IRB through an Expedited review procedure.  Expedited review procedures may be used for:

  1. research in the OHRP Expedited Review Categories, and found by the reviewer to involve no more than minimal risk;
  2. minor changes in previously approved research during the authorized approval period.

To determine if a project qualifies for Expedited Review, please review the OHRP Expedited Review Categories. If the project qualifies for an “Expedited review, please click here: “Request for Review – EXPEDITED Review (PDF)” and complete the form.

All projects involving greater than minimal risk, and not qualifying as Exempt or for Expedited review, requires approval by the IRB. Research at RVU that requires full IRB committee review may include one or more of the following elements:

  • Prisoners
  • Pregnant women
  • In vitro fertilization
  • Deception
  • Fetuses
  • Decisionally-impaired
  • The use of school records of identifiable students or interviewing instructors about specific students
  • Survey or interview procedures with children (participants under the age of 18 years)
  • FDA research except in emergency circumstances
  • Observation of public behavior when the investigator(s) participates in the activities being observed
  • Data collected that includes protected health or medical information when there is a direct or indirect link that would identify the participant
  • Sensitive aspects of the participant’s own behavior, such as illegal conduct, drug use, sexual behavior or use of alcohol

For a Full IRB Review, please click here: “Request for Review – FULL Review (PDF)” and complete the form.

IRB Review Process

The IRB office utilizes an initial pre-review screening process, during which the Compliance Officer reviews each submission for completeness and compliance.

The RVU Compliance Officer may ask the Principal Investigator (PI) to make changes to the submission before it is reviewed by the IRB (pre-review). The IRB reviewer(s) may also ask for changes or clarifications, which the Compliance Officer will communicate to the research team after IRB review (post-review).

IRB

IRB Review Procedures

The IRB Chair or the IRB Chair’s designee will determine whether a submitted research project meets the requirements for exemption from IRB review. The IRB Chair, or the IRB Chair’s designee, can require Expedited or Full Review of any research at his/her discretion, even if the research would otherwise qualify for Exempt review status.

The decision to actually grant Exempt review status is initially made by the IRB Chair, or the IRB Chair’s designee, who must review the full set of documents submitted by the investigator in reaching a decision during an Exempt review.

Please see Steps for Submitting a New IRB Application to determine which documents and forms must be submitted to the IRB for consideration of exempt review.

If it is determined that Exempt review is appropriate for a study, and the IRB Chair or the IRB Chair’s designee wishes to utilize this procedure, the IRB Chair or the IRB Chair’s designee will document his/her determination of risk. The review is then performed by the IRB Chair or the IRB Chair’s designee.

The IRB Chair or the IRB Chair’s designee will evaluate research determined to be Exempt to ensure that it meets Rocky Vista University’s ethical standards. Such an evaluation might include the following:

  1. The research holds out no more than minimal risks to subjects.
  2. Selection of subjects is equitable.
  3. If there is recording of identifiable information, there are adequate provisions to maintain the confidentiality of the data.
  4. If there are interactions with subjects, there will be a consent process that will disclose such information including:

                a)  that the activity involves research;

                b)  a description of the procedures;

                c)  that participation is voluntary;

                d)  name and contact information for the investigator; and

                e)  there are adequate provisions to maintain the privacy interests of the subjects.

When a study has been certified as Exempt from IRB review, continuing review and approval is not required. Certification of Exemption is effective for the life of the study. However, all modifications to a study that has been certified Exempt must be submitted to the IRB for prospective review and certification of exemption prior to implementation.

In some circumstances, changes to the protocol may disqualify the project from Exempt status. If it is determined that the proposed study is exempt, the PI will be provided with a Certificate of Exemption that will include under what category of exemption the study was granted.

If it is determined that the proposed study is not exempt or additional information is needed to determine Exempt status or certification is granted pending acceptance of requested modifications/clarifications, the PI will be notified of this information in     written form.

Expedited review may be carried out by the IRB chairperson or by one or more experienced IRB members designated by the chairperson. All of the requirements for IRB approval of research apply to Expedited review.

Expedited review should not be viewed as a less rigorous review. Under Expedited review, the reviewers may exercise all of the authorities of the IRB, except that the reviewers may not disapprove the research.

Please see Steps for Submitting a New IRB Application to determine which documents and forms must be submitted to the IRB for consideration of expedited review.

Human subjects’ research that is not classified as exempt or expedited requires review by the full IRB at a convened meeting. These meetings are closed meetings that are not open to the public; however, Investigators may be invited to attend the meeting to answer questions from the board.  At the conclusion of the meeting, the board votes and issues a determination.

Please see Steps for Submitting a New IRB Application to determine which documents and forms must be submitted to the IRB for consideration of full review.

Submission of Materials for IRB Review

Please email all application materials described above (and in the Steps to Submitting a New IRB Application document) to the Compliance Officer. Prior to submitting your application, ensure that:

  • You and your study staff/co-investigators have taken the required human subjects protection training
  • You have completed the appropriate IRB application
  • You have obtained all of the proper signatures
  • You have assembled all study-related documents

After you complete the above steps, you may email your completed application and relevant documents to the Compliance Officer.

 

Length of Time for IRB Review

The time to process an application depends on the complexity of the research study and the quality and completeness of the application submitted to the IRB.  Other variables include whether the application can be approved by the IRB Chair or Chair Designee (expedited review) or by the full board.

The most common problem with New Project applications is that not enough detail is provided for the IRB chair or full board to evaluate the study’s purpose and/or procedures.  The more complete the initial description is, the less likely that your application will be routed back and forth between you the IRB to fill in the details.  Read each question in the application carefully.  Provide a complete and accurate answer to each question, and make sure that details throughout the application are consistent.

 

Possible Determinations after IRB Review

  1. Approved – the IRB Chair or full board has approved your application with no required changes. You can start your research as soon as the approval memo is released to you.
  2. Approved Pending – the IRB full board has approved your application, pending the completion of specified required actions.  You will receive notification, which will state the required actions. The IRB Chair can approve the project once the required actions have been completed successfully.
  3. Tabled – the IRB full board has tabled your application and has specified required actions. Following completion of the required actions, the full board must review your application at another meeting.
  4. Disapproved – the IRB full board has disapproved your research application. You must start a new project application if you wish to pursue this application further.
  5. Withdrawn – the application has been withdrawn, either at the request of the PI, or by the IRB, if the PI failed to respond in a timely manner to requests for more information.

 

IRB Application Submission and Review Flow Chart

For a graphical depiction of the IRB application submission and review process, please see the IRB Application Submission and Review Flow chart. (Please note that the time estimates on the chart may vary as indicated above.)

 

Human Subject Protection Training

 All campus-based, full-time faculty, staff and medical students involved in human subjects research at Rocky Vista University must complete a training course covering the privacy laws which apply to the Health Professions to meet requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

In addition, a basic training course in biosafety, as required by the Occupational Safety and Health Administration (OSHA), must be completed.  The avenue chosen for completion of this training is the Collaborative Institutional Training Initiative (CITI), provided through the University of Miami.