On January 21, 2019 the Final Rule to update the current regulations at 45 CFR 46, Subpart A - "Federal Policy for the Protection of Human Subjects" (the Common Rule) will be effective.
Substantive revisions were made to the regulations to “modernize, strengthen, and make more effective” (HHS 2017) the current system of oversight that has been the federal Common Rule since 1991. The revisions are intended to:
- Better protect human subjects involved in research
- Facilitate research
- Remove ambiguity
- Reduce regulatory burden
Impact on Researchers
- Increased number of research categories approved under Exempt review
- Continuing review no longer necessary for most non-exempt research activities
- New Consent Process requirements for Non-Exempt Research
The RIT review process will continue as it is currently with some modifications to existing forms and some researchers may be required to submit additional information. The updated HSRO website will be online January 21, 2019 and the HSRO will assist researchers with the transition during the next few months.
Obtaining informed consent is more than just a signature on a form.
Before involving a human subject in research an investigator shall obtain informed consent of the subject or the subject's legally authorized representative. Obtaining informed consent is an educational process that takes place between the Investigator and the prospective subject; the Investigator uses this opportunity to confirm that each participant understands what will happen and has the opportunity to ask questions.
The goal is to provide information so that prospective subjects understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate. Informed consent is one of the primary ethical requirements of research with human subjects as it reflects the basic principle of respect for persons.
The consent process typically includes providing a written consent document containing the required information (i.e., elements of informed consent) and the presentation of that information to prospective participants. In most cases, investigators are expected to obtain a signature from the participant on a written informed consent document (i.e., to document the consent to participate) unless the IRB waives the consent requirement or the documentation (signature) requirement. Waivers are rare and require specific elements to be granted.
General Requirements of Informed Consent
An informed consent document is typically used to provide subjects with the information they need to make a decision to volunteer for a research study. Federal regulations 45CFR46.116 provide the framework for the type of information (i.e., the "elements") that must be included as part of the consent process. Investigators may seek consent only under circumstances that:
- provide the prospective subject (or representative) enough time to discuss and consider whether or not to participate,
- minimize the possibility of coercion (intimidation) or undue influence, and
- present the information in a language that is understandable to the subject or representative (the person who signs the consent form must be given a copy as a reference and reminder of the information conveyed
- the information that is presented must be that which a reasonable person would want to have in order to make an informed decision about whether to participate
New with the revised 2018 Common Rule is the requirement that the non-exempt research consent document begin with a "concise and focused" presentation of key information that will help potential participants understand why they might or might not want to be a part of a research study.
Key Information Elements for Non-Exempt Research
- Informed Consent must begin with a concise and focused presentation of the key information. "Key information" is information that is most likely to assist a prospective subject in understanding the reasons why a subject may or may not want to participate in the research.
- Information must be presented in sufficient detail and must be presented in a way that facilitates understanding of the reasons why a person might or might not want to participate. This should not consist of a list of isolated facts.
- It is an ethical best practice to include informed consent information in Exempt research. The HSRO reviews the information given to subjects about the study and refers to this as the informed consent document. Even in situations where the IRB may waive the documentation (signature) requirement (e.g., telephone interview, online survey), investigators are expected to present participants with the required key elements of informed consent and with a copy of the written consent documentBasic Elements of Informed Consent