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  1. Hot Topics in Research Compliance Amy LaTulipe, CHRC, CIA, CPA, MBA Senior Manager, Research Compliance Patty Mendoza, RN, CCRC Research Compliance Project Manager

  2. Objectives: • Introduce the Office of Research Compliance • Three “Hot Topics” in Compliance Today • Conflicts of Interest in Research • Proactive Training • Financial Issues in Clinical Trials • Other News • Exports & Deemed Exports • Translations & Interpreters • Documentation in the Hospital Medical Record

  3. What is the role of the ORC? • We provide primary oversight for research compliance. • Our focus is to ensure that research at Methodist is performed in accordance with strict ethical standards, I CARE values, and in compliance with federal, state, and institutional regulations and policies. • Our goal is to help protect the research subject, the research data, the researcher & their staff, and the institution. We strive to meet this goal primarily through audits and education. • We are committed to the highest standards of quality and integrity in all areas of research. REMEMBER… • We are not “out to get you” and we are not the police. • We are on your side!

  4. Office of Research Compliance (ORC)Structure

  5. Conflicts of Interest in Research This section is designed specifically for research coordinators & regulatory personnel, our goal is to: • Help you understand what conflicts of interest (COI) are & how research conflicts of interest (RCOI) are a special class of COI. • Increase awareness & provide examples of RCOI to keep on your radar. • Explain your responsibilities regarding RCOI.

  6. Conflicts of Interest in Research What exactly do we mean by Research Conflicts of Interest? Research Conflicts of Interest (RCOI): Refers to situations in which outside relationships or activities adversely affect, OR have the appearance of adversely affecting, a person’s commitment to his/her duties or responsibilities in research.

  7. Conflicts of Interest in Research OCTOBER 4, 2008 Doctor Didn't Disclose Glaxo Payments, Senator Says By DAVID ARMSTRONG A prominent Emory University psychiatrist failed to tell the school about $500,000 he received from drug maker GlaxoSmithKline PLC while heading a government-funded research project studying Glaxo drugs, Sen. Charles Grassley alleged. The payments to Charles Nemeroff, chairman of the Atlanta university's psychiatry department, compensated him for making presentations to doctors about Glaxo drugs, including its big-selling antidepressant Paxil, according to records Sen. Grassley obtained from Emory and Glaxo. The senator made the allegations in a letter to Emory President James W. Wagner dated Thursday. From 2000 through 2006, Dr. Nemeroff received just over $960,000 from Glaxo, but reported to Emory that he received no more than $35,000, the letter said.

  8. Conflicts of Interest in Research Industry Complies With Settlement Agreements By Mary Ann Porucznik, Managing Editor, AAOS Now Under settlement agreements made with the US Attorney General of New Jersey (Department of Justice, or DOJ), five orthopedic device makers agreed to accept the appointment of federal monitors and to comply with specific reforms mandated by the federal government. The DOJ had been investigating relationships between the device makers and orthopedic surgeons. Criminal complaints were filed against four of the hip and knee implant manufacturers (Biomet Inc., DePuy Orthopaedics, Inc., Smith & Nephew, Inc., and Zimmer, Inc.), charging that the implant manufacturers used lucrative consulting arrangements with orthopaedic surgeons as inducements for the surgeons to use a particular implant manufacturer's implants.

  9. Conflicts of Interest in Research Examples: • $$$$ • Stocks or other equity/ownership interests & stock options • Gifts (including trips and meals) • Loans & other guarantees • Consulting • Knowledge consulting (e.g. on the design of a device) • Teaching/educational • Honoraria for speaking engagements/presentations • Advisory Boards • Speaker Bureaus • CME support • Royalties & licensing fees • Board membership or other fiduciary duties

  10. Conflicts of Interest in Research Why are we concerned about COI in research? • Harm to subjects (Gelsinger) • Erosion of the public’s faith in the reliability of scientific findings and the safety of clinical trials = decreasing numbers of trial participants = decreasing public/federal funding of research • Reputational damage • Loss of self-regulation

  11. Conflicts of Interest in Research A Comparison of Issues that impact COI : GoalConcern Pursuit of knowledge Pursuit of profits Investigator driven priorities Market driven priorities Openness/Transparency Secrecy Academic freedom Exclusive rights Time is relevant Time is of the essence Translational research Ongoing research with little result

  12. Conflicts of Interest in Research • What do we want you to do?

  13. Conflicts of Interest in Research What do we want you to do? • When you RECOGNIZE a potential conflict of interest regarding yourself – DISCLOSE it by completing a Conflicts of Interest in Research form, which can be found on the TMHRI intranet under Forms. • When you RECOGNIZE a potential conflict of interest regarding your PI or another study team member – discuss the potential COI with that person explaining the necessary steps or simply refer them to the Office of Research Compliance (ORC). They will need to DISCLOSE the potential conflict by completing a Conflicts of Interest in Research form, which can be found on the TMHRI intranet under Forms. • If a study team member refuses to complete a disclosure, please contact the ORC or call the Ethics Line at 1-800-500-0333 • Remember – There is no $$$ threshold for disclosure!

  14. Commitment to Proactive Education and Training Like Clara, commitment to the work you are doing is required. Unlike Clara, the commitment you are making to ongoing education and training is life enhancing.

  15. Clara Maass, Nurse & Research Participant • Yellow Fever Experiment: ultimately gave her life as a research subject and nurse • Late 1800’s-early 1900’s: progressive American Nurse, working her way up and through nursing school to become a head nurse; often cited in epidemiology for her contributions • Worldly: originally from New Jersey, traveled to Florida, Georgia, Cuba, and the Philippines during her work as a contract nurse serving for the U.S. Army • Nursing work: 2 tours during the Spanish-American War caring for soldiers while being exposed to typhoid, malaria, dengue, and yellow fever plus a host of other environmental and social issues • Volunteered: in Cuba, where yellow fever was endemic, she agreed to participate in a research study to investigate the mode of disease transmission (mosquito bites vs. contaminated objects) that included an ICF ($100 participation + $100 if you became sick). She was the only American and woman out of 19 subjects and allowed herself to be bitten by known infected Aedes aegypti mosquitoes on two separate occasions. The first time she exhibited a mild case of yellow fever and recovered, the second time she was not so lucky. The investigators, including Major Walter Reed, were hoping to prove active exposure to the disease led to immunity which they could not; instead they moved their focus to mosquito control management eventually making significant reductions in the incidence of yellow fever. FYI, in the Spanish-American War, the Army lost more soldiers to yellow fever, malaria, and dysentery than bullets or injury.

  16. Proactive Training So you are credentialed, degreed, certified, licensed, go to regular research meetings, keep up with your therapeutic area and are well equipped to do your studies, anything else? • Have you documented review of Departmental SOPs?–having a binder isn’t enough • Have you documented review of GCP SOPs?–having a binder is not enough • Have you documented a consistent process to organize and orient your team to a new study?–the Investigator Meeting, if you had one, is not enough • Have you documented training for study related procedures? • When a change in staff occurs, have you documented study specific training? • Have you documented the calibration or biomedical servicing of your study related equipment? • If you notice a trend of protocol deviations, have you documented their occurrence and discussed a corrective action plan?

  17. FDA Warning Letters (483) and Evidence of the Lack of Proactive Training • “Your written response states you will ensure that the nurses who erroneously signed theconsent form as witnesses of verbal consent will have a complete understanding of all FDA regulations regarding the signing of written informed consent forms . You and your staff should be aware of the entire informed consent process. Your response is also inadequate in that you did notdescribe a corrective and preventive action plan . Please provide copies of procedures and training with expected completion dates that are being developed and implemented to prevent the recurrence of these violations in future clinical studies.”http://www.fda.gov/foi/warning_letters/s6764c.pdf • “Our investigation indicates that your supervision of personnel to whom you delegated study tasks was not adequate to ensure that the clinical trials were conducted according to the signed investigator statement, and in a manner that protected the rights, safety, and welfare of human subjects. The investigation found a lack of training docs & no documentation of appropriate delegated task, that you delegated certain tasks to individuals not qualified to perform such tasks.”http://www.fda.gov/foi/warning_letters/s6837c.pdf • “Please provide us with documentation of a corrective action plan, such aswritten procedures for ensuring study training received by you and your study staff on study procedures and requirements, and/or internal study reviews or audits to ensure that such protocol violations have not occurred with other subjects and/or other studies, and that corrective actions have been implemented to prevent recurrence of the problems for future studies.”http://www.fda.gov/foi/warning_letters/s6753c.pdf

  18. Avoid the, “If it’s not written, it didn’t happen” commentand take a Time Out. “Research Time Outs” –similar to the “Surgical Time Out,” establish a documented baseline for trial conduct BEFORE you begin the study Team training: for all studies (chart review, PI initiated, lab studies, drug &/or device studies) document via dated log or memo who’s doing what, when, where, how, and how services will be charged after you discuss it internally within your area. Regulatory oversight: for all studies, make sure that delegation of duties and responsibilities are appropriate and documented from the PI, including study specific training. Internal Site Initiation Plan: establish your own study kick off process and document who was trained and what was discussed; place a memo or log in regulatory file. Answers a lot questions about study specific training when the monitor or auditor comes for a visit.

  19. CAPA…borrowing from quality compliance systemsand good business practices used in research. The credentialing process at TMHRI is a great starting point for the ongoing research training and education you will need to be successful in your work and during an audit; now consider CAPA. CAPA=Corrective and Preventative Action FACT: CAPA is frequently referenced in FDA 483 citations and warning letters for pharmaceutical companies, why? • Organization’s processes are fragmented and disconnected • Procedures are not always well documented • Required process steps are not always completed • Employees don’t always know or understand their individual level of responsibility or authority • Information is not measured, monitored or sharedacross different product lines or business units Similar to the sponsors side, some study team members may not have the same understanding of the study protocol and/or research procedures or responsibilities and discussing what is expected greatly remedies this potential deficiency. Basic research methodology, regulations and Good Clinical Practices require standardized processes and appropriate training of research personnel which needs to be documented to show evidence of this training. Documented CAPA at the beginning of a study can provide you & your research team: √ documented baseline knowledge of a specific research study(i.e.-site initiation training) √ a standardized process for starting your study(i.e.-establishes SOP for study start-up) √standardized research procedures specific to your area(i.e.-evidence of study specific training that may deviate from SOP) √ accountability √ helps prevent misunderstandings about roles and responsibilities √ provides a source for future corrective measures

  20. Proactive Training with the Research Time Out Explains statements: “A strong offense is your best defense” “Failing to plan is planning to fail” “Hades is full of good intentions” Auditors and monitors look for adherence to study protocols, regulations, policies & procedures, and GCPs or the what did you say you were going to do, what did you do, and did you do what you said you were supposed to do within acceptable and approved practice? When research teams stop to make a deliberate Research Time Out to ensure study specific training, verify appropriate task delegation, and define roles their studies definitely have better outcomes (data, subject management and monitoring/auditing findings). The Research Time Out does not take that long and documenting the training that is done for each and every study provides insurance and assurance to all involved. Also, though not as horrible as the wrong limb amputations that prompted the Surgical Time Out, 483s, loads of queries, and diminished reputation have a way of being almost as painful.

  21. Financial Issues in Research Financial issues are auditable. Finances affect all areas in research. All research trials require financial responsibility by the researchers who do the work. Show me the money???

  22. 1)Who is responsible for ensuring appropriate billing of charges related to research studies? • The hospital (TMH), if applicable. • The PI & research team • The physician’s office/clinic, if applicable. • The research subject/participant, if applicable. • A & B • A, B & C • All of the above

  23. 1)Who is responsible for ensuring appropriate billing of charges related to research studies? • The hospital (TMH), if applicable. • The PI & research team • The physician’s office/clinic, if applicable. • The research subject/participant, if applicable. • A & B • A, B & C • All of the above

  24. 2) A research registration form should be completed for all clinical research patients receiving services at TMH regardless of who will be charged for those items or services. • True • False The Research Registration Form can be found on the TMHRI Intranet under Forms.

  25. 2) A research registration form should be completed for all clinical research patients receiving services at TMH regardless of who will be charged for those items or services. • True • False The Research Registration Form can be found on the TMHRI Intranet under Forms.

  26. 3) I need to be concerned about clinical research billing because? • It is my responsibility as part of a clinical study team. • The Office of Research Compliance said so. • The US government regulations and recommendations has made it clear that they are concerned about appropriate billing and payment for items and services provided during a clinical research study. • All of the above

  27. 3) I need to be concerned about clinical research billing because? • It is my responsibility as part of a clinical study team. (√ true) • The Office of Research Compliance said so. (√ yep) • The US government regulations and recommendations has made it clear that they are concerned about appropriate billing and payment for items and services provided during a clinical research study. (√ so true) • All of the above

  28. Financial Issues in Clinical Trials • As you are considering a protocol, building a budget, and negotiating with a sponsor there is one main question to ask yourself: • Does this trial involve a drug or biologic, a device with an IDE, or something else? • If the trial involves a drug or biologic, the PI must certify that the trial is a Qualifying Clinical Trial (QCT) under the Medicare (CMS) regulations. This is usually accomplished using a Medicare Coverage Analysis (MCA).

  29. Financial Issues in Clinical Trials

  30. Financial Issues in Clinical Trials

  31. Financial Issues in Clinical Trials So…the final result is:

  32. Financial Issues in Clinical Trials Now, what does it all mean? Quick definitions: • Conventional care: Care that would normally be provided to the patient for their particular diagnosis absent their participation in a clinical trial. This type of care is typically billable to the patient and their insurance; it is sometimes referred to as standard of care. Note: If a sponsor covers any of these items, they become Additional/Research care and are not billable. • Additional/Research care: Everything else – all items covered by the sponsor (even if they would normally be considered conventional care). This type of care is NOT BILLABLE to the patient and their insurance.

  33. Financial Issues in Clinical Trials What does it mean for drug & biologic trials: • If the trial is a QCT: • Follow general billing guidelines – determine what is conventional care vs. additional care/research care. • If the trial is NOT a QCT: • Nothing considered part of the trial is billable…NOTHING, not even conventional care items. The sponsor must cover everything or a special arrangement must be made with TMHRI and the hospital to cover the trial costs.

  34. Financial Issues in Clinical Trials What does it mean for device trials with IDE status: IGNORE the QCT Analysis!!! • FDA Category A IDE’s: • The device itself is not billable and generally the procedure to implant the device (if applicable) is not billable. A letter must be sent to CMS to determine whether the procedure is billable. [Melissa Cates – Device Specialist] • Follow general billing guidelines for other items in the trial – determine what is conventional care vs. additional care/research care. The device and likely the procedure are considered additional care/research care. • FDA Category B IDE’s: • Generally the device and procedure to implant the device (if applicable) are billable. A letter must be sent to CMS for pre-determination. • Follow general billing guidelines – determine what is conventional care vs. additional care/research care. If the device or procedure is not covered it is considered additional care/research care.

  35. Financial Issues in Clinical Trials What does it mean for other trials (including non-IDE device trials): • Follow general billing guidelines – determine what is conventional care vs. additional care/research care.

  36. Financial Issues in Clinical Trials Risks to watch out for: • Billing a research subject and/or their insurance for ineligible items (items that are considered additional/research care). • Billing a research subject and/or their insurance and the sponsor for the same item (double dipping!). • Allowing the sponsor to pay for items denied by a subject’s insurance carrier, or for co-pays and deductibles (more on this in a minute). REMEMBER - Billing issues can affect your relationship with your study participant and/or study sponsor. Yes!…it is YOUR responsibility too!

  37. Financial Issues in Clinical Trials Something new…sort of: • Sponsors may not cover charges denied by insurance companies or patient co-pays and deductibles, unless the patient qualifies under the System Indigent Care Policy.

  38. Financial Issues in Clinical Trials Essential research duties: • KNOW YOUR STUDY!!! • Understand what is billable under conventional care and what must be billed to the study as additional/research care. • Register your subjects using the Research Registration form with Transaction Management [Lucas Lerma]. • Identify each item appropriately at the point of service/ordering as either conventional care (white) or research care (green) using the proper labels. • Reconcile your institutional accounts TIMELY to ensure charges are correctly posted.

  39. In other news… New and revised policies are on the way: • Sponsor payments in clinical trials • Exports and deemed exports • Research and hospital Medical Records requirements • Translation and Interpreter requirements and standards

  40. Questions? Office of Research Compliance: Amy LaTulipe Senior Manager Ph: 713-441-5840 Fax: 713-441-7512 Email:alatulipe@tmhs.org Patty Mendoza Trae Rohan Project Manager Compliance Specialist Ph: 713-441-5855 Ph: 713-441-7512 Email: pamendoza@tmhs.org Email: tdrohan@tmhs.org