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APPENDIX B 131 (10) When applicable, determination of significant/non-significant devices (for studies under the auspices of FDA investigational device regulations); and (11) Requirements for frequency of continuing review, if more often than annually. (B) The IRB files must include an IRB roster, members' qualifications, and organizational assurances including any relevant appendices, when appropriate. Documents should be archived for reference. Section 3âInvestigators and Other Research Personnel GENERAL COMMENTARY on Section 3: The roles and responsibilities of investigators are influenced by the nature of the environment in which they conduct research (e.g., academic center, private practice/community setting, etc.) and by the type of research in which they are engaged. However, in all circumstances, investigators are an essential element in the protection of individuals enrolled in their respective research studies. Therefore, these Standards should apply irrespective of the manner in which the HRPP is constituted. The presence of an intelligent, informed, conscientious, compassionate, and responsible investigator is the best possible protection for all involved in the research process. 3.1 The investigator should understand and apply the underlying ethical principles as delineated in The Belmont Report when designing, or when evaluating already designed studies, and when conducting human research. 3.2 Investigators must put the rights, welfare, and safety of each individual studied in their research ahead of their professional, academic, financial, personal, or other interests. COMMENTARY on Standard 3.2: The investigator's primary attention must be focused on the safety and welfare of the individuals who volunteer to participate and those included without their consent (e.g., use of preexisting data, etc.). Investigators must identify and avoid conflicts of interest that may interfere with the rights and welfare of research participants and the appropriate conduct of research. 3.3 Investigators must meet organizational requirements for conducting research with human subjects and comply with all applicable federal, state, and local regulations and guidelines dealing with the protection of individuals studied in research. COMMENTARY on Standard 3.3: Investigators are responsible for the overall design, development, conduct, and analysis of the investigation,
APPENDIX B 132 whether the investigator personally developed the protocol or if others prepared the protocol (e.g., as in a multicenter investigation). Investigators must have a collegial relationship with the IRB. Although many IRBs may have information manuals for investigators that cover the requirements, it is the investigator's responsibility to seek out and comply with those requirements even if the IRB does not overtly supply the supportive material. 3.4 Principal Investigators (PIs) must assure that all research involving human subjects is reviewed and approved by an IRB before study initiation and that it remains approved for the duration of the study. COMMENTARY on Standard 3.4: The IRB should be consulted when questions arise regarding whether a given research activity constitutes human research. The IRB should be accorded the authority within the organization to determine what constitutes human research, as the IRB has specific expertise in making such decisions. The PI should be cognizant of the types of research that may be exempt from IRB review, or which can be processed by expedited review. This determination usually requires consultation with the IRB. PIs must be familiar with the criteria for IRB review and approval indicated in Standard 2.7 and, at a minimum, be able to provide the IRB with this information as well as any continuing review information relevant to the research protocol. Appropriate and continuing oversight of a research protocol by the PI includes orderly retention of research records, appropriate level of review, compilation, assessment, and appropriate reporting of adverse events. The PI has the responsibility for the prompt reporting to the IRB and sponsor(s) and appropriate federal agencies of any injuries, adverse events, or other unanticipated problems involving risks to subjects and others. 3.5 Principal Investigators must delegate responsibility only to individuals who they determine are qualified through training and experience for their role in the research. COMMENTARY on Standard 3.5: The qualification of the PI to conduct the proposed research must be submitted to the IRB to provide adequate guidance for review. There should be a documented training and experience for the PI and PIs must assure that all research personnel involved in the protocol are qualified through training and experience to perform their role in the research. 3.6 Principal Investigators must conduct research in which individuals are studied only when supported by adequate resources including
