A. IRB Considerations The qualifications of the principal investigator are considered when reviewing proposals. The investigator's professional development is taken into account and related to the degree of protocol complexity and risk to human subjects. The IRB may require less experienced research investigators to be sponsored by seasoned researchers. Proposals that require skills beyond those held by the principal investigator are modified to meet the investigator's skills, have additional qualified personnel added or be disapproved.
Research investigators will prepare protocols giving complete descriptions of the proposed research. The research plan includes provisions for adequate protection of the rights and welfare of prospective subjects and ensures that pertinent laws and regulations are observed. Samples of informed consent documents are included with protocols. Research investigators are responsible for obtaining informed consent and ensuring that no human subject will be involved in the research prior to obtaining the consent.
The research plan addresses quality assurance standards set by CSU. In addition, applicable external standards for quality assurance are met. External standards are of particular concern for research conducted in clinical facilities. Appropriate reviews for scientific merit are conducted before the research is approved. Mechanisms for monitoring the progress of the research are in place.
Research investigators, through their research design, determine whether the proposed research involves human subjects. All research protocols involving human subjects must be submitted to the IRB for review. When it is not clear whether the research involves human subjects, investigators must seek assistance from the IRB in making this determination. The IRB then determines whether the research is exempted from IRB review under the applicable regulations and institutional policies, and whether full or expedited IRB review is appropriate.
Researchers are responsible for complying with all IRB decisions, conditions and requirements. Research investigators are responsible for reporting the progress of the research to the IRB and/or appropriate institutional officials as often as and in the manner prescribed by the IRB but no less than once per year. Current IRB policies reflect the following:
• Principal investigators - appropriate qualifications, experience and facilities to ensure that all aspects of the project and follow-up are conducted rigorously and with due regard for the safety and well-being of the subjects
• Comprehensive procedures through which the researchers monitor projects and report problems to the IRB
• Investigators' past records with regard to approved research