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.
Monitoring for Unanticipated Risks to Subjects or Others
Goodwyn IRB’s reporting requirements provide a signal for unanticipated / increased risk to research subjects or others. Unanticipated / increased risk can be signaled through information reported during continuing review, new/updated information about the drug products or interventions, requests for modifications of a study, reports of unexpected and study-related adverse events, protocol deviations, subject complaints, breach of confidentiality, and reported or observed non-compliance. Goodwyn IRB systematically looks at this reported information and will determine which are unanticipated problems involving risks to participants or others and which are not.
Adverse
Event Reporting
Study investigators under the jurisdiction of Goodwyn IRB are required to report unexpected, related adverse events / adverse device effects that occur during human research at their site to Goodwyn IRB within 10 working days.
Protocol
Deviation Reporting
A Protocol Deviation is any departure from the current IRB-approved protocol without prior IRB approval. This includes exceptions to the protocol requirements that have been granted by the sponsor.
Study investigators under the jurisdiction of Goodwyn IRB are required to report deviations that occur during human research at their site to Goodwyn IRB within 10 working days.
•The deviation resulted in increased risk to subject or others
•The deviation affected the rights, safety or welfare of a subject(s)
•The deviation affected the integrity of the study
Other Unanticipated Problems
Sponsors and study investigators are required to report information that may represent unanticipated problems involving risks to participants and others to Goodwyn IRB within 10 working days. An unanticipated problem is one that is (1) unforseen and (2) indicates that participants or others are at increased risk of harm. Unanticipated problems involving increased risk might be indicated in the following:
•IND safety letter
•breach of confidentiality
•summary of interim analyses and DSMB reports
•new publications and labeling changes
•subject compaints that indicate unexpected risks
•audit reports
•other events that may represent unanticipated problems
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.