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.