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Institutional Review Board

Kern Medical Institutional Review Board

Federal Registration:

Kern Medical Center IORG0001143
Kern Med Ctr IRB #1 -Biomedical IRB00001544

Federal Wide Assurance

Kern Medical Center (includes the Main Campus, Sagebrush Medical Plaza, Stockdale and Truxton Extension patient care locations) FWA0021463

Members (2020-2021):

Kate Botner, MSL, CPC, CMT (non-scientific, non-institutionally affiliated)
Data Quality Manager, Clinical Documentation & Audit Operations,
Kaiser Permanente, Bakersfield

Shahzad Chaudhry, MS, LMFT (scientific, institutionally affiliated)
Behavioral Health, Kern Medical

Randolph Fok, MD, PhD (scientific, institutionally affiliated)
OB/GYN, Chief, Division of Maternal-Fetal Medicine

Arash Heidari, MD (Scientific, institutionally affiliated)
Infectious Disease Clinic, Director

Shannon Hochstein, JD (non-scientific, institutionally affiliated)
Kern Hospital Authority, Hospital Counsel

Jeffrey C. Jolliff, PharmD, APh, BCPS, BCACP, AAHIVP, CDE (scientific, institutionally affiliated)
Pharmacy Department, Associate Director
Senior Clinical Pharmacist for Infectious Diseases

Marie Joy Quiton-Buaya, PsyD, LMFT (scientific, non-institutionally affiliated)
Kern Behavioral Health and Recovery Services Administrator

Alternate: Dana Brucker, RN (scientific alternate, institutionally affiliated)
Valley Fever Institute at Kern Medical, Research Manager

Alternate: Non-scientific alternate – not filled

Designated Institutional Official for Research: Russell V. Judd, CEO

Human Protections & IRB Administrator: Glenn Goldis, MD, CMO

Staff: Evan Lanuza, IRB Manager
Valley Fever Institute, Director
(925) 786-5631 (mobile)
Evan.Lanuza@kernmedical.com

Frequently Asked Questions

What is research?

The definition is embedded in federal law and regulation [45 CFR 46.102(d)]: “Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge…(truncated).”

HIPAA law, focusing on protected health information (PHI) defines research in the same way: “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” (45 CFR 164.501).

Is Quality Assurance (QA) research too?

Some of the methodologies for QA and research are similar, especially studies involving use of protected health information, private patient data.

QA differs from research in that it IS NOT intended to produce generalizable knowledge as is research. QA is designed to provide internal organization direction for improvement and identification of clinical problems – for use within the organization.

In California, QA research conducted by medical staff or approved through a Medical QA committee is protected from discovery if the hospital is sued; research findings are not protected.

Therefore, research is publishable and publically presentable, QA usually is not unless the organization releases it from discovery protection.

What is the purpose of the Institutional Review Board (IRB)?

This IRB is authorized by the Kern Hospital Authority Board of Directors in compliance with federal regulations covering the protection of human subjects in research and protection of their data and identity. The IRB reviews all research proposals and issues a decision for full approval, conditional approval or denial of approval. A Principal Investigator must have an IRB approval prior to any interventional or data based research.

Does research involve human subjects?

Actually, yes and no… for the Kern Medical, only research that involves humans, identifiable patient data or biospecimens, de-identified lab tests, social research about patients can be conducted at Kern Medical or at the sites the Kern Medical IRB supports for research reviews (also reviews studies when requested for County of Kern Public Health and Behavioral Health Departments). In other settings, with review by qualified IRB’s, research might include prisoners, animals, social science research, lab studies, agricultural studies, etc.)

Are only adults permitted to participate in research reviewed by the Kern Medical IRB?

No, the Kern Medical IRB follows research regulations that permit inclusion of adults (45 CFR 46), pregnant women & their fetuses (45 CFR 46, Subpart B) and children (45 CFR 46, Subpart D) under specific regulatory conditions. The Kern Medical IRB also follows regulation/guidance regarding Federal and/or state government additional research protections for vulnerable populations, special needs individuals, HIV+/AIDS patients and others.

How do I qualify to participate in research?

Everyone, regardless of staff or faculty position, must complete Human Subjects Protections training prior to being permitted to participate in research activities in any study reviewed by the Kern Medical IRB.

The NIH on-line training is the most easily accessed, a completion certificate from the training (or from equivalent training) must be submitted electronically to IRB staff (email please) so that you can be cleared for research activities. NIH Human Subjects Protections Training

What does IRB review mean?

Research has three federal categories that determine the type of review: full committee, minimal risk and exemption from review. Each type has either full committee or starts with review by a single scientific member. An exemption review can be completed by senior IRB staff; if an approval cannot be granted, the review request is referred for minimal risk or full committee review, as appropriate.

45 CFR 46.109 contains the review requirement and the authority to approve, require modifications in (to secure approval) or to disapprove all research covered by the review requirement. Notification of review outcome is in writing. For disapprovals, in the written outcome, the reasons for the decision and an opportunity for the investigator to respond in writing or in person is provided.

Full committee reviews are for studies that are often interventional, had identified or unknown risks for subjects, require informed consent for research, include review of all forms of study advertising/subject use documents, scientific study design (is the study designed in scientific manner so that it will provide either a positive or negative answer for each study hypothesis), protection of identity and data sharing plan and more. Full committee reviews are also for studies that are > minimal risk or that do not plan for a de-identified database.

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. This type of research might be e.g., EMR data based or questionnaire data that results in a de-identified database. A single scientific member conducts these reviews and the list of single-member reviews is validated at a convened meeting of the IRB.

Exemption Review is an administrative function assigned to senior staff for approval determination or advanced to minimal risk or full committee review when necessary.

What is a study team?

When human subjects’ protections training has been completed, previous research experience, sponsorship, the scope of a study and the availability of support may allow for all of the following types of team members:

A Principal Investigator (PI) is the leader and has bottom line responsibility for the legal and ethical conduction of the study by self and all team members.

Sub-investigators, with direction from the PI, have delegated study responsibilities

Research Assistants – with PI or Sub-investigator supervision, may, for example, if provided by Kern Medical with EMR access, abstract EMR data, transfer questionnaire or summary data to the database, interact with subjects if the study is interventional, provide study procedures that are within the scope of their practice license or formal training,

Data Manager or Data Assistant – responsible for abstracting from data sources, entering in the study database, preparing data for analysis.

Who can be a PI?

  • Any faculty member or manager with previous research experience
  • Any resident with a faculty sponsor as identified in the “Investigator’s Assurance” form may act as PI; the faculty sponsor has responsibility to mentor the resident in the PI role and to assure legal and ethical study conduction of all team members.
  • A community-based physician with at least a courtesy appointment at Kern Medical with full-time faculty member sponsorship

Can students participate in research?

Yes, after submitting proof of completion of human subjects’ protection training to the IRB office, rotating students can join a research team, but cannot serve as the PI.

Are forms required to apply for IRB review?

Yes, please contact the IRB office for determination of the type of study; the type of study will dictate the forms necessary which will be sent electronically for completion. Since research training is not a part of formal education at Kern Medical, resources for assistance in developing research projects include:

  • Department faculty with research experience
  • Kern Medical has an experienced biostatistician on contract. Optimally, a biostatistician would begin working with a study team during the PLANNING phase of a study. The biostatistician will advise on variables, intervening variable control, data selection, database set-up with the goal of effective data analysis and will work with the team through data analysis. Referral is available by contacting IRB staff.
  • IRB staff will assist with application preparation, including informed consent (6-8th grade document literacy level is recommended for our patients) and protocol drafts as well as arranging reviews, providing review outcome letters and maintaining review and study files.

When an IRB approves a study, how long does the approval last?

IRB approval for any of the review types can be given for up to one year at a time (federally regulated approval cycle length). The IRB can provide a shorter approval cycle, usually for studies of higher risk or with a minimally experienced PI or require interim reports during an approval cycle. The approval cycle that is granted is in the approval letter and written in the IRB seal imprinted on study documents distributed by IRB staff.

What happens if a study needs to continue for more than a year for data collection or to meet recruitment goals or if any change is needed in study design, subject risk, etc.?

  • Continuing review – if original review was by full committee or by single member, that will usually be the process for continuing review too. The study approval letter clearly describes the PI responsibility to apply for continuing review in a timely manner: for expedited review, at least 2 weeks prior to the end of the approval cycle; for full committee review, at least 4 weeks before the IRB meeting that precedes the end of the approval cycle.
  • Amendment review – for all changes to protocol, consent or subject risk, review and issuance of approval is necessary before changes are made, unless subject safety is at issue. Similar to continuing review for type of review needed for study changes, full committee or expedited.
  • Ongoing exemption – notify the IRB office if study activities will continue beyond the end date of the exemption cycle.

Can Continuing Review occur after the approval cycle ends?

There is no allowance in federal or state research law and regulations to provide retrospective continuing review after the end date of study approval. A PI can, however, apply to the IRB for a new study, under a modified title, using the same protocol and consent with the “new study” application, if additional study activity time is needed.

When an approval ends, can any study activity continue?

Data analysis and publication or public presentation can occur. What cannot happen is collection of new data or continued interventions.