Upcoming Changes to Human Subjects Regulations and Policies

Revised Common Rule Expected in January 2018

Some revisions to the Common Rule (aka the Federal Policy for the Protection of Human Subjects) are expected to go into effect January 19, 2018 and the UW-Madison IRBs are proactively preparing for these changes. The revised Common Rule reduces IRB and other oversight for many research studies involving human subjects that can be classified as minimal risk. Of note, the Food and Drug Administration (FDA) has not issued revised regulations and thus any FDA-regulated research will not be affected by the revisions to the Common Rule. To learn more about these changes, please sign up for one of our upcoming information sessions:

  • Thursday, November 16: 1:30pm - 3:00 pm, 1325 HSLC, register here
  • Thursday, December 14: 11:30am - 1:00 pm, 1220 HSLC, register here

Implementation of the Revised Common Rule

The Department of Health and Human Services requested a delay in implementation of some of the proposed revisions to the Common Rule, but has not identified which aspects of the revised Common Rule would go into effect in 2018 and which would be delayed, if the request is approved, until 2019. The UW-Madison IRBs will begin applying those components of the revised Common Rule that will go into effect in 2018 to new studies approved on or after January 19, 2018 and that are not FDA-regulated. This means that the IRBs may need to apply these new requirements for studies submitted for initial approval prior to the implementation date but for which IRB approval will not be issued until after the implementation date. IRB staff will work closely with study teams to identify the best implementation strategy for each initial review submission.

For studies that were approved prior to January 19, 2018, the UW-Madison is not required to apply the revised Common Rule. However, in some cases moving a study from the prior version of the regulations to the new may be advantageous to the study team. IRB staff will work closely with study teams to identify whether transition to the revised Common Rule is the best strategy for already approved studies.

Summary of Key Changes to the Common Rule

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.

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
  • 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
  • Updating the ARROW application and workflow 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
  • 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 non-exempt medical records research as an exemption application

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 5 pages or fewer will be considered to meet the new Common Rule requirements for presentation of key information
  • For consent documents 5 pages or longer, the UW IRBs already comply with this new component of the informed consent regulations by requiring either an information sheet or executive summary for consent documents > 5 pages long
  • The UW Health Sciences IRBs already 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 IRBs will develop guidance about posting consent forms (e.g., which studies must comply as well as when and where they should be posted)
  • We are working on guidance regarding and a template consent form to allow study teams to leverage broad consent when appropriate
  • For non-exempt initial reviews:
    • In the case of shorter consent forms, begin using the revised templates the UW HS IRBs posted
    • For consent documents > 5 pages long, begin using the information sheet content and structure for your consent documents, including additional language as needed after the elements identified in the information sheet have been addressed
    • 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@medicine.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:Tesha Z.Group:Health Sciences IRBs
Created:2017-10-03 12:37 CSTUpdated:2017-10-19 09:22 CST
Sites:Health Sciences IRBs
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