Changes to Human Subjects Regulations and Policies

This page provides details about the changes to the Common Rule.


After several delays to the implementation of the revised Common Rule, the updated regulations went into effect on January 21, 2019. In preparation for the revised Common Rule, campus policy was revised to allow the IRBs to implement most of the provisions within the revised Common Rule for studies that are not FDA-regulated or were not federally funded. As of January 21, 2019 we can extend these policies to federally supported research that ARE NOT FDA-regulated. Although the FDA is working on harmonizing its regulations with the revised Common Rule, the agency has not announced any updates. The revised Common Rule will be applied to human subjects research as follows: SUMMARY OF KEY CHANGES TO THE COMMON RULE AND IMPLEMENTATION PLAN

The major revisions and some helpful guidance for study teams related to the implementation are outlined below.

The definition of human subject now encompasses obtaining, using, studying or analyzing private identifiable information or identifiable biospecimens. Because the UW-Madison already applied the definition of human subjects to encompass these activities, this update should not represent a significant change for study teams.
Continuing review no longer required for many categories of minimal risk research or for research that is not FDA-regulated where the only remaining activity is the analysis of identifiable data/biospecimens or activity to obtain follow-up clinical data. For studies approved on or after January 21, 2019, the IRB will determine whether the research qualifies for being excused from continuing review at initial review and at subsequent continuing reviews if the study become eligible to be excused (e.g., enters a data or specimen analysis phase).
  • 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.
  • Even when research is excused from continuing review, 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

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.

Exemption Category 1 for research conducted in established or commonly accepted educational settings.
Update: Now includes an additional eligibility criterion for a project to qualify for exemption, which is that the research must specifically involve “normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction.”

Exemption Category 2 Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording).
Update: Now expanded to include the collection of sensitive and identifiable data if the IRB determines that privacy and security provisions are adequate. The following are not allowed under this exemption category:
  • Interventions
  • The collection of biospecimens
  • Linking to additional personally-identifiable data
  • Research with children (except for educational tests or some public observation)
Exemption Category 3 for benign behavioral interventions, which permits data collection via an interaction (e.g., survey, interview, audio/visual recording) from adult subjects with prospective agreement.
Update: This is a new category and replaces the prior category 3 exemption. The following are not allowed under this exemption category:
Exemption Category 4 for secondary research on information and biospecimens
Update: This is similar to the prior version of Category 4, but with some important changes to allow
Exemption Category 5 for federal demonstration projects designed to study or evaluate public benefit/service programs
Update: This category remains largely unchanged, but it now includes a new eligibility criterion that the project must be published on a federal website.

Exemption Category 6 for taste and food quality evaluation and consumer acceptance studies
Update: No changes were made to this category.

Exemption Category 7 and Exemption Category 8, which are new categories that can be used when Broad Consent is obtained. The UW-Madison will not implement these categories at this time (see below).
Several changes related to informed consent documents, 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 released, and whether the biospecimens might be used for who genome sequencing

Other changes related to informed consent:

Changes related to the secondary use of identifiable information or biospecimens, including addition of a Broad Consent provision. The revised Common Rule includes a provision for the institutional use of Broad Consent for the future use of identifiable biospecimens and identifiable information. Broad Consent does not replace the existing framework used by the IRBs to approve the storage, maintenance, and secondary use of identifiable biospecimens and information for future, yet-to-be specified research. Rather, Broad Consent is an optional alternative consent process. In other words, researchers can continue to store and maintain identifiable biospecimens and information with participant consent, and future research use of such biospecimens or information may occur with consent or an IRB waiver of consent, as appropriate.

Broad Consent allows for the storage and maintenance for secondary research, and the secondary research itself, to quality for an exemption under new category 7 and 8 respectively, if Broad Consent was previously obtained. However, Broad Consent also requires the research team or repository to track participant consent or refusal to consent across the entire institution. An IRB may not waive consent thereafter when a participant refuses Broad Consent.

To utilize Broad Consent, the study team and/or the unit/biorepository responsible for the storage of the identifiable information/biospecimens are required to:
The IRB must also conduct what is termed “limited IRB review” to ensure that certain regulatory requirements for the Broad Consent are met, including that Broad Consent is documented and the proposed research falls with the scope of the Broad Consent provided.

Because the definition and implications of Broad Consent are unclear and the tracking requirements may be burdensome and impracticable, the UW-Madison will not implement Broad Consent at this time, which includes new exemption categories 7 and 8, which rely on Broad Consent.

Guidance: There are other ways study teams can seek subject permission for the collection and storage of identifiable private information/biospecimens for future secondary use research through the following processes, such as:

Single IRB review will be required for all non-exempt federally supported multi-site studies as of January 19, 2020. This requirement is in addition to the NIH Single IRB policy that was implemented in January 2018 and means that research teams should need to work with the ED/SBS IRB Office to help identify the appropriate IRB to oversee any federally supported collaborative research.