Ohio Administrative Code › Title 3364 - University of Toledo › Chapter 3364-70 - Research Protection and Practices › Section 3364-70-09 - Compensation for treatment of injuries to subjects in covered commercially sponsored clinical trials

Current through all regulations passed and filed through July 1, 2024
(A)
								Policy
			 statement
It is the policy of the university of
				Toledo ("UT") that clinical trial agreements for covered clinical trials will
				contain a provision by which the sponsor agrees to the conditions of payment
				for medical expenses arising from study related injuries as set forth in this
				policy. A covered clinical trial is a human subject research study that is
				sponsored by a for-profit company, employs a company-originated protocol,
				includes non-FDA approved drugs /devices or FDA approved drugs/devices for a
				new indication, and involves more than minimal risk to study
				subjects.
(B)
								Purpose of policy
The purpose of this policy is to set
				forth the conditions under which company sponsors of covered clinical trials
				must be responsible for the cost of treatment of study related injuries that
				result as a consequence of participation in the clinical
				trial.
(C)
								Procedures
(1)
									Clinical trial agreements for covered clinical trials
			 will be accepted by UT and its health science center only if the sponsor agrees
			 to fully indemnify the university for cost of treatment of study related
			 injuries, according to the following parameters:
(a)
										 In clinical
			 trials with no potential of direct benefit including phase one ("Phase I")
			 trials and any phase clinical trial involving healthy subjects or clinical
			 trials with a reasonable expectation of benefit to study subjects, the sponsor
			 must agree to fully indemnify the university for the reasonable and necessary
			 cost of diagnosis and treatment for study related injuries. A subject's
			 insurance may not be billed for study related injuries in these
			 trials.
(b)
										In clinical trials with a reasonable expectation of
			 benefit to study subjects, a waiver to this rule requiring full indemnification
			 may be made by the vice president for research or the executive vice president
			 for clinical affairs. Consideration in granting a waiver include the phase of
			 the trial, all known risks to human subjects, and other relevant business
			 issues. When submitting a request for a full indemnification waiver, the
			 requesting party must submit the protocol and proposed informed consent
			 document, along with the phase of the study, all known risks to human subjects,
			 and a summary of any relevant business issues. The vice president for research
			 or the executive vice president for clinical affairs may consult others with
			 knowledge of the aforementioned topics prior to making a
			 decision.
(c)
										A waiver of full indemnification allows a clinical
			 trial agreement to be approvable without full indemnification to the
			 university.
(d)
										A waiver under paragraph (C)(1)(b) of this rule must be
			 issued in writing, either via electronic mail or hard copy. A copy of the
			 waiver should be provided to the vice president for research and the director
			 of the Jacobson center for clinical and translational research.