Vocabulary of the Revised Common Rule
This page contains new and updated terms related to the revised Common Rule.
Single IRB refers to any situation where more than one institution is engaged in doing a specific study but only one IRB does the review for most or all of those institutions. The institutions may all be conducting the same procedures (for example, in a multi-site clinical trial) or they may have divided up the procedures among the institutions (for example, a collaborative study in which one institution collects blood samples and another institution analyzes them). The revised Common Rule will require the use of a single IRB for all federally-funded multi-site or collaborative research, beginning on January 20, 2020.
An External IRB is any non-UW IRB that reviews UW research instead of the UW IRB. This is increasingly common because of specialization among IRBs (for example, the Hutch reviews many UW oncology studies) and because of the growing interest in having just one IRB review all of the organizations involved in a specific study. This so-called Single IRB approach is required by NIH for multi-site clinical trials. The revised Common Rule will require the use of a single IRB for all federally-funded collaborative research, beginning on January 20, 2020. A January issue of this newsletter will preview this eventual requirement.
Continuing review is the IRB’s re-review of an already-approved study, which is required by federal human subjects regulations and UW policy. The purpose of the review is to ensure that the study still meets the criteria for approval. The IRB focuses on any new information about: (1) risk assessment and monitoring; (2) adequacy of the informed consent process; (3) researcher and institutional issues, such as changes in the researcher’s situation; and (4) research progress.
Certification is the official notification of a study’s IRB approval from an institution to the federal department or agency that is financially supporting the study. This certification requirement is part of the original and the revised Common Rule. The original Common Rule has also required certification of IRB approval of the grant application (as distinct and separate from the study).
Broad consent is a new concept introduced by the revised Common Rule. It means consent specifically provided for the storage, maintenance, and/or use of identifiable information or biospecimens for secondary research. The broad consent process must include most of the standard elements of consent plus several additional elements. These are described in the revised WORKSHEET: Exempt Determination (release date: late December).
Benign behavioral interventions are a key concept for an important new category of research considered to be exempt (category 3) and for an existing UW-specific category (currently called category 7; renamed category 101 when the revised Common Rule is implemented). Benign means: brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the researcher has no reason to think that the subjects will find the interventions/interactions/observations to be offensive or embarrassing.
Interventions are not allowed in some categories of exempt research, including Category 2. Intervention means an action that is taken with the intent of finding out whether it will change subjects and their behavior, performance, emotions, thinking, or physical being.
Clinical Trial is an important concept. In the past two to three years, federal agencies and regulators have increased their expectations and requirements for clinical trials in order to raise the overall quality of the trials and promote public trust in research. There are several ways to define clinical trial. HSD and the revised Common Rule use the same definition as the National Institutes of Health (NIH): A clinical trial is a research study that prospectively assigns one or more human subjects to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or health-related behavioral outcomes.
Key Information is the phrase used to describe a new requirement for consent processes and forms: Obtaining consent must begin by presenting the potential participants with the key information that is most likely to assist them in understanding the reasons why they might or might not want to participate in the research.
A reasonable person standard is used by the revised Common Rule to describe the information that should be provided in the consent process and form. That is, consent must provide the information that a reasonable person would want to have in order to make an informed decision about whether to participate.
Secondary research (sometimes called secondary use) with private information or biospecimens means using information or biospecimens that were initially collected for one purpose for a second, different, purpose.
- Original source. The information or biospecimens may have been collected from subjects in a research study, or they may have been obtained from a non-research source such as school records or residual clinical specimens.
- The secondary user may be the same researcher who initially collected the information or biospecimens. Or, the researcher may send information or biospecimens to another researcher, a company, or a large national database for secondary research.
- Identifiability. The secondary research may involve identifiable information or biospecimens, or the identifiers may have been removed (deleted or de-linked) prior to the secondary research.
- Planned or not. Researchers sometimes know that they are likely to use data and specimens they collect in the future. But often those specific future secondary uses are not planned and cannot be described to subjects at the time of the original information or biospecimen collection.
Secondary use is an important concept in the revised Common Rule that is virtually absent in the original Common Rule. The revised Common Rule acknowledges the growing prevalence of secondary use as researchers recognize the tremendous potential value of existing information and specimens. The new required elements of consent about possible secondary use reflects these developments.
Research is a word routinely used in the academic setting to describe a very broad range of activities. Most of the time it’s not necessary to define “research”. But the definition matters when it comes to regulatory compliance. Federal and state regulations that affect human subjects research each have their own definition of research; if your activity doesn’t meet the definition, then the regulation doesn’t apply to your activity. One of HSD’s most challenging tasks is to make Research / Not Research determinations. We assess your proposed activity against three different definitions: the Common Rule definition, the Food and Drug Administration definition, and a definition in Washington State law (RCW 42.48).
In Between Applications
HSD is using the term In Between Applications for initial IRB applications that are submitted prior to January 21, 2019, and that are not approved by that date. These applications may have been prepared by researchers per the requirements of the original Common Rule – but the application review and the study itself will be governed by the revised Common Rule. The IRB review process will involve additional work for these researchers if the study has a consent form and if the researchers do not use the revised consent form template (available on October 3) with their applications.
The Common Rule is the informal name given to a set of human subjects regulations that was developed in the 1970s. It was adopted by almost all federal agencies that fund human subjects research – in other words, it is the set of regulations that they all have in common. The Common Rule describes responsibilities and requirements for Institutional Review Boards (IRBs), researchers, and the researchers’ institution. Most academic institutions (including the UW) apply the Common Rule regulations to all human subjects research, even if the research is not funded by a federal agency.