Kern Medical Institutional Review Board
Kern Medical Center IORG0001143
Kern Med Ctr IRB #1 -Biomedical IRB00001544
Kern Medical Center (includes the Main Campus, Sagebrush Medical Plaza, Stockdale and Truxton Extension patient care locations) FWA0021463
Members (2023-2024):
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
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
Leila Moosavi, MD (scientific, institutionally affiliated)
Department of Medicine
Towhid Salam, MD, PhD (scientific, institutionally affiliated)
Depart of Psychiatry
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: Scott Thygerson, CEO
Human Protections & IRB Administrator: Glenn Goldis, MD, CMO
Staff: Kayvon Milani, IRB Manager
Assistant Director, Medical Education
(661) 326-2673
IRB@kernmedical.com
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).
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.
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.
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.)
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.
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
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.
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.
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.
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:
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.
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.
Data analysis and publication or public presentation can occur. What cannot happen is collection of new data or continued interventions.