Principal Investigator

As a general condition for the approval of a research study, the IRB holds the principal investigator of the study responsible for ensuring that:

• Risks to research subjects are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose the subjects to risk; and, whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
• Risks to human research subjects are reasonable in relation to the anticipated benefits (if any) to the individual, and the importance of the knowledge that may be expected to result.
• Selection of human subjects and patients for research participation is equitable.
• Individuals are adequately informed of the risks and benefits of research participation and the procedures that will be involved in the research, and that informed consent will be obtained from each prospective human research subject, or his/her legally authorized representative, in accordance with, and to the extent required, by University policies and federal regulations.
• Informed consent of human research subjects will be obtained in advance of research participation and appropriately documented in accordance with, and to the extent required, by University policies and federal regulations; where appropriate, there is routine monitoring of the data collected to ensure the safety of human research subjects.
• The privacy of human research subjects is protected and the confidentiality of data is maintained.
• Appropriate additional safeguards are included in the study to protect the rights and welfare of human research subjects who are likely to be vulnerable to coercion or undue influence (e.g., children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons).

The IRB holds the principal investigator of an approved research study responsible for:

• Abstaining from enrolling any individual in a research study (i) until such study is approved in writing, by the IRB; (ii) during any period when the IRB or sponsor/principal investigator has suspended study activities; or (iii) following IRB or sponsor/principal investigator-directed termination of the study.
• Ensuring that all associates, colleagues, and other personnel assisting in the conduct of the research study are appropriately informed of (i) the study procedures; (ii) informed consent requirements; (iii) the potential adverse events associated with study participation and the steps to be taken to reduce potential risks; (iv) adverse event reporting requirements; and (v) data collection and record-keeping criteria.
• Conducting the study in strict accordance with the current IRB-approved research protocol except where a change may be necessary to eliminate an apparent immediate hazard to a given human research subject.
• Reporting promptly to the IRB any deviations from the currently approved research protocol.
• Requesting IRB approval of any proposed modification to the research protocol or informed consent documents prior to implementing such modifications.
• Obtaining prospectively and documenting informed consent in accordance with the current IRB-approved informed consent documents (i.e., unless the IRB has granted a waiver of the consent process) maintaining adequate, current, and accurate records of research data, outcomes, and adverse events to permit an ongoing assessment of the risk/benefit ratio of study participation;
  reporting promptly to the IRB (and, if applicable, the sponsor and FDA) any internal or external adverse event that is considered to be 1) unexpected; 2) serious and 3) possibly or definitely related to the study.
• Reporting promptly to the IRB any significant changes in the risk/benefit of study participation.
• Ensuring that, in the event a research subject experiences a significant adverse event, every reasonable effort is made to provide the subject with adequate care to correct or alleviate the consequences of the adverse event to the extent possible.
• Ensuring that human research subjects are kept fully informed of any new information that may affect their willingness to continue to participate in the research study.
• Ensuring that all listed investigators have the appropriate credentials to conduct the portion of the study.
• Maintaining adequate and accurate research subject records to reflect adherence to protocol specific requirements.