Institutional Review Board
- About Natividad's Institutional Review Board (IRB)
- Types of Review Required
- Special Circumstances: SARS-CoV-2 –IRB Involvement in Use of Medications or Biologics for treatment of SARS-CoV-2 (COVID-19)
- COVID-19 convalescent plasma for patients with serious or immediately life-threatening COVID-19 disease
- Single Patient Emergency IND-An alternative for patient access to Convalescent Plasma for the Treatment of COVID-19 Patient
- Clinical Trials
- Required Training for Investigators, Research Staff, IRB Members, and OPRS Staff
- Natividad IRB is a medical staff committee that is a federally approved committee registered with U.S. Health and Human Services- Office of Human Research Protection (OHRP)
- The IRB Committee members include scientists, non-scientists and a community member per federal requirements:
- Coleman, Mary., MD, MPH, IRB Committee Co-Chair
- Wilcox, George E., MD, IRB Committee Co-Chair
- Buscher, Nancy, RN, BSN, MS, DNP
- Chandler, Juliette, PhD, FNP-BC, JD
- Chandler, Peter, MD
- Mills, Walter. MD
- Nothnagle, Melissa., MD, Msc
- Rodriguez, Juan P., LL.B, MA, JD
- Todicheeney, Rydell., PhD, RN, PHN, ACNS-BC
- Tunzi, Marc, MD
- Warren, Jason, PharmD
- Guzman, Melanie B., Senior Secretary
- Auclair-Valdex, Daniela, Coordinator
- Rules, Cindy L., Senior Secretary
- Melanie Guzman, Senior Secretary*
- Natividad requires that all research involving human subjects or identified human material of living or deceased individuals must be reviewed and approved by Natividad IRB before initiation of any research related activities, including recruitment and screening activities.
For more information contact IRB@Natividad.com
Natividad Hospital and Clinics are committed to the ethical and legal responsibilities associated with the conduct of research involving human subjects.To this end Natividad has established a Program for the Protection of Human Subjects.
The components of the Human Subjects Protection Program include:
- An Institutional Review Board that reviews human subjects research protocols
- A program of human subjects research protection education of IRB Members and Natividad staff
- A research compliance program that provides administrative oversight (including privacy/HIPAA) and manages reports of unanticipated problems, protocol violations and incidents and investigates allegations of non-compliance.
The purpose and responsibility of the IRB is to protect the rights and welfare of human subjects.It is guided by the ethical principles applied to all research involving human subjects as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research known as the . (website 1) The IRB also reviews and oversees research to ensure that it also complies with applicable federal regulation including US Department of Health and Human Services and the US Federal Drug Association.It also follows the State of California Health and Safety Code which includes a requirement for a Natividad Research Participant Bill of Rights
How Does the IRB Protect Human Subjects (YouTube Video)
Research is defined according to Department of Health and Human Services (DHHS) as a systematic investigation, including research development, testing and evaluation designed to develop or contribute to generalizable knowledge.A human subject is defined as a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual or identifiable private information.Contributing to generalizable knowledge criteria may include developing publications/papers, thesis dissertations or making public presentations.
- Is it Research?-IRB Determination Letter provided
- Exempt Research-Qualifies as Human Research but does not require a full IRB review
- Expedited Research-Human Subjects Research which may be reviewed by a subcommittee of the IRB and involves no more than a minimal risk
- Full Committee Review-Required for Human Subjects Research with More than a Minimal Risk
At this time Natividad IRB is not reviewing studies that have more than a minimal risk except in the case of an urgent but non-emergency request for expanded access or compassionate release of medication or biologic related to treatment of COVID-19. An IND application for expanded access is an option for patients with serious or immediately life-threatening disease who are not eligible or who are unable to participate in randomized clinical trials (21 CFR 312.305). Instructions.
A physician can also request that his/her patient enroll in an expanded access program for treatment of COVID-19 patients through an external sponsor reviewed and approved by an external full IRB provided the physician has a pre-approval from Natividad administration and Monterey County Counsel.The physician researcher should contact the Natividad IRB Chair and email Natividad IRB at IRB@Natividad.com for such requests.
- Receipt of Single Use Emergency Use- A physician may request a Single-patient emergency access to a medication or biologic for a seriously ill patient if other treatment options have been exhausted and enrollment in an approved clinical trial or expanded access program are not possible. Under these circumstances, single-patient emergency access can be requested by the treating physician, on behalf of the patient. Pharmaceutical companies developing new treatments, as well as the FDA, require that such a request come from a licensed physician who will be overseeing treatment.
Emergency use request instructions are found at https://www.fda.gov/news-events/expanded-access/expanded-access-how-submit-request-forms#AccessPhysEmerg. Physicians are encouraged to promptly contact Natividad IRB Chairman for assistance if an emergency request is being considered.
3-Natividad Application Instructions 3-2020
- Complete Human Subjects Protection Training
- Researchers are required to complete Human Subjects Protection Training through Citi Program
- CITI Registration Instructions for Investigators and Instructions for Citi Program Learners
- Request an application at firstname.lastname@example.org
According to the CDC, “currently there are no Food and Drug Administration (FDA)-approved drugs for COVID-19. However, an array of drugs approved for other indications, as well as multiple investigational agents, are being studied for the treatment of COVID-19 in several hundred clinical trials around the globe. These trials can be accessed at https://clinicaltrials.gov/ct2/results?cond=Sars-CoV2&term=&cntry=US&state=&city=&dist=. In addition, providers can access and prescribe investigational drugs or agents approved or licensed for other indications through various mechanisms, including Emergency Use Authorizations (EUA) (website 8)Emergency Investigational New Drug (EIND) applications, compassionate use or expanded access programs with drug manufacturers, and/or off-label use.” https://www.covid19treatmentguidelines.nih.gov
Four of the clinical trial studies include an Expanded Access Program which means a physician can request to participate on behalf of his/her patient in a single arm opportunity for a medication or biologic https://clinicaltrials.gov/ct2/results?cond=Sars-CoV2&cntry=US&Search=Apply&age_v=&gndr=&type=Expn&rslt=
Natividad IRB has made a preliminary review of one Expanded Access Program for physician request and with Natividad administration approval. The example below pertains to access for one such treatment biologic-namely: Expanded Access to Convalescent Plasma for the Treatment of Patients With COVID-19 sponsored by the Mayo Clinic. Details are below under expanded access:
An IND application for expanded access is an alternative for use of COVID-19 convalescent plasma for patients with serious or immediately life-threatening COVID-19 disease who are not eligible or who are unable to participate in randomized clinical trials (21 CFR 312.305). FDA has worked with multiple federal partners and academia to open an expanded access protocol to facilitate access to COVID-19 convalescent plasma across the nation. For patients with serious or immediately life-threatening COVID-19 who are not eligible for or who are unable to participate in randomized clinical trials, access to this investigational product may be available through participation of acute care facilities in an investigational expanded access protocol under an IND that is already in place. Currently, the following protocol is in place: National Expanded Access Treatment Protocol (Mayo Program) Physicians may contact IRB chair or send an email to email@example.com for more information.
Although participation in clinical trials or an expanded access program are ways for patients to obtain access to convalescent plasma, for various reasons these may not be readily available to all patients in potential need. Therefore, given the public health emergency that the COVID-19 pandemic presents, while clinical trials are being conducted and an expanded access protocol is available, FDA also is facilitating access to COVID-19 convalescent plasma for use in patients with serious or immediately life-threatening COVID-19 infections through the process of the patient’s physician requesting a single patient emergency IND (eIND) for the individual patient under 21 CFR 312.310. This process allows the use of an investigational drug for the treatment of an individual patient by a licensed physician upon FDA authorization, if the applicable regulatory criteria are met. Note, in such case, a licensed physician seeking to administer COVID-19 convalescent plasma to an individual patient must request the eIND (see 21 CFR 312.310(b). Physicians may contact IRB chair or send an email to firstname.lastname@example.org for more information.
Investigators wishing to study the use of convalescent plasma in a clinical trial can submit requests to FDA for investigational use under the traditional IND regulatory pathway (21 CFR Part 312). CBER’s Office of Blood Research and Review is committed to engaging with sponsors and reviewing such requests expeditiously. However clinical trials are not currently available at Natividad.
CITI is a web-based training program in human subjects protection. Completion of 12 Continuing Medical Education (“CME”) credits in the Human Subjects Protection Course offered through the CITI is required of all investigators and research staff who will have contact with research participants and/or identifiable research data (including coded data) prior to approval of their research. The training requirement is applied regardless of funding source. IRB Members and OPRS staff must also complete this training. IRB Members, OPRS staff, and investigators must complete 12 CME credits initially and every two years.
Click HERE to enter CITI Training Portal
Courses available are:
- IRB Committee - Human Subjects Research
- Researchers - Human Subjects Research
- Institutional/Signatory Official
- IRB Committee - IRB Chair Course
- Researchers - Public Health Research
- Visit the CITI Program homepage: https://about.citiprogram.org/en/homepage/
- Use the 'Register' button in the upper right-hand corner of the page.
- In the first step of the registration process type "Natividad Medical Center" into the search box and select it.
- Continue through the guided registration process (inputting email address, creating username/password, etc)
- Note: Step 7 of the registration process is where you select which courses you would like to enroll in. Don't worry if you get something wrong on this step, your course list can always be changed after registration.
All investigators, research staff, IRB Members, and OPRS staff are also required to take the annual HIPAA training provided by Natividad.