PITT CEDE REQUEST

Instructions for Use: To be completed when a Pitt/UPMC investigator is submitting an initial request to rely on an IRB outside of UPitt for a multi-centered research study.

Please email nd include the following:

  • This completed form
  • A protocol summary or the human subjects section of the grant application
  • A copy of the Central IRB agreement the external site requestswe sign (if available)
  • A copy of the consent form template provided by the lead site (if available)

IF ANY OF THE MATERIALS LISTED ABOVE ARE INCOMPLETE OR NOT PROVIDED AT THE TIME THIS REQUEST IS SUBMITTED, THE REQUEST WILL BE RETURNED WITHOUT REVIEW UNTIL A COMPLETE SUBMISSION IS RECEIVED BY OUR OFFICE.

To ensure accuracy, answers to all questions listed in green on the form should be confirmed by IRB staff at the Relying Institution prior to submission. Typically this is most efficiently accomplished by having the Relying Site PI contact their IRB for assistance in completing the form.

Study Title:This is the verbatim title that will appear on the agreement for this project. To reduce confusion, please ensure all sites involved in this project are using the same title.
Pitt/UPMC Principal Investigator:
Name and Degree:
Department:
Email Address:
Contact Person for Pitt/UPMC research team:
Name: Email Address:
Department:
Role of Pitt PI and staff (check all that apply):
Recruitment Data analysis of identifiable data
Obtain consent Data analysis of de-identified data
Data collection Other-specify:
Will this study use a complete waiver of informed consent?
Yes No
Why is the request being made:
Condition of funding Pitt PI is not engaged in human subjects research
Pitt PI relocating Other-specify:
List Funding Source(s)
Federal Government-specify: Other-specify:
Which research office is processing your funding (the grant or subcontract)?
Only 1 can apply- The accuracy of this item is highly important. If you are unsure please contact your Department Grants Manager for clarification
Pitt Office of Research Magee Women’s Research Institute
At which local sites will research procedures be performed?Choose all that apply
Pitt UPMC (including Magee Women’s Hospital)
Children’s Hospital
Does the study involve any vulnerable populations? If yes, indicate all that apply below.
Pregnant Women Children
Fetuses Decisionally impaired
Neonates Prisoners
Does this study involve the use of a drug, device or surgical procedure? Yes No
Name of the Institution you are requesting to act as IRB of record:
Federal Wide Assurance (FWA) # of IRB you are requesting to rely on:
Does this institution have AAHRPP accreditation? Yes No
If no, has the site undergone OHRP self-assessment or another process of assessing standards?
Yes NoIf yes, please describe:
Is this institution a member of Smart IRB ()? Yes No
Is this institution a member of IRBchoice ()? Yes No
Provide the following information for the lead investigator at the institution that will act as IRB of record:
Name and Degree:
Email Address:
Provide the following information for the IRB representative at the institution you are requesting to act as IRB of record
Name:
Email address:
Telephone number:
Required information for grant Letter of Support (LOS): (The NIH grant application may require a LOS indicating we are willing to cede IRB oversight)
Name, title and institution of individual(s) the letter should be addressed to: (typically Lead PI or Lead PI & Co-Is):
Grant #:
Grant title:
Conflict of Interest – The following information is necessary to determine if the local study team has a COI for
this research studythat must be managed.
1)Is this study funded in part or whole by a PHS Agency? Yes No
PHS Agencies Include:
Agency for Healthcare Research & Quality (AHRQ) / Health Resources and Services Administration (HRSA)
Agency for Toxic Substances and Disease Registry (ATSDR) / Indian Health Service (IHS)
Centers for Disease Control & Prevention (CDC) / National Institutes of Health (NIH)
Food and Drug Administration (FDA) / Substance Abuse & Mental Health Services Admin (SAMHSA)
2)Does any investigator* involved in this study:
  • Have a financial interest (aggregated value of equity and remuneration** during the past or next twelve months) in a publicly-traded entity that either sponsors*** this research or owns the technology being evaluated or developed that exceeds $5,000 but not $10,000? Yes No
If yes, Name of individual(s) who has conflict:
  • Have a financial interest (aggregated value of equity and remuneration during the past or next twelve months) in a publicly-traded entity that either sponsors this research or owns the technology being evaluated or developed that exceeds $10,000? Yes No
If yes, Name of individual(s) who has conflict:
  • Receive remuneration (during the past or next twelve months) from a non-publicly traded entity that either sponsors this research or owns the technology being evaluated or developed that exceeds $5,000 but not $10,000? Yes No
If yes, Name of individual(s) who has conflict:
  • Receive remuneration (during the past or next twelve months) from a non-publicly traded entity that either sponsors this research or owns the technology being evaluated or developed that exceeds $10,000?
Yes No
If yes, Name of individual(s) who has conflict:
  • Have equity in a non-publicly traded entity that either sponsors this research or owns the technology being evaluated or developed? Yes No
If yes, Name of individual(s) who has conflict:
  • Receive reimbursement or sponsorship of travel expenses (for one trip or a series of trips during the past or next twelve months) by an outside entity that either sponsors this research or owns the technology being evaluated or developed that exceeds $5,000? Yes No
If yes, Name of individual(s) who has conflict:
  • Have rights as either the author or inventor of intellectual property being evaluated or developed in this research that is the subject of an issued patent or has been optioned or licensed to an entity? Yes No
If yes, Name of individual(s) who has conflict:
  • Have an officer or management position**** with a Licensed Start-up Company overseen by the COI Committee that either sponsors this research or owns the technology being evaluated or developed? Yes No
If yes, Name of individual(s) who has conflict:
  • Receive compensation of any amount when the value of the compensation would be affected by the outcome of this research, such as compensation that is explicitly greater for a favorable outcome than for an unfavorable outcome or compensation in the form of an equity interest in the entity that either sponsors this research or owns the technology being evaluated or developed? Yes No
If yes, Name of individual(s) who has conflict:
*Investigator means the PI, co-investigators, and any other member of the study team, regardless of title, who participates in the design, conduct, or reporting of this research, as well as his/her spouse, registered domestic partner, dependents, or other members of his/her household. The PI is responsible for ensuring that s/he and all other relevant members of the study team review the above questions describing Significant Financial Interests.
**such as salary, consulting fees, honoraria, or paid authorship
***through the provision of funds, drugs, devices, or other support for this research
****Such as serving on the Board of Directors or Board of Managers or a position that carries a fiduciary responsibility to the company (e.g., CEO, CFO, CTO, or CMO).
Education and Training
All local research staff have completed the education and training modules required for this research study.
Yes No
A summary of required training can be found at:

Attestation
I attest the above information is complete and accurate.
______
Principal Investigator’s signature Date

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Version 8_12.22.2017