In order to initiate clinical research in Health First facilities, investigators must ensure that ALL of the following are completed:

• A Health First feasibility assessment;
• Review and approval of the clinical research protocol and associated study materials by Western IRB;
• A documented Medicare Coverage Analysis (MCA) for all clinical research studies anticipating third-party health insurance payments for particular items and services;
• Development of a comprehensive budget that is representative of all expenses emanating from the clinical research project;
• Implementation of a contract between Health First and the investigator/practice, including a Master Services Agreement, Hospital Use Agreement, and Clinical Research Service Request Form as applicable.

Overview of How to Initiate New Clinical Research Studies

Review the "Clinical Research Initiation" flowchart for an illustration of how the process of initiating a new clinical research study at Health First works.  The flowchart illustrates the feasibility assessment process that is conducted upon submission of a complete set of materials.  Upon successful completion of the feasibility assessment, the following four processes are conducted in parallel: 1) IRB review, 2) Contract negotiation (if a Master Service Agreement is not already in place), 3) Budget development, and 4) Medicare Coverage Analysis. 

Did you know that even retrospective chart reviews are subject to the research initiation process? If you are unsure of what kinds of activities constitute "clinical research" that falls under Health First's oversight, please review the Health First policy on "The Authority and Independence of the Health First IRB of Record" for additional information.NOTE: The Health First IRB (a.k.a. The Holmes Regional IRB) is no longer in operation and no longer has oversight over clinical research conducted at Health First. Health First relies entirely on Western IRB for all human subject research conducted within Health First facilities. As such, previous Health First IRB approvals are no longer valid.

What To Submit

Submit all of the materials listed below to the Health First Research Administrative Liaison (RAL). These materials are ideally submitted by email to Clinical.Research@HF.org  but can also be sent in hard-copy form to the RAL's office. Note that incomplete submissions will be not be reviewed.

• Clinical Research Feasibility Assessment Form A
• Feasibility Assessment Form B (if applicable)
• WIRB Initial Review Submission Form
• Study Protocol
• Informed Consent Form
• Principal Investigator's CV and license
• Draft clinical research contract (including draft Master Service Agreement, Clinical Research Services Request form or Clinical Trial Agreement, as applicable)
• Draft study budget
• Other protocol-specific materials as appropriate

Feasibility Assessments

A Feasibility Assessment is a prerequisite to IRB submission for clinical research to be conducted at Health First.  It allows Health First to screen all prospective clinical research to ensure that:

• Health First has the facilities, resources and capacity needed to accommodate the research;
• Any significant financial interests or other potential conflicts of interest are properly disclosed by the individuals involved in the conduct of the research, and managed as appropriate;
• All members of the research team have completed Health First's CITI Training program in accordance with the Health First policy "Clinical Research Training & Education The proposed research is aligned with the Health First policy on "Clinical Research Suitability/Feasibility."
• Please review the Health First Policy on "Clinical Research Initiation" for a description of the feasibility assessment process at Health First.

CITI Training

Principal Investigators must ensure that all members of the investigative team complete the required "Collaborative IRB Training Initiative" (CITI) online training program in human research protections prior to IRB submission of any new protocol. CITI training can be accessed at www.citiprogram.org.   

Note: When completing your "new user" registration during your first visit to the CITI website, please be sure to select "Health First" as your participation institution. This ensures that Health First will be notified upon your completion of the CITI training program. It is recommended that you print your certificate for your records.

WIRB-Approval

Clinical research that is deemed feasible may proceed with submission to Western IRB for review. Note that WIRB will not accept protocol submissions without prior clearance from Health First that the submitted protocol has been deemed feasible.

Investigators may submit their protocol materials to Western IRB via WIRB's online submission portal at the WIRB Online Submissions Page. Alternatively, investigators may submit hard-copies to:

Western Institutional Review Board
3535 Seventh Ave SW
Olympia, WA 98502-5010

Note that either study sponsors or investigators will be financially responsible for the fees associated with WIRB submissions.  Health First is not responsible for the costs associated with IRB review.

Medicare Coverage Analysis

Health First requires a Medicare Coverage Analysis (MCA) to be performed for any clinical research studies anticipating third-party health insurance payments for particular items and services provided at Health First facilities. MCAs can be performed after the feasibility assessment, and concurrently with the IRB approval, budget development, and contract negotiation and finalization processes.

A Medicare Coverage Analysis (MCA) is a systematic review of clinical trial documents, published practice guidelines and national and local coverage determinations to determine the Medicare billing status of items and services that are documented in the research protocol. These MCAs help ensure that billing for both routine care and research procedures is handled appropriately and in compliance with legal requirements. While these MCAs focus on Medicare guidelines, it is important to note that private insurance companies typically follow these guidelines as well.

Please review the Health First policy on "Medicare Coverage Analysis" for a description of the Medicare Coverage Analysis process at Health First.

Budget Development

No study may commence until a budget template is developed and a budget is incorporated into a Study Agreement that is duly executed by the Chief Operating Officer of the HF facility (or facilities) in which the study will be conducted, and the Principal Investigator (and an officer of his or her Practice, if appropriate).

Health First's Research Administrative Liaison will prepare study budgets based on the draft budget information provided by the investigator, and based on the routine costs and research-specific costs identified in the Medicare Coverage Analysis (MCA) billing grid.

Please review the Health First policy on "Budgeting Procedures for Clinical Research" for a description of the budget development and finalization process.

Research Contracts

As always, a clinical research contract must be in place before a clinical research project may begin. In addition to the contract between the PI and the sponsor, investigators must also have a contract in place with Health First if any research activities will be conducted within Health First facilities, even if the investigator believes the service provided at Health First is the standard of care.

Health First uses "Master Services Agreements" to facilitate and expedite the research contract process. Master Service Agreements establish general agreement terms and are supplemented with study-specific "Clinical Research Services Request Forms" that address any study-specific items & services to be performed within Health First facilities.

Note that investigators who elect not to enter into a Master Services Agreement may still enter into a study-specific clinical trial agreement with Health First, but additional legal review fees apply due to the increased legal review time associated with these individual agreements.

The Research Administrative Liaison will work with investigators as well as Health First legal counsel and other institutional officials to coordinate the process of contract review, negotiation, and finalization.

Initiation Fees

The various fees associated with initiating clinical research may vary depending upon the type of clinical research to be conducted. Note that the principal investigator or the investigator's practice group is financially responsible for these fees.

• WIRB review fees
  • WIRB fees fall into several different categories depending on the type of review taking place. See the IRB Fees section of WIRB's website for more information: WIRB Service Fees Page.
• Health First Administrative Review and Processing Fee: $1500
  • This fee applies to all feasible clinical research and covers the time and effort associated with Research Administrative Liaison review and processing of submitted documentation and registration of the protocol in the study management system.
• Health First's Medicare Coverage Analysis Fee: Approximately $2500
  • This fee applies to any clinical research studies anticipating third-party health insurance payments for particular items and services, and may vary depending on the size and complexity of the study.
• Health First Legal Review Fee: $1000
  • This fee applies to the legal review and clinical trial agreement efforts associated with one-time Clinical Trial Agreements. This fee does not apply to investigators/practice groups that have a Master Services Agreement in place with Health First.

After Initiation: Ongoing Clinical Research

Investigators must conduct ongoing clinical research in full compliance with all applicable federal regulations and guidance, good clinical practices and Health First policies and Responsibilities of the Principal Investigator when Conducting Clinical Research describes the general roles and responsibilities of the Principal Investigator when conducting clinical research within Health First's facilities, and emphasizes that the PI remains ultimately responsible for the compliant conduct of his or her clinical research and clinical research team in accordance with an IRB-approved protocol.

Investigators must promptly notify the Health First Research Operations Specialist (ROS) of any clinical research participants who will be receiving items & services related to a clinical research study within Health First facilities.

Investigators must notify the ROS by sending an email to Research.Billing@HF.org  with the Subject line stating: RESEARCH PATIENT NOTICE.

Attached to the email will be a completed "Research Visit Notification Form." The instructions on the form must be followed, and it must be sent at least 5 days prior to a scheduled visit/admission, or within 24 hours after an unscheduled visit/admission.

Note that any non-compliance with this policy or any other Health First policy related to clinical research will be addressed in accordance with the Health First policy on "Reporting, Investigating and Managing Clinical Research Non-Compliance." 

Clinical Research Billing

Health First will bill principal investigators or their practice groups for clinical research initiation fees, as well as all research-related items and services performed within Health First.

Please review the "Overview of Administrative Processes Associated with Ongoing Research" flowchart for an illustration of how Health First identifies research-related items and services and bills investigators/practice groups as appropriate.

Important Forms, Documents, and Links

Forms

• Clinical Research Feasibility Assessment Form A
• Clinical Research Feasibility Assessment Form B
• WIRB Initial Review Submission Form
• Clinical Research Services Request Form
• Patient Visit Form

Health First Policies and Processes

• 9.01 The Authority and Independence of the Health First IRB of Record
• 9.02 Responsibilities of the Principal Investigator when Conducting Clinical Research
• 9.03 The Institutional Official for the Protection of Human Research Participants
• 9.04 Clinical Research Training & Education
• 9.05 Clinical Research Suitability/Feasibility
• 9.06 Clinical Research Initiation
• 9.07 Medicare Coverage Analysis
• 9.08 Budgeting Procedures for Clinical Research
• 9.09 Reporting, Investigating and Managing Clinical Research Non-Compliance
• 9.10 Use of Health First Facilities in Clinical Research
• 9.11 Clinical Research Account Establishment
• 9.12 Clinical Research Charge Capture
• 9.13 Rate Schedules for Clinical Research
• 9.14 Clinical Research Administrative Support Services
• 9.15 Reporting to Regulatory Agencies & Sponsors
• 9.16 Clinical Research Coordinator Policy
• 9.17 Reporting Serious Adverse Events to Health First
• 9.18 Submission of Post-Approval Documentation to Health first Research Administration

Important Western IRB Links:

• Western IRB Home Page

Federal Regulations and Guidance Related to Clinical Research:

• The Code of Federal Regulations Title 45 CFR Part 46, Protection of Human Subjects 
• 21 CFR Part 56, Institutional Review Board Regulations
• 21 CFR Part 50, Informed Consent
• 21 CFR Part 312, Investigational New Drug Application
• 21 CFR Part 812, Investigational Device Exemption
• 45 CFR Parts 160 and 164, Standards for Privacy of Individually Identifiable Health Information (HIPAA Privacy Rule) 
• Centers for Medicare and Medicaid Services' National Coverage Determination 310.1: Routine Costs in Clinical Trials
• International Conference on Harmonization Guidance for Good Clinical Practice

Other Clinical Research Links

• Collaborative Institutional Training Initiative (CITI Program) website

Contact Us

If you have any questions, comments, or feedback about clinical research administration at Health First, or about this website, please feel free to email us at Clinical.Research@HF.org.

If you have any questions specific to Western IRB, please contact Western IRB directly at (800) 562-4789 or at clientservices@wirb.com.