COMIRB CEDES TO AN OUTSIDE IRB - Instructions

Please note that at this time, COMIRB is handling ceding requests via E-mail rather than through the eRA(InfoEd) system.

For protocols where the PI is a faculty member of UCD-AMC or its affiliates, and wishes to use an outside IRB as the primary IRB of record, please complete the following steps:

1)The PI will contact the COMIRB Director (Meredith Mealer; ) by E-mail for permission to cede.

Attached to this request for permission should be:

a)e-mailing the COMIRB Application for Protocol Review (smart pdf, available on the COMIRB website). Please note the following when completing the Application for a ceding request:

  1. In section D, check “Secondary review” in Section D of the form; this will open only the sections needed for a ceding request
  2. In section G (lay summary) include both a brief description of the research as well as a description of what specific role(s) the UCD investigators will play in the study.
  3. In section G, also provide an explanation of where the research procedures will take place; often, only some of the procedures will take place at UCD (or affiliate institution), while the remainder occur elsewhere and carried out by outside researchers.

b)The study protocol, if available. COMIRB needs to understand

Withthe Director's permission to cede is given, the PI will be provided the “IRB Authorization Agreement(IAA) B – Ceding”form.

2)When the Director's permission to cede is given, the PI will be provided the “IRB Authorization Agreement (IAA) B – Ceding” form. The PI must fill in this form with information specific to the study and the IRB of record. Once complete, return the form back to Warren Capell, who will obtain the UCD-AMC signatory official’s signature. Once the UCD signature is obtained, the form will be returned to the PI to forward on to the institution whose IRB will serve as the IRB of record in order to obtain that institution's official's signature. The IAA must be signed by both UCD and the outside institution before COMIRB will approve your project to begin locally.

a)If you would like to preview this form, please note that COMIRB documents can be found on the COMIRB website at:

3)While awaiting the signatures on this form, submit one initial review packet to COMIRB which should contain the following (to be added to the COMIRB Applicationfor Protocol Review):

a)Letter of Approval from the outside IRB of record

b)Reviewer’s comments or feedback letter from initial review of the outside IRB of record, if available

c)Approved protocol

d)Stamped approved consent form(s)

e)Unstamped consent form, in Word format, to be used locally.

  1. If this consent form has built-in HIPAA language, and if identifiable health information will be disclosed from our institutions to a central site, please note that this language must be formatted to allow PHI to be used and disclosed by UCD (or affiliate hospital).
  2. If it is not possible to alter the consent form for local HIPAA language, a separate HIPAA B form formatted for use here at UCD (or affiliate institution) should be included (see [f] below)

f)HIPAA form (if applicable; see [e] above)

g)Any other documents approved by the outside IRB of record.

4)A protocol number will be assigned afterthe COMIRB Application for Protocol Reviewhas been received via E-mail.

5)Only local key personnel should be listed on the COMIRB Application form.Please ensure that all key personnel have completed the COMIRB required training (CITI Basic Course and HIPAA Research Course). The HIPAA Research Course is not required for investigators/personnel on the Downtown Denver Campus

6)Please ensure that all personnel listed on the COMIRB application have uploaded their CV into InfoEd, and have completed a required institutional conflict of interest disclosure.

7)The protocol will undergo an expedited secondary review. When the protocol has been approved, a COMIRB Certificate of Approval - External IRB Oversightwill be e-mailed to the PI.

8)No research activity may begin until the PI has received the COMIRB Certificate of Approval - External IRB Oversight.

9)The expiration date that is listed in InfoEd coincides with the expiration date provided by the outside IRB of record. The PI is not required to e-mail Continuing Review approvals from the outside IRB of record to COMIRB. Also, the PIis not required to e-mail amendment approvals from the outside IRB of record to COMIRB.

10)The PI must E-mail the COMIRB Director all unanticipated problems and non-compliance incidents that occur at the local site during the study (including any complaints) as well as to the outside IRB of record.

11)When the PI closes the protocol with the IRB of record, s/hemust forward COMIRB the closure notice.

CF-181

Instructions on ceding to an outside IRB

Effective 2-26-15