Charter Flashcards
(36 cards)
Core Mission Alignment (NYS Office of Mental Health)
3 Points
- Support the NYS Office of Mental Health’s mission to promote mental health for all New Yorkers
Focus on providing hope and recovery for: - Adults with serious mental illness
- Children with serious emotional disturbances
Ethics & Participant Protection
4 Points
- Ensure the rights, welfare, safety, and wellbeing of clients and research participants
- Uphold the highest ethical standards in:
- Clinical practice
- Conduct of research
Research Institute Objectives
5 points
- Contribute to the knowledge base of the mental health field
- Conduct leading-edge research
- Deliver high-quality clinical care
- Inform and shape policy
- Provide training and educational support
Authority of REC
- The Research Ethics Committee is appointed by the Institutional Official at NYS OMH
- The REC handles Promptly Reportable Information: situations that may involve serious concerns. These concerns may relate to:
- Institutional noncompliance (e.g., not following research rules or procedures)
- IRB noncompliance (e.g., issues with how research was reviewed or approved)
The REC reports to:
- The Research Board of Governance
- The Institutional Official (OMH)
Principal Responsibilities of REC:
- PRI relating to potential IRB or Institutional Non-Compliance to assess whether the information represents an unanticipated problem involving risks to subjects or others, serious or continuing noncompliance.
- Refer items to the Quality Improvement and Education (QIE) division or external Compliance Monitor for follow-up (i.e. inspection, information gathering, monitoring, and overseeing corrective actions as necessary).
- Review and approve corrective and preventative action (CAPA) plans.
- Institutionally suspend research activities.
- Report summary findings to the Research Board of Governance.
- PURPOSE
1.1. This work instruction defines the procedures to be followed for submitting Promptly Reportable Information (PRI) relating to potential Investigator, IRB or Institutional Non-Compliance to the Reportable Events Committee (REC) at the New York State Psychiatric Institute (NYSPI).
1.2. This work instruction defines the procedures to be followed by the Reportable Events Committee (REC) when reviewing Promptly Reportable Information (PRI).
- SCOPE
2.1. This work instruction applies to all NYSPI human research protection program activities regardless of where the activities are occurring.
- RESPONSIBILITIES
3.1. All NYSPI research team members engaged in the conduct of research at NYSPI as well as NYSPI research leadership and staff must:
3.1.1. Comply with the requirements of this work instruction.
3.2. NYS Office of Mental Health (OMH) Human Research Protection Program (HRPP) will:
3.2.1. Administer and manage the operations of the Reportable Events Committee and the REC coordinator.
3.2.2. Provide regulatory advice, guidance, and support to the human research
community at NYSPI.
3.2.3. Led by the Quality Improvement and Education (QIE) division, monitor the
conduct of research at NYSPI.
3.2.4. Provide regulatory guidance and support to the Reportable Events Committee.
Report findings made by the Reportable Events Committee of an unanticipated problem involving risks to subjects or others or serious or continuing noncompliance to the reviewing IRB of record, sponsor, and federal agencies as required by an agreement, contract, terms of an award, terms of assurance, or regulation
3.3. Reportable Events Committee (REC) coordinator will:
3.3.1. Coordinate reviews as delegated by Director of NYSPI Human Research Protection Program (HRPP) and in compliance with the requirements of 45 CFR 46 and 21 CFR parts 50 and 56 as applicable.
3.3.2. Manage agenda creation coordination and information distribution to members of REC with the support of HRPP
3.3.3. Manage the REC review process
3.3.4. Draft Minutes for approval by the REC approval by the REC Chair and subsequent dissemination to the REC.
3.3.5. Draft Report summary findings for the HRPP Director for dissemination to the NYSPI Executive Director on behalf of the REC.
3.3.6. Maintain files for REC in a secure location created by the HRPP with limited accessibility
3.4. Reportable Events Committee (REC) will:
3.4.1. Review Promptly Reportable Information (PRI) relating to potential Investigator, IRB or Institutional Non Compliance to assess whether the information represents an unanticipated problem involving risks to subjects or others, serious or continuing noncompliance.
3.4.2. Conduct review and reporting in compliance with the procedures of this work
instruction.
3.4.3. Refer items to the NYSPI Executive Director or designee (i.e. inspection, information gathering, monitoring, and overseeing corrective actions as necessary).
3.4.4. Review and approve corrective and preventative action (CAPA) plans.
3.4.5. Institutionally suspend research activities.
3.4.6. Direct NYSPI to report items which are determined to be an unanticipated problem involving risks to subjects or others, serious or continuing noncompliance to applicable federal agencies, sponsors and reviewing IRBs
3.5. Executive Director, NYSPI, and Director of Research , NYSPI will:
3.5.1. Report items to the REC.
3.5.2. Implement the directions of the REC.
3.5.3. Draft and submit CAPA plans to the REC.
3.5.4. Monitor the implementation of CAPA plans and report on their progress.
3.5.5. Take appropriate institutional actions, which may include among other items
institutional suspension or termination of research programs, disciplinary actions and reporting to applicable federal agencies, sponsors and reviewing IRBs.
3.6. Institutional Official will:
3.6.1. Ensure this work instruction is followed.
3.6.2. Monitor the implementation of this work instruction.
3.6.3. Ensure corrective and preventative action (CAPA) plans are completed.
3.6.4. Take disciplinary action as required.
- POLICY/PROCEDURE
4.1. Reportable Events Committee (REC) Composition and Appointment
4.1.1. The Reportable Events Committee (REC) will have a minimum of five voting
members sufficiently qualified through experience and expertise to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.
4.1.2. There must be at least two members who are otherwise not affiliated with NYSPI and are not part of the immediate family of a person affiliated with NYSPI.
4.1.3. Members are appointed by the NYS OMH Institutional Official for renewable terms of 1-year and approved by the Governance Board.
4.2. Use of Consultants
4.2.1. The REC may utilize consultants with the appropriate expertise to evaluate or review information.
4.2.2. Consultants are not members of the REC, do not count towards quorum, and
may not vote.
4.2.3. The REC may invite individuals with competence in special areas to assist in
the review of issues, that require expertise beyond or in addition to that
available on the REC.
4.2.4. Consultants are required to disclose any potential conflict of interest and
complete a confidentiality agreement, prior to review.
4.2.5. Consultants will be asked to provide a written statement documenting the
review and recommendations to the REC.
4.2.6. The REC is not bound by the opinion or review of the consultants but takes their
reviews into consideration.
4.2.7. Consultant reviews will be kept with REC files, which will be maintained by the REC coordinator.
4.3. Scope and Authority of REC Review
4.3.1. The REC has the authority to:
4.3.1.1. Determine whether, from the perspective of the FWA holder [NYS Office of Mental Health], an event represents an unanticipated problem, serious or continuing noncompliance.
4.3.1.2. Request additional information
4.3.1.3. Direct, approve, and monitor corrective and preventative action (CAPA) plans
4.3.1.4. Direct that NYSPI report events that represent an unanticipated problem, serious or continuing noncompliance to federal agencies, institutional officials, sponsors, or reviewing IRBs.
4.3.2. Individual Protocols: The REC will:
4.3.2.1. Receive notice of reports of IRB findings for PRIs that are
determined to represent an unanticipated problem, serious or
continuing non-compliance as defined above when
reports of such determinations are received by the HRPP for an
individual project.
4.3.2.2. Conduct an institutional review of PRIs that are determined to
represent serious or continuing non-compliance for human subject
research occurring at NYSPI.
4.3.2.3. Conduct an institutional review of PRIs involving suspension or termination of IRB approval.
4.3.3. The purpose of this notification and institutional review in addition to the reviewing IRB’s review is to:
4.3.3.1. Assess whether any institutional action should be taken to reduce risks
to subjects or others, and/or mitigate compliance concerns.
4.3.3.2. Review for trends that may indicate broader institutional action is
recommended (i.e., training, tools, or policies)
4.3.3.3. Recommend or direct institutional action be taken
4.3.3.4. Ensure prompt reporting to the IRB; appropriate institutional officials;
the department or agency head; and the Office for Human Research Protections, HHS, or any successor office, or the equivalent office within the appropriate Federal department or agency and the Food and Drug Administration (FDA) (if report is related to an FDA regulated study) of (i) Any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with federal requirements or the requirements or determinations of the IRB; and (ii) Any suspension or termination of IRB approval
4.3.4. IRB and Institutional Compliance
The REC will:
4.3.4.1. Serve as the Committee responsible for institutional review of NYSPI IRB
Committee and NYSPI entity compliance with applicable federal
regulations regarding human subjects, including but not limited to
* HHS Requirements for Human Subject Research at 45 CFR 46
* HHS Requirements for HIPPA at 45 CFR 164
* FDA Requirements at 21 CFR 11, 50, 56, 312, 812
4.3.4.2. Receive and review notice of reports/allegations of IRB or NYSPI
institutional noncompliance with applicable regulations governing the conduct of human subject research and will determine whether the report or allegation represents a finding of serious or continuing non-compliance as defined above.
The purpose of this review is to:
4.3.4.3. Assess whether any institutional action should be taken to reduce risks
to subjects or others, and/or mitigate compliance concerns.
4.3.4.4. Review for trends that may indicate broader institutional action is
recommended (i.e., training, tools, or policies)
4.3.4.5. Recommend or direct institutional action be taken
4.3.4.6. Ensure prompt reporting to the IRB; appropriate institutional officials;
the department or agency head; and the Office for Human Research Protections, HHS, or any successor office, or the equivalent office within the appropriate Federal department or agency and the Food and Drug Administration (FDA) (if report is related to an FDA regulated study) of (i) Any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with federal requirements or the requirements or determinations of the IRB; and (ii) Any suspension or termination of IRB approval
4.4. General Requirements for Review
4.4.1. The review refers to the review at a convened REC meeting where a quorum is present.
4.4.2. Quorum is achieved when 1 more than half of REC members are present, including at least 1 non-affiliated member.
4.4.3. A determination requires a majority vote of the quorum present at the
convened REC meeting.
4.4.4. No REC member will participate in the review of any PRI
in which the member has a conflicting interest, except to provide information as requested by the REC. Any reviewer assigned a PRI in which he/she has a conflict of interest shall notify the HRPP immediately so that the PRI can be reassigned.
4.4.5. The REC chair votes as a regular member.
4.4.6. Meetings may be conducted in person or via teleconference.
4.4.7. REC attendance is captured by documenting in the REC meeting minutes the REC members in attendance
4.4.8. If quorum is lost during a meeting, the REC cannot take votes until the
quorum is restored.
4.5. Materials Received by the REC for Review
4.5.1. All REC members receive the following documentation, as applicable to the event:
4.5.1.1. Description of the event prepared by the HRPP, Board of Governance, or External Monitors.
4.5.1.2. Applicable supporting documents responsive to concerns
4.5.1.3. Results of all applicable internal or external monitoring reports
4.5.1.4. Subject information as applicable
4.5.1.5. Determinations of any other review committees (IRB, DSMB, etc.) as applicable
4.5.1.6. Other information as requested to complete the review
4.5.2. If a REC member requires additional information to complete the review, that
member may contact the REC coordinator to request additional information.
4.6. Triage
4.6.1. A reviewer external to the REC serves as the triage reviewer and reviews all potential PRIs.
4.6.2. The triage reviewer may initiate further inquiry or review, depending on the PRI.
4.6.3. Events determined by the triage reviewer to represent potential non-
compliance or a potential unanticipated problem are scheduled for review and evaluation by the REC
4.7. Assignment of Reviewers
4.7.1. The REC will employ the use of primary and secondary reviewers
4.7.2. The REC coordinator as delegated by the REC Chair assigns a primary and (at least one) secondary reviewer for all reports identified during triage as requiring review
4.7.3. The primary and secondary reviewers will prepare a written summary of their review, guided by a checklist, and will present their review to the REC at a meeting for discussion.
4.7.4. Assigned reviewers may try to resolve any noted issues, by contacting the HRPP and asking for additional information, before the REC meeting.
4.7.5. The entire committee will receive a copy of all materials submitted to the REC.
The entire committee is expected to have reviewed all provided material in order to have a meaningful discussion of the presented information during the convened REC meeting
4.7.6. Assigned reviewers will use Reviewer Checklists as a guide to their review.
4.7.7. When an assigned reviewer is absent, they should ask the other reviewer to
present their comments.
