Common Rule Changes
Common Rule Changes
Major Regulation Changes
Final Revisions to the Federal Policy for the Protection of Human Subjects (a.k.a. the “Common Rule”) were issued to the Department of Health and Human Services (HHS). Changes are in effect on January 21, 2019.
- Continuing Review - No longer required for some minimal risk research, including studies where the only remaining activity is the analysis of identifiable data/biospecimens or activity to obtain follow-up clinical data. Additional details are available here.
- Exemptions - New categories and clarification of existing categories. Some exemptions may require "limited IRB review" (similar to an expedited review process. Although exemptions have changed, determinations of exemption must be made by a designated reviewer of the IRB.
- Informed Consent - A new "Key Elements" section and a rearrangement of content is designed to facilitate a potential subject's decision to participate or not. Updated informed consent templates will be available on the IRB website. Please note that there is now a secondary informed consent document with standard language that may be used for varying circumstances (i.e., your research meets the definition of clinical trial, your research includes randomization, you research involves the use of students, etc.) Additional details are available here.
- Future Change Single IRB-of-Record (sIRB) - IRB oversight for most federally-funded collaborative research projects located in the U.S. will be required to use a single IRB (commercial, academic, or hospital-based) starting January 20, 2020. At this time, the default position for UCCS regarding NIH sIRB is to cede oversight to an external IRB. This external IRB could be either a commercial IRB or another academic partner. Please note that the fees for an external IRB, if utilized, must be included in the proposal budget.
- Revised Office of Human Research Protection Common Rule helpful Q&A.
Processes and Other Changes
- IRB application updated
- Informed consent template updated
- Researcher Manual updated
- IRB standard operating procedure updated
- At this time, the default position for UCCS regarding the NIH Single IRB requirement is to cede oversight to an external IRB.
For existing studies, after the implementation of the Common Rule the UCCS IRB may choose to apply the new rules to minimize burden for investigators.
UCCS Implementation of Continuing Review Changes
Effective January 21, 2019, Continuing Review will no longer be required for:
- Most studies that qualify for the expedited review process (this determination is made by the IRB).
- Studies (regardless of review path) that have completed subject intervention/interaction and in which activity is limited to either final analysis of identifiable data/biospecimens or involve accessing follow-up clinical data from procedures that subjects undergo as part of clinical care.
Note: Studies qualifying for expedited review must be of no more than minimal risk and meet one of the OHRP Expedited Review Categories.
Eliminating continuing review for qualifying minimal-risk research reduces administrative burden for both the study team and IRB staff without impact to the human subjects.
UCCS Transition Process for Continuing Review
For existing expedited studies that are approved on or before January 21, 2019 and for full board studies that no longer involve subject intervention/interaction, the IRB will evaluate the need for continuing review at the time of the next Renewal Application submission.
For new studies approved via expedited review on or after January 21, 2019, the IRB reviewer will determine the need for continuing review. Most expedited studies will not require continuing review. Some reasons for maintaining the continuing review requirement include:
- The project is regulated by the Food & Drug Administration (FDA) or by another sponsor that requires continuing review
- The project involves additional regulatory oversight, such as conflict of interest (COI) management
- An amendment or incident report reveals new findings that require additional oversight
- The investigator has had previous serious non-compliance or a pattern of non-serious non-compliance
New Process: Annual Reminder of Study Team Responsibilities and Status Check
Even when continuing review is not required for a project, the study team must still:
- Submit Requests for Change for project changes,
- Report Unanticipated Events/Deviations, and
- Complete the Annual Status Check.
In the absence of the Renewal process for qualified expedited studies, UCCS will implement an annual email reminding the study team of these responsibilities and requesting a status update of the research. The email will be sent prior to the anniversary approval date for the study.
The IRB may re-evaluate its Continuing Review decision for a project depending on the type of change(s) proposed in an amendment (e.g., protocol change that increases subject risk), or as an outcome of the IRB's review of Adverse Events or Deviations.
UCCS Implementation of Informed Consent Changes
Effective January 21, 2019, the requirements for informed consent will change, with the addition of:
- "Key information" to be presented at the beginning of the consent form
- New consent elements
- Changes to waiver criteria and documentation (plus other process changes)
- A "broad consent" option for unspecified future use of identifiable data/bisopecimens. At this time, the UCCS IRB will not mandate nor implement the institutional use of Broad Consent, as the tracking requirements may be burdensome. Exemption categories 7 and 8 will also not be implemented.
The intent of these changes is to facilitate the subjects' understanding of the proposed research and also ensure that they understand how their data and biospecimens may be used.
The preamble to the Final Rule (revised) lists five (5) factors as suggested "key information" that would likely assist a potential subject in understanding the nature of the project and in determining participation.
How a study team applies the "key information" requirement, and to what level of detail, will depend on the complexity of the research project. Many social/behavioral research projects already employ a brief informed consent document, so including a "key information" section may be redundant. The Final Rule preamble includes some considerations regarding the application of this requirement, but further federal guidance is expected at a later date.
New Consent Elements
Below is a summary of new consent elements. Please note that the changes have been incorporated into the Standard Informed Consent Language document on the IRB website.
|When your project will involve...||Include in the informed consent...|
|The collection of identifiable private information or||A statement indicating whether:|
|identifiable biospecimens||● identifiers may be removed, and|
|● de-identified information or biospecimens may or may not be|
|used or shared for future research|
|Use of biospecimens||A statement indicating whether:|
|● biospecimens may be used for commercial profit, and|
|● the subject will share in that profit|
|Clinically relevant results||A statement indicating whether the clinical results, including individual research results, will be returned to the subject, and if so, under what conditions|
|Whole genome sequencing||A statement indicating that the research will or might include|
|(i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen)||whole genome sequencing|
Consent Process Changes
- A waiver of informed consent for the secondary use of identifiable private information/biospecimens (not covered by Broad Consent) must justify why the use of identifiers is necessary to carry out the research.
- Use of identifiable information/biospecimens to identify potential subjects (i.e., screening for recruitment purposes) is allowed without informed consent under certain circumstances. A waiver of consent will no longer be needed for these screening activities. Please note that an IRB approval must be in place to approve the screening as part of the recruitment process prior to the screening occurring.
Note: HIPAA requirements will still apply, if applicable. Those working with the Lane Center should contact the Privacy Officer before accessing any medical records to ensure compliance.
For federally-sponsored clinical trials, a copy of the consent form must be posted to a "publicly available, federal website" (TBD) post-recruitment and no later than 60 days after the last study visit by any subject.
At this time, the UCCS IRB will not mandate nor implement the institutional use of Broad Consent, as the tracking requirements may be burdensome. Exemption categories 7 and 8 will also not be implemented. UCCS will continue to support study teams seeking subject permission for the collection and storage of identifiable private information/biospecimens for future secondary use research through the following processes:
- Study-specific consent and comprehensive IRB review
- IRB waiver of consent (as eligible) and comprehensive IRB review
- Exemption #4
- De-identification to remove the research activity from Common Rule purview and not require IRB review or consent
UCCS Transition Process
Informed Consent Templates
Updated informed consent templates will be available on the IRB website. Study teams should begin using the updated informed consent templates as soon as they are available on the website.
New studies submitted for IRB review after January 21, 2019 may be required to utilize an updated informed consent template to ensure compliance with the revised Common Rule.
Questions? Contact the IRB at firstname.lastname@example.org