UW Research

October 24, 2018

The Common Rule News – October 24, 2018

Issue 6: Other Consent Related Changes
HSD’s Common Rule Webpage


Other Consent-Related Changes

A consent form on a laptop screenWhat is the new consent-related requirement for clinical trials?

How have the requirements changed for waivers related to consent?


A National Repository of Consent Forms

The revised Common Rule requires researchers to upload one unsigned copy of an IRB-approved consent form that was used to enroll subjects to a publicly available federal website that will be established as a repository for such forms.

Which Studies?

which studiesAll clinical trials funded by a federal agency (except the Department of Justice).

The relevant definition of “clinical trial” is the one used by the National Institutes of Health (NIH). See Word of the Week, below.


When?

whenAny time after the trial closes to recruitment but no later than 60 days after the last study visit by any subject as required by the study protocol.


Where?

whereEither of these two publicly available websites may be used: ClinicalTrials.gov, or Regulations.gov (Docket folder HHS-OPHS-2018-0021).


Which Forms?

Which formsMultiple versions. Any one version can be posted as long as it was used for enrollment.

Different forms for different subject groups. Only one form from any one group must be posted.

Multiple sites. Only one form per study must be posted, not one form from each site.


Who?

whoThe awardee (Principal Investigator on the grant supporting the trial) is responsible for ensuring this requirement is fulfilled.


Why?

whyTo promote public trust in research, through transparency.

To improve consent form quality through analysis, public discussion, and the generation of models.


Waiver of Consent or Parental Permission

Studies can be conducted without obtaining consent or (for research involving children) parental permission, but only if the IRB grants a waiver of the consent or parental permission requirement. Analyzing medical records data for a large number of patients is a common example.

The Common Rule allows a waiver to be granted when the procedures involve no more than minimal risk and some other conditions are met. The revised Common Rule adds another condition to the minimal risk justification for a waiver:

Minimal Risk Waiver Justification

Minimal risk
No adverse effect on rights, welfare
Research not practicable without waiver
Provide information after participation, if appropriate
NEW: Research not practicable without identifiable data or specimens

The new requirement means that researchers who do not plan to obtain consent or parental permission will need to describe in the IRB application why they cannot use de-identified data or biospecimens for their research. A question will be added to the IRB Protocol form for this purpose.


Waiver of Documentation of Consent or Parental Permission

Researchers use consent forms or parental permission forms to meet the Common Rule requirement to document consent or parental permission. Studies can be conducted without documenting consent or (for research involving children) parental permission, but only if the IRB grants a waiver of the requirement to document consent or parental permission. A common example is a web-based survey or questionnaire.

The revised Common Rule adds a third acceptable justification to the two existing justifications under the current Common Rule. This new acceptable justification may be especially useful for research that occurs in international settings.

Possible Justifications for Waiving Consent Documentation

Principal risk is link between subject and consent form, OR
Study is minimal risk and involves no procedures for which written consent is normally required outside of the research context, OR
NEW: Study is minimal risk, signing forms is not the norm for the subjects, and consent is documented in an alternative way

The conditions that must be met for this new justification to apply:

  • The subjects are from a distinct cultural group or community in which signing forms is not the norm, and
  • The research involves no more than minimal risk to the subjects, and
  • There is an appropriate alternative mechanism for documenting that informed consent was obtained.

New Resources

Clapper board from a filmHSD has released two new videos:

Both videos are under four minutes long, and present a high-level overview of the upcoming changes to the Common Rule.


Word of the Week

word of the weekClinical 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.


Question From Campus

students on campusQ. Yesterday I submitted a new IRB application that I know involves more that minimal risk and so it will need to be reviewed by the full IRB committee. I submitted it after the October 15th date on your Common Rule timeline at the bottom of your newsletter. Does that mean my study is going to have to comply with all the requirements of the revised Common Rule?

A. Not necessarily. The original Common Rule will apply to your study if the IRB can grant approval or MRSA (Modifications Required to Secure Approval) status to your study before January 21, 2019. if not, then you will need to comply with the revised Common Rule.

HSD and the IRBs will work hard to complete as many reviews as possible before January 21st, regardless of when you submit your application – but be aware this is our most challenging time of year because of holidays, staff and IRB member vacations, and IRB member absences between fall and winter quarters.

The October 15 and December 15 dates are guidelines, not deadlines or promises.

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 7: October 31, 2018
Focus: Exempt Research, Part 1