FLORIDA HOSPITAL HUMAN RESEARCH PROTECTION PROGRAM (HRPP) ACCREDITATION IRB Administration Outreach, Training, and Education

OBJECTIVES AAHRPP Benefits of Accreditation Where Are We In The Process Investigator Preparation

An independent, non-profit accrediting body, that ensures the HRPPs meet rigorous standards for quality and protection.

BENEFITS OF AAHRPP Respect Competitive Edge Reduce Risk Enhance Standing

Where Are We In The Process

FH INVESTIGATOR PREPARATION IRB Website - P/P’s, Guidances, Investigator Manual, etc IRBNet – Forms, Templates Interview Prep - FAQs

MAIN COMPONENTS OF FLORIDA HOSPITAL HUMAN RESEARCH PROTECTION PROGRAM (HRP-010) Investigators & research teams Sponsor Organizational Official (OO) Institutional Review Board (IRB) Office of Research Administration (ORA) – Contracts, budgets, COI, compliance & education visits (audits) Legal – for interpretation of law i.e. who is considered a minor or who can be an LAR (HRP-021) Grants 7

ORGANIZATIONAL OFFICIAL 8 Chief Scientific Officer, Steven Smith, M.D. The person who is ultimately responsible for Human Research Protection Program at Florida Hospital.

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WHAT TRAINING IS REQUIRED FOR RESEARCHERS AT FH? CITI - Every 3 Years Basic Training Modules Good Clinical Practice (GCP) HIPAA ORA COI Training Investigator Forum 10

PER HRP-010 – HRPP BELMONT REPORT HERE AT FH - Regardless of support or geographical location CLINICAL TRIALS – conducted in accordance with ethical principles that have origin in the declaration of Helsinki and are consistent with Good Clinical Practice 11 What ethical standards or guides do you follow?

RESPECT FOR PERSONS – AUTONOMY BENEFICENCE – DO NO HARM JUSTICE – DISTRIBUTION OF RISKS AND BURDENS 12 What are the three ethical principles of the Belmont Report?

13 RESEARCH Defined FDA : Any experiment that involves a test article and one or more, and that either must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the Act, or need not meet the requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. HHS : A systematic investigation designed to develop or contribute to generalizable knowledge What Rules are You Expected to Follow? FDA / HHS Definitions HUMAN SUBJECT Defined FDA : An individual who is or becomes a participant in, either as a recipient of the test article or as a control, or an individual on whose specimen an investigational device is used. HHS : A living individual about whom an investigator conducting obtains (1) data through or with the individual, or (2) information that is both and.

14  State Laws pertaining to Research  Local Laws pertaining to Research  HIPAA pertaining to Research  International as appropriate What Rules are You Expected to Follow? CONT…

FH FWA (FEDERALWIDE ASSURANCE) The Florida Hospital Institutional Review Board (FHIRB) is duly constituted by the Adventist Health System, dba Florida Hospital, and is organized and operates in compliance 45 CFR §46 when research involves human subjects as defined by 45 CFR 46, 21 CFR §50 and §56 when research involves human subjects as defined by 21 CFR 56, International Conference on Harmonisation – Good Clinical Practice E6 (ICH-GCP) for clinical trials, Florida State law, and Florida Hospital policies for the conduct of human subject research. The institute holds a Federalwide Assurance (FWA) from the Office of Human Research Protection (OHRP), under DHHS, and is registered as follows: Florida Hospital Institutional Review Board (IORG # ), Federalwide Assurance (FWA) #2060 (Expires 10/18/2018), FHIRB 1/Panel A (IRB #0842) FHIRB 2/Panel B (IRB #8071)

1.If FH is the federal grant recipient; 2. If for purposes of human subject research: (a) Data about subjects through intervention or interaction; (b) Identifiable private information (c) Informed consent from a research subject 16 What does it mean when we say FH is “engaged” in human subject research? HRP-010 Worksheet for Rules of Engagement UF FHNIH

WHAT IS FH STANCE ON PAYMENTS FOR REFERRALS OR ACCELERATED ENROLLMENT? 17 HRP-010 Legal Requirements – Page 3 Bullet 7 “7. This Florida Hospital prohibits payments to professionals in exchange for referrals of potential subjects (“finder’s fees.”)”

HOW DOES THE HRPP HANDLE INVESTIGATOR SIGNIFICANT FINANCIAL INTERESTS? 18 Research Personnel Log identifies financial interest. IRB works with ORA Visit ORA Website for Policies/Procedures/Training on Conflicts of Interest The IRB will verify that a management plan is in place with the Florida Hospital (FH) Conflict of Interest (COI) Official. If the FH COI Official does not have an approved management plan in place for this research, they will contact the individual(s) indicating the Significant Financial Interest (SFI). Final IRB approval cannot be granted until all SFI matters are settled. When an SFI requires disclosure to subjects, the IRB receives a recommendation from the FH COI Official regarding consent form language. The IRB reserves the right to determine what disclosure language should be in the consent form.

IRB Chair IRB Administration Organizational Official Legal Counsel Department Heads Contact info on HRP-010, IRB & ORA Websites, consent forms Report To: 19 Concerns, Complaints, Suggestions

IRB RESPONSIBILITIES Review Research: Approve Suspend Terminate Determinations Observation

WHO PERFORMS THE ASSESSMENT OF THE SCIENTIFIC DESIGN OF A STUDY? 21 Sponsors FH Scientific Review Committees – Children’s / Nursing & Allied Health IRB members / Consultants as needed WHAT DOES IRB TAKE INTO CONSIDERATION? WORKSHEET HRP-401 such as: Does application accurately describe risks and benefits; Is research likely to yield the knowledge proposed to result; Is there a safer way to perform the research that will still accomplish the aims; Are there any other procedures not described that my reduce risks to subjects with negatively affecting the research

Review Types Not Human Subject Research (NHSR) Exempt Expedited Convened Meeting

WHAT ARE DECISIONS THE IRB COMMITTEE MAY MAKE WHEN CONDUCTING A REVIEW? Approve Modification required to secure approval Deferred Tabled Disapprove 23

24 Reportable New Information (RNI) – New Risk Severe Harm DSMB Reports and the rest…… HRP-801 Prompt Reporting Requirements HRP-204 FORM

OTHER QUESTIONS What are the requirements for data safety plans? Answer: Required for research involving more than minimal risk. The IRB considers the following: What safety information will be collected; how it will be collected; the frequency of collection, when collection starts; the frequency or periodicity of review; whether a data monitoring committee is needed; statistical tests for analyzing the data to detect harm; provisions for the oversight of safety data; stopping conditions When designing/conducting a study, what do you think about to minimize risks to participants? Answer: Utilizing procedures already performed on subjects for other purposes; properly trained staff, proper consent administration with feedback regarding subject comprehension, steps to ensure confidentiality, privacy Describe the processes you use to obtain consent. Answer: Ensure those delegated are properly trained; utilize IRB Investigator Guidance and ORA Guidance What do you do if a prospective participant is unable to make a decision or does not understand the research study? Answer: STOP. Do not enroll unless the protocol has outlined and the IRB has approved procedures to utilize a legally authorized representative to consent the participant for research.

OTHER QUESTIONS What are you expected to do to ensure equitable selection of participants? Answer: PI should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. Equitable selection flows from the ethical principle of justice and does not mean that all groups are represented in proportion to the population. It means that selection criteria should be both fair and appropriate to the research question. Common Justifications for Excluding Non-English Speakers from Participation Studies without a prospect for direct benefit and with procedures that are greater than minimal risk; Assessment tools, surveys, questionnaires or psychological tests that are only available in English; Enrollment required in situations where translators will not be readily available (satellite clinics, after regular working hours, emergencies, etc.) Expectation based on experience that non-English speakers will rarely present to the clinic where enrollment will take place.

OTHER QUESTIONS What is the difference between Privacy & Confidentiality? What is Privacy? Privacy is the control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. For example, persons may not want to be seen entering a place that might stigmatize them, such as a pregnancy counseling center clearly identified by signs on the front of the building. The evaluation of privacy also involves consideration of how the researcher accesses information from or about potential participants (e.g., recruitment process). IRB members consider strategies to protect privacy interests relating to contact with potential participants, and access to private information. Privacy is... About people A sense of being in control of access that others have to ourselves A right to be protected Is in the eye of the participant, not the researcher or the IRB What is Confidentiality? Confidentiality pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others without permission in ways that are inconsistent with the understanding of the original disclosure. During the informed consent process, if applicable, subjects must be informed of the precautions that will be taken to protect the confidentiality of the data and be informed of the parties who will or may have access (e.g., research team, FDA, OHRP). This will allow subjects to decide about the adequacy of the protections and the acceptability of the possible release of private information to the interested parties. Confidentiality... Is about identifiable data Is an extension of privacy Is an agreement about maintenance and who has access to identifiable data In regards to HIPAA, protects patients from inappropriate disclosures of "Protected Health Information" (PHI)

OTHER QUESTIONS What if you just simply don’t know an answer to a question? Or Who do you go to when you have questions about conducting research? You can refer to policies/worksheets/checklists and/or that you would contact IRB Office, IRB Chair, IRB Manager, ORA Office, Coordinators, IRB / ORA Policy and Procedure on Websites and IRBNet. No need to offer more information than necessary to answer the question.

29 Questions?