Internal Use Only: Business Unit: Fresenius Medical Services Region: RVP: Area Manager: Facility # Compliance Policy C-FMS-009.2 of Investigator or Study Coordinator completes the following: Facility Name Street Address City, State, Zip Clinic Manager Facility Number Telephone Number Fax Number Study Title Protocol # (if applicable) Sponsor Principal Investigator PI Telephone PI email Duration of study subject s participation Study Coordinator PI Fax Study Coordinator email Please attach the following documents (please note failure to complete/provide the following could lead to delays in approval) Study protocol (abstracts not accepted) Approval statement from Institutional Review Board (if applicable) Signed copy of 1572 Study specific Patient Informed Consent template, including disclosure of financial reimbursement to physician, staff and facility. Overhead Fee or Application Fee (for investigator initiated or non-profit entities only) Study materials, if any, used for patient recruitment Study specific FMC HIPAA Privacy Authorization template, if consent is not HIPAA compliant (see Attachment 2) Lab contract OR Name of Central Lab: Investigator Statement (Page 2 of Application) Page 1 of 6
Fresenius Medical Services Compliance Policy C-FMS-009.2 Please complete the following: Investigator Statement Investigator s Name: Name of Study: Please check one answer for each statement: 1. Investigator will ensure that the conduct of the study complies with all applicable local, state and federal laws and regulations. 2. Investigator will ensure that all study participants are fully informed of the study and sign an IRB approved consent form. 3. Investigator will promptly inform Sponsor and Institutional Review Board of any Serious Adverse Events. 4. Investigator assures FMCNA that no facility staff will be used in the conduct of the trial. 5. Investigator assures FMCNA that no study labs will be billed to the patient s insurance provider. 6. Investigator assures FMCNA that no dialysis facility supplies (including syringes etc.) will be used for research purposes. 7. Investigator will not change patient s dialysis schedule or delay patient s dialysis treatment for the study. 8. Investigator will make sure that they and their research staff have undergone appropriate training in research.* 9. If Investigator decides to publish study results, Investigator will provide FMCNA with the manuscript two (2) months prior to submission. 10. Investigator will reimburse FMCNA for any lost revenue which occurs as a result of patient participation. 11. Investigator will ensure that approval for study participation has been obtained from study patient s attending physician. 12. Other Yes No N/A Investigator Signature Study Coordinator Signature Date Date * A suggested link to a website for free training in the protection of human participants in research is as follows: https://www.citiprogram.org/ Page 2 of 6
Internal Use Only: Fresenius Medical Services PI Study Compliance Policy C-FMS-009.2 To be completed by Investigator or Study Coordinator at Time of Initial Application for Project Approval 1. Are the labs, medications or services needed by the study different or more frequent from the items and services ordered by the physician as part of the current standard of care? If yes, will study sponsor provide these? 2. As a result of the study or changes in patient care due to the study, will the facility experience any loss of profits for items or services that are either purchased or provided by FMS outside of a study, that are submitted to patients payors for reimbursement? If yes, the study sponsor must reimburse the facility for any such lost profits. 3. Does the study require the use of facility staff for study related administrative or clinical services above and beyond, or outside, the normal day to day responsibilities of patient care and documentation during scheduled work hours? If yes, there must be a written agreement to compensate the facility for this work. 4. Will the Investigator be hiring a member of the facility staff to perform study-related duties outside regularly scheduled work hours? 5. Other than staff-related costs addressed above, will the facility incur any direct costs related to its participation in the study? If yes, the study sponsor must reimburse the facility for any such costs. FMS Sign-Off * To be Completed by RVP * If yes was answered to any questions above FMS staff must certify to the following: Facility has adequate staff resources to provide services required by study without negatively impacting facility operations. RVP: Area Manager: Services to be provided by the facility are accurately documented in a written agreement and compensated at fair market value. The agreement has been reviewed and approved by FMS Law Department and is attached. If applicable, please see Billing and Cost Report Control Procedures, Attachment 1 and follow instructions on implementation procedures. Clinic Manager: FMS Law Department: Page 3 of 6
Protocol: Submitted by: Investigator Date: Return form to: Facility Medical Director Approval: Print Name: Facility Name or #: Corporate Study Coordinator Clinical Studies Department 920 Winter Street Waltham, MA 02451-1457 Clinical Approvals: Vice President of Clinical Research For Internal Use Only Date: Legal Department Approval: Return form to Corporate Study Coordinator Date: Business Approval: Regional Vice President: Date: Compliance Department Approvals: Date: Return form to Corporate Study Coordinator Send Completed form to: Corporate Study Coordinator Clinical Studies Department 920 Winter Street Waltham, MA 02451-1457 If the application is submitted by the Clinical Studies Department, then the Compliance Department must give approval Page 4 of 6
Compliance Policy C-FMS-009.2 Attachment 1 Billing and Cost Report Control Procedures for Clinical Studies The following system-wide procedures have been put in place for FMS to prevent inappropriate billing and cost reporting related to clinical studies: 1.) Facility staff will follow guidelines provided by the Department of Clinical Studies on what may be entered into Proton and Ami. 2.) Accounts have been established to track the following for cost report purposes: a. Clinical Research Revenue Tools have been developed to assist in tracking costs associated with this account. Upon the approval of a clinical study, the following must be implemented at each facility that will participate in the study: 1. The Clinical Studies Department will prepare for every approved study a summary of study procedures that have the potential to impact either billing or facility cost reporting. The summary shall include all items and services that will be provided as part of the study and that may or may not be billed and any customized tools for use by facility staff to track items that may have potential cost report impacts. 2. The study coordinator must provide an in-service to each facility staff member who may be called in any way to participate in study procedures. The in-service shall include a review of the study summary and procedures for documenting study related items and services. The study coordinator will document the in-service to the Clinical Manager for the facility file. In most cases study related items and services provided are not entered into Proton and AMi. If approval has been given to enter study related items and services into Proton or AMi, instructions to use the appropriate code in supply by field must be given. Page 5 of 6
Compliance Policy C-FMS-009.2 Attachment 2 FMCNA Authorization for Use and Disclosure of Protected Health Information for Purposes other than Treatment, Payment and Other Health Care Operations The Health Insurance Portability and Accountability Act, HIPAA, creates additional rights and responsibilities for patients and health care providers. As a requirement of HIPAA, any use or disclosure of protected health information for purposes other than treatment, payment or other health care operations requires authorization. I hereby give my authorization to (FMCNA) and its affiliated companies to use and disclose my protected health information (PHI) as described below. I understand that this authorization is valid only for the use(s) and disclosure(s) specifically described in this agreement and other use and disclosure of my protected health information will require a separate authorization. I also understand that my refusal to sign this form and authorize the use or disclosure of PHI as described below is not a condition to receive treatment from FMCNA. However, I understand that if I do not sign this form FMCNA will not be able to use or disclose the PHI. I understand I have the right to revoke this authorization in writing, except to the extent that FMCNA has already taken action in reliance thereon. For instructions on how to revoke an authorization, please call the FMCNA Privacy Office at 1-866-HIPAA-01. I am aware that information that is disclosed as a result of this authorization may be subject to re-disclosure by the recipient and may no longer be protected by HIPAA. Information to be used or disclosed includes the following: Information that may be collected include your initials, date of birth, your medical history including your medical conditions, any hospitalizations and for what reason (s), your medications, your vital signs, and you laboratory results. If you choose to disclose your medical insurance and employment status verbally during an interview during the study. The information will be used by and or disclosed to the following: Authorized representatives of the sponsor This authorization will expire: Five years from the date of signature or at termination of the study for whatever reason, whichever comes first. Signature Date Print Name Facility If signed by Representative, indicate Authority to act for Individual: Distribution: Patient, Recipient(s) of PHI, Medical Record Page 6 of 6