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Project Team & Responsibilities

Project Team Members

People that are engaged in the research should be listed on the Project Team Form. Someone is considered to be engaged in the research if they are recruiting potential participants, consenting participants, collecting data or information from participants, analyzing identifiable data, or monitoring the progress of the research. Committee members, collaborators, and co-authors that are not engaged in these activities do not need to be listed as project team members. All project team members are expected to have HSR training (through CITI or NIH, see Training & Education page for more information) as well as submit an FCOI disclosure (see below). For researchers that have community partners engaged in the research project, especially international community partners, it is possible to develop a project specific human subjects research training in lieu of CITI. If this is needed for your project, you will need to develop the training and submit it along with the other study documents for IRB review and approval.

Principal Investigator on Student Research

Students are not allowed to be Principal Investigators (PIs) on research reviewed by the UNM IRB; the PI of Record will be a faculty mentor. The faculty member is the person responsible for overseeing the conduct of the research and is responsible to ensure that the project stays in compliance with federal regulation, state and local laws, and UNM policies. This includes submitting or ensuring submission of appropriate paperwork to the IRB for Continuing Review or Closure as well as appropriate handling of any complaints or concerns from participants and the IRB.

Financial Conflict of Interest Annual Disclosure

Financial Conflict of Interest (FCOI) Disclosures are annual disclosures (August through July) that all researchers (including faculty, staff, students, and non-UNM affiliated people) involved with UNM affiliated research must complete. Conflicts of interest may occur when an individual's research responsibilities compete with his or her private interests, such as financial interests, raising questions of objectivity and improper gain. Conflicts of interest are inevitable in modern research universities and do not imply any impropriety on the part of the researcher. A conflict of interest may exist despite the highest standards of conduct and candor. Most conflicts can be successfully resolved or managed without impeding research activities.

To make your FCOI disclosure, visit the Conflict of Interest website.

Researcher obligations after IRB approval

  1. Ensure that there are adequate resources to carry out the research safely. This includes, but is not limited to, sufficient time, oversight, equipment, and space;

  2. Monitor the ongoing conduct of the research and ensure compliance, including participating in post approval monitoring;

  3. Ensure that project team members are qualified and trained to perform procedures and duties assigned to them during the study and submit any changes to the project team for IRB review prior to having them perform research duties;

  4. Personally conduct or supervise the human research in accordance with the IRB approved protocol including ensuring informed consent or permission is appropriately obtained from participants;

  5. Not change the study protocol without prior IRB review and approval unless necessary to eliminate apparent immediate hazards to participants. The IRB will need to be notified of any changes implemented related to immediate hazards within 7 days;

  6. For non-exempt research, submit amendments, continuing review, protocol deviations, events, and closures to the IRB; and

  7. Submit an annual FCOI disclosure and an updated FCOI disclosure within 30 days of a “material change” (i.e. discovering or acquiring a new financial interest).

Note that researchers may not start human research activities or implement proposed changes until the IRB has granted approval.

Faculty Responsibility in Student Research

A faculty member assigning research projects involving human participants must take an active role in assuring that the participants of student research are adequately protected. The University expects that advisors will take an active part in preparing students for the role of researcher, instructing them in the ethical conduct of research, and assisting in the preparation of IRB applications. After IRB approval, the advisor should meet regularly with the student in order to review their work and progress. While a student serves as the primary researcher for the protocol, the faculty advisor is ultimately responsible for the protection of human participants. A faculty member’s signature on the application indicates their willingness to comply with all administrative and federal regulations (University Policy on the Involvement of Human Participants in Research). To comply with this policy, the faculty member who is acting as the Principal Investigator is required to educate and mentor the research team, and is also responsible for maintaining research records as required by law and University policy.