The New Common Rule is here!
The revised Common Rule (45 CFR 46 Subpart A) will become effective on January 21, 2019.
All new studies submitted on IRBNet on or after January 21, 2019 must comply with the new regulations. This applies to faculty who have NOT transitioned to the NYU School of Medicine Faculty Group Practice.
Studies that were approved under the current Common Rule (that is, they were approved prior to January 21, 2019) will not be switched over to the revised Common Rule, unless the researcher chooses to switch (after January 21, 2019 and at the time of the study's continuing review). This switching over may be advantageous for many studies.
There are three main areas of change:
New categories for exemption have been created and some of the existing categories have been modified or clarified. §46.104
Click here for new exemption categories.
Continuing Review may not be required in the following circumstances:
- studies approved through an expedited mechanism
- studies approved by the full board once subject interaction is completed
The NYU Winthrop IRB will make determinations on whether continuing review is required at the next review of either a modification or submitted continuing review.
Note: Modifications cannot be submitted solely to convert to a "no renewal" status. §46.109(f)(l)
Consent Process and Forms
Key Information in Consent Forms
The new rule states that the informed consent must begin with a "concise and focused presentation of the key information" that would help assist subjects in understand the reason why they may or may not participate in the research. It needs to be organized and presented in a way that facilitates comprehension.
Guidance on the summary is available. §46.116(a)
Elements of Informed Consent
Addtional items have been added to the required and additional elements of informed consent. These new elements will be expected in consent forms approved after January 21, 2019.
The new language relates to future use of identifable information or specimans, use of the specimens, commercialization, return of results and whole genome requencing. §46.116(b)(c)
Waiver of Informed Consent
An additional criterion has been added that requires investigators to justify the use of identifiable biospecimens. §46.116(f)
A waiver of informed consent is no longer necessary for screening or recruitment procedures as long as the IRB approves the procedures as a part of the protocol. §46.116(g)
The revised Standard Informed Consent Template, Full/Expedited, Exempt, and Continuing Review Applications, and their corresponding Checklists will be made available on IRBNet on Friday, January 18, 2019.
Major Regulatory Changes
The Revised Common Rule removes the requirement for continuing review for minimal risk research and for full-board research that is in long-term follow-up or data analysis only, unless the research is FDA-regulated.
New Exempt Categories and revisions to existing exemptions: For details, see the NYUWH IRB Exempt Research decision Trees.
Limited IRB Review
When reviewing the exempt categories 2 and 3 the limited IRB review assures adequate protections for the privacy of subjects and adequate plans to maintain the confidentiality of the data.
The term “Broad Consent” as defined by the Common Rule implemented in 2018 applies to consent for storage and secondary research of identifiable private information or biospecimens. This concept must be implemented on an institutional level and requires tracking of individuals who decline to provide consent. Because there is no guidance from OHRP and because of the implications of tracking individuals who do not provide consent and excluding their data from all future research, NYUWH is not pursuing broad consent at this time. Investigators can continue to use biospecimens that are coded or to seek a waiver of consent for use of biospecimens with identifiers retained consistent with current practices.
Consent Documents must begin with a concise and focused presentation of key information that participants want in order to make a decision (e.g., statement that the project is research and that participation is voluntary and a summary of the purpose, duration, procedures, risks, discomforts, benefits, appropriate alternatives, costs and payment). This summary will be included in a revised informed consent template.
New elements of informed consent must be included (when applicable):
- Potential for future use of deidentified information
- Potential for commercial profit and sharing of profits with subjects
- Whether clinically relevant research results will be disclosed to subjects and, if so, under what conditions
- For research involving biospecimens, whether the research will involve whole genome sequencing
- Certain clinical trial consent forms must be posted on a government website. This requirement applies to studies that are conducted or supported by a federal agency. The posting must occur no more than 60 days after the last study visit by any subject. The specific government website has not yet been named.
Single IRB-of-Record (sIRB)
The new Common Rule states that federally funded studies where the same protocol will be conducted at more than one domestic site must use a single IRB. The single IRB provision is effective for grant applications received for due dates on or after January 25, 2018. For contracts, the policy applies to all solicitations issued on or after January 25, 2018. When developing the budget for your research grant, you should take into account the possible costs related to using a single IRB. Additional information about NIH single IRB requirements can be found on the NIH Single IRB for Multi-site Research FAQs page.
What to Expect
For new studies, expect to see:
- IRB application changes
- Informed consent template revisions
- IRB Policy & Procedures Manual updates
Decisions Made to Date (posted 03/31/2018)
Existing Full Board Protocols – Protocols that were reviewed by a full board and are open to enrollment or still in an intervention phase will see the fewest changes under the new Common Rule. At the time of the next renewal that occurs after 7/19/18, you will be requested to update the waiver and consent form to meet the new requirements.
Existing Expedited Protocols – Most studies that were originally expedited by the IRB under the old rule will now be eligible for less frequent review beginning on 7/19/18. At the time of the next renewal that occurs after 7/19/18, you will be requested to update the waiver and consent form to meet the new requirements.
Existing Exemption Protocols – There will be no changes to these protocols. If you have an exempt study that has ended, it is important to close the study with the IRB.
sIRB – NYU Winthrop Hospital (NYUWH) will continue to assess its criteria for whether NYUWH will serve as the single IRB-of-Record or cede review to another institution or a commercial IRB.
Broad Consent – NYUWH will not implement the new regulatory "Broad Consent" option as an informed consent process at this time. Exemptions 7 & 8, which rely on Broad Consent, also will not be implemented.
What You Can Do
- Check this web page periodically for new information. We will continue to add information, as it becomes available.
NIH Regulatory Changes
The National Institutes of Health (NIH) is implementing a variation of the Single IRB-of-Record policy beginning January 25, 2018. The NIH sIRB policy applies to:
- NIH-sponsored multi-site studies, where the same protocol is used at multiple sites
- Domestic research only
Read our IRB Winter Newsletter for more information.
NIH Clinical Trial Policies
The NIH has issued several other policies and guidance designed to "enhance the accountability and transparency of clinical research":
Where to Find Help
To help you identify whether your NIH-funded research would be considered a clinical trial under this definition and, therefore, subject to all the related policies (e.g., NIH sIRB, ClinicalTrials.gov registration and reporting, etc.), the NIH offers the following resources:
View video on the Overview of New NIH Policies on Human Subjects Research.