- Policies & Procedures
Principal InvestigatorThe
Principal Investigator (PI) is ultimately responsible for assuring compliance with applicable University IRB policies and procedures, DHHS Federal Policy Regulations, and FDA regulations and for the oversight of the research study and the informed consent process. Although the PI may delegate tasks to members of his/her research team, s/he retains the ultimate responsibility for the conduct of the study. Who May Serve as a Principal InvestigatorBecause PI responsibilities involve
direct interaction and supervision of the research team, the PI must be a current employee or student of the University and/or UPMC who is operating within their University or UPMC role to oversee the conduct of the study. PIs leaving the institution are responsible for notifying the IRB well in advance of their departure so that they can make arrangements to either close the study or name another appropriately qualified individual currently at the institution to serve as the PI. The
following individuals may serve as PI(s): General Responsibilities of Principal InvestigatorsAs 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, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons).
Specific Responsibilities of Principal InvestigatorsThe IRB holds the
principal investigator of an approved research study responsible for: - Promptly responding to all requests for information or materials solicited by the IRB, including the timely submission of the research study for IRB renewal;
- Ensuring that adequate resources and facilities are available to carry out the proposed research study;
- 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) reportable new information 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 of deviations that meet the definitions outlined in Chapter 17 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 reportable new information 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 unexpected, 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 in which they are involved and have completed the applicable University required training
modules;
- Ensuring that conduct of the research study adheres to Good Clinical Practice guidelines, if applicable. If the study meets the NIH definition of a clinical trial, ensuring that all research investigators and coordinators have completed the Good Clinical Practices training required by the University IRB;
- Maintaining adequate and accurate research subject records to reflect adherence to protocol specific requirements.
- Complying with additional requirements for
federal agencies as outlined in Chapter 26.
Responsibilities of investigators are further detailed in the references outlined below. - DHHS: Office of Human Research Protections (OHRP): Investigator Responsiblities FAQs
- FDA: Statement of the
Investigator Form FDA 1572 FAQ [pdf]
- FDA: Guidance: Investigator Responsibilities - Protecting the Rights, Safety and Welfare of Study Subjects [pdf]
- FDA: 21 CFR 312, Subpart D: General
Responsibilities of Sponsors and Investigators: Drugs
- FDA: 21 CFR 812, Subpart E: Responsibilities of Investigators: Devices
Sub-Investigators and Research StaffAppropriately qualified sub-investigators and research staff may perform tasks as delegated by the Principal Investigator but they do not accept primary
responsibility for the research study. General Responsibilities of the Sub-Investigator and Research Staff- Completing required institutional and protocol specific training
- Adhering to the federal regulations, state and local laws, institutional policies and procedures surrounding the safety and protection of human participants
- Assuring participant privacy and confidentiality according to HIPAA guidelines, institutional regulations, and HRPO policies and
procedures.
Version 10.9.2015; revised 11.2.2018
Who is ultimately responsible for ensuring protocol integrity in clinical trials?
It is important to conduct research in an ethical manner. Investigators must be diligent throughout the conduct of a clinical trial: while designing the protocol, when deciding which trials to conduct, during the performance of the study, and after conclusion of the study (Fig 1).
Who develops a clinical trial protocol?
The actual writing of a protocol is a team effort with contributions from a medical expert, a statistician, a pharmacokinetics expert, the clinical research coordinator, and the project manager, who all provide input to the medical writer to produce the final document.
Who is responsible for trial monitoring?
Safety monitoring of a clinical trial is conducted by an independent physician with relevant expertise. This is accomplished by review of adverse event, immediately after they occur, with timely follow-up through resolution.
Who is responsible to prepare essential documents like protocol?
Investigator.. Ethics committee.. Scientist.. Sponsor..
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