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MARSHALL
UNIVERSITY
HUMAN RESEARCH PROTECTION PROGRAM (HRPP)
The Marshall University Human
Research Protection Program (HRPP) is a comprehensive and organized system
to ensure the protection of human volunteers participating in research.
The objective of this system is to assist the institution in meeting
ethical principles and regulatory requirements for the protection of human
subjects in research.
I. Ethical
Principles Concerning the Protection of Human Research Participants
BACK
The
ethical principles described in the
Belmont Report (April 18, 1979),
include 1) respect for persons, 2) beneficence, and 3) justice. These are the basic underlying ethical principles that Marshall
University (MU) Institutional Review Boards (IRBs) consider when reviewing
research protocols involving human subjects.
II.
Written Assurance
BACK
Marshall
University stringently adheres to the assurance prescribed in its Federal
Wide Assurance (FWA #00002704).
III. Types of Activities Under HRPP
BACK
The HRPP has the authority
and responsibility to oversee all human research conducted by any employee, student, or other agent of Marshall University
(or affiliate by means of a Memorandum Of Agreement) conducting research as part of their
assigned duties. Marshall University IRBs have sole authority to review,
approve, disapprove, or require changes in research or related activities
involving human subjects conducted by MU or affiliated investigators
IV.
What Constitutes Research
BACK
Research is defined as: A
systematic investigation, including research development, testing, and
evaluation, designed to develop or contribute to generalized knowledge, or
a clinical investigation.
Under FDA regulations
research is defined as any experiment that involves a test article and one
or more human subjects, and that either must meet the requirements for
prior submission to the Food and Drug Administration.
V. Components of HRPP BACK
The components of the
program include the IRB, the participants, the investigators who design,
oversee, and conduct the research and the research staff who support them
and carry out all necessary protection functions for a particular
protocol.
VI. Responsible Institutional
Official
BACK
The responsible
Institutional Official for all
institutions affiliated with the MU IRBs is the Marshall
University Vice President for Research. He/she is responsible for
ensuring the independence of the IRB, it's support and it's standing
within the institution. He/she has the responsibility
for the implementation and operation of the HRPP. The Director/Staff
of the Office of Research Integrity (ORI) assist in the day-to-day
operations of the HRPP.
VII.
Organizational Structure
BACK
The
President of Marshall University serves as the Chief Executive Officer of
the institution. The Senior Vice President and Provost serves as the
Chief Academic Officer for Marshall University. The Vice President
for Research, who also serves as the HRPP Institutional Official, reports
to the Provost. The Director, ORI,
reports to the Vice President for Research and serves on the MU IRBs (as a
non-voting member). The IRB Chairmen and IRB members
are appointed by the Director, ORI. The staff of ORI report to the
Director and assist with all administrative duties involved with the HRPP.
Org Chart
VIII. Responsible
Individual for Implementation of HRPP
BACK
The
Director, Office of Research Integrity, is responsible for:
A).
Implementation of the institution’s HRPP policy
B). Review and evaluation of reports and results of compliance
assessment and quality improvement
activities (QIA).
C). Implementation of needed improvements and follow-up
on
actions, as appropriate.
D). Monitoring changes in federal and state regulations
and
policie that relate to human research
protections.
IX.
Institutional Review Board (IRB) BACK
Marshall
University has two IRBs of record registered with OHRP (IRB#1: 00002205
and IRB#2: 00003206).
Marshall
University IRBs’ Standard Operating Procedure (SOP) entitled “IRB Membership”
details the membership composition, and their roles and responsibilities
in evaluating the scientific and ethical integrity of proposed research
including conflict of interest issues .The accurate maintenance of records
for each active protocol (e.g., date originally approved, date of most
recent approval, and date scheduled for next continuing review, reported
adverse events, etc.) is a responsibility of the IRB Coordinator.
X.
Safety Monitoring BACK
When reviewing research that is more than minimal risk, the IRBs are
responsible to determine that the protocol includes adequate provisions
for monitoring the data collected to ensure the safety of participants.
XI.
Systemic Budgeting for HRPP
BACK
A
systematic budgeting process for the Marshall University HRPP including
its IRBs is described in the IRB SOP entitled “Budget“ based on
consideration of the following factors :
A).
Analysis of the volume of research to be reviewed.
B). IRB
performance (e.g.content and accuracy of informed consent
forms, IRB analysis of risks and
benefits, provision of special
considerations and protections for
vulnerable or potentially
vulnerable populations).
C). Feedback
from IRB members and staff.
XII.
Conflict of Interest BACK
The
policies to identify and manage institutional , IRB member
, and investigator conflict of interest with
research conducted at Marshall University are described in the IRB SOP
entitled “Conflict of Interest.“
XIII.
Participant Involvement
BACK
The
Marshall University institutional policies to address complaints and
non-compliance are
listed in the SOP entitled “Complaints,
Non-Compliance, and Regulatory Improprieties.”
In addition, the ORI obtains feedback from research
participants,
and engages research subjects in planning, design, or review of
protocols.
XIV.
Investigational Product Management
BACK
The
Marshall University institutional policies for the management of
investigational drugs (IND) [including investigational pharmacy, IND log, IND dispensing,
pharmacy evaluation and reporting, and
pharmacy corrective action], and investigational
devices is specified in the SOP entitled “Investigational
Drugs.”
XV.
Quality Improvement Program
BACK
The
procedures that the Marshall University HRPP is using for its continuous
quality improvement (CQI) process to measure investigator
and HRPP performance and take corrective actions to
improve these activities as appropriate are described
in the SOP entitled “QA and Monitoring.”
XVI.
Education and Training Program
An on-going education
and training program that meets federal requirements
and provides guidance to investigators on informed consent documents and
processes is described in the SOP entitled “Education and Training.“
In addition, an educational tracking system is
in-place in the Office of Research Integrity.
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