UW Research

The Changes

Minor Changes that affect only HSD or the IRBs are not described here.

The Changes

Consent

Change #1. Four new required elements of consent. These new items of information must be included in the consent form or (if there is no consent form) covered during the consent process, unless the IRB grants a waiver for not including them.

Required for all studies that collect identifiable private information or identifiable biospecimens

  • A statement about whether subject’s private information or biospecimens could be used for future research studies or distributed to another investigator for future research studies, with or without identifiers.

Required when appropriate to the study

  • A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit.
  • A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions.
  • For research involving biospecimens, whether the research will (or might) include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).

Change #2. Key information. The consent form (or consent process, if there is no consent form) must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject in understanding the reasons why one might or might not want to participate in the research. This part of the consent form or process must be organized in a way that facilitates comprehension. It is generally not required if the consent form is less than 2000 words (not counting the signature section and investigator list).

Change #3. Criteria for granting a waiver of consent. A new criterion has been added.

  • No more than minimal risk to subjects.
  • The research could not practicably be carried out without the waiver.
  • The waiver will not adversely affect subjects’ rights and welfare.
  • The subjects will be provided with any additional pertinent information after participation.
  • NEW If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format.

Change #4. Criteria for granting a waiver of documentation of consent. A third set of criteria has been added, meaning that there are three different reasons why a waiver of documentation of consent can be granted.

  • The only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. OR
  • The research involves no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. OR
  • NEW If the subjects are members of a distinct cultural group or community in which signing forms is not the norm, the research involves no more than minimal risk of harm, and there is an appropriate alternative mechanism for documenting that consent was obtained.

Change #5. Posting of clinical trial consent form. For each clinical trial conducted or supported by a federal agency that has signed the revised Common Rule, one IRB approved consent form used to enroll subjects must be posted on a publicly available federal website that is established as a repository for such consent forms. This is the responsibility of the researcher or the federal agency.

Exempt Studies

Exempt status means that a study is considered to be human subjects research but that it is not subject to the requirements of the Common Rule because the risks to subjects are low. Exempt status is determined by whether the study methods fit into one or more categories.

The change. The exempt categories have been significantly expanded. This means that more studies will qualify for exempt status.

Exceptions. This does not apply to studies that are:

  • Regulated by the Food and Drug Administration (FDA)
  • Funded by the federal Department of Justice

See the revised WORKSHEET: Exempt Determinations.

Continuing Review

Continuing Review is the requirement for the IRB to re-review a study and renew the IRB approval, after a specified time period. Almost all studies with IRB approval must go through continuing review once a year or once every three years.

The change. The following types of studies will no longer need to go through Continuing Review at all. However, HSD may send a short automated “check-in” email once a year.

  • Studies whose initial application was reviewed by the “minimal risk” process, called expedited review
  • Studies whose remaining research procedures consist solely of:
    • Data analysis (including analysis of identifiable private information or identifiable biospecimens), and/or
    • Obtaining clinical care data from records, for follow-up purposes

Exceptions. This does not apply to studies that are:

  • Regulated by the Food and Drug Administration (FDA)
  • Funded by the federal Department of Justice

Single IRB

Unlike all of the other changes, this change is implemented on January 20, 2020.

The change. For studies that involve more than one institution or organization, the same IRB must conduct the review for all of the institutions. This is in contrast to the current situation, where each institution has its own IRB do the review. This “Single IRB” requirement applies to all research that is funded by any of the federal agencies that adopted the revised Common Rule:

Agency for International Development (USAID) Department of Homeland Security
Central Intelligence Agency Department of Housing and Urban Development
Consumer Product Safety Division Department of Labor
Department of Agriculture Department of Transportation
Department of Commerce Department of Veterans Affairs (VA)
Department of Defense Environmental Protection Agency (EPA)
Department of Education National Aeronautics and Space Administration (NASA)
Department of Energy National Science Foundation (NSF)
Department of Health and Human Services Social Security Administration (SSA)

Clarifications

General Wording Clarification

The entire revised Common Rule refers to information and biospecimens instead of just information (or data). The purpose of this change is to clarify that the Common Rule applies (and always has) to specimens, too.

Use of Information and Biospecimens

The revised Common Rule clarifies that working with human subjects information and biospecimens includes not just obtaining them but also using, studying, analyzing, or generating them. The Preamble to the revised Common Rule describes this as a clarification of what “obtains” means.

What is Research?

The definition of research has not changed. However, the revised Common Rule provides this clarifying information about specific activities that are considered to be Not Research.

  • Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individual about whom the information is collected.
  • Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
  • Criminal justice. Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
  • National security. Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

What is a Public Health Authority?

Public health authority means an agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate.

What is “Interaction” Between Participants and Researchers?

The revised Common Rule provides a definition (which was absent in the original Common Rule). Interaction includes communication or interpersonal contact between investigator and subject. This is how HSD has always interpreted the word.

No Changes

Except as described above, the basic process and criteria for IRB approval are the same. Also, there are no changes in the definition of these fundamental concepts:

  • Research
  • Human Subject
  • Engagement
  • Minimal Risk