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The Human Subjects Research Review Process

All research studies involving human subjects must be reviewed by the IRB regardless of the funding source.

 

This process is designed to ensure that research protocols protect the rights and welfare of human subjects - for example, by minimizing risks, selecting subjects equitably, obtaining informed consent and ensuring privacy and confidentiality. IRB approval must precede initiation of any work involving human subjects.

 

Investigators seeking IRB approval of research must follow the CDPHE IRB Meeting and Protocol Submittal Schedule.

 

Investigators must submit to the IRB a completed IRB Summary of Proposed Research Form word document , a complete and final research protocol, and all associated documentation (fact sheets, consent forms, dialogue scripts, etc). IRB Summary Requirements Form must accompany all protocols submitted to the CDPHE IRB prior to all levels of review (exempt, expedited, or full board review). The IRB Summary Requirements Form may be submitted in advance of the full final protocol to provide the IRB an overview of the proposed research and may allow a preliminary determination of the required type of review.

 

At a minimum, all CDPHE or affiliated principal investigators, planning or engaging in research involving human subjects, must complete a human participant protections tutorial. Substitution of this requirement with equivalent or similar training should be discussed with the IRB chair.

 

The IRB may review research protocols through the expedited or full board review process. Protocols accepted for an expedited review may be reviewed by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review by the full IRB.

 

Protocols requiring a full board review will be assigned to a scheduled CDPHE IRB meeting. The principal investigator and/or designee(s) will attend this meeting to discuss the protocol with members of the board. The board will deliberate in private session following discussion with the investigators. The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its purview.

 

Once the IRB is satisfied that required modifications have been completed and all documentation has been submitted to the IRB in final form, the IRB will provide the principal investigator a Protection of Human Subjects, Assurance Identification/Certification/Declaration Form (as-fm310), which should be forwarded by the investigator to the funding agency if required.

 

Federal regulations require a that all IRB approved research, whether through the expedited or full board review process, receive continuing review no less than once within a 12-month period from the approval date shown on the Protection of Human Subjects Assurance Form (as-fm310). The frequency of review is dependent on the level of risk to the research subjects associated with the research protocol, which is determined by the IRB. An IRB Continuing Review Form word document should be completed and submitted to the IRB prior to the end of the 12-month review period.

 

If human subjects are harmed, including physical injury, improper disclosure of private information, economic loss or other harmful occurrences, the IRB must be notified.