Templates

Revised Human Subjects Regulations (Common Rule) Wednesday, June 20th 2018

The regulations that human subjects researchers must adhere to (referred to as the Common Rule Regulations) were established in 1991. In 2011, federal agencies began the long-awaited process to revise these regulations and, on January 18, 2017, the final revisions to the Common Rule (Final Rule) were posted in the federal register. The effective and implementation dates have recently changed. As posted in the federal register on June 18, 2018, the revised final Common Rule is both effective and to be implemented on January 21, 2019 with the option of implementing 3 burden-reducing provisions before January 21, 2019.

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Throughout your research study (from recruitment to the end of a participant’s involvement), it is the responsibility of the researcher to have an open and ongoing dialogue with research participants. This is to provide them information and answer their questions about the research in language that is clear and easily understood by the participant. How you consent your participants, including the process itself and document or script used, will vary according to the research and the population, but the requirement to obtain Informed Consent is the cornerstone of human subjects protection.

Office of Human Research Protections: The informed consent process involves three key features: (1) disclosing to potential research subjects information needed to make an informed decision; (2) facilitating the understanding of what has been disclosed; and (3) promoting the voluntariness of the decision about whether or not to participate in the research. Informed consent must be legally effective and prospectively obtained. HHS regulations at 45 CFR 46.116 and 45 CFR 46.117 describe the informed consent requirements. HHS Frequently Asked Questions.

Click the buttons below and you will find consent, assent, and recruitment templates, along with tips and checklists to assist you in protocol creation. Have a question about what template would be best for your study? Please contact the IRB Coordinators.