The University's adverse effects compensation program is intended to apply to projects carried out by University personnel and under University sponsorship. To be covered, the project must also be one which has been approved in writing by the University's Human Subjects Review Committee. The program applies only to adverse effects resulting from the study procedure itself.
Compensation under the program is intended to be on a "no-fault" basis (i.e., the claimant need not demonstrate University fault or negligence), and is designed as a substitute for the traditional tort system. It is voluntary from the viewpoint of the claimant, who must agree to give up his or her right to pursue a traditional tort action in order to receive the benefits provided under the program. The benefits to be provided are as follows:
| A. | All medical expenses immediately and directly associated with the
adverse effect, up to a maximum of $10,000. |
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| B. | Such additional expenses or compensation as may be agreed to by the parties. If the claimant is unwilling to give up his or her right to sue, then the matter will be handled as a traditional tort claim and will be settled or defended on that basis. |
If an investigator believes an adverse effect has occurred, the investigator shall immediately prepare a report summarizing the background, nature and result of the adverse effect. The report shall be submitted to the Human Subjects Office and the Office of Risk Management, who may consult with representatives of the Attorney General's Division and the Human Subjects Review Committee which reviewed the project involved, in making a determination as to the applicability of the compensation program. If the situation is one for which compensation is appropriate, the Office of Risk Management will arrange for paying the applicable benefits and securing a release from the subject.
If a subject believes an adverse effect has occurred, the subject may independently prepare a report containing the information mentioned above to be submitted to the Human Subjects Office and Office of Risk Management, and a determination as to applicability of the compensation program will be made. If compensation is appropriate, it will be arranged as described above; if it is not, the subject will be so notified. Any such report must be submitted within one year of the occurrence of the adverse effect.
BR, June 1980.