Partners Healthcare is an integrated health care system, founded by Brigham and Women's Hospital and Massachusetts General Hospital that offers patients a continuum of coordinated and high-quality care. In addition to its two academic medical centers, Partners system includes community and specialty hospitals, a managed care organization, a physician network, community health centers, home health and long-term care services, and other health care entities. Partners HealthCare is committed to patient care, research, teaching, and service to the community. Partners is one of the nation's leading biomedical research organizations and is a principal teaching affiliate of Harvard Medical School. Partners HealthCare is a non-profit organization. We have opportunities in Finance, Information Systems, Human Resources and many other areas that work behind the scenes in support of the Partners mission.
|Location:||Boston - Longwood Medical Area, MA,|
|Employee Type:||full time|
|Experience:||5 - 8 years|
Under the general direction of the Director, Human Research Review and Compliance and Assistant Directors, incumbent serves as the Administrative Chair of the Partners Human Research Committees (PHRC), the Institutional Review Board (IRBs) charged with the review of all research involving human subjects. Incumbent is a voting member of the PHRC and participates in initial and continuing review of human-subjects research, and proposed changes in approved research, as well as review of unanticipated problems involving risks to subjects or others in accordance with federal, state, and local laws and regulations, the Partners Human Research Committee Policies and Procedures, and the ethical principles described in the Belmont Report. Incumbent is authorized to review research and (1) make exemption determinations; (2) approve non-exempt minimal risk research using the expedited review procedure; (3) approve minor changes in approved research not otherwise eligible for expedited review; or (4) review unanticipated problems involving risks to subjects or others that are not serious. Working with the Director, Human Research Review and Compliance and others, as appropriate, participates in the development of PHRC policies and procedures. As needed, interacts with federal and state regulatory agencies, such as the Food and Drug Administration (FDA), the National Institutes of Health (NIH), the Office for Human Research Protections (OHRP), and the Massachusetts Department of Public Health. Incumbent reports to the Director, Human Research Review and Compliance and/or Assistant Director.
1. Reviews human research protocols and consent forms for completeness and accuracy as well as adherence to all applicable federal/state regulations and institutional policies and guidelines governing protection of human subjects in research in preparation for PHRC meetings.
2. Attends meetings of the convened PHRC and provides guidance to membership, as needed, on regulatory issues and institutional policies and procedures. Ensures quorum requirements are met for each protocol review.
3. Composes letters 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.
4. Composes minutes of PHRC meetings, to include attendance at meetings; actions taken by the PHRC; 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) summary of the discussion of controverted issues and their resolution; and (4) findings and determinations required by regulation.
5. As an experienced voting member of the PHRC: (1) determines whether a research activity submitted to the PHRC for review is human-subjects research or a clinical investigation subject to PHRC review; (2) determines exemptions from 45 CR 46; (3) reviews modifications in research required by the PHRC at a convened meeting to secure approval, and confirms that all modifications have been made as required by the PHRC; (3) approves non-exempt minimal risk research using the expedited review procedure; (4) approves minor changes in approved research not otherwise eligible for expedited review; or (5) reviews reports of unanticipated problems involving risks to subjects that are not serious.
6. Identifies requirement 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.
7. Oversees membership to ensure that the PHRC continues to have members with the necessary experience and expertise to review the breadth of research conducted at the BWH and MGH. Participates in orientation of new PHRC members.
8. Provides guidance to investigators and clinical research personnel to the PHRC policies and procedures.
9. Works with the Director and Chairs to identify and resolve problems. Works with management staff to formulate short- and long-term goals and objectives.
10. Keeps current on federal, state, local laws and regulations governing human-subject research through attendance at conferences, workshops, seminars, or lectures pertaining to human-subject protection.
Partners HealthCare System is an Equal Opportunity Employer