YALE UNIVERSITY
INSTITUTIONAL REVIEW BOARDS
Request to Submit a Research Protocol to WIRB
Complete this form to request Yale to cede review of the research protocol to WIRB. See below for the requirements that need to be
met for WIRB review to be considered. Submit this form with the study protocol and all research related documents. All fields must
contain a response. Hover your mouse over phrases in blue for further explanations.
1.
PI’s attestation that the protocol meets the following
eligibility criteria for possible WIRB review (all conditions
must be met):
Principal Investigator’s Name: Click here to enter text.
Contact Information: Click here to enter text.
1.
☐ A multi-site clinical trial
☐ Written and designed by the sponsor (without any
scientific contribution by Yale University faculty)
☐ Sponsored by a for-profit entity/company
☐ Does not involve planned emergency research, gene
transfer, embryonic stem cells, prisoners, or Phase I
trials in healthy controls
☐ Does not receive federal funding or funds from
another not-for-profit funding agency
☐ The principal investigator (PI) meets Yale University
requirements to serve as PI on a research project
☐ No PRC (or other committee) restrictions on approval
☐ The PI does not hold an IND
Correspondent’s Name: Click here to enter text.
Contact Information: Click here to enter text.
Yale Research staff (include names, roles, NetIDs): Click here to
2.
enter text.
3.
Sponsor Name Click here to enter text.
4.
Protocol Title Click here to enter text.
5.
Protocol date and version Click here to enter text.
6.
7.
Sponsor Billing address: Click here to enter text.
Number of Consent Forms Click here to enter text.
8.
Version and/or date of Consent Forms Click here to enter text.
9.
Will non-English speaking subjects be included?
10.
Who will be responsible for providing a translated consent form? Click here to enter text.
11.
Will a short form be used?
12.
Attach Investigator’s brochure if applicable Or check not applicable for non-drug study ☐ not applicable
13.
Date and version of investigator’s brochure Click here to enter text.
14.
For a device study, attach a device manual or instructions on how to use the device. ☐ not applicable
15.
Date and version of device manual Click here to enter text.
16.
Are there any investigational devices used or investigational procedures performed at YNHH, e.g., YNHH Operating Room or
YNHH Heart and Vascular Center? Yes
No
☐ Yes
☐ No
☐ Yes
☐ No
Must be attached and counted in the consent # question
If Yes, please be aware of the following requirements:
a.
A YNHH New Product/Trial Request Form must be completed;
b.
Your request must be reviewed and approved by a Hospital Committee before patients may be scheduled; and
c.
The notice of approval from YNHH must be submitted to the HIC for the protocol file.
21.
Number of Participant materials (questionnaires, surveys, diaries) Click here to enter text.
Or check not applicable ☐ not applicable
22.
Number of recruitment materials (ads, posters, flyers, TV or radio scripts) Or check not applicable ☐ not applicable
23.
Additional approvals required?
*YCCI-Scientific and Safety Committee (YCCI-SSC)
*YCC Protocol Review Committee (YRC-PRC)
Approval Date: Click here to enter text.
Approval Date: Click here to enter text.
*Dept. of Veterans Affairs, West Haven VA HSS
Radioactive Drug Research Committee (RDRC)
YNHH-Radiation Safety Committee (YNHH-RSC)
Magnetic Resonance Research Center PRC (MRRC-PRC)
YSM/YNHH Cancer Data Repository (CaDR)
24.
Does the study include Billable Services? ☐ Yes
Approval Date: Click here to enter text.
Approval Date: Click here to enter text.
Approval Date: Click here to enter text.
Approval Date: Click here to enter text.
Approval Date: Click here to enter text.
☐ No
A billable service is defined as any service rendered to a study subject that, if he/she was not on a study, would normally generate
a bill from either Yale-New Haven Hospital or Yale Medical Group to the patient or the patient’s insurer. The service may or may
not be performed by the research staff on your study, but may be provided by professionals within either Yale-New Haven
Hospital or Yale Medical Group (examples include x-rays, MRIs, CT scans, specimens sent to central labs, or specimens sent to
pathology). Notes: 1. There is no distinction made whether the service is paid for by the subject or their insurance (Standard of
Care) or by the study’s funding mechanism (Research Sponsored). 2. This generally includes new services or orders placed in EPIC
for research subjects.
If you answer “Yes”, this study will need to be set up in OnCore, Yale’s clinical research management system, for Epic to
appropriately route research related charges. Please contact oncore.support@yale.edu
25.
Other attachments (list each attachment) Click here to enter text.
Assurances
I am requesting review from WIRB for the above referenced study. I attest that the study will be carried out according to the policies
and standards of Yale University, Federal Regulations and guidance and local laws. I will report to the reviewing IRB and the HIC any
serious injuries and/or other unanticipated problems involving risk to participants according to HRPP policy 700.
I am responsible for delegation of authority to research staff and other investigators as applicable.
___________________________________
Signature of PI
_____________
Date
Department Chair’s Assurance Statement
Do you know of any real or apparent institutional conflict of interest (e.g., Yale ownership of a sponsoring company, patents,
licensure) associated with this research project?
Yes (provide a description of that interest in a separate letter addressed to the HIC.)
No
As Chair, do you have any real or apparent protocol-specific conflict of interest between yourself and the sponsor of the research
project, or its competitor or any interest in any intervention and/or method tested in the project that might compromise this research
project?
Yes (provide a description of that interest in a separate letter addressed to the HIC)
No
I assure the HIC that the principal investigator and all members of the research team are qualified by education, training, licensure
and/or experience to assume participation in the conduct of this research trial. I also assure that the principal investigator has
departmental support and sufficient resources to conduct this trial appropriately.
____________________________
Chair Name (PRINT) and Signature
_________________________________
Department
Date