Training

This section outlines the process for submitting and handling complaints related to IRB activities. It ensures that complaints are managed fairly and consistent with institutional policies and regulatory requirements. All complaints and related proceedings will be handled with strict confidentiality to protect the privacy of the individuals involved. Concerns or recommendations regarding the human research protection program, including the IRB review process, should be directed to the IRB email address: IRB.research@umassd.edu.

1. Filing a Complaint: To file a complaint, individuals should provide a detailed description of the issue, including:

• The name of the study and Principal Investigator (PI).
• A clear account of the complaint, including specific deviations from approved protocols or IRB policies.
• Any relevant documents supporting the complaint.

2. Review and Evaluation: Upon receipt of a complaint, the IRB will:

• Acknowledge receipt of the complaint within [specific time frame, e.g., 5 business days].
• Review the complaint to assess the validity and relevance.
• Gather additional information if necessary to understand the context and impact of the complaint.

3. Resolution: The IRB will determine appropriate actions based on the complaint review, which may include:

• Discussing the issue with the PI and/or relevant parties.
• Requesting corrective actions or modifications to the research protocol.
• Implementing additional monitoring or oversight measures.
• If the complaint involves serious violations/concern or remains unresolved at the IRB level, it will be escalated to the Institutional Official (IO) for further review and action.

5. Follow-Up: The IRB will document all complaints and actions taken. The complainant will be informed of the resolution and any actions implemented.

IRB Chairs:

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.

Principal Investigator (PI):

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 (described below).

Responsibilities:

• To not commence research until 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, 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 prior to 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.

Student Investigators:

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.