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Job Summary
The Mass General Brigham (MGB) Institutional Review Board (IRB) Vice 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 Vice Chair leads meetings in an organized and collaborative manner engaging and respecting the perspectives of both the scientists and community board members. This position will lead the weekly Other Events Committee and conduct reviews of Other Events involving reportable new information submitted to the IRB. Depending on their contributed FTE, this position may also regularly conduct expedited reviews as designated by the IRB Chair. 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.
RESPONSIBILITIES:
Convened Meeting Activities
1. 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.
2. 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.
3. 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.
4. Review and approve reviewer assignments for convened IRB meetings.
5. Guard the independence of the IRB decision process with respect to inappropriate outside influence or conflict of interest.
6. Participate as a voting member of the IRB charged with reviewing reports of possible serious or continuing noncompliance and making determinations regarding corrective and preventative action plans.
7. Act as a primary or secondary reviewer as needed for protocol items on the agenda of convened meetings.
8. 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.
9. Review changes made by the PI subsequent to a convened meeting as needed in order to secure approval.
10. Participate in ongoing education activities during and outside of IRB meetings and in orienting new members to IRB review policies and procedures.
11. Provide guidance to members on regulatory issues and institutional policies and procedures.
Other Events Committee
1. Prior to the weekly meeting, the IRB Chair (or designee) sends out an agenda for the meeting including brief descriptions and assessments of the OEs to be reviewed that week.
2. At the weekly meetings, the IRB Chair (or designee) gives a brief presentation on OEs in which an IRB action is yet to be determined.
3. The IRB Chair (or designee) informs Investigators in advance about regulatory requirements to report to federal agencies and institutional officials any event that meets the definition of UPIRTSO, as well as serious and/or continuing noncompliance.
4. If the noncompliance is determined not to be serious and/or continuing and the proposed corrective action plan is appropriate, the IRB Chair (or designee) documents review in the Insight expedited review checklist.
5. The IRB Chair (or designee) is responsible for note-taking during the OEC meeting and documenting the Committee's review determination and recommendations for IRB routing.
Expedited Review Activities
1. Work independently to review research activity submitted to the MGB IRB to
a. determine research is not human subjects research or a clinical investigation subject to IRB review;
b. determine if research meets exemption criteria
c. approve non-exempt minimal risk research using the expedited review procedure
d. approve minor changes in approved research
e. conduct continuing review of approved minimal risk research
f. review other events.
2. 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.
3. 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.
4. 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.
5. 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.
6. Participate in meetings of designated Expedited Reviewers as needed.
7. Adhere to turnaround times for review and processing activities; identify opportunities for improvement; participate in process improvement activities; implement requested changes.
8. Other duties as assigned.
General Activities
1. 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.
2. Participate in periodic evaluations related to service on the IRB and evaluation of the IRB Chairs and HRO meeting staff.
3. 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.
Additional Job Details (if applicable)
QUALIFICATIONS:
Medical Doctor (MD) and 2 years of relevant experience.
Extensive knowledge of federal, state, and local laws and regulations governing human subjects research.
Certified IRB Professional (CIP) certification desirable.
SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:
1. Ability to conduct meetings in an effective and efficient manner
2. Excellent oral and written communication skills
3. Excellent organizational skills with ability to prioritize work and adhere to timelines
4. Ability to assess institutional and federal criteria, apply to a variety of situations, and make decisions based on specified criteria
5. 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.
6. Ability to problem solve and successfully negotiate and collaborate with others of different skill sets, backgrounds and levels within and external to the organization
7. Self-motivated, independent and possesses the ability to learn quickly
Please note, this position can be a 0.75 - 1.0 FTE.
Remote
399 Revolution Drive