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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Additional Resources


The Principal Investigator (PI) is charged to conduct objective research that generates independent, high quality, and reproducible results.  The Principal Investigator is responsible for the management and integrity of the design, conduct, and reporting of the research project and for managing, monitoring, and ensuring the integrity of any collaborative relationships.  Additionally, the Principal Investigator is responsible for the direction and oversight of compliance, financial, personnel, and other related aspects of the research project and for coordination with school, department, and central administration personnel to assure research in is conducted in accordance with Federal regulations and University and sponsoring agency policies and procedures.

Step 1: Complete the Required Human Subject Protection Training

Principal Investigators and their co-investigators/study staff are required to take a human subjects protection training.  To begin your training, review the Required Human Subject Training information.

Note: Not all projects require IRB review and approval.  Before getting started, determine if IRB approval is required.  Please retain a copy of your certificate to submit with your application.

 

Step 2: Determine Which Application to Submit

Projects that involve human subjects’ research may undergo one of three types of review:

The type of review depends on the risk level of the research and if the research falls into one of the expedited or exempt categories as defined by the federal regulations.

For assistance in determining which application should be completed for your study, please refer to the IRB’s guidance: Types of IRB Review.

Once the application is received by the Compliance Officer, the IRB Chair will make the final determination on the type of review.

What happens if you send in the wrong application?

The IRB may be able to obtain the necessary information from the application that was initially submitted. If additional information is needed, the IRB will let you know. In some cases, the IRB will ask that you complete the correct application for your study type.

 

Step 3: Obtain Appropriate Signatures & Approvals

There are several signatures required on the IRB application. The IRB does accept scanned, faxed, or copied versions of the signature page.  If you do not have access to a scanner, you can mail a copy of the signature page to the Compliance Officer. Be sure to include a cover sheet that indicates the study title and Principal Investigator.

For Student Investigators:

  • Be sure to include the Student Research Project Checklist form
  • Your signature is required on the application
  • Your Faculty Advisor must also sign the application and be listed as a co-investigator
  • Some schools/departments have an IRB pre-reviewer and IRB applications must first be reviewed by the pre-reviewer. Student investigators are asked to check with their school’s research administration and/or Faculty Advisor to determine if a pre-review is appropriate

For Faculty Investigators:

  • Your signature is required on the application
  • Your Department Chair must also sign the application. If you are the Department Chair, your Dean must sign the application.

 

Step 4: Assemble Study-Related Documents for IRB Review

The IRB reviews most study-related documents. The following documents should be included with your submission, as applicable:

If the project is federally funded and RVU is the prime awardee, submit a full copy of the grant application. If RVU receives a subcontract, submit relevant sections of the grant application and/or the scope of work.  Additional steps are required if the project is related to grant funding.

 

Step 5: Email Application to the Compliance Officer

Prior to sending in your application, ensure that:

  1. You and your study staff/co-investigators have taken the required human subjects protection training
  2. You have completed the appropriate IRB application
  3. You have obtained all of the proper signatures
  4. 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.

Exempt and Expedited submissions are reviewed on a rolling basis. If the study qualifies for Full Board review, it will be reviewed at the next Full Board meeting.  Full Board meetings occur four times per year in March, June, September, and December.

A complete description of the planned research (i.e., protocol) must be submitted with initial applications for IRB or exempt review. The research protocol should provide the information needed for reviewers to determine that the regulatory and Human Research Protection Program (HRPP) policy requirements have been met. There is no required format or template; different sections and formatting may be used, provided the necessary information is included.

For additional information on submission for IRB or exempt review, see HRPP policies, IRB Submission and Pre-Review and Exempt Research.

 

Objectives

The purpose of the study (research questions and / or study objectives) should be clearly and succinctly stated. In experimental designs, objectives will be stated as hypotheses to be tested.

 

Background and Rationale

Summarize and synthesize the available research (including published data) to provide justification for the study. Evaluate prior research for relevance to the research question under study. When the proposed research is the first of its type to involve human participants, the results of relevant animal studies must be included. Discuss the anticipated results and potential pitfalls. Describe the significance of the research including potential benefit for individual subjects or society at large. Discuss how public health and social welfare might be enhanced.

 

Procedures

The procedures should include the following:

A. Research Design

The research design should be identified and should be appropriate to answer the research question(s) under study. Describe the type of research proposed (e.g. experimental, correlational, survey, qualitative) and specific study design that will be used (e.g. pre-test /post / test control group design, cross-sectional design; prospective longitudinal cohort design; phase III double-blind randomized control group design).

B. Sample

Describe the sampling approach. For experimental designs, include justification for sample size determination. Identify the procedures that will be used to recruit, screen, and follow study volunteers. Specifically define the study sample (number of subjects to be enrolled, characteristics of subjects to be included in and excluded from the research).

C. Measurement / Instrumentation

Identify the variables of interest and study endpoints (where applicable). Justify measurement techniques selected. Provide validity and reliability data for selected measures.

D. Detailed Study Procedures/Methods

Methods for study data collection and for avoiding / minimizing subject risks should be included. Include a timeline for subject evaluations and the duration of subject participation in the project. Identify the plans the proposed safeguards for subject confidentiality (plans for coding data and for securing written and electronic subject records). Indicate how long personal information will be stored once the study is completed.

Methods will vary with the research approach used (qualitative, quantitative, or mixed). The selected methods should be sufficiently described to justify the use of the approach for answering the defined research question. Methods should also be described in adequate detail so that IRB members may assess the potential study risks and benefits.

E. Internal Validity

Threats to internal / external validity should be considered. Describe measures that have been taken to avoid study bias.

F. Data Analysis

Specify the analytic techniques the researcher will use to answer the study questions. Indicate the statistical procedures (e.g. specific descriptive or inferential tests) that will be used and why the procedures are appropriate. For qualitative data, specify the proposed analytic approaches.

 

Bibliography

Include a reference list of literature cited to support the protocol statement.


Research-design-figure
The “Common Rule” (45 CFR 46 subpart A) defines a set of research activities that may be exempt from its purview, unless otherwise required by Department or Agency heads. Exempt research has very little, if any, associated risk. These research activities, as defined by 45 CFR 46.101(b), include six exempt categories:

  1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
  1. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:

a) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and

b) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.

  1. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if:

a) the human subjects are elected or appointed public officials or candidates for public office; or

b) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

  1. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
  1. Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine:

a) public benefit or service programs;

b) procedures for obtaining benefits or services under those programs;

c) possible changes in or alternatives to those programs or procedures; or

d) possible changes in methods or levels of payment for benefits or services under those programs.

  1. Taste and food quality evaluation and consumer acceptance studies,

a) if wholesome foods without additives are consumed or

b) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Note:  RVU policy allows the IRB to disallow exemptions that are allowable under federal law.  Also, the IRB Chair and/or the IRB Chair’s designee may determine whether a submitted research project meets the requirements for exemption from IRB review. If the research project does not meet criteria for exemption, the PI will be notified and the project will require resubmission for either expedited review or review by the full IRB.

Q1: Does your proposed activity involve the use of “Human Subjects”?

1. Will You Collect or Utilize Data:

a) Physically gathered from a person?
b) By manipulating a person or their environment?
c) By communicating with a person (e.g., via verbal or written survey/interview)?

2. Will you collect or utilize privately identifiable information (i.e., the identity of the subject can be readily obtained by the investigator or from the information) from/about a person?

Examples include:

– Medical records/tests (including previously archived test data),

– Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place,

– Any information provided by an individual which was/is reasonably expected to not be made public.

3. Is there an intervention or interaction with a living person that would not be occurring, or would be occurring in some other fashion, but for your activity?

If you answered “No” to every question, your activity does not need IRB approval. You do not need to contact the IRB.

If you answered “Yes” to any question above, your activity requires action by the IRB. Proceed to Question 2.

 

Decision Tree: Formal Review

Q2: Does your proposed human studies activity require formal IRB review?

Since your activity involves human subjects, some form of IRB action is required. YOU MUST CONTACT THE IRB. Please continue reading.

1. Does your proposed activity include a systematic investigation, (including research development, testing and evaluation) designed to develop or contribute to generalizable knowledge?

Example activities likely not designed to develop or contribute to generalizable knowledge:

– Course projects used to explore, teach “textbook” knowledge.

If you answered “No”: Inform the IRB that approval is not required.

Example activities likely designed to develop or contribute to generalizable knowledge:

– Project whose results might be published in a scientific journal/conference.

– Most federally-sponsored investigations; most investigations sponsored by not-for-profit agencies; most industry-sponsored projects (even if the results may be held proprietary).

If you answered “Yes”: Your activity requires IRB review. Proceed to Question 3.

 

Decision Tree: Exemption

Q3: Should you apply to the IRB for an “Exemption”?

The government exempts human studies activities for one of six specific reasons. To apply for an exemption, your activity must be contained within one or more of these categories. The categories are summarized in the Exemption from IRB document.

1. Do You Believe That Your Activity Is Contained Within One Or More of the Exemption Categories?

If you answered “Yes”: Apply for an IRB exemption for your activity using the IRB Application Form to apply for an IRB Exempt Review.

If you answered “No”: Your activity is not exempt. Proceed to Question 4.

 

Decision Tree: Expedited Review

Q4: Since your research does not qualify for an exemption, should you apply to the IRB for an “Expedited Review”?

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Example activities likely to be considered “minimal risk”:

  • Written or verbal surveys on non-controversial topics or on topics not likely to evoke strong emotion.
  • Non-invasive physiologic recordings (e.g., ECG, EEG).

Example activities likely not to be considered “minimal risk”:

  • Written or verbal surveys on controversial topics or on topics likely to evoke strong emotion (e.g., incidents of assault, sexually transmitted diseases).
  • Invasive physiologic recordings.

1. Is your activity of “minimal risk” to all human subjects involved?

If you answered “Yes”: Submit a completed IRB Application Form to apply for an IRB Expedited Review.

If you answered “No”: Submit a completed IRB Application Form to apply for an IRB Full Review.

The purpose of an informed consent is to help investigators protect research participants by informing them about the nature of the research, including the procedures to be followed and any associated risks or benefits to participation. In compliance with federal regulations, the IRB carefully reviews informed consent documents.

Consent documents vary in the way they are written and formatted. The IRB discourages the use of a “model” consent document because it believes that participants’ rights will be better protected if investigators determine the appropriate language, format, and tone of the consent based on what they feel will best convey study information that is accurate and understandable to their participants.

Regulations require that certain basic elements be included in an informed consent. As a general rule, the following points should be considered when writing an informed consent:

  • Include the basic required consent elements specified by the federal regulations.
  • Use simple language. Many IRBs suggest that a consent form be written at no more than an 8th grade reading level.
  • Avoid technical and legal terms.

For additional information, please see Human Subject Protection (Informed Consent): 21 CFR Part 50.

The RVU IRB has been designated to review all research protocols 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 Department of Health and Human Services.  In accordance with Federal regulation, the RVU IRB Membership Roster includes:

  • a minimum of five (5) members
  • at least one (1) female and one (1) male member
  • members of varied backgrounds and professions
  • at least one (1) member whose primary experience is in nonscientific areas
  • at least one (1) member whose primary experience is in scientific areas
  • at least one (1) member who is not affiliated with Rocky Vista University

Federal regulations also stipulate that the membership of an institutional review board include:

  • reviewers with expertise in all of the areas of research being reviewed*
  • a diversity of backgrounds, including racial and cultural diversity
  • members with sensitivity to community attitudes
  • knowledge of institutional commitments and regulations, applicable laws, and standards of professional conduct and practice
  • knowledge and experience with vulnerable populations**
  • a consideration of potential conflicts of interest amongst its membership***

*At its own discretion, the RVU HIRB may invite individuals with specific competency to assist in reviews when specific expertise is required.

**For protocols that involve vulnerable populations, the HIRB will consider including an individual with knowledge and experience with vulnerable subjects.

***A member who has a conflict of interest cannot participate in the review of the conflicting project, nor in the committee vote on that project.

These regulations and standards are designed to protect the rights and welfare of all individuals participating as subjects in research studies, and to insure that all studies conducted at, or in affiliation with, Rocky Vista University demonstrate the appropriate respect for involved persons, subject beneficence, and meet expectations of justice, as outlined in the Belmont Report on “Ethical Principles and Guidelines for the Protection of Human Subjects of Research”.