Non-indemnified Clinical Study Approval Process

The University of Kentucky Healthcare Risk Management Committee (UKHC RMC) administers a self- insurance program to protect its physicians from medical malpractice claims, which could result from their participation in the conduct of clinical studies.

UKHC RMC review is required for all clinical studies that are investigator initiated, studies where the sponsor does not provide indemnification or limits time or dollar amount of indemnification for medical malpractice liability, with the exception of studies that meet the exclusion criteria detailed below.

UKHC RMC review assesses the medical malpractice liability for conducting a clinical study. UKHC RMC review also determines whether the protection of this program will be given to a clinical researcher for medical malpractice claims that may arise from participation in a particular clinical study. Medical malpractice liability protection is contingent on UKHC RMC review and approval of proposed clinical studies.  

It is the responsibility of the principal investigator to initiate the non-indemnification review process for all eligible clinical trials, as defined below.

NOTE: Contact Cliff Iler (clifton.iler@uky.edu or  859-323-1161) for any questions regarding protocol eligibility or the non-indemnification submission/review process.

 

I. Features of Clinical Studies Requiring UKHC RMC Review

Inclusion criteria for UKHC RMC Review:

  1. All non-indemnified human clinical research that is not IRB exempt or expedited regardless of the funding source.
  2. Surveys and medical record chart reviews are included if they require Full IRB review.
  3. All human clinical research for which a drug, device, investigative procedure or financial support are provided by the sponsor, but full indemnification is not provided (i.e. limitation on time or dollar amount). This will require a review of the CTA (Clinical Trial Agreement). 
  4. All VA cooperative studies utilizing UK services (i.e. VA Merit Awards).
  5. Studies 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

The following studies do not require review by UKHC RMC.

  1. Industry supported clinical studies that provide full indemnification.
  2. IRB review was Expedited
  3. IRB review was Exempt
     

Expedited Review

Low risk studies may qualify as expedited review by UKHC, RMC

 

 

II. Instructions for Submission

The Principal Investigator (PI) is responsible for reviewing the inclusion/exclusion criteria for the review process. The PI can ask for legal advice on the requirements at 323-1161.

If a study qualifies for review then the PI should initiate the process described below:

 

To submit an application for review, aubmit the following items to nonindemnification@uky.edu:

  1. Completed Clinical Project Risk Assessment Evaluation Form (sections I, II and III). The Clinical Project Risk Assessment Evaluation Form is below under "Documents for download". 
  2. Research description (Form B) or study protocol
  3. IRB approval letter
  4. IRB-approved consent document
  5. Clinical Trial Agreement (CTA) or study contract if no indemnification is provided or if indemnification is limited.  

After the UKHC RMC review, the PI will receive notification of approval. 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 STUDY MUST NOT BE STARTED.

If an investigator does not forward a study 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.
 

Documents for download: 

 

Contacts