Changes to Human Subjects Regulations and Policies
This page provides details about the changes to the Common Rule.
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.
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).
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:
Update: This is a new category and replaces the prior category 3 exemption. The following are not allowed under this exemption category:
- Research with children
- Deception, unless prior agreement obtained
- Physiological data collection methods (e.g., EEG; wearable devices; blood pressure monitors)
- Linking to additional personally-identifiable data
Update: This is similar to the prior version of Category 4, but with some important changes to allow
- prospective data review
- maintenance of identifiers if all study data is protected health information (i.e., governed by the HIPAA Privacy Rule)
- research that is conducted by, or on behalf of, a Federal department/agency or using government-generated or government-collected information obtained for non-research activities.
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:
- Requirement to post some consent forms: One IRB-approved consent form used to enroll subjects must be posted by the awardee on a designated Federal public website for each clinical trial conducted or supported by a Federal department or agency.
- Limits on waivers or alterations of informed consent: The revised Common Rule allows the use of "broad consent" for the collection and use of identifiable private information and identifiable biospecimens for future research in limited situations but also includes limits on waivers or alterations of informed consent when broad consent used.
- Additional criterion for waivers of informed consent: For researchers to use identifiable information or identifiable biospecimens, IRBs are now required to determine if research involving identifiable information or biospecimens could not be practicably carried out using non-identifiable information or biospecimens.
- Elimination of the need for a waiver of informed consent for screening, recruiting, or determining eligibility: An IRB may now approve a research study in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective subjects without the informed consent of the prospective subject or the subject's legally authorized representative, if either of the following conditions are met:
- The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative; or
- The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.
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.
- identify the types of research that may be conducted with the information/biospecimens,
- record and track who has agreed to or refused consent, and
- to track the terms of consent to determine whether proposed future secondary research use falls within the scope of the identified types of research
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.
- Study-specific consent or the future use with IRB review and approval
- IRB waiver of consent for the secondary use of identifiable private information/biospeciments → the revised Common Rule now requires IRBs to determine if research involving identifiable information or biospecimens could not be practicably carried out using non-identifiable information or biospecimens
- Using the new exemption category #4
- Can be used for identifiable health information (no biospecimens) protected under the HIPAA Privacy Rule
- Can be used for coded information or biospecimens when the researcher does not have access to the code (e.g., when held by an honest broker)
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.
- See the Single IRB Guidance for UW Research Administrators, although this document is directed at NIH grant preparation it has useful single IRB tips.
- Contact the ED/SBS IRB for help or guidance in working with other institutions to set up reliance arrangements. The ED/SBS IRB will be updating and documents to our website to include more information about the single IRB mandate that will go into effect in January 2020.