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  1. As a researcher, how do I comply with the Pennsylvania Supreme Court ruling on informed consent?

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    The Pennsylvania Supreme Court’s ruling in Shinal v. Toms,1 states that physicians have a duty, which cannot be delegated, to disclose information required to obtain patients’ informed consent for procedures  stipulated in the Pennsylvania Medical Care Availability and Reduction of Error (MCARE) Act.2

    Category (5) of the MCARE Act, which includes, “Administering an experimental medication, using an experimental device or using an approved medication or device in an experimental manner,” may implicate procedures conducted within the context of research. While Quorum aims to assist sites with following local regulations, the principal investigator is ultimately responsible for complying with state laws. As such, we recommend that Pennsylvania investigators work with local experts and legal counsel to meet the requirements of the Court’s decision and the MCARE Act.

    1 162 A.3d 429 (Pa. 2017)
    2 Act of Mar. 20, 2002, P.L. 154, No. 13 40

  2. How do I comply with the New Jersey Access to Medical Research Act?

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    The New Jersey Access to Medical Research Act [N.J. Rev. Stat. § 26:14-1 to 26:14-5] sets forth requirements for medical research involving persons who lack cognitive capacity. These requirements complement, and in some cases go beyond, the federal regulation standards for using legally authorized representatives to obtain informed consent.

    Quorum Review facilitates compliance with the Access to Medical Research Act, when applicable, by providing investigative sites in New Jersey consent forms that meet all of the Act’s requirements, including, but not limited to, a signature line for an otherwise uninvolved person to attest that the Act’s requirements for consent have been met [N.J. Rev. Stat. § 26:14-4c].

    New Jersey investigators are responsible for fulfilling all other requirements of the Access to Medical Research Act. Among other things, this includes having an attending physician with no connection to the proposed research assess the potential subject’s capacity; identifying an appropriate authorized representative(s) to act according to the subject’s known health care instructions and to provide surrogate consent, if appropriate; and ensuring the subject has not otherwise objected to the assessment of capacity or the proposed research.

    Please refer to the New Jersey Access to Medical Research Act for more information.