As a not-for-profit organization, Partners HealthCare is committed to supporting patient care, research, teaching, and service to the community by leading innovation across our system. Founded by Brigham and Women's Hospital and Massachusetts General Hospital, Partners HealthCare supports a complete continuum of care including community and specialty hospitals, a managed care organization, a physician network, community health centers, home care and other health-related entities. Several of our hospitals are teaching affiliates of Harvard Medical School, and our system is a national leader in biomedical research.
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Our employees use the Partners HealthCare values to govern decisions, actions and behaviors. These values guide how we get our work done: Patients, Affordability, Accountability & Service Commitment, Decisiveness, Innovation & Thoughtful Risk; and how we treat each other: Diversity & Inclusion, Integrity & Respect, Learning, Continuous Improvement & Personal Growth, Teamwork & Collaboration.
General Summary: The Mass General Brigham (MGB) Institutional Review Board (IRB) Chair is responsible for chairing convened IRB meetings on a regular basis and conducting expedited reviews as needed in compliance with federal, state, and local laws and regulations, MGB Policies and Procedures, and the ethical principles described in the Belmont Report. The IRB Chair leads IRB meetings in an organized and collaborative manner engaging and respecting the perspectives of both the scientists and community board members. The IRB Chair is a member of the IRB Executive Committee contributing to the development of policies and procedures for the ethical conduct of human subject research. Depending on their contributed FTE, the IRB Chair may also conduct expedited reviews. This position involves regular interaction with Principal Investigators and research team members to discuss their IRB applications and regular meetings with the IRB and HRA leadership to contribute to the development of policies and ethical approaches to the protection of human subject research.
Principal Duties and Responsibilities:
Convened Meeting Activities
Chair and act as a voting member of convened IRB meetings during which the IRB conducts: (i) initial and continuing review of research activities involving human subjects; (ii) review of proposed changes in approved research during the period of approval; (iii) review of unanticipated problems involving risks to subjects or others, including adverse events that are serious, unexpected and related to the research.
Ensure research reviewed at each convened meeting is assessed based on the federal regulatory "Criteria for Approval" and complies with all applicable federal, state and local regulations as well as institutional policies, procedures and guidelines.
Support and participate in IRB initiatives on diversity, equity and inclusion (DEI) with respect to the IRB membership, the approach to review of research, as well as the conduct of human subject research and translation into improved health care in our community.
Participate as a voting member and serve as the Chair (in the absence of the Senior IRB Chair) of the IRB charged with reviewing reports of possible serious or continuing noncompliance and making determinations regarding corrective and preventative action plans.
Review and approve reviewer assignments for convened IRB meetings.
Guard the independence of the IRB decision process with respect to inappropriate outside influence or conflict of interest.
Act as a primary or secondary reviewer as needed for protocol items on the agenda of convened meetings.
Review and approve meeting minutes and PI correspondence of IRB determinations to include attendance at meetings; actions taken by the IRB; the vote on these actions, including: (1) the number of members voting for, against, and abstaining; (2) the basis for requiring changes in or disapproving the research; (3) a summary of controverted issues and their resolution; and (4) findings and determinations required by regulation.
Review changes made by the PI subsequent to a convened meeting as needed in order to secure approval.
Develop and implement processes and procedures in collaboration with HRA leadership to ensure efficient, effective and consistent review by the IRB and expedited reviewers.
Participate in development and implementation of processes and procedures to ensure interactions between the IRB and PIs and their research teams are collaborative and professional in support of the ethical conduct of research.
Participate in teaching IRB member onboarding and continuing education programs.
Participate in meetings of designated Expedited Reviewers as needed.
Participate in ongoing education activities during and outside of IRB meetings and in orienting new members to IRB review policies and procedures as needed.
Provide guidance and interpretation to Vice Chairs and members on regulatory issues and institutional policies and procedures.
Participate in developing and presenting educational programming for the research community.
Expedited Review Activities
Work independently to review research activity submitted to the MGB IRB to
determine research is not human subjects research or a clinical investigation subject to IRB review;
determine if research meets exemption criteria
approve non-exempt minimal risk research using the expedited review procedure
approve minor changes in approved research
conduct continuing review of approved minimal risk research
review other events.
Review human research protocol submissions according to standard operating procedures to ensure that human subject research overseen by the MGB IRB complies with all applicable federal, state and local regulations as well as institutional policies and procedures and guidelines.
Compose correspondence to investigators articulating modifications required in the research to secure IRB approval and any questions, concerns, or clarifications that need to be addressed before IRB approval can be considered.
Identify requirement(s) for review by the ancillary committees, or communication or coordination with other departments, groups, or individuals within the institution that share responsibility for human subject protection.
Work with the research community in a collaborative manner to provide guidance and consultation to investigators and clinical research personnel about the MGB IRB policies and procedures and changes needed to secure IRB approval of submitted protocols.
Adhere to turnaround times for review and processing activities; identify opportunities for improvement; participate in process improvement activities; implement requested changes.
Other duties as assigned.
Stay current on federal, state, local laws and regulations governing human subject research and attend conferences, workshops, seminars, or lectures that pertain to human subject protection.
Participate in periodic evaluations related to service on the IRB and evaluation of the IRB Chairs and HRO meeting staff.
If selected, participate in interviews with teams from the Association for the Accreditation of Human Research Protection Programs during on-site accreditation reviews which occur every 5 years.
Medical Doctor (MD) and relevant experience in clinical research.
Well respected and recognized professional dedicated to continuous quality improvement and collaboration with the research community.
Skills/Abilities Competencies Required:
Ability to conduct meetings in an effective and efficient manner
Excellent oral and written communication skills
Excellent organizational skills with ability to prioritize work and adhere to timelines
Ability to assess institutional and federal criteria, apply to a variety of situations, and make decisions based on specified criteria
Excellent interpersonal skills to effectively and professionally communicate and collaborate with researchers and staff at all levels of the organization and both scientific/medical and non-scientific/medical persons.
Ability to problem solve and successfully negotiate and collaborate with others of different skill sets, backgrounds and levels within and external to the organization
Self-motivated, independent and possesses the ability to learn quickly
Working Conditions: Standard office environment with possible local travel to MGB sites
Supervisory Responsibility: No direct reports; may indirectly provide leadership and guidance to IRB members
Fiscal Responsibility: Demonstrates fiscal responsibility by effectively using MGB resources
EEO Statement Partners HealthCare is an Equal Opportunity Employer & by embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. Partners Healthcare System Inc. is acting as an Employment Agency in relation to this vacancy.
MGH Institute of Health Professions, founded by Massachusetts General Hospital in 1977, is an innovative and independent graduate school in Boston that is a member of Partners HealthCare. A progressive leader in developing comprehensive models of health care education, the MGH Institute prepares advanced practice professionals in the fields of nursing, physical therapy, occupational therapy and communication sciences and disorders through a distinctive combination of academic study, clinical practice, and research. More than 1,200 students are enrolled in graduate level and certificate programs, with an increasing number of courses available online. The Institute is accredited by the New England Association of Schools and Colleges (NEASC).