Main Content

Checklists

The IRB ensures that appropriate safeguards exist to protect the rights and welfare of research subjects [45 CFR 46.111]. In fulfilling these responsibilities, the IRB reviews all the research documents and activities that bear directly on the rights and welfare of the subjects of proposed research. The application or protocol, the consent/assent document(s), research equipment form, tests, surveys, questionnaires and similar measures, and recruitment documents are examples of documents that the IRB reviews. Before any human subject is involved in research in relationship to this institution, the IRB will give proper consideration to:

  1. The risks to the subjects;
  2. The anticipated benefits to the subjects and others;
  3. The importance of the knowledge that may reasonably be expected to result; and
  4. The informed consent process to be employed.

The IRB has the authority to approve, require modifications to secure approval, and disapprove all research activities overseen and conducted by the organizations. The IRB has the authority to suspend, place restrictions, or terminate approval of research activities that fall within its jurisdiction that are not being conducted in accordance with IRB requirements or that have been associated with serious harm to subjects. The IRB has the authority to observe or have a third party observe the consent process and/or the research if the IRB determines it to be indicated.The OPRS has developed several checklists that are used during the pre-review and review of submissions.

Checklists

  • Investigators

    This checklist will provide guidance for investigators new to the IRB process and will help them determine if they need to submit their research for IRB review. 

  • Reviewers

    This checklist assists OPRS and the IRB in their reviews of compensation in human subject research. The checklist is a guide and need not be completed or retained.

  • Investigators

    Effective January 17, 2017, OPRS will implement procedures for granting IRB approval, for eligible protocols, for an extended period of three years. This checklist assists OPRS and the research team to determine whether or not a protocol is eligibel for the extended approval period.

  • Investigators & Reviewers

    This checklist provides both the investigator and the reviewer all the key points that should be provided by the RPI when seeking informed consent.

  • Investigators

    The Exempt Categories document lists the explanations for the 6 categories of exemption.

  • Reviewers

    This checklist provides reviewers with the key points that should be covered by an RPI if they are applying for an exemption. By completing this checklist, reviewers will be able to determine if RPIs have provided all information required to obtain an exemption.

  • Investigators

    The Expedited Categories document lists the 9 categories of Expedited/Full Board review. 

  • Reviewers

    This checklist provides reviewers with all the items and sections that should be completed from the to-do list before approving an RPI and his/her new protocol. 

  • Reviewers

    This checklist provides reviewers with all the items and information that should be covered by the RPI before approving the RPI’s research protocol involving children as research subjects.

  • Reviewers

    This checklist provides reviewers with all items and sections about the information provided by the RPI that should be completed before approving them and their research protocol involving pregnant women, human fetuses or neonates as research subjects.

  • Reviewers

    This checklist provides reviewers with all items and information that should be covered by the RPI before approving the RPI’s research protocol regarding prisoners as human subjects.

  • Investigators & Reviewers

    Checklist to assist OPRS and the IRB in their reviews of human subject research. The checklist is a guide and need not be completed or retained.