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Describe how the Investigator has the resources necessary to protect participants before conducting the research study

Robert Hood

08/07/2008 03:53 pm

Researcher Help: Describe how the Investigator has the resources necessary to protect participants before conducting the research study

Sufficient Resources

Information

General Considerations Investigators should describe how they have adequate resources to protect human participants, including:
  • Sufficient time to conduct, monitor, and complete research. One way to demonstrate the investigator has sufficient time would be to upload in to IRBWise an annual academic workload report as a supplemental document in IRBWise; another way would be a letter of support from a supervisor such as a department chair or bureau chief or health department director. Federal agencies are starting to audit researchers’ time accounting. For example, audits conducted by the National Science Foundation have determined that investigator’s time reporting for grants may add up to greater than 100% of their time. In a study of 1800 NIH grantees, Martinson found researchers used funds awarded for one project for other projects. (See Resources, below)
  • Sufficient time to document how partcipants in research are protected by completing an initial IRB application, all amendments, and continuing review applications, and reporting any problems requiring prompt reporting.
  • Adequate numbers of qualified staff (provide details in IRBWise Summary question G)

  • A process to ensure that all persons assisting with the research are adequately trained to understand their research-related duties and their obligations to protect human participants.(provide details in IRBWise Summary question H)
  • Adequate facilities for the research purposes of the protocol (provide details in IRBWise Summary question I)
  • Sufficient time to ensure that all persons assisting with the research are adequately informed about the protocol and their research-related duties and functions.(provide details in IRBWise summary question J)
  • Access to a population and resources that will allow recruitment of the necessary number of participants.
  • For research conducted at health departments, approval in advance from County Health Department Directors/Administrators uploaded as a study document in IRBWise (provide details in IRBWise Summary question K)
  • For research involving central office programs, approval in advance from the appropriate program director uploaded as a study document in IRBWise (provide details in IRBWise Summary question K)
Required Determinations by the IRB The IRB must determine the principal investigator and key study personnel have sufficient resources to conduct and complete the research. The IRB may consider whether an investigator’s research has expired previously when determining whether the researcher has adequate resources to protect participants.
Accreditation Element Element III.1.E: The Investigator determines that the resources necessary to protect participants are present before conducting the research study.
DOH Policy
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