Research

1. Research

2. Introduction to Research Among the University of Mississippi Medical Center’s primary missions is the charge to support and achieve “cutting edge biomedical research to expand the body of basic and applied knowledge1.” In the past, Compliance Training has focused mainly on educating all workforce members on the Federal and State rules and regulations that govern our healthcare practices. That focus has been expanded to include this separate training module which is intended to highlight those regulations and internal policies that govern UMMC’s research practices. All workforce members, even those not directly involved with conducting or overseeing research, are encouraged to become familiar with these regulations. 1. http://www.umc.edu/mission.aspx

3. Regulations • 42 CFR part 50, Subpart F HHS Regulations for Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding Is Sought Human Subject Regulations: • 45 CFR part 46 HHS Regulations for the Protection of Human Subjects • 45 CFR parts 160 and 164 Health Insurance Portability and Accountability Act (HIPAA) Regulations for Standards for Privacy of Individually Identifiable Health Information • 21 CFR part 50 FDA Regulations for the Protection of Human Subjects • 21 CFR part 56 FDA Regulations for Institutional Review Boards Animal Regulations: • Health Research Extension Act of 1985, PUBLIC LAW 99-158, November 20, 1985"ANIMALS IN RESEARCH" amended 2002. • Final Rules: Animal Welfare; 9 CFR Parts 1 and 2. Federal Register, Vol. 54, No. 168, August 31, 1989, P. 36112-36163 (USDA)

4. Research Conduct Typically, research activities are funded, i.e. paid for, by either internal and/or external sources. The funding source, in part, determines which rules and regulations should be followed. It is the policy of UMMC that all basic and clinical research activities adhere to the guidelines established by government and non-government agencies and UMMC. • Internally Funded Internally funded studies are subject to applicable state and federal regulations and UMMC policies and procedures. • Externally Funded Research activities funded through external sources are subject to the funding agency’s policies and procedures in addition to state and federal rulesandUMMC policies and procedures.

5. Research Conduct It is the responsibility of all investigators to conduct their professional activities according to high standards of scholarship. Their responsibility to the community at large demands that they be honestly and sincerely devoted to the ideals of discovery and dissemination of knowledge. Fraud in research undermines the academic enterprise.

6. Responsibilities of the Principal Investigator/Project Director (PI/PD) The PI/PD is responsible for: • The overall conduct of the study including supervision of all personnel who have been delegated responsibility • Programmatic and financial monitoring of the project and any subrecipients • Ensuring that all applicable assurances (Institutional Review Board, Institutional Animal Care and Use Committee, etc.) have been obtained and appropriately addressed if PI/PD leaves UMMC

7. Research Misconduct • All University of Mississippi Medical Center faculty and staff are expected to maintain high ethical standards in research. • Any allegation of research misconduct will be handled in accordance to the UMMC Policy on Misconduct in Research. http://research.umc.edu/private/documents/policies/ResearchMisconduct-attach30_04-09.pdf

8. Policy on Misconduct in Research Misconduct includes: • Plagiarism • Falsification • Fabrication • Other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, performing, or reviewing research or reporting research results

9. Research Reference Handbook UMMC will continually strive to support the growing scientific activities of the institution and provide our faculty and staff with the support and resources necessary to uphold high standards in research. The Research Reference Handbook is provided as a guide to the resources and support services available to UMMC faculty and staff, from the pre-award phase through the post-award phase of research. The objective of the collaborating divisions, each described in this guide, is to fulfill the University’s mission and to foster a research environment conducive to good clinical practices, integrity in research, and regulatory compliance. It is important that research is undertaken with knowledge of the UMMC research infrastructure and applicable rules and regulations for research. Please familiarize yourself with the Research Reference Handbook http://research.umc.edu/private/documents/Research_Handbook.pdf

10. Research Involving Humans • Human Subject - A living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual or obtains identifiable private information. 45 CFR 46.102(f) • Regulations governing the use of human subjects in research also include use of human organs, tissues, and body fluids and graphic, written, or recorded information derived from such individuals.

11. Research and HIPAA When can Protected Health Information (PHI) be used for research? • As a general rule, researchers are permitted to use PHI for research purposes when a signed authorization that satisfies section 164.508 of the Privacy Rule is obtained from the participant. • There are four (4) exceptions to this rule in which an authorization would not be required. These are briefly mentioned on the next slide.

12. When can PHI be used for research without an authorization? • If the covered entity receives appropriate documentation that an IRB has granted a waiver of the Authorization requirement or if the covered entity obtains documentation of an IRB’s alteration of the Authorization requirement as well as the altered Authorization from the individual; • For research solely on decedents’ information with certain representations and, if requested, documentation obtained from the researcher that satisfies section 164.512(i)(1)(iii); • For reviews preparatory to research with certain representations obtained from the researcher; or • If the PHI has been de-identified in accordance with the standards and the information is released in the form of a limited data set, with certain identifiers removed and with a data use agreement.

13. Informed Consent Process • The requirement to obtain the legally effective informed consent of individuals before involving them in research is one of the central protections provided for under the HHS regulations at 45 CFR part 461. • The informed consent process is the critical communication link between the prospective human participant and an investigator, beginning with the initial approach to the potential participant (including through a flyer, brochure, or any advertisement regarding the research study) and continuing until the completion of the research study.1 1. http://answers.hhs.gov/ohrp/categories/1566

14. Informed Consent… Informed consent is not a single event or only a form to be signed. It is an on-going process between the investigator and the participant. • Consent must be voluntary. • The written consent form must be approved by the IRB prior to presenting it to the participant.

15. Informed Consent… A copy of the informed consent document must be filed in the medical record if the research involves the care, diagnosis or treatment of the patient, unless otherwise stipulated by the sponsor or informed consent document. The informed consent forms must be properly completed and signed by a study investigator.

16. Informed Consent - Clinical Trials • For applicable clinical trials initiated on or after March 7, 2012, the informed consent documents must be in compliance with the requirement in 21 CFR § 50.25(c) and include a specific statement that refers to the trial’s description on http://clinicaltrials.gov/ Exact statement required… • “A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”

17. Why is it necessary to include this new statement in informed consent documents? • The requirement for this provision was included in section 801 of the Food and Drug Administration Amendments Act of 2007. This law also provides for mandatory registration and results reporting of certain applicable clinical trials on http://clinicaltrials.gov/ • It is the policy of UMMC that all applicable clinical trials shall be registered on http://clinicaltrials.gov/ before enrollment begins.

18. Clinical Research Billing • Faculty, providers, and staff must ensure that clinical services associated with research studies are billed appropriately and in compliance with relevant laws, regulations and contractual requirements. Any research related billing must be coded and charged based on actual services rendered; must be allowable by regulations governing medical billing practices; and must be consistent with the informed consent signed by the research subject. • No services paid for by the sponsor of the research study will be billed to third party payers or patients. Effective communication is essential to proper research billing. • UMMC has developed a Research Registration/Billing Task Force. Principal Investigators/study teams are required to attend a meeting of the task force for guidance on registration and billing processes prior to enrolling participants into a new clinical study. For questions about this task force please contact Robert Douglas rdouglas@umc.edu

19. Research Involving Animals Institutional Animal Care and Use Committee (IACUC) - The committee's charge is to oversee the care and use of animals in research, testing, and education at the University of Mississippi Medical Center; to review all proposed and ongoing research protocols involving the use of live animals, to ensure compliance with all federal, state and institutional policies and to ensure the inclusion of adequate and proper record keeping and surveillance.

20. Research Involving Animals It is the policy of UMMC that all activities conducted at UMMC involving the use of live animals in research, research training, experimentation, and biological testing will comply with the Animal Welfare Act (Public Law 99-158), the Public Health Service Policy on Humane Care and the Use of Laboratory Animals, and the Guide for the Care and Use of Laboratory Animals. UMMC acknowledges and accepts responsibility for the care and use of animals involved in activities covered by these federal statutes.

21. UMMC Conflicts of Interest Policy The purpose of the policy is to provide guidelines for identifying and disclosing potential conflicts, procedures for reviewing and addressing conflicts that may occur and establishing sanctions for violation of the policy. The policy is also intended to comply with the revised Final Rule on Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Funding is sought (42 CFR part 50 Subpart F)(August 25, 2011). Each employee is required to complete or update their Conflict of Interest Disclosure Form: • annually • at the time of application for PHS funding • within 30 days of discovering/acquiring a new financial interest.

22. Controlled Substances Used in Research UMMC faculty and staff conducting research activities with controlled substances must comply with the federal regulations regarding the handling and safeguarding of controlled substances (Title 21, Code of Federal Regulations). It is the responsibility of UMMC to assure that employees maintain adequate records on the acquisition, use, and disposal of controlled substances and that adequate control is established to prevent unauthorized use or diversion of controlled substances. Please visit the following site to access Information for Researchers Using Controlled Substances: http://research.umc.edu/private/documents/Information%20Sheet%20for%20Researchers%20Using%20Controlled%20Substances_Aug%202012_Final.pdf

23. Effort Reporting Effort reporting may be defined as “the mechanism used to confirm that salaries and wages charged to each sponsored agreement are reasonable in relation to the actual work performed” (COGR, 2007)1. Effort reporting ensures that individuals confirm effort expended on federally funded activities. When do I have to complete an effort report? • You work on an externally funded project that requires certification of effort; or • You are required to complete the report in order to substantiate UMMC’s claim for Medicare and Medicaid reimbursement (1) Council on Governmental Relations

24. Consequences of non-compliance Sanctions for violation of UMMC policies and federal and state regulations related to research may include, but are not limited to, • Termination of employment • Withholding of federal funds • Disbarment from participation in federal grant funding

25. Contacts • Human Research Office (601) 984-2815 • Institutional Animal Care and Use Committee (601) 815-5006 • Institutional Biosafety Committee (601) 815-5074 • Radiation Safety Office (601)984-1078 • Grants Accounting (601)984-1040 • Office of Integrity and Compliance (601) 815-3944 • Office of Research (601) 815-5000

26. Question 1 Which of the following is not considered research misconduct? CLICK ON THE ACCURATE ANSWER a. plagiarism b. falsification c. fabrication d. honest error or honest differences in interpretation or judgments of data

27. Question 1 CORRECT Which of the following is not considered research misconduct? Click here to go to next question a. plagiarism b. falsification c. fabrication d. honest error or honest differences in interpretation or judgments of data

28. Question 1 INCORRECT Which of the following is not considered research misconduct? Click here to go back a. plagiarism b. falsification c. fabrication d. honest error or honest differences in interpretation or judgments of data

29. Question 2 Clinical services paid by the study sponsor can also be billed to third party insurance or the patient CLICK ON THE ACCURATE ANSWER TRUE FALSE

30. Question 2 CORRECT Clinical services paid by the study sponsor can also be billed to third party insurance or the patient Click here to go to next question TRUE FALSE

31. Question 2 INCORRECT Clinical services paid by the study sponsor can also be billed to third party insurance or the patient Click here to go back TRUE FALSE

32. QUESTION 3 According to UMMC Policy, when must a clinical trial be registered at http://clinicaltrials.gov/ CLICK THE ACCURATE ANSWER A. At the end of the study B. When 100 participants have been enrolled C. Before any participants have been enrolled

33. QUESTION 3 CORRECT According to UMMC Policy, when must a clinical trial be registered at http://clinicaltrials.gov/ Click here to go to the end A. At the end of the study B. When 100 participants have been enrolled C. Before any participants have been enrolled

34. QUESTION 3 INCORRECT According to UMMC Policy, when must a clinical trial be registered at http://clinicaltrials.gov/ Click hereto go back A. At the end of the study B. When 100 participants have been enrolled C. Before any participants have been enrolled

35. The End of Research Training Please close out of this training presentation and proceed to the next training presentation