Is this research? - Rowan University

Research Regulatory Committees
An Overview of the Institutional
Review Board (IRB)
Presented by
Rowan University Foundation / University
Office of Sponsored Programs
April 22, 2014
Provide assistance and guidance to
investigators to ensure ethical conduct and
compliance in performance of research in
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
IRB Organization Structure
 MANAGEMENT: Institutional official and IRB
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
Human Subject Protection
Mission and Services
 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
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
Conducting periodic reviews of research involving human subjects, and
Serving as the Institution’s HIPAA Privacy Board.
Belmont Report
 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:
 An analytical framework and a guide to solve ethical
problems arising from human subject research
 It contains three discussion topics:
Boundaries between practice and research
The distinction is blurred because research and practice
occur together
Therapeutic misconception ( to treat versus gaining
Basic ethical principals
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
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
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
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
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
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:
 Is this research?
 Does it involve human subjects
 Is the study minimal risk and can the study can be expedited?
 Can the study be exempt from IRB review?
Some of these decision are made by OR in consultation with the Chair.
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
 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.
Approval by Ancillary
 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
Reviewing human subject application.
Evaluating and protecting the rights and
welfare of research subjects
Determining that risks to subjects are
Ensuring that the investigators use
procedures that are consistent with sound
research design and that do not expose
subjects to risk
IRB Responsibilities
Determining that selection of subjects is equitable by taking into
 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
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.
Administrative Support
Screens research applications for completeness prior to initiating the IRB review
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
Sends notices of approval, study closure (other than closure of the study by the
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
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
subjects, or their communities, to enhance their understanding of research involving
human subjects.
Office of Institutional
Effectiveness, Research &
Planning (IERP)
 IERP and IRB online surveys
 Contact IERP upon receipt of IRB approval/exemption of protocol
for research requiring online surveys
 IERP survey support role does not supersede the policies and
procedures of the IRB
IERP’s goal is to:
 Protect the rights, privacy, and safety of potential survey
respondents and populations protected by FERPA
 Minimize survey fatigue
 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
 Unlimited number of questions per page and per survey
 11 different question types
 Skip/branch/display logic
 Piping from responses or panels
Verint distribution highlights
 Deploy surveys via the Web, email, mobile, Facebook, etc.
 Email campaign management
 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
 Check IERP Survey Calendar on website
 Detailed description of your
 Questionnaire w/logic
 Invitation/reminders
 Proof of IRB approval
Things to Remember
IRB Uses reasonable person standards –
Expectations of a reasonable person consenting to
participate in a research study.

similar documents