PALOMAR POMERADO HEALTH

INVESTIGATIONAL REVIEW COMMITTEE

RESEARCH SUBMITTAL GUIDELINES

Thank you for your interest in submitting a project for review by the Palomar Investigational Review Committee (IRC). This document outlines the process for submitting studies to the IRC for review. Applications are required for all research projects using human subjects in accordance with the Federal Policy for the Protection of Human Rights, the Food and Drug Administration (FDA) regulations, and the Federalwide Assurance granted by the Health and Human Services Office of Human Research Protections (OHRP).

The Principal Investigator/Project Coordinator is responsible for submitting the appropriate documents to the IRC office.For Nursing Research, please submit to Isis Montalvo () and Margaret Talley () for review prior to submitting to the IRC.

Alldocuments are to be submitted electronically in either MS Word or PDF format to . The checklist below outlines the documents required for initial submission. The submission must be in the office of the PPH IRC no later than two (2) weeks prior to the next scheduled IRC meeting. Projects will not be forwarded to the Committee for consideration until the submission has been determined to be complete.

Please note that the Principal Investigator/Project Coordinator must be

  1. a member of the medical staff with admitting privileges at the institution(s) at which the study will take place or
  2. an employee of Palomar Pomerado Health
  3. a contractor from an academic affiliation

For further information on obtaining privileges at either Palomar Medical Center of Pomerado Hospital, contact the Medical Staff Services office at either Palomar Medical Center at (760) 739-3140 or Pomerado Hospital at (858) 613-4358. The Principal Investigator/Project Coordinator may be required to attend the meeting at which the study will be considered and provide a brief (5 minute or less) overview of the study to the Committee prior to addressing any of their concerns or questions regarding the study.

If you have questions regarding the submission process, please contact Isis Montalvo or Margaret Talley at Palomar Medical Center, or Cheryl Jarman/IRC Administrator by email at .

The administrative Review Process should be started prior to submitting the application to the IRC. Please contact your CNS Director or Margaret Talley.

General Instructions:

Prior to study approval by the IRC:

An administrative review process will be started to:

  1. Determine if EBP or Research study
  2. Determine what parts of the patient’s care are “standard” versus part of the trial
  3. Agree upon a budget with the sponsor and/or Principal Investigator/Project Coordinator to reimburse Palomar Health for any care that is provided, overhead and other expenses
  4. Ensure that the IRC fee is paid (N/A for Employees)
  5. Work out logistics with Palomar Healt6h departments that will be affected by the trial
  6. Create a process for tracking patients so they are not billed for any care that the Sponsor does not pay for
  7. Negotiate contract terms, complete the legal review process and obtain signatures on the contract documents
  8. Submit documentation of in-service training for at least 80% of affected staff within 30 days of study start day

All studies, but in particular those which may have a financial and/or resource impact on Palomar Health

facilities and departments, may not proceed until after administrative approval is obtained

ADMINISTRATIVE REVIEW PROCESS

IRC Submittal Fee:

A list of the fees charged by the IRC is available on the Palomar Health Website. Contact Christopher

Alnutt at for further information regarding submittal fees.

Proof of Inservice/Training:

Documentation of the completion of the training will be submitted as part of the administrative review by Principal Investigator/Project Coordinator

Clinical Research Coordinator Application:

Please note that clinical research coordinators and other study staff who will have contact with patients or patient records at any Palomar Health facility must be credentialed through the Human Resources Dept. at Palomar Health. Please contact Traci Fickel at (760) 740-6332 for further information on this process. Documentation of completion of this process must be provided to the IRC.

Documents to be submitted to the Institutional Review Committee

Study Application:

The study application will include the following: name and signature of principal investigator, study location, protocol title, study phase (I, II, III or IV), name of the study sponsor, a few paragraphs describing the background, goals and overall objectives of the study, brief outline of the study design, number of subjects anticipated, study length (per subject), overall study duration, description of the protections of human subjects, detailed financial impact on patients and Palomar Health and possible benefits of the protocol. The form is available on beginning on page 8 of this packet.

Complete Study Protocol:

The study protocol should be comprehensive and include information on the rationale and objective of the study, complete description of the study procedures including monitoring required, patient inclusion and exclusion criteria, and potential liability or costs to the institution in which the study will be performed.

Informed Consent:

  1. The PPH IRC strongly urges Principal Investigators review the National Institutes of Health website regarding Guidelines for Writing Informed Consent Documents at
  2. The informed consent forms must be provided as it will be used in the study utilizing letterhead stationary of the Principal Investigator.
  3. A copy of the signed patient consent must be placed in the patient’s chart and kept as a permanent part of the medical record.
  4. The informed consent shall be accompanied by the California Experimental Subjects Bill of Rights as mandated by California regulations, see Appendix “A” for a sample or access the document at
  5. The informed consent must have all the paragraphs numbered and be accompanied by the completed Checklist for Review of Informed Consent Compliance (see Appendix “C”).

Informed Consent forms, other than those written in English, will only be approved if they are meet the criteria outlined by regulatory bodies and are accompanied by a certified Affidavit of Accuracy and the translation was performed by a qualified translation service or individual.

Curriculum Vitae of the Principal Investigator:

Submission of the most recent curriculum vitae of the Principal Investigator demonstrating that he/she has the appropriate background and training to conduct the required research for the study is mandatory.

Human Subjects Protection Education:

Submission of a copy of the completion certificate for the NIH course entitled Human Subjects Protection Education for the Principal Investigator and Research Coordinators at is required for all Principal Investigators, sub-investigators, co-investigators and research personnel involved in the study.

Content of all In-Service Training and Materials:

Each Principal Investigator is responsible for arranging for in-service education of at least 80% of the affected staff and other personnel participating in the study prior to implementation of any protocol involving an investigational drug or device. Copies of the content of the in-service education including any presentations, handouts, or other materials provided to the trainees will be provided to the Committee at the time of initial study submission. Documentation of the completion of the training will be submitted as part of the administrative/business review. The IRC must be promptly informed when all requested training has been completed.

Questionnaires, Interview Scripts and/or Subject Diaries:

Copies of any questionnaires, interview scripts, subject diaries or any other item that will be used by subjects or by research staff to obtain information from subjects shall be included with each study submission.

Recruitment Materials, Advertisements:

Copies of all recruitment materials, advertisements and other study information that will be provided to potential subjects shall be submitted to the IRC. These may include, but not be limited to, any advertising or publicity information such as recruitment letters, flyers, posters, public service announcements, newspaper, radio and television advertisements and internet content seeking subjects for research

Medication Summary Sheet:

This document will supplement the in-service training required to be provided to staff to ensure that they all have the necessary information that they need to safely and effectively administer study medications. This medication summary sheet will accompany each dose of study medication sent to the patient. Please provide the following pertinent data and any other appropriate information necessary for the safe and proper administration of the study medication: brief study summary, inclusion/exclusion criteria, drug dose/route/frequency, storage and stability information, monitoring parameters and required blood draws, special handling requirements and any other pertinent information.

Investigator’s Brochure/Drug Monograph:

A complete study drug or product monograph detailing the mechanism of action, indication, dosage, administration, and toxicity must be submitted for all studies involving investigational medications. Study drugs must be prepared and dispensed from the hospital pharmacy if the patients are to receive the investigational drug while in the hospital. The pharmacy will provide information on the administration and potential adverse effects to the study medication to the nursing staff caring for the patient.

Disclosure of Position/Affiliation/Financial Interest:

The PPH IRC Disclosure of Position/Affiliation/Financial Interest form must be completed by the Principal Investigator to assist the Committee in determining if any conflict of interest exists (refer to Appendix “G”).

Exception for Informed Consent Requirements for Emergency Research:

Investigators requesting an Exception from Informed Consent Requirements for Emergency Research should refer to the checklist in Appendix “D” for guidance.

Waiver of HIPAA Authorization:

Investigators requesting a waiver of completion of HIPAA authorization by each subject should refer to the checklist in appendix “E” for guidance.

Waiver of Requirement to Obtain Informed Consent:

Investigators requesting a waiver of the requirement to obtain informed consent or waiver of documentation of informed consent should refer to Appendix “F” for guidance.

Study Closure

The IRC must receive a study closure form at the end of the study. An abstract and results should be submitted with this form. The study closure form can be found on the Palomar IRC website.

General Guidance:

NOTE:The Palomar Health Investigational Review Committee Operational Procedures govern review of all proposed research and clinical investigations involving human subjects. The materialprovided below is for informational purposes only. Reference should be made to the Operational Procedures of the Investigational Review Committee for more specific and detailed treatment of the requirements addressed herein.

A letter from the Chairman of the Investigational Review Committee to the Principal Investigator will indicate final approval, deferral, denial or request for modification to the protocol. Approval of any significant research or clinical investigation to be undertaken in one or both Hospitals shall also be subject to approval by the Executive Committee and Administration of the Hospital(s) involved. The Board of Directors also retains discretion to approve or disapprove research for clinical investigation.

No changes except those necessary to eliminate apparent immediate hazards will be made without prior IRC approval. Reporting of protocol deviations is left to the discretion of the Principal Investigator within the context of the following guidelines.

Researchers are required to submit protocol deviations which are:

1)Intended to eliminate apparent immediate hazard to research participation

2)Harmful (caused possible harm to participants or others, or places them at increased risk of harm – including physical, psychosocial, economic or social harm)

3)Possible serious or continued noncompliance (such as deviation that has happened previously and is not being repeated)

Prompt reporting means that the report should be submitted as soon as possible after the Principal Investigator learns of the event or within 5 working days. The deadline for reporting begins at the time the investigator learns of the event. If the report is submitted late, a written explanation of its tardiness must accompany the report.

Study amendments and/or modifications to an approved protocol may not be implemented without prior IRC review and approval. Requests for amendment/modification of an approved protocol must be turned into the Palomar Health IRC office at least two (2) weeks prior to the next scheduled Committee meeting.

The Principal Investigator is responsible for ensuring that approval of the research to be conducted at Palomar Health does not expire by submitting a Request for Continuing Review and a copy of the Informed Consent Form being utilized by the study to the IRC for review and consideration prior to the expiration of the study (see Appendix “H”). Failure to comply with continuing review requirements will result in the study being terminated for non-compliance.

No study related activities will be allowed to be performed if study approval by the Palomar Health IRC has expired unless the discontinuation of the study will bring harm to the patients. Any such situation of study activity occurring outside the approval period must be reported to the Palomar IRC within five (5) working days.

The IRC must be informed of any serious, unexpected or alarming adverse events (SAE) that occur during the approval period, whether related to the study or not. The adverse event must be unexpected and related and suggest that the research places subjects or others at greater risk of harm than was previously known or recognized. These are reportable if they are events which are not described or defined in the study protocol. The report to the IRC must include the following information: relationship of the SAE to the drug, device, intervention or study protocol; whether or not a change in protocol is necessary to minimize risks, and whether or not the information about the SAE is relevant to consent and/or re-consent of participants already enrolled. Serious adverse events must be promptly reported. Prompt reporting means that the report should be submitted as soon as possible after the Principal Investigator learns of the event or within 5 working days. The deadline for reporting begins at the time the investigator learns of the event. If the report is submitted late, a written explanation of its tardiness must accompany the report.

The IRC must be informed of any sponsor notification of safety information within ten (10) days of receipt of the report by the Principal Investigator.

The IRC must be informed of any sponsor notification of safety information within ten (10) days of receipt of the report by the Principal Investigator.

The IRC must receive an annual update form, whether the study is closed or continuing, prior to the IRC approval expiration date.

Requests for copies of medical records must be accompanied by an appropriate authorization or waiver approved by the Palomar IRC. These requests should be forwarded to Health Information Services (HIS) and identified as records pertaining to a study patient. HIS may charge the Principal Investigator for the cost of copies. For information, contact Director of Health Information Services at (760) 739-3290.

Updated 16Jan2015/cjPage 1 of 7