UW Research

October 3, 2018

The Common Rule News, October 3, 2018

Issue 3: Foundational Concepts
HSD’s Common Rule Webpage


Foundational Concepts

Pile of colorful blocksThis week’s issue focuses on the Foundational Concepts in the Common Rule regulations. These concepts are woven throughout the regulations. They are the basis of fundamental distinctions that affect how your study is reviewed and what requirements it must meet. Keep reading to find out whether the revised Common Rule changes the definition or interpretation of:


Research

multi colored blocksBottom line: There is no change in the definition of “research” or the interpretation of the definition.

The wording of the definition. The definition has a one word change: Research is means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

The interpretation of the definition. The revised Common Rule provides clarification about when certain types of activities are, or are not, considered to be research. The Preamble to the revised Common Rule states that this new information is intended as clarification and that it is not a change in interpretation. HSD’s interpretation of the definition of research has been aligned with this clarifying information for the past several years. Therefore, this information is expected to have no impact on HSD determinations about whether a proposed activity is “research”. See the HSD Common Rule webpage for this clarifying information about:

  • Scholarly and journalistic activities
  • Public health surveillance activities
  • Criminal justice or investigative activities
  • National security activities
RESEARCH CLARIFICATION
Click on “Clarifications” in the Accordion Menu

Human Subject

Pile of black and white blocks stacked like a staircaseBottom line: There is no change in the definition of “human subject” or the interpretation of the definition.

The wording of the definition. The definition has some minor wording changes. The word “data” is replaced by “information or biospecimens”. The word “obtains” is replaced by “obtains and uses, studies, analyzes, or generates”. The definition is now:

A living individual about whom an investigator (whether professional or student) conducting research:

  1. Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
  2. Obtains uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

The interpretation of the definition. Existing federal guidance as well as the Preamble to the revised Common Rule make it clear that the term “data” used in the original Common Rule was always intended to include biospecimens. The Preamble also states that the other wording changes are considered to be minor wording changes that are “merely intended to clarify how the word ‘obtains’ is currently interpreted”.

Related information

  • Definition of interaction between participants and researchers. The revised Common Rule provides a definition; the original Common Rule did not. Interaction includes communication or interpersonal contact between investigator and subject. This is how HSD has always interpreted the word.
  • The special case of de-identified newborn dried bloodspots. The implementation of the revised Common Rule marks the end of a four-year period during which de-identified newborn dried bloodspots were considered to be “human subjects”, because of the federal Newborn Screening Saves Lives Reauthorization Act in late 2014.

Minimal Risk

Pile of blocks in a blurry photographBottom line: These is no change in the definition of “minimal risk” or the interpretation of the definition.

The wording of the definition. The definition continues to be:

  • The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

The interpretation of the definition. Neither the revised Common Rule nor its Preamble provide any new information about the interpretation of “minimal risk”.


Private Information

bright orange blockBottom line: There is no change in the definition of “private information” or the interpretation of the definition.

The wording of the definition. The definition continues to be:

  • Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).

The interpretation of the definition. Neither the revised Common Rule nor its Preamble provide any new information about the interpretation of “private information”.


Identifiability

tan colored blocked lined up like dominosBottom line: There is no change in the definition of “identifiability” or the interpretation of the definition.

The wording of the definition. The definition continues to be:

  • The identity of the subject is or may readily be ascertained by the investigator or associated with the information or biospecimen.

The interpretation of the definition. Neither the revised Common Rule nor its Preamble provide any new information about the interpretation of “identifiability”.


Engagement

bright red blockBottom line: There is no change in the definition of “engagement” or the interpretation of the definition.

The wording of the definition. This foundational concept defines which institutions or organizations are considered to be involved in research (and therefore must obtain IRB review). It is not defined in the original or the revised Common Rule. Instead, the definition is described in terms of types of activities that are, or are not, considered to be “engagement in the research” in a lengthy 2008 guidance document from the federal Office of Human Research Protections.

The interpretation of the definition. Neither the revised Common Rule nor its Preamble provide any new information about the interpretation of “engagement”.


Word of the Week

word of the dayResearch 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).


Questions from Campus

students on campusQ. I’ve heard that the definition of human subjects research doesn’t change in the revised Common Rule, but I’ve also heard that many more studies will now qualify for exemption. How can that be true? Doesn’t exemption (exempt status) mean that something isn’t human subjects research?

A. They are two different things. HSD makes human subjects research determinations for all initial applications, to assess whether your planned activity meets the regulatory definition of “research” or “human subject”. If it doesn’t, you don’t need IRB review. If it does meet the definition, then HSD makes an exempt determination to assess whether your research qualifies for exempt status. Exempt status means that your activity IS human subjects research but that it is not required to comply with the Common Rule because it involves very little risk to the research participants.


Q. I thought the revised Common Rule was going to define all biospecimens as “human subjects”, even when they are de-identified or anonymous (because of the Henrietta Lacks scandal). What happened? And aren’t biospecimens basically identifiable anyway no matter what, because they contain unique DNA?

A. The first draft of the revised Common Rule did indeed propose that all biospecimens should be treated as if they were inherently identifiable. This proposal received strong negative reactions during the public comment period, so it was dropped from the final version of the revised Rule. Also, current technology and databases don’t provide a way to readily link up the DNA from a specimen with a specific person. However, the federal agencies recognized that technology and databases are rapidly evolving. So the final revised Common Rule requires the agencies to re-assess the definition of private identifiable information and the impact of analytic technologies and techniques every four years. (The Henrietta Lacks scandal is fascinating. See the book called the Immortal Life of Henrietta Lacks, by Rebecca Skloot.)

Send your questions about the revised Common Rule to hsdinfo@uw.edu. Each issue of this newsletter will answer one or more questions.


Summary of Changes

Summary of Common Rule ChangesHSD’s Common Rule webpage has a summary of the changes. Each issue of this special newsletter will focus on one of these changes – providing in-depth details about how it will affect researchers, the IRB review process, consent forms, application forms, and the Zipline e-IRB system. It will also link to any resources that are available to help with the change. The schedule of topics and newsletter dates are posted on the HSD Common Rule webpage.


Up Next

Issue 4, October 10, 2018
New Elements of Consent