Florida Hospital

FLORIDA HOSPITAL

INSTITUTIONAL REVIEW BOARD

HANDBOOK

212 E. WINTER PARK ST.

ORLANDO, FL, 32804

TELEPHONE: 407 303 5581

FACSIMILE: 407 303 3638

EMAIL:

BY THE AUTHORITY OF

ADVENTIST HEALTH SYSTEM, d.b.a.

FLORIDA HOSPITAL

601 E. ROLLINS ST.

ORLANDO, FL 32803

TABLE OF CONTENTS

FLORIDA HOSPITAL

INSTITUTIONAL REVIEW BOARD

HANDBOOK

The Florida Hospital Institutional Review Board (IRB) Handbook (Handbook) outlines policies and procedures that govern the IRB.[1] Investigators who submit research studies to the IRB for review and approval must comply with FDA Regulations, the Common Rule, other federal and state research regulations, HIPAA Privacy Rule regulations, and this Handbook.

I.  Institutional Authority[2]

Adventist Health System/ Sunbelt, Inc. (AHS), d/b/a Florida Hospital (FH), has established and maintains an IRB that operates in accordance with applicable federal and state laws, FH Policies regarding research[3],[4] and this Handbook.

II.  Purpose[5]

The purpose of the IRB is to ensure the protection of human subjects/participants in research. For purposes of this Handbook, the words “subject(s)” and “participant(s)” are interchangeable.

III.  Principles

The IRB is guided by the ethical principles set forth in the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research report entitled Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the “Belmont Report”), applicable federal and state laws and guidance, local standards and expectations, and this Handbook. These principles include:

A.  Respect for Persons - Respect for persons incorporates at least two ethical convictions: first, individuals should be treated as autonomous agents; and second, those persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy.

B.  Beneficence - Persons are treated in an ethical manner, not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well being. The term “beneficence” is often understood to cover acts of kindness or charity that go beyond strict obligation. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do no harm, and (2) maximize possible benefits and minimize possible harms.

C.  Justice - An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly. Another way of conceiving the principle of justice is that equals ought to be treated equally. There are several widely accepted formulations of just ways to distribute burdens and benefits. Each formulation mentions some relevant property on the basis of which burdens and benefits should be distributed. These formulations are:

1.  To each person an equal share;

2.  To each person according to individual need;

3.  To each person according to individual effort;

4.  To each person according to societal contribution; and,

5.  To each person according to merit.

Florida Hospital IRB Handbook 03-20-13 3

IV.  Authority of the IRB

The IRB has the authority to:

A.  Review all research conducted at Florida Hospital. The IRB may also review research for other AHS entities as outlined in agreements with those entities and with Florida Hospital affiliated physicians. Research to be considered by the IRB includes device, drug, biologics, behavioral, and any research that meets the FDA’s and/or Common Rule’s definition of research, or otherwise requested by Florida Hospital.

B.  Approve, require modifications to, or disapprove all applications for human subject research brought before the IRB. IRB actions are based upon applicable federal and state laws, this Handbook, and such other requirements as may be adopted by the IRB.[6]

C.  Conduct continuing review of all human research studies approved by the IRB, as required by applicable federal and state laws and the IRB Handbook. This continuing review shall include mandatory progress reports for renewal submitted by the applicable investigator. The IRB’s review for renewal of research shall be conducted at intervals appropriate to the degree of risk, but not less than once per year. [7]

D.  Observe or have a third party observe the consent process, the research, and the investigator files.[8]

E.  Suspend or terminate approval of human subject research that is not conducted in accordance with federal and state laws and IRB’s requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for IRB’s action and shall be reported promptly to the investigator, appropriate institutional administration, and federal agencies, as required.[9]

F.  Place restrictions on human subject research, as necessary, to protect human subjects and to comply with federal and state laws and this IRB Handbook.[10]

V.  IRB Relationships

A.  Institution – Florida Hospital’s President has ultimate oversight responsibility of the IRB’s compliance with federal and state laws and hospital policies concerning human subject research. The President may delegate this responsibility to an appropriate Institutional Official (designee). The President or his designee will receive IRB minutes and other pertinent IRB information.

B.  Other Institutional Committees and Department Leaders - The IRB will respond to other committees and department leaders requesting information, as appropriate.

1.  The IRB will be responsible to Florida Hospital’s President (or his designee, also referred to as the Institutional Official (IO) regarding matters of compliance as outlined in this Handbook.

2.  Medical staff department chairpersons/leaders shall have access to IRB minutes as deemed appropriate by the IRB chairperson. Department chairpersons/leaders shall receive notification of research studies being conducted within their departments. The IRB will communicate with and receive documentation from hospital committees or departments when such information is pertinent to the IRB’s review of research.

3.  The Office of Research Administration (ORA) will be notified of IRB actions and will receive a copy of the approved IRB minutes.

C.  Research Investigators - IRB staff will guide investigators concerning IRB submission and, as appropriate, will direct investigators to other resources. The IRB will counsel the investigator regarding matters of federal and state laws (or refer the investigator to IRB designated Adventist Health System attorneys) and the IRB Handbook. The IRB will request information, as necessary, to confirm investigator qualifications to conduct human subject research.

1.  IRB Investigator Requirements – FH Investigators shall complete the following before beginning research projects:

a.  CITI Training Courses: Basic, Health Information Privacy and Security (HIPS), and, if conducting FDA-regulated research, Good Clinical Practice (GCP) – to be uploaded into IRBNet profile

b.  current curriculum vitae (CV) or resume – to be uploaded into IRBNet profile

2.  Refresher Course / CV Update – IRB requires the CITI training to be renewed, at a minimum, every three years. An updated CV will also be required. Investigators are encouraged to attend IRB classes provided for their benefit as well as other research conferences when time allows.

IRB reserves the right to waive IRB requirements as the chairperson/designee deems appropriate.

D.  Sponsor/Investigator - An investigator who both initiates and conducts, alone or with others, a research investigation, that is, under whose immediate direction the investigational drug or device is administered, dispensed, or used, shall be obligated as an investigator and as a sponsor.[11] Other research studies that are not FDA regulated, i.e., behavioral and others, may be studies wherein the investigator is the sponsor and/or author of the protocol. The sponsor/investigator shall comply with all IRB requirements and federal and state regulations as the sponsor and as the investigator.

E.  Clinical Research Coordinators - The IRB staff maintains a relationship with investigators’ clinical research coordinators who manage daily operations of IRB approved research. The clinical research coordinator will be qualified to conduct research in the same manner as the investigator (see paragraph C above). The principal investigator remains ultimately responsible for the safety and welfare of research participants in his/her study as well as the overall management and integrity of the study. The IRB will have unobstructed access to the principal investigator, sub-investigators and other research team members.

If an investigator or coordinator is research certified through a professional organization which the IRB accepts and provides a copy of a current certification, he/she will not be required to take a HSRP program. HIPAA certification, license, and CVs must be maintained.

F.  Other Institutions and IRBs – The IRB will communicate with other institutions and IRBs, as appropriate. Investigators wishing to conduct research at Florida Hospital are required to submit their research studies to the Florida Hospital IRB for review and approval. In the conduct of federally funded cooperative research studies, FH remains responsible for safeguarding the rights and welfare of human subjects participating in research at FH and for complying with federal regulations, but the IRB may elect to rely on the review of other IRBs for those studies. This review would only occur in accordance with the FH’s Federalwide Assurance (FWA). Under agreement and in compliance with applicable federal and state laws and this Handbook, the FH IRB may act as the IRB of record for studies conducted at other facilities or for research conducted at Florida Hospital in conjunction with other institutions, i.e., universities and others.