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