Principal Investigator Responsibilities - IRB Independent Review Board Services

The ethical principles employed by IntegReview that govern the conduct of human research are those identified in the Belmont Report; respect for persons, beneficence and justice. IntegReview 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, one of the following must be provided to the IRB as documentation of the IND or IDE number:

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).

CANADA – Additional Responsibilities for Research Conducted in Canada:

All studies shall be registered before recruitment of the first participant in a recognized and easily web-accessible public registry. The Principal Investigator must provide the number assigned to the study upon registration to the REB.
Researchers shall consult with the REB when, during the conduct of the research, changes to the data collection procedures may present ethical implications and associated risks to the participants.
As with all alternative choices of a control, a placebo control is ethically acceptable in a randomized controlled clinical trial only if:

1. Its use is scientifically and methodologically sound in establishing the efficacy or safety of the test therapy or intervention; and
2. It does not compromise the safety or health of participants; and
3. The researcher articulates to the REB a compelling scientific justification for the use of the placebo control.

For clinical trials involving a placebo control, the researcher and the REB shall ensure the general principals of consent are respected and that participants or their authorized third parties are specifically informed (refer to TCPS2, Article 3.2):

1. About any therapy that will be withdrawn or withheld for purposes of the research; and
2. Of the anticipated consequences of withdrawing or withholding the therapy.

REBs and researchers should be conscious of the phenomenon of therapeutic misconception, and ensure that procedures for recruitment and consent emphasize which specific elements of a clinical trial are required for research purposes, as well as the differences between research and the standard clinical care patients might otherwise receive.
Researchers should promptly report new information that may affect the welfare or consent of participants to the REB, and to other appropriate regulatory or advisory bodies. When new information is relevant to participants’ welfare, researchers shall promptly inform all participants to whom the information applies (including former participants). Researchers shall work with their REB to determine which participants must be informed, and how the information should be conveyed.

You may obtain answers to questions, express concerns, and convey suggestions regarding IntegReview’s Human Research Protection Program (HRPP) via e-mail to Robert Orozco, Director of Compliance or by dialing (512) 326-3001, extension 207.

We welcome you to complete IntegReview’s Customer Survey to offer suggestions or to voice any concerns regarding our processes or services. Customer surveys that reflect concerns will be reviewed by IntegReview’s Management Team.