If you are new to human subjects inquiry, the IRB process can be overwhelming. This checklist volition assistance you get started and keep you on rails for submitting an Initial Application to the IRB and what to exercise after blessing.

  • ​Are you a pupil? You will need a Faculty Advisor.
    Kinesthesia Advisors are responsible for monitoring all aspects of student enquiry; educatee research cannot be submitted without a Faculty Advisor.

  • ​​Do you take admission to eRA? If non, y'all may demand a POI number.
    All IRB-related documents are submitted through the Electronic Research Assistants Portal (eRA). If you practice non take a electric current employment relationship with CU Bedrock, you lot will need a POI in order to access eRA. If you accept a POI and still cannot access eRA, contact for assist.

  • ​​Complete DEPA.
    All faculty, and whatsoever other employee or student involved in the blueprint, conduct, and/or reporting of research, are required to submit a Disclosure of External Professional Activities (DEPA) Form to the Office of Conflicts of Interest & Commitment in social club to encounter University and federal conflicts of interest and commitment reporting requirements.

  • ​​Complete appropriate CITI training.
    All researchers involved with a protocol must consummate the advisable course for the inquiry: Social Behavioral Inquiry Investigators and Fundamental Personnel or Biomedical Research Investigators and Cardinal Personnel.

  • ​​Read the Investigator Transmission.
    The Investigator Transmission is designed to guide you through policies and procedures related to the conduct of human being inquiry. This manual will answer many common questions and volition be a valuable reference throughout the lifetime of your study.

  • ​​Develop study materials.
    The IRB needs to review and approve final versions of everything you need to behave research. This includes things that subjects will come across (or hear) such as the consent class, recruitment materials, and assessment tools; as well equally documents subjects will not run across, like the protocol document. The first pace in developing study materials for an Initial Awarding is to download blank templates from the IRB website.

  • ​​Submit materials in eRA.
    For footstep-by-step instructions on submitting materials to the eRA, meet eRA Submission Guides.

  • ​​Wait for IRB response.
    The IRB review process takes time and the showtime response yous receive from the IRB may not be an approval. Run into Review Timelines for information regarding how unlike review types are handled. A straightforward protocol that does non crave review by a convened board could take upwards to 40 business days for blessing. If the IRB requests boosted data, see the Response folio for your adjacent steps.

  • ​​Download approved documents from eRA.
    After yous have received an Blessing alphabetic character from the IRB, The IRB approved versions of report documents are the "official" copies and you are required to utilize these versions to acquit your research. This means you must download the approved versions to use.

  • ​​Begin research.
    After yous take downloaded the approved documents, you may begin your research as described in the approved protocol.

  • ​​Manage ongoing research.
    Through the course of your inquiry, you lot may find that changes are needed (which volition demand IRB approval) or after a year, you volition need to submit materials for continuing review. See beneath for a large-moving picture view of research that requires IRB review.

The Life of a Protocol

Protocol Lifecycle

one. Development

Review IRB Investigator Manual, consummate CITI training, and blueprint materials using IRB templates.

2. IRB Submission

Submit final version of all documents related to the report in eRA.

three. IRB Process

The submitted materials will be reviewed as Exempt or Expedited in the IRB Part, or referred to a convened lath for review. Resulting determination volition be Incomplete, Approved, Modifications Required, or Deferred.

4. Post Approval

Download approved documents from eRA and begin research. If changes to the research are needed, submit an amendment to the IRB. Report events when required.

five. Maintain Approval

IRB blessing expires after one year. In club for the research to continue, and IRB approval to be maintained, submit a continuing review annually.

6. Closeout

After all research-related procedures are complete and the data has been de-identified, close the study with the IRB by submitting a Concluding Report.