Research Regulatory Committees An Overview of the Institutional Review Board (IRB) Presented by Rowan University Foundation / University and Office of Sponsored Programs April 22, 2014

OFFICE OF RESEARCH ROWAN UNIVERSITY

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Provide assistance and guidance to investigators to ensure ethical conduct and the following areas:

 Human subjects protection    Animal care and use Use of hazardous agents, radioactive materials and recombinant DNA material Responsible conduct of research (Ethics and Integrity)

IRB Organization Structure

 MANAGEMENT: Institutional official and IRB director 

GOALS:

   Centralized single Human Subjects Protections Administrator (HSPA) for both institutions Centralized compliance office for all regulated research Management of institution’s sponsored programs are maintained directed by Vice President for Research

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Human Subject Protection Program Mission and Services

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To protect the rights, dignity, welfare, and privacy of human research subjects by adhering to the principles of the Belmont Report, the regulations of the Department of Health and Human Services (DHHS), State and Local regulations. The Human Subjects Protection Program and the IRBs serves its purpose by: Administratively supporting the Institution’s IRBs; Reviewing all research involving human research subjects before it is initiated; Working to protect the rights and welfare of human research subjects by fostering and advancing the ethical and professional conduct of persons who engage in research with human participants; Providing education to IRBs, researchers, research staff and the public; Conducting periodic reviews of research involving human subjects, and Serving as the Institution’s HIPAA Privacy Board .

Belmont Report

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The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research prompted by the problems arising fro m the Tuskegee syphilis study. The commission (1979) produced the report. It provides:

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An analytical framework and a guide to solve ethical problems arising from human subject research

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It contains three discussion topics:

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Boundaries between practice and research

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The distinction is blurred because research and practice occur together

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Therapeutic misconception ( to treat versus gaining knowledge)

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Basic ethical principals

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Applications

Belmont Report Three Basic Ethical Principles 1. Respect for Persons

a. Treat individuals as autonomous persons allowing them to choose for themselves b. Individuals with limited autonomy should receive additional protection c. Periodically reevaluate individual’s lack of autonomy

Belmont Report

2. Beneficence a. Do not harm b. Risks are reasonable in relation to anticipated benefits c. Maximize possible benefits and minimize potential harms

Belmont Report

3. Justice

a. Fair distribution of burdens and benefits of research based on focus of research b. Treat people fairly c. Prevent exploitation

Belmont Report Application

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Respect to persons

 Informed consent process 

Beneficence

  Assessing risk/benefits

Justice

 Selecting appropriate research participants (who ought to receive the benefits of research?)   Fair distribution of costs and benefits

Who implements?

 IRBs and Researchers

IRB OFFICES - FUNCTIONS Facilitating IRB Applications

  Assist in making determination whether the study involves human subjects or not Provide guidance to investigators :      Training at departmental level Class room presentation in person or online One-on-one tutorials Pre-review in advance of formal applications Workshops

IRB Responsibilities

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The IRB is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. The IRB has the authority to approve, require modifications in, or disapprove research activities that fall within its jurisdiction as specified by both the federal regulations, state, local and institutional policy. Research that has been reviewed and approved by an IRB may be subject to review and disapproval by officials of the institution. However, those officials may not approve research if it has been disapproved by the IRB.

Fundamental Questions to ask:

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Is this research?

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Does it involve human subjects Is the study minimal risk and can the study can be expedited?

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Can the study be exempt from IRB review?

Some of these decision are made by OR in consultation with the Chair .

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Authorities of IRB

All human subjects research carried out at the Institution or under its auspices must be reviewed and approved by an IRB prior to the start of the research. Institution’s IRBs review human subject research projects when:  The research is sponsored by the Institution;  The research is conducted by or under the direction of any employee or agent of the Institution in connection with his or her Institution’s responsibilities;  The research is conducted by or under the direction of any employee or agent of the Institution using any property or facility of the Institution;  The research involves the use of the Institution’s non-public information to identify or contact human subjects, and  Any research determined by the Institution’s VPR The IRB and Chairs have the authority to suspend or terminate approval of human subject research that is not being conducted in accordance with the IRB requirements or that has been associated with unexpected serious harm to subjects.

Authority of Biomedical IRB

 All biomedical research projects involving human subjects, regardless of source of funding is reviewed by the Biomedical IRB.  Research project includes medical and behavioral interventions of adults and children that includes minimal and more than minimal risk.

 Involves patients, staff or students of the Institution   Its research affiliates such as Kennedy Hospitals Conducted by faculty, staff, or students in the School of Osteopathic Medicine, informally known as RowanSOM.

Social and Behavioral IRB

    All non-medical social and behavioral research projects involving human subjects, regardless of funding source conducted by Rowan University faculty, staff, or students .

Studies will not involve physical, psychological or physiological interventions that will impact the health of the participant.

Studies will involve healthy subjects.

Minimal and more than minimal risk studies within the paradigms of research practices in sociology, history, anthropology, psychology, business or information technology.

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Approval by Ancillary Committees

Institution’s IRBs and the Office of Research coordinate reviews with other institutional committees Office of Research establishes communication between the committees regarding status of review and/or conditions of approval Protocols are not approved by the IRB until ancillary committees approve the study Final authority for participation of human subjects in research falls on the IRB.

Referral to other IRBs

    The Office of Research or chair of each of the IRBs may request that a study scheduled for review or continuing review by their IRB be transferred to one of the other IRBs listed in the assurance document as necessary. All clinical trials sponsored by pharmaceutical companies (drugs, biologics and devices) will be referred to the Western Institutional Review Board (WIRB) for review and approval. Studies with institutional conflict of interest Reliance on other institution’s IRBs (Single or Multiple Study Authorizations)

IRB Responsibilities

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Reviewing human subject application.

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Evaluating and protecting the rights and welfare of research subjects

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Determining that risks to subjects are minimized

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Ensuring that the investigators use procedures that are consistent with sound research design and that do not expose subjects to risk

IRB Responsibilities

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Determining that selection of subjects is equitable by taking into account:

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special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, cognitively or mentally impaired persons, or physically impaired persons, or economically or educationally disadvantaged persons. Determining if the informed consent is legible, adequate and contains all required elements including evaluating levels of comprehension.

Determining whether the request for the informed consent waiver and documentation of consent meets regulatory requirements

IRB Responsibilities

    Review all required documentation in the application submission package before the assigned project(s) is/are presented. Discuss any questions about the assigned projects with the investigator, other IRB members, or consultants prior to the IRB meeting. Decide whether the investigator should attend the meeting to discuss any problems or concerns noted with the project. Determine if specific changes are needed in the application, protocol or consent form, and come to the meeting with recommended wording to be transmitted to the investigator.

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Administrative Support

Screens research applications for completeness prior to initiating the IRB review process Maintains files on all human subjects research (including copies of all correspondence between the IRB and investigators) that takes place at the Institution Provides staff support to the IRBs for all written correspondence Maintains databases for tracking studies Prepares meeting minutes Maintains files of minutes of full board and subcommittee meetings Acts as a resource for investigators on general regulatory information, guidance with forms, and assistance in preparing an application for IRB review Maintains the Institution’s Federal-wide Assurance and the IRB membership rosters investigator), and termination Generates and sends reminder notices to investigators of upcoming continuing reviews; Maintains information on federal regulations relating to human subjects research Provides education regarding the IRB process and regulations to the Institution community; Provides educational opportunities to IRB members Maintains records of IRB membership including training Conducts audits (for cause/not for cause) for the Office of Research and IRB Chairs and prepare reports Assists in preparing and providing educational opportunities to subjects, prospective

Office of Institutional Effectiveness, Research & Planning (IERP)

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IERP and IRB online surveys

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Contact IERP upon receipt of IRB approval/exemption of protocol for research requiring online surveys

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IERP survey support role does not supersede the policies and procedures of the IRB IERP’s goal is to:

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Protect the rights, privacy, and safety of potential survey respondents and populations protected by FERPA

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Minimize survey fatigue

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Eliminate collection of duplicate information

Office of Institutional Effectiveness, Research & Planning (IERP)

IERP approved online software that provides tools for designing, distributing and analyzing surveys Verint design highlights

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Unlimited number of questions per page and per survey

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11 different question types

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Skip/branch/display logic Piping from responses or panels Verint distribution highlights

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Deploy surveys via the Web, email, mobile, Facebook, etc.

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Email campaign management

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Personalized email invitations Automation of reminder scheduling View and report on open, click-through, and survey completion rates

Office of Institutional Effectiveness, Research & Planning (IERP)

IERP requirements for survey research support

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Check IERP Survey Calendar on website

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Detailed description of your population/sample

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Questionnaire w/logic

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Invitation/reminders

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Proof of IRB approval

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Things to Remember

Clarity Consideration Consistency Completeness Communicate Consent Compliance Congratulations IRB Uses reasonable person standards – Expectations of a reasonable person consenting to participate in a research study.