Required Approval Process for All Non-Indemnified Clinical Trials


Non-Indemnification Policy Statement
The University has a program of self insurance to provide protection to its employed physicians who might have asserted against them claims of medical malpractice. This program is administered by the The Risk Management Committee (RMP).  With the exception of NCI/NIH/VA multicenter cooperative clinical trials, when the sponsor does not provide indemnification, review by the RMP is required. This review is necessary to assess the risk and determine if the protection of this fund will be extended to the clinical researcher for medical malpractice claims arising out of the trial.  Such protection to the clinical researcher will not be afforded unless the RMP reviews the proposed clinical trial and approves.  

NOTE: If you have questions as to your protocol qualifying for review or regarding the submission process contact John S. Thompson at (859) 281-4927 or jsthom1@uky.edu.  

I. Potentially Qualifying Clinical Trials

Inclusion criteria:

1.  All investigator initiated human clinical research not supported by an outside agency (surveys and medical record chart reviews unless they are exempt from IRB review are included)

2.  All investigator initiated human clinical research for which a drug, device, investigative procedure or financial support are provided but indemnification is not provided.

3.  Investigator initiated NIH-supported trials that are not a cooperative study.

4.  Industry-initiated and supported trials that do not provide indemnification.

5.  Orphan Drug trials that do not have indemnification

6.  Investigator initiated, non-indemnified, non-sponsored genetic and HIV research.

7.  Trials for which the PI is UK/VA but outside physicians participate at their sites.

8. Trials in which there is no physical risk to the subject but there could be risk to the institution based on social, political or ethical issues.

Exclusion criteria:

1.  All VA Cooperative Study Trials.

2.  All NCI Cooperative Study Trials (i.e. RTOG, SWOG, etc.).

3.  Other multi-center trials, including industry sponsored trials, which have an external Data Safety      Monitoring Board.

4. All IRB exempt protocols. 

5.  Research in which the study only involves studying samples obtained in the course of routine medical care.

6.  Industry supported trials that provide indemnification.

II. Instructions for submission to each of the three review committees:

The Principal Investigator (PI) is responsible for reviewing the inclusion/exclusion criteria for the review process and if a trial qualifies for review then the PI should initiate the process described below: 

A scientific review needs to be completed by ONE of the following THREE committees:

Scientific Review Committees

Non-Indemnified Risk Management Committee

Chair: John Slevin, MD

This committee does the scientific review for studies that do not have to go through the Markey Cancer Center PRC committee or the GCRC committee.  For questions regarding this submission contact John Slevin (Chair) Email: jslevin@uky.edu; Phone: (859) 281-4920.

Clinical Project Risk Assessment Evaluation Form and Routing Form are located on the CCTS web site: www.ccts.uky.edu (UK Research Policies) or see OSPA: www.research.uky.edu/ospa/site.html (Non-indemnified Trials).

 To submit and application for review:
 

1. Complete section I, II, III of the Clinical Project Risk Assessment Evaluation Form.
2. Complete Investigator Name/Date and protocol title on the Routing Form
3.  Submit the Clinical Project Risk Assessment Evaluation Form, Routing Form, study protocol and draft informed consent to Dr. John Slevin via email to jslevin@email.uky.edu.
4.  Once Dr. Slevin has completed his review he will sign and date the routing form and forward the routing form and the Clinical Project Risk Assessment Evaluation Form to Dr. John Thompson.

Markey Cancer Center (PRC Review)

Chair: Jeff Moscow, MD

This Committee does the scientific review for all cancer studies.  For questions regarding this submission contact Jeff Moscow (Chair) Email: jmoscow@uky.edu Phone: (859) 323-1436, ext. 266.

New Protocol Registration Form is located at markey.uky.edu/crcc/documents/PRCSubmissionForm.pdf). Routing form is located on the CCTS web site: www.ccts.uky.edu (UK Research Policies) or see OSPA: www.research.uky.edu/ospa/site.html (Non-indemnified Trials).

1. Complete the New Protocol Registration Form.
2. Complete Investigator Name/Date and protocol title on the Routing Form.
3. Submit the New Protocol Registration Form, the Routing Form, draft informed consent and an electronic copy of the protocol via email to Katie.Bugg@uky.edu.
4. Once Dr. Moscow has completed his review he will sign and date the routing form and forward the routing form, protocol and the Risk Assessment to Dr. John Thompson.

General Clinical Research Center (GCRC)

Chair: Tom Getchell, PhD

This Committee does the scientific review for all studies that utilize the GCRC. For questions regarding this submission contact Tom Getchell (Chair) Email: tgetche1@uky.edu Phone: (859) 257-1412, ext. 321.

A link to the Clinical Project Risk Assessment form and Routing form are located at www.mc.uky.edu/gcrc/Home.aspx under “application process”.

1.  Complete section I, II, III of the Clinical Project Risk Assessment Evaluation Form. 
2.  Complete Investigator Name/Date and protocol title on the Routing Form
3.  Submit Clinical Project Risk Assessment Evaluation Form, study protocol and draft informed consent to: alcose0@uky.edu (Abby Cosentino).
4.  Once Dr. Getchell has completed his review he will sign and date the routing form and forward the routing form and the Risk Assessment to Dr. John Thompson.

The PI should forward a copy of the IRB approval and the IRB approved, stamped consent form to Dr. Thompson upon receipt. The Review process cannot continue until Dr. Thompson has received these documents.  Dr. Thompson will communicate any necessary changes or initial concerns to the Principal Investigator via email.

Dr. Thompson will perform an assessment and send a copy of the Scientific Review Committee’s assessment, the routing form, protocol, IRB approval letter, stamped consent, summary and recommendations to legal counsel.

Legal counsel will assess and prepare for either expedited or full Risk Management Committee review. Please note that the full Risk Management Committee meets once per month.

After the Risk Management Committee’s review, legal counsel will notify the Principal Investigator and their designee (if applicable), Department Chair and Scientific Review Committee Chair of the status of their protocol via email. Legal counsel will send the original signed routing form to the Principal Investigator and/or their designee for filing in the regulatory file. Upon receipt of this approval, the PI may proceed with the steps necessary to initiate the protocol. 

Even though IRB approval has been obtained, if the Risk Management Committee has not given approval, THE TRIAL MUST NOT BE STARTED.

If an investigator does not forward a trial for review that qualifies for Inclusion in the Indemnification Process and a problem occurs and a claim is made, the University is not obligated to defend the investigator.

III. Flow Chart Points to Consider:

1.  If a trial fits in one of the inclusion criteria, start the process outlined in the flow chart immediately so that this proceeds in parallel with the IRB approval and Contract (if applicable). 

Although there may be occasions when Sponsored Projects may eventually obtain indemnification, don’t wait for this to occur.  This may happen on rare occasions and on these occasions the work by the Scientific Review Committees will have been unnecessary—but this is worth the effort to generally move the process forward as quickly as possible. 

2.   Submit the protocol, draft consent form, risk assessment evaluation form with section I, II and III competed and routing form to the appropriate committee. The committees that do scientific reviews are Non-Indemnified Risk Management Committee, Protocol Review Committee (PRC) at Markey Cancer Center or the GCRC Scientific Review Committee. The committee will review and make recommendations to the review officer.

3. Electronic submission may help to expedite routing through this process.

4.   The Review Officer will notify the PI and their designee of any suggested changes or initial concerns that will need to be made to the protocol or the consent form.

5.  The Office of Legal Council will refer the review packet to the Risk Management Committee (RMP) for review. The RMP will notify the Principal Investigator (PI), the PI’s designee, the Department Chair, Scientific Review Committee Chair and other designees of the final decision.