Federal Agencies Propose to Further Delay Implementation of Sweeping Revisions to the “Common Rule”—but Offer Incentives for Institutions Willing to Transition Existing Research Projects

by K&L Gates LLP

K&L Gates LLP

On April 20, 2018, as anticipated, 17 federal departments and agencies (the “Agencies”) [1] issued a notice of proposed rulemaking (“2018 NPRM”) in which the Agencies propose a six-month delay to the general compliance date for the updated Federal Policy for the Protection of Human Subjects (the “Common Rule”), from July 19, 2018 until January 21, 2019. [2]

The Common Rule is designed to protect human subjects in connection with research conducted or supported by one of the Agencies. The Common Rule requirements are codified at various places, including, for example, 45 C.F.R. Part 46. The Common Rule applies only to:

  1. Human subject research; and
  2. Research either conducted or supported by the federal government or otherwise covered by a U.S. Department of Health and Human Services Office for Human Research Protection-approved federal-wide assurance.

The Agencies also propose that institutions may elect to voluntarily transition existing research projects to the new Common Rule requirements once those requirements go into effect on January 21, 2019. Under the proposal, institutions that make this election could, during the six-month interim period from July 19, 2018 to January 21, 2019, adopt three burden-reducing provisions, discussed in more detail below, that are lifted from the provisions that are otherwise being delayed. Alternatively, an institution can choose to forego the three burden-reducing provisions and continue to have existing research projects be subject to current Common Rule requirements (i.e., even past January 21, 2019).


The Agencies made sweeping revisions to the Common Rule in a final rule published on January 19, 2017 (the “2018 Requirements”). [3] The 2018 Requirements defined new categories of research as exempt from Institutional Review Board (“IRB”) review, altered patient consent requirements, imposed a new provision for broad consent for future research, and made multiple additional changes to IRB requirements. For a more detailed discussion of the 2018 Requirements, see our January 22, 2018 alert, “Federal Agencies Delay Implementation of Common Rule Requirements.” [4]

The 2018 Requirements were to take effect on January 19, 2018 (with the exception of the revisions to the cooperative research provision.) However, on January 17, 2018, the Agencies published an interim final rule delaying the effective date and general compliance date for the 2018 Requirements for six months, from January 19, 2018 until July 19, 2018. The interim final rule also stated that the Agencies anticipated issuing additional rulemaking to further extend the compliance date, which has now come to fruition with the 2018 NPRM to delay the general compliance date for the 2018 Requirements for an additional six months, from July 19, 2018 until January 21, 2019.

2018 NPRM Burden-Reducing Provisions and Delay of Implementation

Recognizing the complexity involved with implementing the revised Common Rule, the Agencies propose in the 2018 NPRM to provide additional time for regulated entities to prepare for the implementation of the 2018 Requirements.

The 2018 NPRM, if finalized, would require regulated entities to continue to comply with the requirements of the current Common Rule (hereafter, the “pre-2018 Requirements”) until January 21, 2019. Research initiated (i.e., initially approved by an IRB, or for which IRB review was waived pursuant to § 46.101(i), or determined to be exempt) on or after January 21, 2019, would need to be conducted entirely in compliance with the 2018 Requirements. However, research initiated before January 21, 2019, would, by default, continue to be subject to the pre-2018 Requirements for the duration of the research.

Significantly, however, the 2018 NPRM proposes to allow institutions to elect to take advantage of three burden-reducing provisions in the 2018 Requirements for existing research projects if they document that election between July 19, 2018 and January 21, 2019, and agree, after January 21, 2019, to transition those projects to the 2018 Requirements. (Note that, except for the three burden-reducing 2018 Requirements, institutions that choose the option between July 19, 2018 and January 21, 2019, will still be required to comply with the pre-2018 Requirements until January 21, 2019.)

The first-available burden-reducing provision is the use of the 2018 Requirements’ definition of “research,” which deems certain activities not to be research subject to IRB review and approval. Specifically, the 2018 Requirements exclude four categories of endeavor from the definition of research:

  1. Scholarly and journalistic activities, including the collection and use of information that focuses directly on the specific individuals about whom the information is collected; [5]
  2. Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority; [6]
  3. Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes; [7] an
  4. Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions. [8]

The second-available burden-reducing provision is the relaxation of the need for annual continuing review of the following categories of research, unless an IRB determines otherwise:

  1. Research eligible for expedited review (in accord with 45 C.F.R. § 46.110);
  2. Research given limited IRB review (as described in 45 C.F.R. § 46.104(d)(2)(iii)); and
  3. Research that is part of an IRB-approved study and has progressed to the point that it involves only one or both of the following:

    1. data analysis, including analysis of identifiable private information or identifiable biospecimens; or
    2. assessing follow-up clinical data from procedures that subjects would undergo as part of standard care for their medical condition.

The third-available burden-reducing provision is the elimination of the requirement that IRBs review grant applications as well as funded research grants.

Institutions can elect to take advantage of the burden-reducing provisions for ongoing studies, as well as for studies newly initiated after July 19, 2018, at any time between July 19, 2018 and January 21, 2019. An institution may elect to implement the three burden-reducing provisions on a protocol-by-protocol basis, for a class of protocols (e.g., all minimal risk research), or for the institution’s entire research portfolio. An institution could also elect as a matter of institutional policy to adopt a more stringent standard in the interim period (provided pre-2018 Requirements continue to be met).

The 2018 NPRM does require that where an institution opts for the three burden-reducing provisions, it must follow the 2018 Requirements effective January 21, 2019. Thus, as the commentary in the 2018 NPRM notes, an institution’s decision on whether to transition a study to the 2018 Requirements to take advantage of the three burden-reducing provisions may vary depending on the “nature and progress” of the study, including whether study activity that would be affected by the 2018 Requirements is expected to extend beyond January 21, 2019. For example, ongoing studies planning to recruit additional subjects on or after January 21, 2019, will be subject to the 2018 Requirements for obtaining informed consent if the institution elects to transition to the 2018 Requirements, which may caution against electing to transition.

In summary, the proposed rule would create three options, available beginning July 19, 2018, that institutions may choose to follow for research studies initiated before January 21, 2019. The first option, and the default one, is to continue to follow all of the pre-2018 Requirements for the duration of a research study. The second option is to choose to follow the pre-2018 Requirements, except for the three burden-reducing 2018 Requirements, until January 21, 2019, when all of 2018 Requirements would become applicable. The third option would be to follow the pre-2018 Requirements beyond January 21, 2019, but at some point thereafter choose to follow all of the 2018 Requirements for the duration of a research study.

Solicitation of Additional Comments

Additionally, the 2018 NPRM solicits comments on the following topics:

  • The advisability of the alternative of delaying the effective date and general compliance date until January 21, 2019, but without the option to implement certain 2018 Requirements during that delay period;
  • The desirability of the alternative of delaying the effective date and general compliance date beyond January 21, 2019; and
  • The advisability of not making the changes proposed in the 2018 NPRM (i.e., allowing the effective date and general compliance date to remain as July 19, 2018).

Comments to the Agencies on the 2018 NPRM are due on or before May 21, 2018, to be ensured consideration. Given the Agencies’ past activity and prior statements that they would seek further delays, the likelihood of the Agencies adhering to the July 19, 2018 effective date seems low, and indeed, it is quite possible that further refinements or delays of the 2018 Requirements could be implemented between now and January 21, 2019.

[1] The Agencies include the Department of Homeland Security; Department of Agriculture; Department of Energy; National Aeronautics and Space Administration; Department of Commerce; Consumer Product Safety Commission; Social Security Administration; Agency for International Development; Department of Housing and Urban Development; Department of Labor; Department of Defense; Department of Education; Department of Veterans Affairs; Environmental Protection Agency; Department of Health and Human Services; National Science Foundation; and Department of Transportation.

[2] 83 Fed. Reg. 17595 (April 20, 2018), https://www.federalregister.gov/documents/2018/04/20/2018-08231/federal-policy-for-the-protection-of-human-subjects-proposed-six-month-delay-of-the-general.

[3] 82 Fed. Reg. 7149 (Jan. 19, 2017), https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf.

[4] http://www.klgateshub.com/details/?pub=Federal-Agencies-Delay-Implementation-of-Common-Rule-Revisions-01-22-2018.

[5] 45 C.F.R. § 46.102(l)(1) (effective January 21, 2019).

[6] Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters). 45 C.F.R. § 46.102(l)(2) (effective January 21, 2019).

[7] Id. at (l)(3) (effective January 21, 2019).

[8] Id. at (l)(4) (effective January 21, 2019).


Written by:

K&L Gates LLP

K&L Gates LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide

JD Supra Privacy Policy

Updated: May 25, 2018:

JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.

This Privacy Policy describes how JD Supra, LLC ("JD Supra" or "we," "us," or "our") collects, uses and shares personal data collected from visitors to our website (located at www.jdsupra.com) (our "Website") who view only publicly-available content as well as subscribers to our services (such as our email digests or author tools)(our "Services"). By using our Website and registering for one of our Services, you are agreeing to the terms of this Privacy Policy.

Please note that if you subscribe to one of our Services, you can make choices about how we collect, use and share your information through our Privacy Center under the "My Account" dashboard (available if you are logged into your JD Supra account).

Collection of Information

Registration Information. When you register with JD Supra for our Website and Services, either as an author or as a subscriber, you will be asked to provide identifying information to create your JD Supra account ("Registration Data"), such as your:

  • Email
  • First Name
  • Last Name
  • Company Name
  • Company Industry
  • Title
  • Country

Other Information: We also collect other information you may voluntarily provide. This may include content you provide for publication. We may also receive your communications with others through our Website and Services (such as contacting an author through our Website) or communications directly with us (such as through email, feedback or other forms or social media). If you are a subscribed user, we will also collect your user preferences, such as the types of articles you would like to read.

Information from third parties (such as, from your employer or LinkedIn): We may also receive information about you from third party sources. For example, your employer may provide your information to us, such as in connection with an article submitted by your employer for publication. If you choose to use LinkedIn to subscribe to our Website and Services, we also collect information related to your LinkedIn account and profile.

Your interactions with our Website and Services: As is true of most websites, we gather certain information automatically. This information includes IP addresses, browser type, Internet service provider (ISP), referring/exit pages, operating system, date/time stamp and clickstream data. We use this information to analyze trends, to administer the Website and our Services, to improve the content and performance of our Website and Services, and to track users' movements around the site. We may also link this automatically-collected data to personal information, for example, to inform authors about who has read their articles. Some of this data is collected through information sent by your web browser. We also use cookies and other tracking technologies to collect this information. To learn more about cookies and other tracking technologies that JD Supra may use on our Website and Services please see our "Cookies Guide" page.

How do we use this information?

We use the information and data we collect principally in order to provide our Website and Services. More specifically, we may use your personal information to:

  • Operate our Website and Services and publish content;
  • Distribute content to you in accordance with your preferences as well as to provide other notifications to you (for example, updates about our policies and terms);
  • Measure readership and usage of the Website and Services;
  • Communicate with you regarding your questions and requests;
  • Authenticate users and to provide for the safety and security of our Website and Services;
  • Conduct research and similar activities to improve our Website and Services; and
  • Comply with our legal and regulatory responsibilities and to enforce our rights.

How is your information shared?

  • Content and other public information (such as an author profile) is shared on our Website and Services, including via email digests and social media feeds, and is accessible to the general public.
  • If you choose to use our Website and Services to communicate directly with a company or individual, such communication may be shared accordingly.
  • Readership information is provided to publishing law firms and authors of content to give them insight into their readership and to help them to improve their content.
  • Our Website may offer you the opportunity to share information through our Website, such as through Facebook's "Like" or Twitter's "Tweet" button. We offer this functionality to help generate interest in our Website and content and to permit you to recommend content to your contacts. You should be aware that sharing through such functionality may result in information being collected by the applicable social media network and possibly being made publicly available (for example, through a search engine). Any such information collection would be subject to such third party social media network's privacy policy.
  • Your information may also be shared to parties who support our business, such as professional advisors as well as web-hosting providers, analytics providers and other information technology providers.
  • Any court, governmental authority, law enforcement agency or other third party where we believe disclosure is necessary to comply with a legal or regulatory obligation, or otherwise to protect our rights, the rights of any third party or individuals' personal safety, or to detect, prevent, or otherwise address fraud, security or safety issues.
  • To our affiliated entities and in connection with the sale, assignment or other transfer of our company or our business.

How We Protect Your Information

JD Supra takes reasonable and appropriate precautions to insure that user information is protected from loss, misuse and unauthorized access, disclosure, alteration and destruction. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. You should keep in mind that no Internet transmission is ever 100% secure or error-free. Where you use log-in credentials (usernames, passwords) on our Website, please remember that it is your responsibility to safeguard them. If you believe that your log-in credentials have been compromised, please contact us at privacy@jdsupra.com.

Children's Information

Our Website and Services are not directed at children under the age of 16 and we do not knowingly collect personal information from children under the age of 16 through our Website and/or Services. If you have reason to believe that a child under the age of 16 has provided personal information to us, please contact us, and we will endeavor to delete that information from our databases.

Links to Other Websites

Our Website and Services may contain links to other websites. The operators of such other websites may collect information about you, including through cookies or other technologies. If you are using our Website or Services and click a link to another site, you will leave our Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We are not responsible for the data collection and use practices of such other sites. This Policy applies solely to the information collected in connection with your use of our Website and Services and does not apply to any practices conducted offline or in connection with any other websites.

Information for EU and Swiss Residents

JD Supra's principal place of business is in the United States. By subscribing to our website, you expressly consent to your information being processed in the United States.

  • Our Legal Basis for Processing: Generally, we rely on our legitimate interests in order to process your personal information. For example, we rely on this legal ground if we use your personal information to manage your Registration Data and administer our relationship with you; to deliver our Website and Services; understand and improve our Website and Services; report reader analytics to our authors; to personalize your experience on our Website and Services; and where necessary to protect or defend our or another's rights or property, or to detect, prevent, or otherwise address fraud, security, safety or privacy issues. Please see Article 6(1)(f) of the E.U. General Data Protection Regulation ("GDPR") In addition, there may be other situations where other grounds for processing may exist, such as where processing is a result of legal requirements (GDPR Article 6(1)(c)) or for reasons of public interest (GDPR Article 6(1)(e)). Please see the "Your Rights" section of this Privacy Policy immediately below for more information about how you may request that we limit or refrain from processing your personal information.
  • Your Rights
    • Right of Access/Portability: You can ask to review details about the information we hold about you and how that information has been used and disclosed. Note that we may request to verify your identification before fulfilling your request. You can also request that your personal information is provided to you in a commonly used electronic format so that you can share it with other organizations.
    • Right to Correct Information: You may ask that we make corrections to any information we hold, if you believe such correction to be necessary.
    • Right to Restrict Our Processing or Erasure of Information: You also have the right in certain circumstances to ask us to restrict processing of your personal information or to erase your personal information. Where you have consented to our use of your personal information, you can withdraw your consent at any time.

You can make a request to exercise any of these rights by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

You can also manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard.

We will make all practical efforts to respect your wishes. There may be times, however, where we are not able to fulfill your request, for example, if applicable law prohibits our compliance. Please note that JD Supra does not use "automatic decision making" or "profiling" as those terms are defined in the GDPR.

  • Timeframe for retaining your personal information: We will retain your personal information in a form that identifies you only for as long as it serves the purpose(s) for which it was initially collected as stated in this Privacy Policy, or subsequently authorized. We may continue processing your personal information for longer periods, but only for the time and to the extent such processing reasonably serves the purposes of archiving in the public interest, journalism, literature and art, scientific or historical research and statistical analysis, and subject to the protection of this Privacy Policy. For example, if you are an author, your personal information may continue to be published in connection with your article indefinitely. When we have no ongoing legitimate business need to process your personal information, we will either delete or anonymize it, or, if this is not possible (for example, because your personal information has been stored in backup archives), then we will securely store your personal information and isolate it from any further processing until deletion is possible.
  • Onward Transfer to Third Parties: As noted in the "How We Share Your Data" Section above, JD Supra may share your information with third parties. When JD Supra discloses your personal information to third parties, we have ensured that such third parties have either certified under the EU-U.S. or Swiss Privacy Shield Framework and will process all personal data received from EU member states/Switzerland in reliance on the applicable Privacy Shield Framework or that they have been subjected to strict contractual provisions in their contract with us to guarantee an adequate level of data protection for your data.

California Privacy Rights

Pursuant to Section 1798.83 of the California Civil Code, our customers who are California residents have the right to request certain information regarding our disclosure of personal information to third parties for their direct marketing purposes.

You can make a request for this information by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

Some browsers have incorporated a Do Not Track (DNT) feature. These features, when turned on, send a signal that you prefer that the website you are visiting not collect and use data regarding your online searching and browsing activities. As there is not yet a common understanding on how to interpret the DNT signal, we currently do not respond to DNT signals on our site.

Access/Correct/Update/Delete Personal Information

For non-EU/Swiss residents, if you would like to know what personal information we have about you, you can send an e-mail to privacy@jdsupra.com. We will be in contact with you (by mail or otherwise) to verify your identity and provide you the information you request. We will respond within 30 days to your request for access to your personal information. In some cases, we may not be able to remove your personal information, in which case we will let you know if we are unable to do so and why. If you would like to correct or update your personal information, you can manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard. If you would like to delete your account or remove your information from our Website and Services, send an e-mail to privacy@jdsupra.com.

Changes in Our Privacy Policy

We reserve the right to change this Privacy Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our Privacy Policy will become effective upon posting of the revised policy on the Website. By continuing to use our Website and Services following such changes, you will be deemed to have agreed to such changes.

Contacting JD Supra

If you have any questions about this Privacy Policy, the practices of this site, your dealings with our Website or Services, or if you would like to change any of the information you have provided to us, please contact us at: privacy@jdsupra.com.

JD Supra Cookie Guide

As with many websites, JD Supra's website (located at www.jdsupra.com) (our "Website") and our services (such as our email article digests)(our "Services") use a standard technology called a "cookie" and other similar technologies (such as, pixels and web beacons), which are small data files that are transferred to your computer when you use our Website and Services. These technologies automatically identify your browser whenever you interact with our Website and Services.

How We Use Cookies and Other Tracking Technologies

We use cookies and other tracking technologies to:

  1. Improve the user experience on our Website and Services;
  2. Store the authorization token that users receive when they login to the private areas of our Website. This token is specific to a user's login session and requires a valid username and password to obtain. It is required to access the user's profile information, subscriptions, and analytics;
  3. Track anonymous site usage; and
  4. Permit connectivity with social media networks to permit content sharing.

There are different types of cookies and other technologies used our Website, notably:

  • "Session cookies" - These cookies only last as long as your online session, and disappear from your computer or device when you close your browser (like Internet Explorer, Google Chrome or Safari).
  • "Persistent cookies" - These cookies stay on your computer or device after your browser has been closed and last for a time specified in the cookie. We use persistent cookies when we need to know who you are for more than one browsing session. For example, we use them to remember your preferences for the next time you visit.
  • "Web Beacons/Pixels" - Some of our web pages and emails may also contain small electronic images known as web beacons, clear GIFs or single-pixel GIFs. These images are placed on a web page or email and typically work in conjunction with cookies to collect data. We use these images to identify our users and user behavior, such as counting the number of users who have visited a web page or acted upon one of our email digests.

JD Supra Cookies. We place our own cookies on your computer to track certain information about you while you are using our Website and Services. For example, we place a session cookie on your computer each time you visit our Website. We use these cookies to allow you to log-in to your subscriber account. In addition, through these cookies we are able to collect information about how you use the Website, including what browser you may be using, your IP address, and the URL address you came from upon visiting our Website and the URL you next visit (even if those URLs are not on our Website). We also utilize email web beacons to monitor whether our emails are being delivered and read. We also use these tools to help deliver reader analytics to our authors to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

Analytics/Performance Cookies. JD Supra also uses the following analytic tools to help us analyze the performance of our Website and Services as well as how visitors use our Website and Services:

  • HubSpot - For more information about HubSpot cookies, please visit legal.hubspot.com/privacy-policy.
  • New Relic - For more information on New Relic cookies, please visit www.newrelic.com/privacy.
  • Google Analytics - For more information on Google Analytics cookies, visit www.google.com/policies. To opt-out of being tracked by Google Analytics across all websites visit http://tools.google.com/dlpage/gaoptout. This will allow you to download and install a Google Analytics cookie-free web browser.

Facebook, Twitter and other Social Network Cookies. Our content pages allow you to share content appearing on our Website and Services to your social media accounts through the "Like," "Tweet," or similar buttons displayed on such pages. To accomplish this Service, we embed code that such third party social networks provide and that we do not control. These buttons know that you are logged in to your social network account and therefore such social networks could also know that you are viewing the JD Supra Website.

Controlling and Deleting Cookies

If you would like to change how a browser uses cookies, including blocking or deleting cookies from the JD Supra Website and Services you can do so by changing the settings in your web browser. To control cookies, most browsers allow you to either accept or reject all cookies, only accept certain types of cookies, or prompt you every time a site wishes to save a cookie. It's also easy to delete cookies that are already saved on your device by a browser.

The processes for controlling and deleting cookies vary depending on which browser you use. To find out how to do so with a particular browser, you can use your browser's "Help" function or alternatively, you can visit http://www.aboutcookies.org which explains, step-by-step, how to control and delete cookies in most browsers.

Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at: privacy@jdsupra.com.

- hide

This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.