Roles & Responsibilities

The Institutional Official (IO) is the legally authorized individual who acts on behalf of the institution to obligate the institution to the Terms of the Assurance. The IO is responsible for ensuring the Human Research Protection Program (HRPP) IRB functions effectively and that necessary resources and support are provided to comply with all requirements for research involving human subjects. The IO represents the institution named in the Federalwide Assurance (FWA).

Responsibilities:

• Designate IRBs: Designate one or more Institutional Review Boards (IRBs) to review research covered by the institution's FWA.
• Resource Allocation: Provide sufficient resources, space, and staff to support the IRB's review and record-keeping duties.
• Training and Education: Ensure training and educational opportunities for IRB members and investigators.
• Promote Ethical Culture: "Set the tone" by promoting an institutional culture of respect and conscience, supporting the ethical conduct of human subjects research at the highest levels of the organization.
• Effective Communication: Ensure effective institution-wide communication and guidance on human subjects research.
• Investigator Responsibilities: Ensure that investigators fulfill their responsibilities.
• Encourage Participation in Education: Encourage all staff engaged in the conduct or oversight of human subject research to participate in educational activities.
• Point of Contact: Serve as a knowledgeable point of contact for the Office for Human Research Protections (OHRP) and other federal agencies, or delegate this responsibility to an appropriate individual.

Limitations: The IO cannot approve research that has been disapproved or has not yet been approved by the IRB.

The Director of Institutional Ethics & Compliance (DIEC) serves as the Director of the IRB/HRPP is responsible for the leadership and direction of day-to-day management and oversight of the institution’s IRB, ensuring alignment with the institution’s mission and compliance with regulatory requirements. This role ensures that all human research conducted under the institution's auspices complies with federal, state, and institutional regulations and policies.

Responsibilities:

Leadership and Management:

• Program Oversight: Oversee the daily operations of the HRPP and IRB to ensure compliance with regulatory requirements and institutional policies.
• IRB Membership: Appoint IRB members and suspend or terminate the membership of any individual who is not fulfilling their responsibilities and obligations.
• Evaluation: Perform periodic evaluations of the performance of IRB chairs, members, and administrative staff and provide this evaluation to the Chief Research Officer (CRO) and/or Provost. Evaluations will consider the following:
• Knowledge and application of regulations, ethical principles, and IRB policies/procedures.
• Completion of member training.
• Meeting attendance and participation.
• The quantity, quality, and timeliness of reviews completed.
• Recruitment: Recruit qualified members to include expert, non-scientific, and unaffiliated representation on the IRB.
• Strategic Planning: Engage in strategic planning for the IRB, including identifying goals, objectives, and metrics for program improvement and growth. 

Administrative Duties:

• Review Process: Oversee the IRB’s review process to ensure all submissions meet ethical and regulatory standards. Guide the IRB in making informed decisions regarding the approval, modification, or disapproval of research protocols based on ethical and regulatory criteria.
• IRB Meeting Development: Oversee the development of agendas and minutes for IRB meetings. Coordination of IRB meetings, distribution of materials, and documentation of meeting minutes.
• Meeting Facilitation: Preside over IRB meetings, ensuring they are conducted efficiently, fairly, and in accordance with institutional policies and regulatory requirements.
• Policy Development: Develop, implement, and update IRB policies and procedures to ensure compliance with applicable laws, regulations, and ethical standards.
• Memoranda and Agreements: Review and sign memoranda of understanding and cooperative agreements between the institution and other organizations, including those that establish reliance on IRBs of record for collaborative research (e.g., IRB Authorization Agreements, Individual Investigator Agreements).
• Training Resource: Provide training resources for IRB members, investigators, and research staff to promote understanding and adherence to regulatory and ethical requirements. Ensure ongoing training opportunities are available for researchers to remain current on regulatory changes and best practices.

Compliance and Monitoring:

• Regulatory Compliance: Ensure the institution’s compliance with federal regulations, state laws, and institutional policies regarding human subjects research.
• Quality Assurance: Develop and oversee quality assurance and quality improvement programs to monitor and improve HRPP operations and outcomes.
• Audits and Inspections: Prepare for and respond to audits and inspections by regulatory agencies, ensuring that any findings are addressed promptly and effectively.

Communication and Collaboration:

• Point of Contact: Serve as the primary point of contact for correspondence addressing human subjects research with the Office for Human Research Protections (OHRP), Food and Drug Administration (FDA), and other agencies as applicable. Serve as the primary liaison with external regulatory agencies, sponsors, and other relevant organizations regarding human research protections.
• Internal Communication: Facilitate communication between the IRB, investigators, and other institutional offices to ensure coordinated and compliant research activities.
• Stakeholder Engagement: Engage with stakeholders across the institution to address and resolve issues related to noncompliance, unanticipated problems, and other challenges that arise in the conduct of human research and to promote a culture of ethical research and continuous improvement in human research protections.

Limitations: The DIEC cannot approve research that has been disapproved of by the IRB.

The IRB Chair and Vice Chairs are appointed by the DIEC after consultation with the IO. The Chairs are selected from tenured faculty who have prior service on the IRB and have demonstrated sufficient experience and expertise to be suitable for the position. The IRB Chair is responsible for leading the IRB in its mission to protect the rights and welfare of human research subjects. The Chair oversees the IRB's review process, ensuring all research protocols meet ethical and regulatory standards.

Responsibilities:

Leadership and Oversight:

• Agenda Setting: Collaborate with the DIEC to set meeting agendas, prioritizing protocol reviews and other IRB business.
• Meeting Facilitation: Preside over IRB meetings, ensuring they are conducted efficiently, fairly, and in accordance with institutional policies and regulatory requirements.
• Decision-Making: Guide the IRB in making informed decisions regarding the approval, modification, or disapproval of research protocols based on ethical and regulatory criteria.
• Problem-Solving: Address and resolve issues related to noncompliance, unanticipated problems, and other challenges that arise during the conduct of research.
• Suspension or Termination of Research: Suspend or terminate the approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects.
• Policy Development: Contribute to the development and revision of IRB policies and procedures, incorporating feedback from IRB members and other stakeholders. Ensure that IRB policies and procedures are consistently applied and updated as needed to reflect regulatory changes and best practices.

Protocol Review:

• Regulatory Review: Conduct regulatory review for all research protocols, conduct or delegate the review of research that qualifies for expedited or exempted review, and ensure a timely and thorough evaluation.
• Non-Engaged in Research Review: Assess research activities to determine if they qualify as non-engaged in research, and ensure appropriate categorization and compliance with regulatory guidelines.
• Conflict of Interest Management: Identify and manage potential conflicts of interest within the IRB, ensuring unbiased review and decision-making.
• Initial Review: Lead the review of new research proposals, ensuring they meet all ethical and regulatory standards before approval.
• Continuing Review: Oversee the ongoing review of approved research to ensure continued compliance with IRB requirements and human subjects protections.
• Documentation: Ensure IRB review decisions, meeting minutes, and other documentation are accurate, complete, and maintained in accordance with institutional policies and regulatory requirements.

Education and Training:

• Regulatory Knowledge: Maintain current knowledge of federal, state, and institutional regulations governing human subjects research.
• IRB Member Training: Provide orientation and ongoing training for IRB members to ensure they are knowledgeable about their roles and responsibilities.
• Investigator Guidance: Offer guidance to researchers on ethical and regulatory issues related to their protocols, fostering a culture of compliance and ethical conduct.

Communication and Collaboration:

• Institutional Liaison: Serve as a liaison between the IRB, researchers, and institutional leadership, facilitating communication and addressing any concerns or issues.
• External Engagement: Represent the IRB in interactions with external regulatory agencies, sponsors, and other stakeholders as needed.
• Reporting: Report IRB activities and findings to the IO and other relevant institutional leaders.

The IRB Members are appointed by the DIEC after consultation with the IO. IRB members are responsible for evaluating research study proposals and informed consent documents to ensure they meet regulatory criteria, ethical standards, and institutional policies. They attend IRB meetings, actively participate in discussions, and vote on protocol approvals, modifications, or disapprovals. IRB members also contribute to policy improvements, report compliance issues, participate in ongoing education, manage conflicts of interest, and maintain diversity within the IRB to support comprehensive review perspectives.

IRB Membership Composition, Qualifications, and Diversity:

• The IRB must consist of at least five members with diverse backgrounds to review research activities effectively with at least one member with a scientific focus and one with a nonscientific focus, plus at least one member unaffiliated with UMassD and not a family member of an UMassD affiliate.
• The IRB is composed of 9 members: 4 selected by the Faculty Senate and 5 selected by the DIEC (as designated by the IO), one which must not be affiliated with the UMass
• Members should have knowledge of institutional commitments, regulations, applicable laws, and professional standards, and may include representatives from administration.
• The IRB's composition must reflect diversity in race, gender, cultural backgrounds, and sensitivity to community attitudes to uphold the rights and welfare of human subjects.
• For research involving vulnerable subjects, the IRB may include members or consultants with relevant experience.
• The IRB adheres to equal opportunity principles and does not discriminate based on race, color, religion, sex, pregnancy, disability, national origin, citizenship status, ancestry, age, genetic information, marital status, sexual orientation, gender identity, gender expression, arrest record, military status, or military discharge status.
• Each member is to have a 3‐year term which may be renewable. The terms are to be staggered so that no more than three (3) terms terminate concurrently.

Responsibilities:

• Disclose and manage conflicts of interest appropriately, including recusal from discussions and voting when conflicts arise.
• Evaluate research study proposals and informed consent documents for compliance with regulatory criteria, ethical standards, and institutional policies. Assess the level of risk involved in proposed research activities (minimal or greater than minimal). Participate in decisions regarding the frequency of continuing reviews for greater than minimal risk studies.
• Complete at least 70% of assigned protocol reviews, including initial reviews, continuing reviews, modifications, reports of unanticipated problems, and closure requests.
• Attend at least 70% of IRB meetings, actively participating in discussions and voting on protocol approvals, modifications, or disapprovals.
• Participate in initial and ongoing education sessions to stay informed about institutional policies, regulatory updates, and ethical standards pertinent to human subjects research.
• Recommend improvements to IRB policies and procedures to enhance human subject protections and streamline the research review process.
• Promptly report instances of noncompliance or ethical concerns related to human subject research to the IRB Chair and DIEC.
• Maintain confidentiality and adhere to legal and ethical principles during all IRB activities and deliberations.

The Meeting Chair role is held by the IRB Chair, Vice Chair, or any member assigned the role of Meeting Chair by the IRB Chair to serve in the absence of the IRB Chairs. At an IRB meeting, the Meeting Chair is responsible for oversight of meeting conduct at the IRB meeting and is expected to:    

• Lead the IRB meeting.
• Facilitate IRB review.
• Ensure this SOP is followed.
• Monitor the IRB's decisions for consistency.
• Vote as an IRB member.
  • Help IRB members meet their member expectations and responsibility.
  • Encourage IRB members to:
    • Ask questions.
    • Speak their minds at every protocol review
    • Share information that has not been discussed.
    • Listen and learn from the group.
    • Respect dissenting opinions.
    • Think, participate, and vote independently.
  • Mentor and guide IRB members to use the criteria for approval by:
    • Facilitating members’ understanding of the research to apply the criteria for approval.
    • Having members base concerns and recommended changes on the criteria for approval.
    • Framing difficult or controverted issues in terms of the criterion that is the basis of the controversy.
    • Taking votes on the criterion for approval that is the basis for a controversy, if after sufficient discussion a controverted issue remains unresolved. Reminding members who believe that one or more criteria for approval voted are not met that they should not vote for approval.
    • Removing issues from consideration when members determine they do not affect the criteria for approval.
    • Supporting and rewarding dissent based on the criteria for approval.
    • Obtaining assistance from DIEC when members are uncertain whether an issue affects the criteria for approval.
  • Ensure that IRB members can actively and equally participate in all discussions. Encourage member engagement by:
    • Reinforcing member expectations.
    • Encouraging members to use their unique perspective to contribute to deliberations.
    • Providing recognition and praise to members.
    • Encouraging members to develop their review skills.
    • Ensuring opinions of members count.
  • Ensure members know the definition of and self-identify their Conflicting Interests. If there are individuals (either members or consultants) with a Conflicting Interest related to an agenda item, neither should not participate in the review (including discussion or voting), except to provide information requested by the IRB. Conflicted members may be present for discussion and to answer questions will be asked to recuse themselves from the vote. If a committee member is unaware of any conflict of interest or potential conflict of interest at the time they sit in a meeting, and later discovers the Conflict of Interest, the member should inform the Meeting Chair and DIEC immediately. If a committee member is in any doubt about whether or not they are in a potential conflict situation, they must state this to the committee members at the commencement of the meeting. Faculty members residing in the same Department are allowed to review protocols and registrations coming from the same Department as long as the Committee member does not have a personal interest or stake in the research being proposed.
  • If the study is eligible for Non-Convened Review, the Meeting Chair can make a motion for members to vote on taking no action and have the item reviewed via Non-Convened Review.

PI Eligibility: To be eligible to serve as a principal investigator, an individual must hold one of the following titles: professor, associate professor, assistant professor, or research professor. Other full-time benefited individuals holding titles other than professor, associate professor, assistant professor, and research professor must obtain approval from the Chief Research Officer (CRO) or his/her designee to submit an IRB protocol. Students may serve as a Co-PI if they have a faculty sponsor.

Responsibilities:

• To not commence research until the IRB approval letter and all other required approvals have been obtained, such as radiation safety approval, biosafety approval, and approvals of departments or divisions that require approval of the use of their resources. If there are any questions about whether you are conducting research involving human subjects, contact the IRB before commencing the study. Ensure any human subjects work conducted has an IRB approval, where required, and that such approval remains valid while human subjects work is conducted. Note, that failure to comply with this condition on funded work can result in suspension and/or termination of any associated award. 
• Comply with all requirements and determinations of the IRB. Conduct the research in accordance with the relevant current protocol approved by the IRB.
• Ensure there are adequate resources to carry out the research safely. This includes, but is not limited to, sufficient investigator time, appropriately qualified research team members, equipment, and space.
• Ensure that research staff are qualified (e.g., including but not limited to appropriate training, education, expertise, credentials, protocol requirements, and, when relevant, privileges) to perform procedures and duties assigned to them during the study.
• Personally conduct or supervise the research.
• Protect the rights, safety, and welfare of subjects involved in the research.
• Submit proposed modifications to the IRB before their implementation. Do not make modifications to the research without prior IRB review and approval unless necessary to eliminate apparent immediate hazards to subjects.
• Submit continuing reviews when requested by the IRB.
• Submit a closure form to close research (end the IRB’s oversight) when:
  • The protocol is permanently closed to enrollment
  • All subjects have completed all protocol-related interventions and interactions
  • No additional identifiable private information about the subjects is being obtained.
  • Your analysis of private identifiable information is completed.
• If research approval expires, stop all research activities and immediately contact the IRB.
• Do not accept or provide payments in exchange for referrals of potential subjects (“finder’s fees.”)
• Do not accept payments designed to accelerate recruitment tied to the rate or timing of enrollment (“bonus payments”) without prior IRB approval.
• For studies regulated by a federal department or agency, follow any additional obligations, as applicable.

Faculty Sponsor Eligibility: Generally, only those who have a full-time academic appointment with the titles of professor, associate professor, assistant professor, or research professor may serve as Faculty Sponsors.  However, there may be circumstances when individuals who do not have an academic appointment or full-time status may be the best person to oversee a student’s research.  In such cases, a Faculty Sponsor Approval must be obtained from the CRO and included with the student's IRB application. Any studies deemed greater than minimal risk will require a full-time academic appointment at UMassD.

A faculty sponsor is required for all student investigators conducting human subjects research. Faculty sponsors guide student investigators through each phase of the IRB process and therefore, must be familiar with research methods specific to their field and stay informed about the rules and regulations governing research at UMassD. The faculty sponsor should be the primary resource for student investigators with questions or needing assistance with their projects. Faculty sponsors play a crucial role in ensuring the ethical and regulatory compliance of student research projects. The faculty sponsor must approve the student's application before IRB submission and serve as the primary contact for any concerns or questions related to human subjects in the research. Their guidance helps maintain the integrity of the research process and safeguards the rights and welfare of research participants. The IRB offers office hours and appointments to both students and faculty sponsors to facilitate this process.

Responsibilities:

Verification:

• Confirm the student investigator has sufficient knowledge and experience to conduct the proposed research.
• Verify the scientific merit and appropriate study design for the relevant field.
• Ensure the project meets criteria for degree satisfaction.
• Confirm adherence to field-specific codes of conduct.
• Ensure completion of required online human subjects protection training (CITI) and any other relevant protocol-specific research-related training.
• Ensure the proposed research is not initiated (including advertisement/recruitment) until final written approval from the IRB has been obtained.

Ongoing Supervision:

• Supervise the submission and conduct of the study, advising the student on clarifications/changes requested by the IRB.
• Monitor the progress of the project to ensure continued adherence to the protocol and regulatory requirements.
• Ensure timely submission of reports on unanticipated problems, issues of noncompliance, and use of approved documents/tools.
• Avoid over-enrollment of subjects.

Staying Informed:

• Keep abreast of the policies and procedures of the IRB.
• Stay updated on the published guidelines for the ethical conduct of research relevant to the field of inquiry, as well as state and federal regulations.
• Provide the student with guidance on the protection of human subjects as necessary.

Student investigators play a crucial role in upholding ethical standards and regulatory compliance throughout the research process, thereby contributing to the integrity and validity of the study outcomes. Student investigators are able to serve as Co-PIs, under the direction of a Faculty Sponsor.

 Responsibilities:

• Ensuring that research activities do not commence until receiving final approval from the IRB.
• Taking charge of the overall design and execution of the study, ensuring adherence to the IRB-approved protocol throughout the research period.
• Maintaining regular communication with the Faculty Sponsor and the IRB to address any questions regarding the IRB submission process or the conduct of the research.
• Overseeing the research team to ensure that all members have reviewed and understood the protocol and are adequately trained in the relevant study procedures.
• Safeguarding the rights and welfare of human subjects by obtaining informed consent, ensuring privacy during interactions, and maintaining confidentiality of data as specified in the approved protocol.
• Submitting modifications and awaiting IRB approval before implementing any changes to the study protocol.
• Promptly reporting any unanticipated problems or instances of noncompliance identified by the study team members to the IRB using the designated Report Form.
• Consulting with the Faculty Sponsor to identify and implement protocol modifications necessitated by unexpected events or circumstances.

The IRB holds all study personnel responsible for meeting certain obligations.  All study personnel are required to:

• Fulfill the training requirement for the protection of human participants in research (CITI online training modules, www.citiprogram.org), and understand the ethical standards and regulatory requirements governing research activities with human participants,
• Comply with applicable IRB policies and procedures and federal regulations regarding human subjects research,
• Document contact with participants, e.g., obtaining informed consent or informing participants of changes that may affect their willingness to continue participating,
• Ensure a thorough explanation of the study in lay terms to the participant during the consent process.
• Provide the participant with an opportunity to ask questions and have them answered when obtaining informed consent and throughout their participation.
• Understand the appropriate use of an investigational intervention (treatment, drug, or device) as described in the protocol, investigator brochures, product information/drug labeling, and various other available sources such as newsletters, safety alerts, or communications from sponsors, if applicable.
• Be familiar with and follow the adverse event and protocol deviation reporting requirements.