Principal Investigator Responsibilities
The ethical principles employed by IntegReview IRB that govern the conduct of human research are those identified in the Belmont Report; respect for persons, beneficence and justice. IntegReview IRB expects Principal Investigators to abide by these principles as well.
It is the responsibility of the Principal Investigator to:
- Follow federal, ICH Guidelines for GCP, as well as any applicable state and local laws governing research and the consent process.
- Provide any safety information to IntegReview throughout the course of the study and after study completion, which may help to provide additional protections for research participant’s safety and well-being.
- Ensure communication of results from a research study to participants when those results directly affect their safety or medical care.
- Respond to research participant’s complaints or requests for information in a timely manner.
- Ensure that research participants are provided adequate time with study personnel to address questions during the consent process.
- Ensure that the informed consent process is free from coercion or undue influence.
- Ensure that procedures are in place to guarantee that consent has been voluntarily obtained and properly documented.
- Establish an informed consent process and method of documentation appropriate to the type of research and the study population, concentrating on the importance of participant comprehension and voluntary participation.
- Ensure that additional safeguards are in place to protect any vulnerable populations involved in research.
- Ensure procedures are used to maintain the confidentiality of the research data.
- Ensure the privacy of research participants is protected.
- Understand the importance of the plan for monitoring data for the safety of participants, and comply with that plan.
- Notify IntegReview upon learning that a research participant has become incarcerated while participating in a research study. Also, all research interactions and involvement with, as well as obtaining identifiable private information about the incarcerated participant, must stop until the requirements of Title 21, CFR 45, Part 46, Subpart C have been fulfilled.
- Consider, disclose, and manage conflicts of interests that might affect the relationship with the research participant or the outcome of the research.
- Commit enough time and personnel to adequately conduct the study in a way that will protect the rights and welfare of research subjects and to have adequate space and appropriate equipment to conduct this research study.
- When an IND or IDE is required, per Title 21, CFR, §312.20(b), a clinical investigation, to include screening and recruitment, shall not begin until the investigation is subject to an IND which is in effect. Therefore, IntegReview will hold the informed consent document and recruitment materials, as applicable, until the IND number is received.Per Title 21, CFR, §812.42 – same as above applies for significant risk device studies and the requirement for the IDE to be effective.
- Although a subject is not obliged to give his or her reasons for withdrawing prematurely from the clinical trial, the investigator should make a reasonable effort to ascertain the reason, while fully respecting the subject’s rights.
- The investigator provides evidence of such qualifications through up-to-date curriculum vitae other relevant documentation requested by the sponsor, the IRB, or the regulatory authority.
- The investigator is familiar with the appropriate use of the investigational product(s), as described in the protocol, in the current Investigator’s Brochure, in the product information and in other information sources provided by the sponsor.
- If the sponsor terminates or suspends a clinical trial, the investigator informs the IRB.
- If the IRB terminates or suspends its approval of the clinical trial, the investigator should promptly notify the sponsor.
- Upon completion of the trial, the investigator informs the IRB with a summary of the trial’s outcome, and the regulatory authority with any report required.
- The investigator provides written reports to the IRB on any changes significantly affecting the conduct of the clinical trial or increasing the risk to subjects.
- The investigator maintains a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties.
- For reporting deaths, the investigator supplies the sponsor and the IRB with any additional requested information (e.g., autopsy reports and terminal medical reports).