Upcoming Changes to Human Subjects Regulations and Policies

Revised Common Rule Expected in July 2018

On January 17, 2018, the Office for Human Research Protections confirmed that implementation of the revised Common Rule would be delayed until July 19, 2018 with the possibility of a further delay in implementation. Although this delay means the UW-Madison cannot apply most of the provisions within the revised Common Rule to federally funded research (or FDA-regulated studies), campus policy has been revised to allow the IRBs to implement most of the provisions within the revised Common Rule for studies that are not FDA-regulated or have never been federally funded, including:

Please see this decision tree for help in determining if campus policy may apply to your study.

Of note, the Health Sciences IRBs will begin working with study teams to mirror the recommended approach to informed consent within the revised Common Rule for all studies, because this provision does not conflict with the current Common Rule and reflects a best practice.

For studies already approved by a Health Sciences IRB, which have not been federally funded or FDA-regulated, the IRB will work with the study team to determine if transitioning the study to the revised Common Rule is advantageous and, if so, help the study team transition the research to new regulations. See the information below for more details about implementation.

Summary of Key Changes to the Common Rule and Implementation Plan

The major revisions and what the UW-Madison IRBs have done or plan to do related to the updates are outlined in the table below. See also the slides from the Summary of Common Rule presentations.

Common Rule Change IRB Actions Impact on Research Teams
Updating the definition of human subject to specifically reference that the concept encompasses obtaining, using, studying or analyzing private identifiable information or identifiable biospecimens
  • Updating guidance and forms to address to include the revised definition
  • Educating IRB staff, IRB members, and the research community regarding this expansion of the definition of human subject
  • Campus policy will incorporate these definitions for research that is not federally funded or FDA-regulated before implementation of the revised Common Rule
  • Research teams will need to be aware of additional situations that may constitute research involving human subjects and thus subject to IRB oversight
Continuing review no longer required for many categories of minimal risk research
  • In anticipation of this change, the UW-Madison IRBs began assessing whether non-federally funded studies that are not FDA-regulated could be excused from continuing review and communicating the outcome of the assessment to study teams. The UW-Madison recently revised its institutional policy to allow for more studies to be excused from continuing review.
  • When the revised Common Rule goes into effect, the IRBs will be able to begin excusing some federally funded research that is not FDA-regulated from continuing review as well.
  • The ARROW application and workflow were updated to include an “Approved No Continuing Review” state
  • Revising IRB approval letters to address whether continuing review required and include reminders to study teams or ongoing responsibilities (e.g., submission of changes of protocol, reportable events, closure reports)
  • Even when research is excused from continuing reviewing, study teams will be responsible for:
    • ensuring any changes of protocol are approved by the IRB prior to implementation (unless to eliminate an apparent immediate hazard to subjects
    • reporting any unanticipated problems, noncompliance, and new information to the IRB
    • submitting a closure report

  • Some research teams will still need to submit continuing review reports for FDA-regulated research or research that does not meet the criteria to be excused from continuing review
Expansion of exemption categories (e.g., for some research involving brief benign behavioral interventions with adults or the secondary use of information and biospecimens, including identifiable information and biospecimens under some circumstances) and the new requirement for limited IRB review for some categories
  • Updating the ARROW application and reviewer checklists to include the new exemption categories
  • Revising the ARROW workflow to allow changes of protocol for some exemption categories that require limited IRB review
  • Revising guidance and forms to address expanded categories and concept of limited IRB review
  • When the revised Common Rule goes into effect, the IRBs will be able to implement the expanded exemption categories for non-FDA-regulated, federally funded research.
  • Become familiar with the new exemption categories and which ones may require changes of protocol for the IRB to confirm that the exemption determination is still appropriate
  • Submit medical records research using the new application type, Initial Review Application: Health Care Records for Research, which replaces the Initial Review Application: Non-exempt Medical Records 

Several changes to informed consent, such as:

  • Re-organization of consent documents to begin with a concise and focused presentation of the key information that is most likely to assist in understanding the reasons why one might or might not want to participate in the research
  • New elements of consent required related to collection of biospecimens, such as whether they will be used for future use, could be used for commercial profit, whether clinically relevant results will be obtained and release, and whether the biospecimens might be used for whole genome sequencing
  • Posting consent forms on a designated public website in for some clinical trials
  • Allowing use of “broad consent” for the collection and use of identifiable private information and identifiable biospecimens for future research in limited situations
  • Limits on waivers or alterations of informed consent when broad consent used
  • Revising guidance and forms to address new elements of consent and changes to consent form organization
  • Consent forms will be considered to meet the new requirements for presentation of key information if:
    • They are 5 pages or fewer
    • Are 10 pages or fewer and are based on current UW-Madison Health Sciences IRBs templates

  • The UW Health Sciences IRBs worked with a community group to revise their consent form templates to improve readability for subjects and usability for study teams
  • As we learn more, the UW will develop guidance about posting consent forms (e.g., which studies must comply as well as when and where they should be posted)
  • Once the federal agencies provide more guidance and the revised Common Rule goes into effect, we will work on guidance regarding and a template consent form to allow study teams to leverage broad consent when appropriate
  • For non-exempt initial reviews:
    • Begin using the revised templates the UW HS IRBs posted when possible
    • Reference the “Informed Consent: Additional Model Language” for wording regarding release of results (i.e., Adventitious Findings), Banking of Data and/or Specimens for Future Use, Sharing of Data, Specimens, Images for Future Research

  • Monitor for announcements related to posting requirements for clinical trial consent documents
Requires single IRB review for multi-site studies as of January 19, 2020
  • The UW Health Sciences IRBs have been a national leader in the development of single IRB review and anticipated this requirement by setting up statewide and regional IRB consortia, contracting with independent IRBs to oversee industry-generated and industry-sponsored research, and helping to develop and launch SMART IRB, which includes a master IRB authorization agreement, informatics tools to support reliance arrangements, and other resources in support of single IRB review
  • Updating ARROW to improve the application to cede review to other institutions (including those that will be reviewed by independent IRBs) and the application to allow the UW to serve as the Reviewing IRB for other institutions
  • Working with RSP to develop guidance and processes to accommodate the NIH Single IRB Policy that will go into effect on January 25, 2018
  • Review Single IRB Basics to become familiar with these requirements
  • Contact the UW Health Sciences IRBs Reliance Team at irbreliance@wisc.edu for help or guidance in working with other institutions to set up reliance arrangements

Keywords:Common Rule, exemptions, sIRB, single IRB   Doc ID:77150
Owner:Faye L.Group:Health Sciences IRBs
Created:2017-10-03 12:37 CSTUpdated:2018-03-28 15:38 CST
Sites:Health Sciences IRBs
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