Corporate Research Policy I. SCOPE:

Transcription

1 Corporate Research Policy I. SCOPE: IASIS Healthcare LLC ("IASIS") and its affiliated facilities, including but not limited to hospitals, ambulatory surgery centers, home health agencies, physician practices, other owned businesses and all Corporate Departments, Divisions and Groups, and all personnel related thereto (referred to herein as the "IASIS Facility" or "IASIS Facilities"). II. PURPOSE: The purpose of this Policy is to set forth requirements for participation in clinical research that test or tracks patient progress or gathers data on medical devices, drugs or procedures on human research subjects. III. POLICY: A. General Statement on Clinical Research 1. Clinical Research. Clinical Trials are studies performed on human volunteer subjects to answer specific questions about vaccines, medical devices, new therapies or new ways of using known treatments. This policy applies to Phase I- IV Clinical Trials or research which is sponsored by: a) National Institutes of Health (NIH) of other governmental agency b) Pharmaceutical or biotech companies c) HMOs d) Medical device or equipment companies e) Any other organization pre-approved by IASIS Legal Department B. Specific Clinical Trial Policy Requirements 1 Clinical Trials Checklist: A Clinical Trials Checklist (attached hereto as Exhibit B- 1) must be completed for each clinical trial to be conducted at an IASIS Facility. The individual responsible for clinical trials at the Facility must sign this form. 16 December

2 2. Patient Identification: The Principal Investigator shall submit a Patient Enrollment tification Form (Exhibit B-5) to provide the names of each patient who is participating in a clinical trial at an IASIS facility. In addition, the Principal Investigator must provide a copy of the informed consent from each patient which shall be placed in the patient's medical record chart. The Facility Risk Manager shall be responsible for ensuring that a yellow copy of the Patient Enrollment Form and patient s Informed Consent are placed in the patient medical record chart so that each Facility caregiver or healthcare provider can recognize the patient as a Clinical Trial participant. 3 Institutional Review Board ("IRB"). It is the policy of IASIS to conduct itself ethically and in compliance with all federal and applicable state laws regarding clinical trials. There are three basic principles of ethics relevant at IASIS Facilities in the conduct of clinical trials. These 3 principles are now accepted as the 3 quintessential requirements for the ethical conduct of research involving human subjects ("The Belmont Report: Ethical Principals and Guidelines for the Protection of Human Subjects of Research"). a. Respect for persons: recognition of the personal dignity and autonomy of people and the need for special protection for people with diminished autonomy, such as children. or prisoners; b. Beneficence: obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks; c. Justice: fairness in distribution of the benefits and burdens of research. Every Clinical Trial conducted at an IASIS Facility must be approved and periodically monitored by one of the following IRBs that are approved by IASIS: a. Western Intuitional Review Board (WIRB) b. Schulman Associates IRB c. Quorum IRB d. university IRB oversight for NIH grants 4. Principal/Clinical Investigator: The Principal Investigator (a physician or dentist conducting a clinical trial) must submit the following documents to I-CARE: a. The Final Protocol 16 December

3 b. A completed Research Evaluation Form c. Copy of the IRB application submitted for initial review d. Copy of Informed Consent e. Proof of protocol and GCP training f. Annual Investigator's Financial Disclosure Form as described in the Disclosure and Management of Conflicting Financial Interests in Research Policy. 5 Clinical Trial Evaluation Form. A Clinical Trial Evaluation Form (attached hereto as Exhibit B-2) must be completed and uploaded to I- CARE webpage or ed to ICARE. The purpose of this form is to prospectively identify the tests/procedures included in the protocol that are not typically provided absent a clinical trial or research study and require IASIS Facility resources (space, equipment, supplies, personnel, etc.) to successfully conduct a clinical research project. The information on this form will be used to coordinate activities between the investigator and hospital departments, identify the costs of research related procedures, and clarify payment mechanism. A study protocol must be submitted along with a completed Clinical Trial Evaluation Form for review by I-CARE and appropriate facility Administrators and Department Directors. The director of each hospital department that is directly impacted by the study must review and concur with the performance of the study prior to initiation. The investigator may not initiate the study without an approval letter from I-CARE. 6 Clinical Research Feasibility Review. Prior to approval, appropriate sections of the protocol, the complete Clinical Trial Evaluation Form and a proposed study budget will be presented to applicable facility Department Directors for a Research Feasibility Review. I-CARE personnel and representatives from those departments that will provide services in support of the conduct of a specific study will evaluate the proposed research is to assure that the study can be performed safely, ethically, appropriately as defined by the protocol and cost effectively. The primary purpose of the Feasibility Review is as follows: a. Assure compliance with Good Clinical Practice (GCP), state and IASIS Healthcare regulations. 16 December

4 b. Evaluate the impact of the protocol on current resources (personnel, space, and equipment) prior to initiating the project. c. Assess any fees for services provided by the Facility in support of the protocol. d. Implement a system to track study participants status, report adverse events and reconcile patient s insurance and research payment for services An I-CARE representative presents the fees for services and terms for payments to the Principal Investigator for approval. i. A Clinical Trial Evaluation Form is part of the I-CARE submission package uploaded into MediTract for IASIS review and approval ii. The Clinical Trial Agreement or Service Agreement is not submitted to IASIS Legal Department for review until the Principal Investigator accepts the fees and terms and signs the Clinical Trial Evaluation Form. 7 Financial Disclosure: In accordance with 21 CFR 54 and 21 CRF , the Principal Investigator and Sub-Investigators must sign Financial Disclosure Certifications. A copy of this certification must be submitted to the I-CARE office and uploaded into MediTract as other supporting document 8 Informed Consent. The Informed Consent Form must comply with requirements outlined in 21CFR50 and approved by the IRB. The Informed Consent must also include the following IASIS facility Injury Statement: (Insert IASIS facility) has not set aside funds to provide payment for such injuries. You are not giving up any legal rights by signing this document, nor are you releasing, (Insert IASIS facility), doctors or staff from responsibility for carelessness unrelated to the nature and risk of treatment. Further information on the above, as well as information regarding this research may be obtained from (Insert Principal Investigator) office and I-CARE (IASIS Center for the Advancement of Research and Education) office at (813) Informed Consent must be obtained from each clinical trial participant before any research test or procedure is performed. 16 December

5 9 Confidentiality Agreement: Everyone assisting in the conduct of a clinical trial is required to sign the attached Confidentiality Agreement (attached hereto as Exhibit B-3). These Agreements shall be kept on file at I-CARE at all times. If the research is sensitive or of a confidential nature, including but not necessarily limited to studies involving drug and alcohol abuse or studies on mental health patients, contact IASIS Legal Department for additional requirements and information. 10 CATS: A CATS form must be completed and signed by the IASIS Facility Administrators prior to uploading into MediTract i. Clinical Trial Agreements and Hospital Use Agreements use the I- CARE CTA with facility CEO, CNO, CFO signatures ii. Service Agreements use the IASIS CATS with CEO signature 11. OIG, EPLS and FDA Reports: Prior to study approval, a database search must be performed via the following websites: urancelist/default.htm Printed reports of the search results are uploaded into MediTract as part of Legal review for approval. C Restrictions on Clinical Trials and Research Studies Consistent with, and not in addition to any other statement of IASIS policy, it is the policy of lasls that any Clinical Trial conducted at any IASIS Facility shall first have been approved by one or more of the following agencies: U.S. Food & Drug Administration U.S. Department of Health & Human Services Other Government Agencies pre-approved by IASIS Legal Department D. Funds Policy From time to time lasls Facilities and physicians may participate in clinical trials or research studies which may be funded by research funds or contracts. In order to ensure that participation in research activities complies with IASlS' mission 16 December

6 statement, the conditions placed upon the funds by the donor, and applicable federal and state laws and regulations, in addition to the policy stated above, IASlS has issued the requirements related to funds and clinical trials or research studies. 1. lasls is committed to maintaining its high standards for integrity and excellence on all clinical trials and research studies that are conducted either at an IASlS Facility or in conjunction with IASlS. lasls is also committed to ensuring that the acceptance of research funds complies with all federal and state laws and regulations. All IASlS employees and staff members who conduct research will follow these procedures governing the acceptance of research funds: a. An investigator may not initiate a research protocol until the Research Evaluation has first determined that the research that is to be conducted is a bona fide research project with value to both lasls and the medical community. Therefore, before enrolling any research subjects, I-CARE must coordinate the review of both the research proposal/protocol to verify the legitimacy of the research project and the financial impact of conducting the protocol at an IASIS facility. b. Projects from suppliers, vendors or other entities in a position to obtain patient referrals from IASlS or any lasls employee in conjunction with its sales or marketing activities will be denied. Research tied to the purchase of any goods or products from any supplier or vendor or the referral of any patients from IASlS will also be denied. Additionally, approval will not be granted is suppliers or vendors offer research funds as a mechanism for reducing the price of goods or services that the supplier or vendor provides to IASlS. c. When a private source offers a research fund, both IASIS and the funding source will include in the proposal an estimate of the grant amount for the project based upon a per patient cost. In no event shall the amount of the research funds exceed the actual amount earned for services provided for the conduct of the study. d. All research funds from private sources shall be made pursuant to a written contract between the Sponsor, Principal Investigator and IASIS that is reviewed by the Legal Counsel. The research project may not be 16 December

7 initiated until the IASIS has approved the written contract (Clinical Trial Agreement or Clinical Trial Service Agreement). 2. Payment for all research funds must be made directly to an lasls facility and not to the individual or department conducting the research, although the funds may be earmarked for use by the individual or department for the purpose of conducting the research. Research funds must be used in the manner specified. lasis shall not keep any excess funds or equipment remaining at the conclusion of the research project without the approval of lasis Legal Department and prior written consent of the Sponsor. 3. A copy of the IRB approval letter must be on file for all research proposals that involve human subjects to ensure compliance with all federal regulations, state laws and IASIS policies. IV. APPROVAL PROCEDURE: B. Certification The Principal Investigator must complete and submit the Clinical Research Evaluation Form, protocol, and informed consent to I-CARE. Upon acceptance of the Clinical Research Evaluation Form and supporting documents I-CARE shall consult with the appropriate facility Department Heads, Administrators and Legal Counsel to provide the Investigator with fees for services performed at the facility in support of the proposed research. In addition, I-CARE will provide the facility s Injury Statement and approved Letter of Indemnification so the investigator will be able to submit the Clinical Trial Agreement for legal review simultaneously with the clinical trial submission to the IRB. The certification shall include an acknowledgement on the part of I-CARE that (i) IASlS Facility has been finally approved for participation in the proposed clinical trial, (ii) that all appropriate documentation and contracts with the clinical trial sponsor have been finalized, and (iii) that the Facility's Director of Business Office has been expressly informed about the reimbursement methodology for all services and procedures performed pursuant to the proposed clinical trial. In order to be approved by IASIS Legal Counsel, the Clinical Trial Agreement must: 16 December

8 1. Contain an indemnification clause, whereby the facility is indemnified from any or monetary responsibility for wrongdoing or damages suffered by clinical trial participants, which are as a result of participation in the clinical trial. This indemnification must be separate and apart from the investigator physician s indemnification and cannot be coupled with or dependent upon the investigator's action in any way. 2. A confidentiality statement written in accordance with HIPPA or any relevant or applicable state confidentiality laws. 3. Adequate provisions for the Facility to cease participation in the clinical trial. C. Forms The forms approved by IASIS Legal Counsel for the approval of a clinical trial are available on I-CARE website. The Principal Investigator shall use these standard forms, as may be amended from time to time. D. Approval I-CARE will assist with obtaining the final approval from IASIS facility, the applicable Division President and IASIS Legal Department. The investigator may not enroll study participants until Final Approval is granted. 1. The Facility will not accept a shipment of Investigational Product without notification of Final Approval 2. I-CARE will notify the IASIS Facility Administrators, Risk Manager and applicable Department Heads when an Investigator has received Final Approval for a clinical trial, which grants permission to assist the investigator as outlined on their copy of the Clinical Trial Evaluation Form. 3. In the event that (a) an IASIS facility or a Principal Investigator is conducting trials outside of this Policy or (b) if Principal Investigator fails to adhere to this Policy, I-CARE may 16 December

9 i. Terminate all enrollment in any or all clinical trials at the facility ii. Terminate all studies currently being conducted by the violating Principal Investigator 16 December

10 Exhibit B-1 CLINICAL RESEARCH CHECKLIST A. Study Title: B. Principal Investigator s Name: Investigator s Clinical Background Copy of Curriculum Vitae Copy of current applicable state license Copy of Driver s License or other photo ID OIG,EPLS and FDA research reports Copy of clinical research ethics training dated expiration date expiration date dated dated C. Investigator s Research Staff Copy of clinical research ethics training Copy of HazMat Training Signed Confidentiality Agreement dated dated dated D. Required Documents Initial Date Principal Investigator has received the following: Guidelines for clinical research protocol submission Guidelines for Informed Consent 16 December

11 Guidelines for investigational drugs Guidelines for reporting adverse events Guidelines for requesting patient s medical records Guidelines for storing study supplies at IASIS Facilities Indemnification Agreement from Sponsor for Facility List of PIs Research Team members including their roles & responsibilities Copy of signed Financial Disclosures Conflict of Interest Disclosure Statement Signed CATS form All of the required documents have been provided to the ICARE Office and the Principal Investigator has documented the knowledge and skills necessary to perform the procedures required for the protocol Signature: Printed Name: 16 December

12 Exhibit B-2 Clinical Trial Evaluation Form General: The purpose of this form is to identify the tests/procedures included in a research protocol that are beyond current standards of care at IASIS Facility and /or require IASIS Facility resources (space, equipment, supplies, personnel, etc.) to successfully conduct clinical research project. The information on this form will be used to coordinate activities between the Clinical Trial Investigator and hospital departments, identify the costs of new procedures or research related procedures, and clarify payment mechanism. A copy of the study protocol must be submitted to ICARE along with this form. The Clinical Trial Investigator may not initiate the study without an approval letter from I- CARE. Choose an Sponsor: Other: item. General: Choose an item. Protocol Title: Coordinator: IRB: Choose an item. Other: Facilities: (check all that apply) Davis Hospital Jordan Valley Mountain Vista Odessa Regional Palms of Pasadena Pioneer Valley 16 December

13 Salt Lake Hospital St. Luke s Medical Center Tampa Memorial A one time fixed administrative set-up fee of $1,000 is charged to cover the cost of study startup at the designated IASIS facility. PI/Sub-Is: Full Name IASIS employee Group/Employer Name (if not employed by IASIS) PI: Sub-I: Sub-I: Sub-I: Primary Contact Information: Name: Address: Phone: Fax: Pager: This section is to identify IASIS Facility resources, which will be required as a result of this clinical trial that is not currently part of Standard Patient Care. Please list all tests and procedures, which will be performed as a result of this research project on a per patient basis. 16 December

14 Will the clinical trial require the use of any IASIS facilities or staff for research related care? If no, then no further information is needed. Please skip to the last page to sign and date. Pharmacy: (All medications must be stored in and dispensed by the Department of Pharmacy) Will the IP be stored in the hospital pharmacy? Will the Pharmacist Prepare or Dispense drug? Does IP require sterile admixture? Will the Pharmacist be required to manage inventory? Will Pharmacist be responsible for randomization? Will the Pharmacist be responsible for blinding? Drug Name: Storage Requirements: Route/Rate of Administration: Dosage: Pharmacy Binder Provided? 16 December

15 Items Provided by Sponsor: Study Drug IV Bags Syringes Control Drug/ Placebo Filters Tubing Pumps Other: Labs and EKGs: Local Labs: Central Labs: Refrigerated/Frozen Labs (dry ice): Local Microbiology: Save Isolates? Central Microbiology: Save Isolates? Local EKG: Central EKG: Address of Central Lab: Other Tests: Pathology: Local Labs: Central Labs: Address of Central Lab: 16 December

16 Other Tests: Radiology/Nuclear Medicine: Will the trial require radiology or nuclear medicine services? Central Labs: Address of Central Lab: Other Tests: Respiratory Care/Pulmonary Medicine: Will the trial require respiratory care of pulmonary medicine? Services: Frequency: Cardiovascular Medicine: Will the trial require cardiovascular medicine services? Services: Frequency: Anesthesia/Surgery/Operating Will the trial require anesthesia, 16 December

17 Room: surgery, or OR services? Services: Frequency: Nursing Services: Will the trial require nursing? Services: Frequency: Dietary Services: Will the trial require dietary services? Services: Frequency: ANY OTHER Ancillary Services: Will the trial require any other ancillary services? Services: Frequency: Study Details: Enrollment Goal: Pre-screen Effort: Below Average 16 December

18 Average Above Average Potential SAEs: Below Average Average Above Average Translator Services Required: Patient Stipend: How much? INVESTIGATOR STATEMENT This research project requires resources, as delineated on this form, which are part of an IRB approved clinical research protocol and are not subject to reimbursement by the patient and/or their insurer. I am submitting this form in accordance with established IASIS Healthcare policy and procedures. As principal investigator for this research project, I: A. Have reviewed the information contained on this form and agree that it is complete and accurate; B. Will work cooperatively with IASIS personnel to facilitate completion of the research review process and subsequent conduct of the protocol; C. Understand that it is my responsibility to present documentation of appropriate IRB approvals and Sponsor s letter of indemnification; and D. Understand that administrative review and signed letter of agreement must be completed prior to initiating this research project. 16 December

19 By: Signature of Principal Investigator Name: Date: The approval letter will be issued upon receipt of the investigator s signed Clinical Agreement, IRB approval letter and a copy of the IRB approved informed consent. 16 December

20 Exhibit B-3 Contract Approval Term Sheet (CATS) General: Sponsor: Other: Facility: Principal Investigator: Other: Agreement Type: (check one) Has Clinical Trial Evaluation Form been completed? Medical Device Pharmaceutical Other Are Devices/Drug FDA Approved? ATTACH COPIES OF THE FOLLOWING: Clinical Trial Agreement or Service Agreement Protocol Annual Investigator Financial Disclosure Clinical Trial Evaluation Form Hospital will receive Sponsor: 16 December

21 compensation from: Third Party Payor: Medicare/Medicaid TOTAL ANNUAL DOLLAR AMOUNT OF AGREEMENT INVESTIGATOR STATEMENT The undersigned hereby certifies that the dollar amount in the Agreement is fair market value, was not determined in a manner that takes into account the value or volume of any business generated between the parties, would be commercially reasonable even if no referrals were made between parties, and the proposed transaction complies with the Company s applicable policies and procedures. It is further certified that the undersigned has no knowledge of or reason to believe that the party with whom we are contracting has been convicted of a criminal offense related to healthcare, listed as a federal agency as debarred, excluded or otherwise ineligible for federal program participation. Reviewed and approved for submission: ICARE DIRECTOR DATE 16 December

22 Exhibit B-4- RESEARCH ENROLLMENT NOTIFICATION FORM RESEARCH RELATED PROCEDURE, TEST, OR SERVICE THAT IS TO BE BILLED IN PART OR ENTIRELY TO THE RESEARCH CENTER or INDEPENDENT PHYSICIAN *Use ONE form per visit For Admitting USE Medical Record # Account # Location/Facility FAX form to: Scheduling and ICARE Research Participant Information Name of Study (include protocol number) - IRB Number: Last Name: First Name, MI: 16 December

23 Address: Date of Birth Home Phone ( ) Screening/ Randomization #: Alternate Phone ( ) Test, Procedure, or Service Requested Date and Time to be performed Health Care Provider Information Principal Investigator: (last) (first) Contact Person or Research Coordinator: Contact Phone #/ Insurance Plan A-Code Group Name (Physician Name) Policy Number (Study Name) Group Number (Study Number) First Payor Second Payor Third 16 December

24 Payor Please note any other aspects of research specific assessments/tests: 16 December

25 Exhibit B-5 Conflict of Interest Disclosure Statement I, hereby execute and submit this Conflict of Interest Disclosure Statement pursuant to the requirements of the Policy GC.002, a copy of which has been given to me. I certify that I and members of my family and household are in compliance with all provisions of this Policy except as I indicate below. I further certify that I am not aware of any issues that may constitute fraud and/or abuse. Exceptions: (If none, please indicate ne ) Statements contained herein are true and correct to the best of my knowledge and belief. Executed this day of, Signature: Title: Please return to: Rita Johnson I-CARE Research Supervisor 2900 Swann Avenue Tampa, FL December