HRPP Policies & Forms Chapter Two. Created/Revised for AAHRPP June 1, 2007. REVISED POLICIES. Revised Policy. SOP 202 Management of IRB The performance of the IRB Chairs, Vice Chairs, and IRB Members shall be evaluated on an annual basis.
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Created/Revised for AAHRPP
June 1, 2007
Management of IRB
The performance of the IRB Chairs, Vice Chairs, and IRB Members shall be evaluated on an annual basis.
This periodic evaluation is conducted to assess performance taking into consideration, completion of education requirements, attendance, preparedness, knowledge and abilities in applying the ethical principles and regulations governing human research, and knowledge of IRB policies and procedures.
Chair/Vice Chair Evaluation Form
Board Member Evaluation Form
Initial Review - Criteria for IRB Approval
The IRB shall evaluate proposed research for scientific or scholarly validity based on the following:
As an outcome of continuing review, the IRB may require that the research be suspended or terminated as per SOP 411 Suspension or Termination of IRB Approval.
As an outcome of continuing review, the IRB may require that any significant new findings that arise from the continuing review process and that might relate to participants’ willingness to continue participation will be provided to participants.
Unanticipated Problems Involving Risks to
Participants or Others & Protocol Deviations
Protocol Deviation Report Form
Emergency Use of FDA Regulated Products
Planned emergency research is defined as planned research involving a life-threatening emergency where the requirement to obtain prospective informed consent has been waived.
The research plan must be approved in advance by the FDA or DHHS and the IRB, and project, as well as its results, are publicly disclosed to the community in which the research is conducted.
The IRB will not review and waive the requirement to obtain consent for planned emergency research. Therefore, no planned emergency research can be conducted at OU.
IRB Communication and Notification
Notification to Institutional Offices and Officials
The HSC IRB shall notify the HSC Office of the Provost, Senior Vice President and Provost as Institutional Official of IRB findings and actions. The Institutional Official shall receive a copy of the IRB meeting minutes for each IRB.
Questions, Concerns and Suggestions Regarding the
Human Research Participant Protection Program
Consent Process & Documentation
Waiver of Documentation of Informed Consent
If documentation of informed consent is waived, theInvestigator will ask whether the participant wants documentation linking the participant with the research, and the participant’s wishes will govern.
Legally Authorized Representative
For research conducted outside of Oklahoma, individuals who meet the definition of a legally authorized representative are those individuals as described under the applicable law of the jurisdiction in which the research will be conducted.
If recruiting a participant from a legally authorized representative the investigator must report this category of participant on the IRB application and provide to the IRB the definition of legally authorized representative for the applicable jurisdiction.
Investigator-initiated studies, where the investigator holds an IND/IDE, are the primary targets of routine evaluation.
When assuming the role of the sponsor, the investigator is evaluated to ensure compliance with the additional regulatory requirements as outline in SOP 802 Sponsor Responsibilities and good manufacturing practice.
The investigator is required to submit an annual report to the FDA and is notified by the IRB sixty days in advance of its due date. Compliance with this requirement is monitored by the IRB staff via the continuing review application.
Observation of the Consent Process
The IRB has the authority to observe, or have a third party observe, the informed consent process of research it has approved, and to verify that the study is being conducted as required by the IRB and within the institutional policies and procedures and site-specific procedures, as appropriate.
Before the IRB or third party observes the consent process, verbal consent of the participant may be sought.
The IRB may determine it is necessary to observe the
informed consent process in order to provide additional
protections and may conduct informed consent
observations in the following situations:
Informed Consent Observation Checklist
IRB Internal Evaluations/Improvement Plan
The HRPP shall measure and improve the program’s effectiveness, quality, and compliance with organizational policies and procedures and applicable federal, state, and local laws.
IRB Internal Evaluations
If someone other than the investigator will be conducting the interview and obtaining consent, the investigator must formally delegate the responsibility to an individual who has received appropriate training to perform this activity.
For VA research the legally authorized representative is
defined as the following persons in the following order of
Exempt Research Category #2
Research involving the use of educational tests (cognitive,
diagnostic, aptitude, achievement), survey procedures,
interview procedures, or observation of public behavior,
Exempt Research Category #2
For VA research that expires because continuing review is not completed the IRB shall notify the sponsoring agency, private sponsor, Office of Research and Development, Office of Research Oversight, or other Federal agencies, as appropriate.
Drug Dispensing & Accountability
June 1, 2007