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1.9 Resources Necessary to Protect Subjects

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for resources that are necessary for human subject protection, care of research participants, and safety during the conduct of research.

2.0 Policy

  • 2.1.

    It is the policy of the Organization that

    during
      the
    • 2.1. conduct of research thereThere must be adequate resources to protect human subjects during the conduct of research.
    • 2.2. It is the policy of the Organization that theThe Principal Investigator is responsible for ensuring the necessary resources are available to protect the rights and welfare of human subjects.

    3.0 PI Responsibilities

    • 2.3.1. ItThe isPI must describe in the policyIRB ofapplication the Organizationresources that Departmental Chairperson/authorized delegate or appointed review committee of the Principal Investigator’s school, department or division must certify that the necessary resources are available to safely conduct andresearch completeat theeach study site specified in a manner which fully protects the rights and welfare of research subjects

    3.0 PI and Certifier Obligation

    • 3.1. The PI is required to sign an assurance (that is part of the IRB application)application. stating that there are adequate resources to protect the rights and welfare of subjects. TheseSuch resources include (but are not limited to):
      • 3.1.1. The PI hasand all investigators have the necessary qualifications, experience and credentials to conduct the research.
      • 3.1.2. There isare an adequate number of qualified, licensed and credentialed research personnel available and facilities/equipmentassigned to completeconduct the research.
      • 3.1.3. The PI has adequate time (in consideration of other academic or employment obligations, and other open research protocols in which he/shethey isare participating) to conduct and complete the research.
      • 3.1.4. The investigatorPI has, or will have, necessary the financial resources to conduct the research.
      • 3.1.5. There is adequate physical space, clinical resources (as appropriate), laboratory equipment,equipment (as appropriate), clerical and administrative support, data analysis and storage capability, and other resources necessary to complete the research.
      • 3.1.6. There is appropriate emergency equipment, personnel, or services necessary to respond promptly to adverse events or unanticipated problems involving risk to the subject or otherothers.
      • 3.1.7. InvestigatorsFor research protocols conducted solely by the Organization, investigators have ethical access to a sufficient number of potential subjects forto meet the purposesscientific aims of the research.
      • 3.1.8. ThereAs appropriate based on the nature of and potential risks associated with the research, there are adequate available medical or psychosocial resources in consideration of the nature of the research (for example, medical services, counseling, social support services),.
        • and
      • 3.1.9. As appropriate, there are adequate resources necessary to facilitate communication with individuals who do not speak English or who have otheradditional impairments.needs or vulnerabilities.
    • 3.2. The Departmental Chairperson/authorized delegate or appointed review committeeSubmission of the PI’sapplication school,by departmentthe PI constitutes an assurance that resources described in the application are, or divisionwill mustbe, alsoavailable certifyfor (asthe partexpected duration of the IRB application) that the resources described above, and any others necessary to fully protects the rights and welfare of research subjects, are available to the PI and research staff.protocol.
    • 3.3. The PI is required tomust notify the IRB if, during the course of the research, there are significant changes in the availability of researchers or if the necessary resources become unavailable.

    4.0 IRB Responsibilities

    • 4.1. In accordance with HRPP policy 2.5 (Criteria for IRB Approval) the IRB or expedited reviewer will review resources available as described in the IRB application at initial submission and at continuing review.
    • 4.2. Significant changes in availability of resources reported by the PI or research team will be reviewed by the IRB to determine if ethical and regulatory criteria for approval continue to be met, and if the research can continue to be safely conducted. If the necessary resources cannot be obtained and adequate protection of human subjects cannot be assured, the IRB may suspend or terminate the research, in accordance with HRPP policy 8.6 (Study Hold, Suspension, and Termination).

    4.0 IRB Review of Resources

    • 4.1. The IRB will review resources available as part of its review of the research at initial submission and at continuing review.

    DOCUMENT HISTORY:

     Written: 5/6/2016 (Approved: 5/6/2016) - original author not documented

     Revised: 9/27/2017 - revision not documented

     Revised: 3/3/2018 - revision not documented

     Revised 1/16/2025 – deleted requirement for certification by Departmental Chairperson/authorized delegate or appointed review committee that resources are available; added that PI or research team must report significant changes in the availability of resources (section 3.3); added that significant changes in availability of resources reported by the PI or research team will be reviewed by the IRB; stylistic changes. {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

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