Overview
of Operations
The fundamental responsibility of Goodwyn
Institutional Review Board, Ltd. is to assure, both in advance
and by periodic monitoring, that appropriate steps are taken to
protect the rights and welfare of human research subjects. The
objectives of Goodwyn IRB’s operation are:
•
To support timely, comprehensive review and oversight of proposed
studies.
• To support timely, comprehensive documentation of its
review and oversight for regulatory and business purposes.
• To support actions in the best interest of human research
subjects with due regard to the requirements of relevant regulatory
agencies, applicable laws and in good faith with respect to
both applicants and the community.
Review
of Research Protocols
All research
studies involving human subjects and patients must be reviewed
and approved by an Institutional Review Board prior to their implementation
at investigative sites.
Approval is
defined as the determination of the majority of the Board, a quorum
being present, that the research has been reviewed and may be
conducted at specific institution(s) within the constraints set
forth by the IRB and by other state and federal requirements.
Goodwyn Institutional
Review Board, Ltd. operates using a primary
reviewer system. Under this system, a protocol and associated
aspects of consent, consent process and local research context
for investigative sites are assigned to one or more Members by
the Chair/Vice Chair. Then, at the convened meeting the study
and each associated aspect are presented by the primary reviewer(s)
and, after discussion by the full Board, a vote for action is
taken.
Research activities
involving no more than minimal risk or modification to approved
research may qualify for expedited review. If the Administrator
and Chair/Vice Chair agree that a research activity is eligible
for expedited review, it is reviewed and may be approved by one
or more experienced Member(s) outside of a convened meeting.
Written
Communications of IRB Decisions
Goodwyn Institutional
Review Board, Ltd. decisions will be communicated to principal
investigators through a letter outlining the approval status and
concerns, questions and/or comments of the Board. Initiation of
the research study at the research site may not proceed until
a written notification of final approval has been received from
the IRB. Notification of decisions from a Board meeting will be
available to the investigator within 48 hours of the meeting.
Cooperative
Research
Cooperative
Research studies involve more than one institution. Goodwyn Institutional
Review Board, Ltd. requires cooperative research agreements to
be documented in writing and detail the respective responsibilities
of the parties involved. Copies of the documentation must be furnished
to all parties of the agreement and to those responsible for ensuring
compliance with the regulations and IRB determinations.
Oversight
of Research Protocols
Goodwyn Institutional
Review Board, Ltd. reviews ongoing research in order to be aware
of unexpected problems.
Adverse
Event Reporting
Study investigators
under the jurisdiction of Goodwyn Institutional Review Board,
Ltd. are required to report any serious or unexpected adverse
event that occurs during human research at their site to the IRB
within 5 days of their observation. Investigators under the jurisdiction
of Goodwyn Institutional Review Board, Ltd. are also required
to report to the IRB any notification from the study sponsor of
serious and/or unexpected adverse event(s) observed by any other
investigator participating in the study within 15 days of receipt
of such notification.
Adverse events
of mild to moderate severity, which are listed in the Board-approved
research protocol and informed consent document(s) and occur at
an expected frequency, are not required to be reported to the
Board. (However, investigators are responsible for reporting all
adverse events to the study sponsor and FDA in accordance with
applicable requirements.)
Protocol
Deviation Reporting
Protocol
deviations occurring during study conduct can represent a change
in study design and therefore must be promptly reported to Goodwyn
IRB. Significant deviations must be reported to Goodwyn IRB.
Significant
deviations are those that affect the safety of the subjects. Such
deviations include, but are not limited to:
Enrollment
of patients that do not meet the eligibility criteria for the
trial.
Study procedures – in particular procedures in place to
monitor safety – are not performed or significantly delayed.
Failure to obtain informed consent prior to conducting any study
procedure.
Failure to administer and/or account for study drug as described
in the protocol.
On-Site
Evaluation
The IRB will
routinely select a number of investigator sites participating
in each protocol for an on-site process review. When and if the
IRB is concerned about a study site, an on-site process review
may be necessary to assure that compliance with policies, guidelines
and pertinent law is satisfactory.
Patient
Complaints
The IRB will
investigate all reasonable complaints reported by patients to
the IRB to determine if they reflect broader problems in the study
or its conduct.
Periodic
Reports
To facilitate
the Board’s determination of whether changes have occurred
in the risk/benefit estimation, the IRB requires a status report
from each investigator at least once during the study approval
period. These report(s) and all accumulated adverse event(s),
on-site evaluation(s) and patient complaint report(s) will be
reviewed in the aggregate .
Modifications
to the Research Protocol and Informed Consent Document(s)
Modifications
to research protocols and informed consent documents may be required
as data related to respective risks and benefits are accrued.
Human subjects must be informed of any important new information
that might affect their willingness to continue participation
in the research study. However, the IRB must approve any proposed
modification to a Board-approved research protocol (or associated
study documents) prior to implementation. The only exception to
this requirement is removal of a subject from a protocol that
may be necessary to eliminate an apparent immediate hazard to
the given subject.
The research
sponsor can request Board approval for modifications to research
protocols and informed consent documents at any time. A modification
may also be mandated by the IRB due to information collected from
monitoring activities (adverse event, periodic reports, etc.).
Renewals
Annual renewal
of all research protocols is required including research protocols
in which human research subject accruals have been closed and
the research interventions completed, but data continue to be
collected and analyzed.
The Board
may, however, require more frequent review of certain research
protocols based on the degree of risk involved; and the vulnerability
of the study subject population.
Study
Completion, Termination or Suspension
Investigators
must report when they have finished conducting the protocol.
Also, Goodwyn
Institutional Review Board, Ltd. has the authority to suspend
or terminate approval of research that is not being conducted
in accordance with the Board’s decision, conditions and
requirements, or that has been associated with unexpected serious
harm to subjects. Serious or continuing noncompliance with the
determinations of the IRB may result in the IRB withdrawing approval
for a study.
Record
Keeping
Goodwyn Institutional
Review Board, Ltd. prepares and maintains documentation of all
Board review activities.
Records are
retained for at least 15 years after completion of the research
and the records are accessible for inspection and copying by authorized
representatives of DHHS/FDA at reasonable times and in a reasonable
manner.
Study sponsors
may be provided membership rosters and pertinent portion(s) of
minutes upon request. Goodwyn Institutional Review Board, Ltd.
Standard Operating Procedures (SOPs) are accessible to authorized
representatives of sponsors for review.