Note: This checklist must be included in IRB Submission.

DUHS IRB Protocol Submission Checklist

Departmental or CRU Review

Version: 12/03/2007, 08/19/2008, 02/01/2016, 03/02/2016

PI: Check: New Review OR Renewal

Item Needed

/ New / RENEWal /

Notes

Required elements prior to submission for IRB review
Is the funding source cited?
If funding is Federal, AHA or March of Dimes, are the entire grant & budget attached?
Is the IRB application concordant with the grant application?
If funding is from private industry, is the sponsor’s protocol attached?
If funding is from private industry and involves an investigational drug/device, is the investigational brochure included?
Number of subjects in the study population.
Age of study population.
Are there exclusions in study population?
Are exclusions justified? / If not, why?
Data Use Agreement?
Potential subject identification & recruitment:
--Will a review preparatory to research occur? IF NOT,
--Is a waiver of HIPAA authorization for records review requested?
--How subjects will be identified?
--How subjects will be recruited?
--Is PHI to be collected justified?
Plan for protection of subject privacy?
Plan for protecting confidentiality of PHI &/or specimens?
Is a consent form attached?
--If not, is a waiver of consent request attached?
--If a waiver is requested, is it justified?
If a consent form is attached, are the specific requirements for valid authorization listed below included in the document:
--The information
--Who may use or disclose the information
--Who may receive the information
--Purpose of the use or disclosure
--Expiration date or event
--Individual's signature and date
--Right to revoke authorization
--Right to refuse to sign authorization
--Re-disclosures not protected
Are the following additional consent form requirements included:
--Is sponsor paying DUHS to perform this research?
--Does the research include providing medical care?
--If treatment is involved, must the unused drug be returned?
--If treatment is involved and the subject is withdrawn, will the
subject be asked to return for a trial checkup?
--If no treatment is involved, will the subject be asked to complete
closeout tests?
--If tissue/blood/RNA/DNA stored, are sample withdrawal options
described?
--If subjects are not Duke patients, will study data relevant to
healthcare be sent to the subject's physician?
--Is there 24-hour contact information to contact PI for questions/problems, complaints, concerns or suggestions?
--Is there a contact number to contact IRB for questions about research rights, to discuss problems, concerns, or suggestions, or to offer input?
Are copies of any questionnaires used in this study attached?
If a non-competitive renewal & funding is Federal :
Is the 2-page progress report from the grant renewal included?
If a renewal:Are annual & cumulative progress reports included with race/gender data?
Required elements prior to IRB Approval (all of these items can be obtained concurrently with IRB review).
Is investigational drug/device number included? If Yes, supplynumber/status. If No, why?
If an IDE, is the FDA class (A or B) documented? Documentation is needed from the sponsor or the FDA.
Minors / children in study population:
--If Yes, is the Pediatric Risk Form included?
Advertising included:
--If Yes, has the ad been approved by the department chair?
Have the following signatures been obtained as appropriate:
Co-PIs/Department Chair
Cancer Protocol Review Committee
Center for Living
Clinical Research Unit
Hypo/hyperbaric Unit
Radiation Safety Committee
Institutional Biosafety Committee
VA Hospital
Durham Regional Hospital
Duke Health Raleigh Hospital
Other Community Hospital Sites: (specify)
Pathology Department/Tissue Review

Reviewer’s Comments:

Investigator’s Response:

Recommended Consent Form Modifications: (If substantive changes are needed, e-mail the PI and IRB medical writer assigned to your department to work with the PI on needed changes.)
Departmental or CRU Reviewer: ______Date:______

Printed Name:______

Amount of time required to conduct review: ____ : ____ (HH:MM)