§ 5403 — Definitions

Pennsylvania § 5403

• Jurisdiction: Pennsylvania
• Title 35: HEALTH AND SAFETY
• Part: PART III
• Ch. 54: CANCER TRIAL ACCESS FOR PENNSYLVANIA PATIENTS

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The following words and phrases when used in this chapter shall have the meanings given to them in this section unless the context clearly indicates otherwise:

"Cancer clinical trials."Research studies that test new cancer treatments on people, including chemotherapies, stem cell therapies and other new treatments.

"Department."The Department of Health of the Commonwealth.

"IEC."An Independent Ethics Review Committee that is an appropriately constituted group formally established in accordance with applicable United States Food and Drug Administration regulations or outside the United States by other equivalent and applicable international regulations and guidelines in order to review and monitor biomedical research involving human subjects, and specifically having the authority to approve or disapprove research or to require modifications in research to secure approval.

"Inducement."Paying a person money, including a lump sum or salary payment, to participate in a cancer clinical trial.

"IRB."An Institutional Review Board that is an appropriately constituted group formally established in accordance with applicable United States Food and Drug Administration regulations or outside the United States by other equivalent and applicable international regulations and guidelines in order to review and monitor biomedical research involving human subjects, and specifically having the authority to approve or disapprove research or to require modifications in research to secure approval.

"Patient-subject."A person participating in a cancer clinical trial.

"Third-party reimbursement entity."A third-party nonprofit corporation or public charity that specializes in assisting cancer patients and increasing enrollment, retention and minority participation in cancer clinical trials.