Upcoming Changes to Human Subjects Regulations and Policies
REVISED COMMON RULE EFFECTIVE JANUARY 21, 2019
The updated common rule is now in effect January 21, 2019. In preparation for the revised Common Rule, campus policies were previously revised to allow the IRBs to implement most of the provisions 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:
- For studies that are FDA-regulated: In the case of federally supported research that is FDA-regulated, studies will be transitioned to the revised Common Rule to the extent the regulations are compatible with FDA regulations if approved by a Health Sciences IRB on or after January 21, 2019. Otherwise, FDA-regulated research will not be transitioned to the revised Common Rule. Of note, FDA-regulated research cannot be excused from continuing review requirements until the FDA harmonizes its regulations with the revised Common Rule.
- For studies approved by a Health Sciences IRB by January 21, 2019 that are not FDA-regulated: the Health Sciences IRBs office will work with the study team to determine if transitioning the study to the revised Common Rule will reduce burden on the study team and, if so, help the study team bring the research in compliance with the new regulations. Note that for many studies, transitioning them to the revised Common Rule will increase the burden on the research team (e.g., because of requirements to post informed consent documents; new informed consent format and content; additional requirements for waivers of informed consent), and thus should not be moved to the revised Common Rule. To help the IRB and study teams identify when a study should be transitioned and what updates may be required to do so, we developed a Guide for Considering Whether Non-Exempt Research Approved by the IRB Prior to January 21, 2019 should be Transitioned to the Revised Common Rule. If, after using this decision tool, you think your study should be considered for transition to the revised Common Rule, please email firstname.lastname@example.org to request consideration and include the UW-Madison IRB number, name of Principal Investigator, and study title.
- For studies determined by a Health Sciences IRB to be exempt human subjects research prior to January 21, 2019: no transition needed.
- For studies not yet approved or determined to be exempt by a Health Sciences IRB by January 21, 2019: the Health Sciences IRBs will apply the revised Common Rule to any non-FDA-regulated studies that are under review or have been submitted for review on or after January 21, 2019.
Common Rule Changes
Summary of key changes to the common rule and implementation plan
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).
NOTE: 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.
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:
- 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:
- 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
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
- 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.
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 subjects in understanding the reasons why they 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 uses or commercial profit, whether clinically relevant results will be obtained and released to subjects, and whether the biospecimens might be used for whole genome sequencing
For non-exempt initial reviews:
- Begin using the revised templates the UW HS IRBs posted when possible and use 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
Other changes related to informed consent:
- Requirement to post some consent forms: For each clinical trial conducted or supported by a Federal department or agency, one IRB-approved consent form used to enroll subjects must be posted by the awardee on a designated Federal public website
- 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. See below for more details and the UW-Madison’s current position on broad consent.
- 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.
1. The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative; or
2. The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.
- Additional situation when an IRB can waive the need for documented informed consent: The current Common Rule allows an IRB to grant waivers of documentation of informed consent when a) the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality or b) the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. In addition to these situations, the revised Common Rule now permits IRBs to waive the requirement for researchers to document informed consent for minimal risk research if subjects or their legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm and there is an appropriate alternative mechanism for the study team to document that informed consent was obtained.
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 use Broad Consent, the study team and/or the unit/biorepository responsible for the storage of the identifiable information/biospecimens are required to:
- 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
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.
Although UW—Madison will not be implementing Broad Consent at this time, study teams have other options for seeking subject permission for the collection and storage of identifiable private information/biospecimens for future secondary use research, such as:
- Study-specific consent for the future use with IRB review and approval
- IRB waiver of consent for the secondary use of identifiable private information/biospecimens 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 (not 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. Research teams should work with the UW-Madison Health Sciences IRBs Office to help identify the appropriate IRB to oversee any federally supported collaborative research.
- Review Single IRB Basics to become familiar with these requirements
- See the Single IRB Guidance for UW Research Administrators and How the Reliance Team Can Help with the NIH Single IRB Policy, although these documents are directed at NIH grant preparation it has useful single IRB tips.
- Contact the UW Health Sciences IRBs Reliance Team at email@example.com for help or guidance in working with other institutions to set up reliance arrangements