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FAQ related to the Revised Common Rule

Definitions:

Common Rule: The Federal Regulations that govern research involving human subjects approved prior to January 21, 2019.

Revised Common Rule: The Federal Regulations that govern research involving human subjects approved on or after to January 21, 2019.

FAQs:

Q. Do applications approved before January 21, 2019 have to comply with the Revised Common Rule?

A. No. Applications approved before January 21, 2019 do not have to comply with the Revised Common Rule. These applications will continue under the provisions of the Common Rule.

Q. If a change in research is approved after January 21, 2019 does that mean an application previously approved under the Common Rule must now comply with the Revised Common Rule?

A. No. All applications approved before January 21, 2019 will continue to be considered under the Common Rule. Only new applications initially approved on or after January 21, 2019 must comply with the Revised Common Rule.

Q. If a continuing review application is approved after January 21, 2019 does that mean an application previously approved under the Common Rule must now comply with the Revised Common Rule.

A. No. All applications approved before January 21, 2019 will continue to be considered under the Common Rule. Only new applications initially approved on or after January 21, 2019 must comply with the Revised Common Rule.

Q. Has the Revised Common Rule changed the definition of research?

A. Yes. The Revised Common Rule adds a provision that identifies four types of activities that are not “research” as defined in the Rule. In other words, the Revised Common Rule does not apply to the following types of activities because they do not meet the regulatory definition of research:

1.       Certain scholarly and journalistic activities,

2.       Certain public health surveillance activities,

3.       Collection and analysis of information, specimens, or records, by or for a criminal justice agency for certain criminal justice or investigative purposes, and

4.       Certain authorized operational activities for national security purposes

Q. Has the Revised Common Rule changed the definition of human subject?

A. Yes.  The definition of Human Subject is different for the Revised Common Rule than it is for the Common Rule. Please see definitions below:

Common Rule definition:

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains

  1. Data through intervention or interaction with the individual, or
  2. Identifiable private information.

Private Information:

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

Revised Common Rule Definition:

Human subject means a living individual about whom an investigator (whether professional or student) conducting research:

  1. Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
  2. Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).

  1. Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
  2. An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

Q. Has the Revised Common Rule changed the categories for exempt research?

A. Yes. The Common Rule has six exempt categories in 46.101(b). The Revised Common Rule gives exempt categories an entire section in 46.104, and includes eight categories in 46.104(d) (1-8).   The Johns Hopkins Enterprise has made an Institutional decision that Broad Consent will not be permitted at this time. As a result, the JHM IRB will not consider applications under the new exempt categories 7 and 8, which require broad consent. Research that may otherwise meet criteria under exempt categories 7 and 8 may be submitted for consideration as minimal risk (expedited) research.  A full list of the categories for exempt research can be found at https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML#se45.1.46_1104

Q. What is limited IRB review?

A. Limited IRB review is a process that is applicable for certain exempt categories, and does not require consideration of all the approval criteria described in §46.111. In limited IRB review, the IRB must determine that certain conditions, which are specified in the regulations, are met. Limited IRB review may be completed by a single IRB member via the expedited review mechanism.

Q. Have the requirements for continuing review changed?

A. Yes. Under the Revised Common Rule, continuing review is no longer a regulatory requirement for the following types of research:

  1. Research that is eligible for expedited review,
  2. Exempt research conditioned on limited IRB review,
  3. Research that has completed all interventions and now only includes analyzing data, even if the information or biospecimens are identifiable,
  4. Research that has completed all interventions and now only includes accessing follow-up clinical data from clinical care procedures.

The JHM IRB may determine that continuing review is required for a specific project at any time even if it meets the above criteria. The JHM IRB may also require the study team submit a progress report for projects that meet the above criteria. Otherwise, there would be no reoccurring reporting requirement for these projects.  

Q. What does it mean if the IRB requires a progress report for a study that does not have a regulatory requirement to submit a continuing review?

A. Under the Revised Common Rule, the regulations no longer require annual continuing review for minimal risk (expedited) research studies. The IRB may; 1) still require a continuing review, 2) require submission of a progress report at periodic intervals, or 3) not require additional reporting on the study’s progress. At the time of initial approval, the IRB will determine what type of reporting is required and will specify the interval for submission in the approval notice. If a progress report is required, the JHM IRB may set the interval for reporting  at 1, 2 or 3-years. Future reporting requirements will be assessed during each review and may be changed at any time. Progress reports must be submitted in eIRB using the progress report application.

 Without regard to the requirement set by the IRB for reporting study progress (continuing review,  progress report, or no reoccurring report of progress), investigators still must inform the IRB of any changes to the protocol and inform the IRB of reportable events.

Q. Is the consent form being changed under the Revised Common Rule?

A. Yes. There are several major changes to the general requirements for informed consent in the Revised Common Rule. 

  1. One change is introducing the requirement that informed consent must give prospective subjects the information that a reasonable person would want to have in order to make an informed decision about whether to participate. 
  2. An additional change is that the information needs to be presented in sufficient detail and organized and presented in a way that facilitates an understanding of why one might, or might not, want to participate.
  3. There is also a new requirement that key information about the study must be provided at the beginning and must include information that is most likely to assist a participant in understanding why s/he might or might not want to participate. This information must be presented in a concise and focused manner, and not simply list information about the study.
  4. One new element has been added to the basic elements of informed consent.   This new element requires a notice about whether participants' information or biospecimens collected as part of the current research might be used for other research in the future. The purpose of this is to increase transparency by letting participants know whether future research may happen with any biospecimens or information collected, even if that future research occurs after the data/biospecimens have been stripped of identifiers. If potential participants find it objectionable, they may not want to participate in the study.

Please Note: The JHM IRB has created a new consent form template (Version 16) to address these changes. The Version 16 consent template should be used only for studies approved under the Revised Common Rule (on or after 1/21/2019). All studies approved under the Common Rule (prior to 1/21/2019) must continue to use the Version 15 IRB consent form template.

Q. Are there any changes to the conditions for waiving informed consent?

A. Yes. There is one new criterion, which applies to research with identifiable private information or identifiable biospecimens. This new criterion is that the IRB must determine that the research could not practicably be carried out without using the information or biospecimens in an identifiable form. 

Q. Are there changes to the consent form for clinical trials?

A. Yes. Under the Revised Common Rule, the term “clinical trial” refers to research studies in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of the intervention on biomedical or behavioral health-related outcomes. For such studies, one IRB-approved version of a consent form that has been used to enroll participants must be posted on a public federal website designated for posting such consent forms. The form must be posted after recruitment closes, and no later than 60 days after the last study visit.  Consent forms do not have to be reposted every time there is a change, only one IRB-approved version of a consent form that has been used in the course of the study to enroll participants needs to be posted.

Q. Does the Revised Common Rule affect the FDA regulations for human subject research?

A. No. The Common Rule regulations are separate from FDA regulations. The FDA regulations have NOT changed, so FDA still requires annual continuing review for all FDA-regulated studies. However, under the 21st Century Cures Act the FDA has been charged with harmonizing their regulations with the Common Rule to the extent possible. The deadline for this requirement is December 2019.

Q. Will new applications still be submitted in eIRB after January 21, 2019?

A. Yes. Applications must still be submitted using eIRB.

Q. Does the Revised Common Rule change the single IRB requirements?

A. Yes. Beginning January 25, 2018 all multi-center NIH-funded studies are required to use single IRB review for the domestic sites. The Revised Common Rule introduces a new requirement that single IRB review is required for studies conducted or supported by other federal agencies starting in January 2020. 

Q. Will the eIRB application be changed to comply with the Revised Common Rule?

A. Yes. The application will be changed to comply with the Revised Common Rule. Applications subject to the Revised Common Rule will look similar to applications subject to the Common Rule. The system will recognize whether an application is subject to the Common Rule or the Revised Common Rule based on the approval date. The most noticeable change will be in applications for exempt/not human subject research.  Additional changes are being made to the eIRB application to make completion and review of the application more streamlined.

Q. How will I know if an application is subject to the Common Rule or the Revised Common Rule?

A. There will be text on the top right side of the Application Workspace to indicate which version of the Federal regulations is applicable to each application. You will also know by looking at the application approval date; new applications approved prior to 01/21/2019 are subject to the Common Rule and new applications approved on or after 01/21/2019 are subject to the Revised Common Rule.

Q. When will the eIRB application changes be available?

A. Regulations do not permit implementation of the Revised Common Rule in its entirety prior to January 21, 2019.  For that reason, eIRB application changes will not be available until that date.

Q. Are there resources available to get more information on the Revised Common Rule?

A. Yes. Additional information can be found online using the following links:

https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html

https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/revised-common-rule-q-and-a/index.html

https://about.citiprogram.org/en/final-rule-resources/

https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM623211.pdf