Changes to the Common Rule Regulatory Requirements

Important: On January 21, 2019, the Revised Common Rule regulations (also called the 2018 Common Rule) that apply to human research will go into effect. For an overview of these changes, please see below.

Any study that is approved on or after January 21, 2019 will be subject to the new requirements unless it is FDA-regulated or funded by the Department of Justice. If you are planning to submit a new study in January, we recommend that you consult with your IRB Analyst in preparing your submission. We highly recommend that researchers wait until after January 21, 2019 to submit new studies to the IRB.

The Common Rule is the major set of federal policies that regulate research involving human subjects. Changes to the Common Rule were announced on January 18, 2017 by the U.S. Department of Health and Human Services and fifteen other federal departments. Most of these Common Rule changes will go into effect on January 21, 2019.

Please note: The revised Common Rule does NOT apply to FDA-regulated and Department of Justice studies at this time.

This webpage is a resource for information and updates on the Common Rule for those researchers at University Park and other campuses.  Researchers at Hershey and the College of Medicine should vist: https://infonet.pennstatehershey.net/web/irb/resources/updates.

Major Changes to the Common Rule - The 2018 Requirements vs. the Pre-2018 Requirements

In federal language, the new regulations are referred to as the "2018 Common Rule Requirements" and the expiring regulations are referred to as the "Pre-2018 Common Rule Requirements." The Office for Research Protections has adopted this "2018 Requirements" and "Pre-2018 Requirements" terminology, and it will appear in communications from the office, as well as the in the documents in CATS IRB.

  • The 2018 Requirements: The regulations effective January 21, 2019
  • The Pre-2018 Requirements: The old regulations

Below, we highlight major changes that investigators can expect. In coincidence, expect changes to the CATS IRB system, documents in CATS IRB, and the IRB review process.

There is no change in the process for determining that something is human research. The 2018 Requirements do identify some activities that are “not human research and do not require IRB review.” These include:

  • Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
  • 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. 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.
  • 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.
  • Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

The revised rule shifts the focus of informed consent to the potential subject with:

  • Information that a “Reasonable Person” would want in order to make an informed decision;
  • Changes to facilitate subject’s understanding of the key reasons he/she would or would not choose to participate in research; and
  • Requirement that Key Information essential to that decision be presented first in the document and consent discussion.

There are several new basic elements of consent that are required, some only if/when appropriate to the specific research. These include:

  • A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the LAR, if this might be a possibility OR
  • A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies

Additional required elements if/when appropriate to the specific research:

  • A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit
  • A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions
  • For research involving biospecimens, a statement whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen)

Waiver of Consent- Additional Criterion

The IRB may waive the requirement or approve an alteration of elements of informed consent if it finds and documents that the research meets certain criteria. In addition to the current criteria for waiving or altering consent, the rule adds consideration of a fifth criterion. This new requirement is that the research could not practicably be carried out without accessing or using information or biospecimens in an identifiable format. Researchers will need to provide justification that all five criteria are met in the study protocol.

Screening or Determining Eligibility

The IRB may approve a protocol 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 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 use identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.

Waiver of Documentation of Consent

The IRB may waive the requirement to obtain a signed consent document for some or all of the subjects if it finds and documents that the research meets certain criteria. In addition to the current criteria for waiving documentation, under the 2018 Rule a waiver may be granted for international research where the signature on the consent form is not culturally appropriate. Researchers will need to provide justification that all five criteria are met in the study protocol.

There has been no change in the process for determining what activities meet the federal definitions of research and human subject and require IRB review. The 2018 Requirements provide determinations on select activities that are considered “not human research and do not require IRB review” if the activities meet on the of the descriptions below.

  • Record reviews qualifying for the new Exemption Category 4, will allow both prospective and retrospective review of records, whereas in the past, only retrospective reviews qualified for Exemption Determination.
  • Benign Behavioral Interventions
  • Collection of identifiable, sensitive data from adult participants via surveys or interviews (with limited IRB review- see below)

In addition to making the exemption determination, the IRB is required to conduct a limited review for select exempt categories, in order to ensure there are adequate provisions to protect the privacy of subjects and maintain confidentiality of data. In these situations, the IRB will also need to review a copy of the proposed consent information and recruitment materials and modifications related to these determinations made via limited IRB review will be required.

Some studies that are reviewed at the expedited level may no longer require continuing review, however, Penn State plans to continue to have a process by which investigators will annually provide information to the IRB that will be reviewed administratively. In addition, other studies that have progressed to a certain point may no longer require continuing review and will follow the same process for administrative review.
Multi-institutional research studies will be required to use a single IRB for review. The implementation date for this requirement is January 19, 2020. We have an FAQ page where you can learn more about single IRB review.

To Whom Does the 2018 Rule Apply?

Any study approved prior to January 21, 2019 must comply with the Pre-2018 Requirements. These studies will not be expected to comply with any of the changes outlined on this page. At this time, Penn State has no plan to transition studies that were approved before this date to the 2018 Rule.

With the exception of FDA-regulated and DOJ-funded research, any study approved on or after January 21, 2019 - including those submitted prior to this date that did not yet receive IRB approval - must comply with the 2018 Requirements. Investigators will experience a number of changes to the IRB review process, review requirements, and template documents as a result of the 2018 rule.

At this time, the Food and Drug Administration (FDA) has not yet revised their regulations, and the Department of Justice (DOJ) has not signed onto the 2018 Rule.  Consequently, the 2018 Rule does not currently apply to FDA-regulated and DOJ-supported research.

What Do I Need to Do?

In order to best prepare for the upcoming changes, we recommend the following:

  • Read communication from our offices! Subscribe to our listserv by emailing orp@psu.edu.  
  • Check on this webpage frequently for new updates.
  • Attend the informational session offered on April 3.
  • View a previous informational session among the list below.
  • Ask questions! For general questions please email us at IRB-ORP@psu.edu.  If you have specific questions related to a protocol to be submitted on or around January 21, 2019, please contact your IRB Analyst.

Recorded Informational Sessions

December 6 Recording: Prevention Research Center Seminar Series: Common Rule Changes (60 minutes)

January 18 Recording: New IRB Requirements for 2018: Focus on the Revised Common Rule (45 minutes)

March 21 Recording: New IRB Requirements for 2018 (Focus on the Revised Common Rule)

Read More

Interested in learning more about the Common Rule changes?  At the Office for Human Protections website, you can read the regulatory text, read their FAQs, and see their educational resources.  Here are a few articles that may also be of interest:

Science: What do revised U.S. rules mean for human research?

Council on Governmental Relations: Common Rule Summary Table

Association for Psychological ScienceRevision to the Common Rule: Implications for Behavioral and Social Sciences Research