Significant change to the Common Rule proposed in the NPRM: Informed consent
After years of debate and speculation, sixteen federal agencies have collaborated on a notice of proposed rulemaking (NPRM) with the stated purpose of modernizing, strengthening, and making more effective the federal policy for the protection of human subjects. While the NPRM does not tackle as many issues as the Advanced Notice of Proposed Rulemaking (ANPRM) of July 2011, it nevertheless proposes a number of bold moves to streamline the clinical trial process. The U.S. Department of Health and Human Services has identified eight of the proposed changes as “most significant.” The following is the first of these significant changes and a brief description of the change prepared by Quorum Review’s regulatory attorneys:
Change proposed in the NPRM
Improve informed consent by increasing transparency and by imposing stricter new requirements regarding the information that must be given to prospective subjects, and the manner in which it is given to them, to better assure that subjects are appropriately informed before they decide to enroll in a research study.
Quorum’s description of the proposed change
Due to the shifts in science, technology, and public health engagement with research participants, the Department of Health and Human Services (HHS) is undertaking a re-evaluation of the fundamental ethical principles that underlie the Common Rule. The goals of the Notice of Proposed Rule Making (NPRM) are to: increase human subjects’ ability and opportunity to make informed consent decisions; better protect research subjects’ trust relating to informed consent; increased transparency; impose strict new requirements on information that must be given to prospective subjects; and the manner in which information it is given to participants to better assure an informed decision before enrollment. The proposal calls for a requirement of the final version of the consent form to be posted on a public federal website. In addition, consent forms would no longer be unduly long documents and the important information will be easier to find; with more appropriate details provided about the research that is most relevant to a person’s decision to participate. The presentation of the form should highlight key information. Further, informed consent would be required for secondary research with a biospecimen even if the investigator is not given information that would enable identification of whose biospecimen it is. Such consent would not need to be obtained for each research use of the biospecimen, but rather could be obtained using a “broad” consent form to future unspecified research uses. The goal of new transparency aims to minimize the possibility of coercion and underlies a true compliance with the spirit of Informed Consent regulations.
Read all the changes
Click here to read all of the significant changes to the Common Rule proposed in the NPRM.