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Organization TypePublic Interest
Years of Experience
Date Last Verified
ProfileAssociate Chair Duties: Under the general direction of the Director, serves as Associate Chairperson of the Human Research Committees, the Institutional Review Board (IRBs) charged with the review of all research involving human subjects at Partners HealthCare affiliated institutions (MGH, BWH, McLean, SRN, etc.). Will responsible for 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, Human Research Policies and Procedures, and the ethical principles described. Review research and make exemption determinations; approve non-exempt minimal risk research using the expedited review procedure; approve minor changes in approved research not otherwise eligible for expedited review; and review unanticipated problems involving risks to subjects or others that are not serious. Works with others, as appropriate, on the development of or updates to Research policies and procedures. Involves regular interaction with others within the Partners system with responsibility for some aspect of the human research protection program. 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, sponsors, such as the National Institutes of Health (NIH) and Department of Defense (DoD), and accrediting organizations, such as Association for the Accreditation of Human Research Protection Programs (AAHRPP). Determining whether a research activity submitted for PHRC review is human-subjects research or a clinical investigation subject to PHRC review; Determining exemptions from 45 CFR 46; Conducting expedited review of the following: Initial and continuing review of research activities; proposed minor changes in approved research during the period of PHRC approval; and unanticipated problems involving risks to subjects or others, including adverse events that are unexpected and related to the research, but are not serious; Convened Meeting Activities Attending or presiding as Chair at convened meetings during which the PHRC conducts: initial and continuing review of research activities involving human subjects; review of proposed changes in approved research during the period of approval that are not minor; review of unanticipated problems involving risks to subjects or others, including adverse events that are serious, unexpected and related to the research; and review of reports of possible serious or continuing noncompliance; Reviewing and voting on human research protocol submissions on the agenda of convened meetings and ensuring quorum requirements are met for each protocol reviewed at convened meetings; Composing minutes of PHRC meetings, to include attendance at meetings; actions taken; the vote on these actions, including: the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving the research; summary of the discussion of controverted issues and their resolution; and findings and determinations required by regulation; Reviewing modifications in research required at convened meetings to secure approval, and confirming that modifications have been made as required; Overseeing membership to ensure that the continues to have members with the necessary experience and expertise to review the breadth of research conducted by Partners investigators; Orienting new members and providing guidance to members on regulatory issues and institutional policies and procedures; Expedited and Convened Meeting Activities Reviewing human research protocol submissions to ensure that human subject research overseen by the PHRC complies with all applicable federal, state and local regulations as well as institutional policies and procedures and guidelines; Composing 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; Identifying 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; General Activities Providing guidance to investigators and clinical research personnel to the policies and procedures; Participating in the development and implementation of educational workshops and activities for the research community; Participating with Directors and others on development of and updates to human research policies and procedures; Working with the Directors and others to identify and resolve problems and formulate short- and long-term goals and objectives; Keeping current on federal, state, local laws and regulations governing human-subject research and attending conferences, workshops, seminars, or lectures that pertain to human-subject protection.
Qualification and Experience
Qualifications: Medical Doctor (MD) or advanced degree in a biomedical science, social science, law or ethics discipline or regulatory field (e.g., PhD, ScD, EdD, DNP, MS, MSN, MSW, MPH, MPA, MSCI, PharmD, JD Degree) and 2 years of relevant experience or other healthcare professional (e.g., BSN) with 5 years of relevant experience in clinical research or regulatory affairs. Extensive knowledge of federal, state, and local laws and regulations governing human-subjects research. IRB professional (CIP) or IRB Manager (CIM) Certification desired. Excellent oral and written communication skills. Excellent organizational skills. Excellent interpersonal skills to effectively communicate with cross functional teams including staff at all levels of the organization, including both scientific/medical and non-scientific/medical personnel. Exceptional problem solving and negotiation skills. Ability to effectively conduct meetings, both formal and informal, and to lead and facilitate large working sessions with all levels of staff. Self-motivated, independent and possesses the ability to learn quickly. Ability to successfully negotiate and collaborate with others of different skill sets, backgrounds and levels within and external to the organization.
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