For privately sponsored studies that are conducted pursuant to a private sponsor’s protocol (industry sponsor), the sponsor of the study is required to pay for the reasonable cost of treating injuries or complications directly resulting from participation in the study, including injuries or complications resulting from the study material or research procedures performed pursuant to the study protocol, to the extent that injuries/complications were not a result of negligence, willful misconduct or failure to reasonably act on the part of the study personnel.
When the trial is not conducted pursuant to a private industry sponsor protocol, the costs of treating study subjects for injuries or complications directly resulting from a study material or research procedures will be the responsibility of the subject or the subject’s Medicare/private insurance plans. In these cases, the IRB requires following language in the consent form to notify participants of their financial responsibility:
"In the unlikely event you become injured as a result of your participation in this study, medical care is available. It is the policy of this institution to provide neither financial compensation nor free medical treatment for research-related injury. By signing this document, you are not waiving any rights that you have against The Pennsylvania State University for injury resulting from negligence of the University or its investigators."