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Research Investigator Responsibilities

The  IRB holds the PI responsible for the overall management of an approved  study.  Management of the study  encompasses the ethical, technical, administrative, and fiscal elements of a project.  The PI may delegate certain tasks, but retains ultimate responsibility and accountability.  Principal investigators are required to:

Acknowledge and accept their responsibility for protecting the rights and welfare of human research participants, including the equitable selection of research participants, ensuring that risks to participants are minimized, and that the risks are reasonable in relation to anticipated benefits,

Fulfill the training requirement for the protection of human participants in research (CITI on-line training modules, www.citiprogram.org), and to understand the ethical standards and regulatory requirements governing research activities with human participants,

Supervise all study personnel and ensure that all personnel abide by the ethical principals of respect for persons, beneficence and justice, as outlined in the Belmont Report,

Ensure that all study personnel are knowledgeable of, and conduct the study in accordance with the approved protocol (including approved amendments),

Ensure that all research activities have IRB approval and other approvals required by the institution before human participants are involved, and implement the research activity as it was approved by the IRB,

Report any real or potential conflicts of interests of the PI or any study personnel in compliance with conflict of interest policies and management plans,

Obtain informed consent from participants before participants are involved in the research, and document consent as approved by the IRB.  A copy of the IRB-approved informed consent document must be used.  Participants must be provided with a copy of the form after it has been signed, unless the IRB has specifically waived this requirement.  Documented evidence of informed consent of the participants or their legally authorized representative is to be retained in a manner approved by the IRB.  The consent process involves two required elements: 1) a discussion of the study by the person obtaining consent and the participants, and 2) an opportunity for participants to read the consent form.  Please note that it is never appropriate to forgo the discussion, even if participants will then read the consent form.  Participants must be given the opportunity to have the consent form read to them if they have difficulty reading,

Maintain written records of IRB reviews, decisions, research records and informed consent documents,

Obtain IRB approval for and notify the sponsor (if applicable) of any proposed change to the research protocol prior to its implementation, except when necessary to eliminate apparent immediate hazards to the participants,

Obtain re-approval by reporting progress of approved research to the IRB, in the manner prescribed by the IRB, but not less than once per year,

Promptly report to the IRB any adverse events, protocol deviations or other unanticipated problems involving risks to participants or others.  PIs should not undertake any action with an external funding agency regarding an unanticipated problem or noncompliance without first contacting the IRB Chair, the AVPR or the ADRC in order to determine the correct course of action,

Verify that IRB approval has been obtained from all participating institutions in collaborative activities with other institutions, and that continuing review by other institutions is maintained,

Ensure the confidentiality and security of all information obtained from and about human participants, and the privacy of participants is maintained,

Use the most current version of IRB forms and document templates, which can be downloaded from the IRB website (http://www.irb.uconn.edu/forms.html),

Oversee the budget and expenditures related to the study to ensure that adequate resources are available, including staff, equipment supplies, storage space etc., to conduct the study at the University and any other performance site for which the PI is responsible,

Ensure charges assessed to insurance carriers are for procedures for illness or injury directly resulting from the research procedures of the study, if applicable,

Provide the IRB with audit or inspection reports or findings issued by regulatory agencies, cooperative research groups, contract research organizations, the sponsor or the funding agency,

Communicate, when applicable, the investigator’s plans to meet with representatives of the community from which individuals will be recruited, about community concerns, values and expectations,

Maintain, when applicable, accurate records on the receipt, use and disposition of excess drugs/devices,

Conduct the study in compliance with internal policies and regulations including 45 CFR 46 and 21 CFR 50 – Protection of Human Participants, 21 CFR 312 – Investigational New Drug Application and 21 CFR 812 – Investigational Device Exemptions; with Good Clinical Practices and, when applicable, 21 CFR 210 – Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs and 21 CFR 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals.

Responsibilities of All Key Personnel

The IRB holds all study  personnel (including PI and co-investigators) responsible for meeting certain  obligations.  Study personnel are  required to:

Fulfill the training requirement for the protection of human participants in research (CITI on-line 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,

Document contact with participants, e.g., obtaining informed consent or informing participants of changes that may affect their willingness to continue participating,

  • Provide 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 (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.

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