UW Research

October 10, 2018

The Common Rule News, October 10, 2018

Issue 4: New Elements of Consent
HSD’s Common Rule Webpage


New Elements of Consent

What are the new elements of consent that the revised Common Rule requires?

Under what circumstances are they required?

After which date should they be included?


Breaking News

The revised UW standard consent template is now available on HSD’s website and in Zipline on the Consent SmartForm. It incorporates the revised Common Rule requirements, including the new elements of consent. They must be used with all studies approved on or after January 21, 2019.

Q. Can I use this template now, or should I wait until January 21?

A. You can use it now. The new required elements are optional for studies approved before January 21, but they are considered “best practice” and they provide study participants with useful information.


Q. If I include the new consent elements now, does that mean the revised Common Rule will apply to my study after January 21?

A. No. If your study is approved before January 21, the original Common Rule is the version that will continue to apply to your study after January even if you voluntarily include these new consent elements in your consent form.


The New Elements of Consent

Secondary Use
Secondary Use
Commercial Profit
Commercial Profit
Disclosure of Clinically Relevant Results
Disclosure of Clinically Relevant Results
Whole Genome Sequencing
Whole Genome Sequencing

New Consent Element: Secondary Use
Information about the possibility of secondary research, using wording consistent with one of these two statements.

  1. If secondary research is a possibility: A statement that identifiers might be removed and then the information or biospecimens could be used for future research or distributed to another researcher for future research without additional consent from the subject.
  2. If secondary research will not occur: A statement that the information or biospecimens will not be used or distributed for future research, even if the identifiers are removed.

Required? Yes, this consent element is required for all research that collects identifiable private information or biospecimens, unless the IRB specifically waives the requirement.

UW standard consent template. A new section called Use of Information and Specimens has been added to the revised UW consent template as a suggested place to put these statements.


New Consent Element: Commercial Profit
A statement about the possibility 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.

Required? This is an additional element that is required only if it is appropriate for the study. It should be included if there is any possibility of this type of use. If there is no such possibility, it can be left out.

UW standard consent template. This element has been included in the new consent template section called Use of Information and Specimens.


New Consent Element: Disclosure of Clinically Relevant Results
A statement about whether there will be disclosure of clinically relevant results (including individual results) to the subjects and, if yes, under what conditions.

Required? This is an additional element that is required only if it is appropriate for the study. It should be included if there is any possibility of returning clinically relevant results to some or all of the subjects before the study is completed. If there is no such possibility, it can be left out.

Discussion. Consider the results of screening tests as well as study procedures. The UW IRB generally expects that results should be shared with subjects if the results are clinically actionable, valid, and urgent. For example, might screening tests reveal the presence of dangerously high blood pressure or a tumor mass? Researchers have discretion to decide whether to propose returning results that do not meet the three criteria of clinically actionable, valid, and urgent. For these cases, the IRB will do a risk/benefit analysis to decide whether the return is appropriate.

UW standard consent template. This element has been included in the new consent template section called Use of Information and Specimens.


New Consent Element: Whole Genome Sequencing
A statement about whether there might be whole genome sequencing to generate whole genome or exome sequences.

Required? The UW IRB believes that this element is appropriate (i.e., should be included) if biospecimens are being collected as part of the study. If no biospecimens will be collected, it can be left out.

Discussion. The revised Common Rule defines whole genome sequencing as sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen.

UW standard consent template. This element has been included in the new consent template section called Use of Information and Specimens.


Word of the Week

word of the daySecondary 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.


Question from Campus

students on campusQ. I have a UW IRB approval for a study I’m doing now. I’ll still be enrolling and consenting subjects after January 21, 2019. Will I need to (1) Submit a modification for my consent form, to add the new required elements, and (2) use the modified consent form for all new subjects after January 21st, and/or (3) re-consent the subjects that I consented before January 21st who are still participating in the study after January 21st?

A. No, to all parts of your question. Your study was approved under the original Common Rule and it continues to be governed by that version of the Common Rule even after January 21st. Sometime in the future, you and the IRB might mutually decide it would be advantageous to switch over your study from the original Common Rule to the revised Common Rule. If you are still enrolling and consenting subjects at that time, then you will need to modify your consent form to include the new elements and you will need to use the modified consent form with any new subjects.

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 5: October 17, 2018
Focus: Consent: Key Information for a Reasonable Person